CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to, and the benefit of, U.S. Provisional Application Serial Number 62/597,785, filed on December 12, 2017, the contents of which are hereby incorporated by reference in its entirety.

TECHNICAL FIELD

This invention relates to adjustable therapeutic pillows designed to be placed under the head and neck of a person lying in a supine and/or side-lying position, and methods involving the use thereof.

BACKGROUND

Because approximately one-third of all human existence is spent in a supine position, there has been great interest in developing pillows or cushions that properly support a person’s body in such position. Some pillows are marketed as being posture or cervical pillows that are designed to support the head and spine, and in particular, the neck vertebrae, in the most normal, comfortable and unstressed position, thereby aiding in relieving stress in the cervical or neck portion of the upper spine, and for promoting proper posture.

The neck of a person lying in a supine or side-lying position is often out of alignment with the person’s spine. This may be especially true when using either standard or contoured commercial pillows. This is commonly the case when the person’s neck is supported by a pillow or multiple pillows such that the neck lies at an angle defined by the deflected height of the pillow(s) and this angle is typically not co-planar with the spine. The deflected height of the pillow is closely related to its stiffness, which is conventionally provided by filling material disposed within a fabric covering. Conventional filling material includes feathers, cotton, and synthetic fillers.

Recently, a number of pillows have been formed of viscoelastic material, such as a viscoelastic foam (e.g. memory foam) material. These types of pillows are often referred to as memory foam pillows. The memory foam responds to changes in temperature such that body heat molds the pillow to conform to the curves of a body for comfort and support. This allows the shape of the pillow to more closely follow the contours of the body and offers an alternative to conventional pillow materials.

While currently available pillows provide comfort and some therapeutic effect, they often do not promote optimal alignment of the neck and spine. People come in all different shapes and sizes and have widely varying postures. People also sleep on mattresses of widely varying firmness, resulting in significant differences in supine and side-lying spinal alignment, depending on the extent to which the mattress“gives” under the person’s body weight. Present pillows which conform to the body contours of the user fail to correct misalignments in the users’ posture, and instead, may exacerbate such misalignment by simply conforming to the existing contours of the person. It would therefore be desirable to have pillows which instead help promote improved or optimal spinal alignment by having a person’s body conform to the contours of the pillow.

Pillows currently on the market are generally sold in a few selected, pre-set sizes.

Whether such a pillow can promote optimal alignment of a particular user’s spine is pure happenstance. Indeed, many currently available pillows can even promote the misalignment of the neck and spine in otherwise healthy users. Thus, what people need are pillows that help conform the user’s spinal alignment to the shape of the pillow, in order to improve that alignment if they are misaligned to begin with, or to maintain their proper alignment if they are properly aligned to begin with. Therefore, there is a need to provide improved pillows and other neck support devices that are not only comfortable, but also provide a therapeutic effect and promote improved alignment of the neck and spine when a person is seated, or in a supine or side-lying position.

There is a need for a more customizable pillow, one that can easily be modified to accommodate people having different body shapes, body sizes, and degrees of cervical curvature, and who are sleeping on mattresses of varying degrees of firmness. Pillow

manufacturers sell pillows of discrete sizes, such as small, medium, large, each having a different thickness. People have a need for truly functional pillows of different thicknesses during different stages of their life, independent of the size of the pillow. For example, a person’s optimal pillow thickness may change as they gain or lose weight, and when they are treated for injuries, or as they respond to chiropractic, or other medical treatments. Even absent changes in body size, weight, or medical condition, when a person gets a new mattress of differing firmness, or is traveling and ends up sleeping on a mattress with a different firmness, they will need to adjust the thickness of their pillow to maintain optimal alignment of their spine. Such a person may need a thicker or thinner pillow to achieve optimal spinal alignment.

It is pure happenstance if a person’s spinal alignment is optimally supported with currently available pillows. In addition, pillows can be a substantial financial investment for some people, and as such it would be beneficial to have a single pillow that is customizable in its thickness to accommodate a person’s changing needs. Thus, there is a need for truly functional therapeutic pillows, ones that consistently provide optimal spinal alignment support, and which are more versatile due to the customizability of their thickness.

BRIEF SUMMARY

The present disclosure provides therapeutic pillows, as well as methods of using the same to maintain or improve the alignment of the cervical and/or thoracic vertebrae of users. The pillows of the present disclosure are specifically designed to have a person’s neck and cervical spine conform to the contours of the pillow, rather than vice versa, in order to support the head and spine in a neutral resting state. This applies both to persons having medical or chiropractic issues as well as those who do not. No traditional, commercial pillow provides this benefit. The pillows of the present disclosure are particularly suited to persons having mild to moderate cervical misalignment, and use of these pillows will help correct such misalignment.

In a first aspect, the present disclosure provides the Pillow 1, for example as shown in Figures 1A-1I, which is designed for use in either a supine position (back- sleeping) or a side- lying position (side-sleeping), or both. The support needed to maintain a person’s optimal spinal alignment in a supine position versus in a side-lying positions is different because the profile of a person’s anatomical structures varies significantly in a supine versus in a side-lying position. Thus, the Pillow 1 provides separate portions for use in these very different bodily positions.

As shown in Figure 1A, the Pillow 1 is composed of a minimum of three independent portions, 1, 2 and 3. The portion 1 forms a base layer and covers the full width and depth of the pillow. The upper portions 2 and 3 rest on top of the base portion 1. Each of the three portions has its maximum thickness towards the functional front of the pillow.

In some embodiments, the three independent portions are designed with a means to affix the portions together to form a functional pillow having the unique three-dimensional design as described herein. For example, the opposing surfaces between the portions may be fitted with hook-and-loop fasteners, adhesive strips, snap closures, button closures, interlocking or mating parts, or other suitable means of attachment. Alternatively, or additionally, any of these means of attachment may operate by way of the side walls of the portions. For example, by pieces of fabric attached to one or both of the adjacent side walls and having a means of attachment between the fabric pieces, such as by a button or snap closure, or adhesive or hook-and-loop fasteners. In some embodiments, there are no direct connections or affixations between the portions, and the portions are instead held together by fitting into a tightly-fitting fabric enclosure.

Each portion 2 and 3 covers the full depth of the pillow, and each portion 2 and 3 has a width that is less than half of the full width of the pillow. In some embodiments, each portion 2 and 3 has the same width, and in some embodiments, the widths of said portions is each approximately one-third the width of the entire pillow (e.g., from 0.3 to 0.4 times the full width, or about 0.35 times the full width).

When placed together, the three portions of the pillow form a pillow composed of three distinct segments arranged adjacent to one another, wherein the middle segment is designed for use while back-sleeping, and the flanking (lateral) segments are designed for use while side- sleeping. The base portion 1 includes the entire back-sleeping segment 4 as well as the lower parts 5 and 6 of the two side-sleeping segments. The upper portions 2 and 3 form the upper part of each side- sleeping segment.

The provision of three independent portions permits the customization of the thickness of the side-sleeping segment without similarly changing the thickness of the back-sleeping segment, or vice-versa. One or more inserts 7 can be inserted between the base portion 1 and the upper portion 2 in order to increase the thickness of the right-side side-sleeping segment of the pillow. Likewise, one or more inserts 8 can be inserted between the base portion 1 and the upper portion 3 in order to increase the thickness of the left-side side-sleeping segment of the pillow. In some embodiments, one or more inserts 7 and 8 in are used in equal numbers or equal net thickness to produce a pillow having side-sleeping segments of equal total thickness. In either instance, the addition of inserts 7 and/or 8 does not affect the thickness of the middle back-sleeping segment of the pillow 4. In addition, or alternatively, in some embodiments, one or more inserts 9 can be inserted underneath the base portion 1 of the pillow. Any one or more of inserts 7, 8, or 9, may be used in order to adjust the thickness of the different segments of the pillow in a multitude of ways to suit a user’s needs. In some embodiments, the pillow portions 1, 2 and 3 are used without any inserts. Each pillow portion 1, 2 and 3, is formed of a foam body having a top surface, an opposing bottom surface, a rear edge, an opposing front edge and lateral sides. The pillow is specifically designed with a functional front edge and back edge intended to support the proper positioning of the head on the pillow. Each pillow portion 1, 2 and 3, may be made from a different foam material or from the same foam material. Preferably, pillow portions 2 and 3 are made of the same foam material, and further preferably the pillow portion 1 is also made of the same foam material.

Each of the one or more inserts 7, 8 and/or 9, is formed of a foam body having a top surface, an opposing bottom surface, a rear edge, an opposing front edge and lateral sides.

Optionally, the foam inserts are made of a different foam material than the foam body, e.g., either a stiff er (more rigid) foam or a softer (more compressible) foam compared to the foam of the portions 1, 2 and 3. In some embodiments, the various foam inserts are made of the same foam material, while in other embodiments, any of the foam inserts may be made of a different foam material from any other foam insert or from any of the portions 1, 2 or 3.

Each of the inserts 7 has a plan form that matches, or substantially matches, the plan form of the portion 2 (i.e., the shape of the insert 7 differs from the shape of the portion 2 only in its thickness profile). Likewise, each of the inserts 8 has a plan form that matches, or substantially matches, the plan form of the portion 3 (i.e., the shape of the insert 8 differs from the shape of the portion 3 only in its thickness profile). Likewise, each of the inserts 9 has a plan form that matches, or substantially matches, the plan form of the portion 1 (i.e., the shape of the insert 9 differs from the shape of the portion 1 only in its thickness profile).

Each of the inserts 7, 8 and/or 9 has a thickness that is uniform from front to back and from side to side. In some embodiments, each of the inserts 7, 8 and/or 9 has a thickness not more than the maximum thickness of the Pillow 1 (measured at whichever point of the pillow has maximum thickness). In some embodiments, each of the inserts 7, 8 and/or 9 has a minimum thickness of ¼ inch (6.35 mm). In some embodiments, each of the inserts 7, 8 and/or 9 has a maximum thickness of 3 inches. In some embodiments, each of the one or more inserts 7, 8 and/or 9 has a thickness selected from the group consisting of about ¼ inch (6.35 mm), about 1/3 inch (8.47 mm), about ½ inch (12.7 mm), about 2/3 inch (16.94 mm), about ¾ inch (19.05 mm), about 1 inch (25.4 mm), about 1.25 inches (31.75 mm), about 1.5 inches (38.1 mm), about 1.75 inches (44.45 mm), about 2 inches (50.8 mm), about 2.25 inches (57.15 mm), about 2.5 inches

(63.5 mm), about 2.75 inches (69.85 mm), and about 3 inches (76.2 mm). In some embodiments, the pillow comprises any combination of: (1) from zero to six inserts 7, (2) from zero to six inserts 8, and/or (3) from zero to six inserts 9.

In some embodiments, any one or more of the inserts 7, 8 and/or 9, is designed with a means to affix the inserts to each other and/or to the base portion 1 or upper portions 2 or 3 of the pillow. For example, the opposing surfaces between any inserts or between any insert and any portion may be fitted with hook-and-loop fasteners, adhesive strips, snap closures, button closures, interlocking or mating parts, or other suitable means of attachment. Alternatively, or additionally, any of these means of attachment may operate by way of the side walls of the inserts and/or portions. For example, by pieces of fabric attached to one or both of the adjacent side walls and having a means of attachment between the fabric pieces, such as by a button or snap closure, or adhesive or hook-and-loop fasteners. In some embodiments, there are no direct connections or affixations between any inserts or between any insert and any portion, and the inserts and portions are instead held together by fitting into a tightly-fitting fabric enclosure. In such a case, customization of the thickness of any segment of the pillow is affected by opening the enclosure and adding or removing any desired inserts to adjust the thickness of any segment of the pillow. Any such enclosure may have an opening that is reversibly sealed with a zipper, or a sliding fastener, or with one or more snap or button closures, or with one or more strips of hook-and-loop fasteners or adhesive, or by any other suitable means. Preferably, the fabric of the enclosure is of a type of material that is elastic in its sidewalls but relatively non-elastic on its top and bottom surfaces so that the enclosure can tightly fit to the pillow within regardless of the number of inserts present within the enclosure.

Taken together, including both the portions 1, 2 and 3, and the optional inserts 7, 8 and/or 9, the overall design of the Pillow 1 creates an optimum profile for correction of cervical spine misalignments and other abnormalities, as fully discussed in US 2015/0047646 and US

2013/0283534, the contents of each of which are incorporated by reference in their entireties.

As shown in the side-view of Figure 1C, the body of the middle segment of the pillow is defined by a first region 11 that includes the front edge 14, a second region 12 adjacent the first region and a third region 13 adjacent the second region and defining the rear edge 15. The first region has a convex shape, the second region has a concave shape and the third region has a convex shape. The middle pillow segment has a maximum thickness in the first region and a minimum thickness in the second region. The first region has a first section 16 that extends to the front edge and has a positive slope (convex increasing section) and has an adjacent second section 17 that has a negative slope (convex decreasing section) and extends to the edge of the second region. The pillow also includes a plurality of ribs 18 extending longitudinally between the lateral side and being located within the first section 16 of the first region. In some embodiments, the second section of the first region is free of ribs, or is substantially free of ribs. In some embodiments, the second region and/or the third region are free or ribs, or are substantially free or ribs. In some embodiments, ribs are contained only within the first section of the first region, and are absent in the second section of the first region, as well as absent in the second region and the third region. The ribs which are present in the first section of the first region function as a way to adjust and improve the curvature of the cervical vertebrae. As shown in Figure 1B, when the user sleeps in the supine position, the user’s neck arches over the first region of the middle segment, with the head resting in the second and third regions of the middle segment. As such, the first region of the Pillow 1 defines the functional front of the pillow.

As shown in Figure 1C, the lateral side-sleeping segments of the pillow form a foam body having a step configuration between the front edge 19 and the rear edge 20. The lateral segments have a maximum thickness at the front edge, and minimum thickness at the rear edge, and thickness varying in steps between the front and rear edges. The front edge includes cut-outs 10 designed to position a user’s head and neck on the functional contours of the pillow top when the user’s shoulder is positioned within the cut-out. The bottom parts of the lateral segments are integrated into and uniform with the body of the middle segment, the whole forming the base portion 1. The upper parts of the lateral segments are formed from independent portions 2 and 3. The inserts 7, 8 and 9 include matching cut-outs 10 so that when combined a single uniform cut out is formed in each lateral segment to receive the shoulder of the user in a side-lying position.

In a second aspect, the present disclosure provides the Pillow 2, for example as shown in

Figures 2A-2I, which is designed for use in the side-lying (side-sleeping) position. The Pillow 2 corresponds substantially to lateral segment of the Pillow 1. The Pillow 2 comprises a foam body 30 having a step configuration between the front edge 31 and the rear edge 32. The pillow has a maximum thickness at the front edge, and minimum thickness at the rear edge, and thickness varying in steps between the front and rear edges. The front edge includes two cut-outs

33 designed to receive the user’s shoulder. A user can insert one or more inserts 34 underneath the foam body of the Pillow 2 in order to uniformly change the thickness of the pillow. In some embodiments, the pillow is used without any inserts. The inserts include matching cut-outs 35 so that when combined two uniform cut-outs are formed in the pillow to receive the shoulder of the user in a side-lying position. The inserts may be further defined in any manner as described for the inserts of the Pillow 1, as described herein.

In a third aspect, the present disclosure provides the Pillow 3, for example as shown in Figures 3A-3I, which is designed for use in the supine (back- sleeping) position. The Pillow 3 corresponds substantially to the middle segment of the Pillow 1. The Pillow 3 comprises a foam body 50 having is defined by a first region 51 that includes the front edge 54, a second region 52 adjacent the first region and a third region 53 adjacent the second region and defining the rear edge 55. The first region has a convex shape, the second region has a concave shape and the third region has a convex shape. The pillow has a maximum thickness in the first region and a minimum thickness in the second region.

The first region has a first section 56 that extends to the front edge and has a positive slope (convex increasing section) and has an adjacent second section 57 that has a negative slope (convex decreasing section) and extends to the edge of the second region. The pillow also includes a plurality of ribs 58 extending longitudinally between the lateral side and being located within the first section of the first region. The ribs of the pillow are as otherwise described for the middle segment of the Pillow 1. A user can insert one or more inserts 59 underneath the foam body of the Pillow 3 in order to uniformly change the thickness of the pillow. In some embodiments, the pillow is used without any inserts. The inserts may be further defined in any manner as described for the inserts of the Pillow 1, as described herein.

In another aspect, the present disclosure provides a method of maintaining or improving the alignment of the cervical vertebrae in a person (either a healthy person or a patient in need of improved alignment), the method comprising sleeping with the head and neck supported by any of the aforementioned pillows of the present disclosure. Such a method may ameliorate many of the adverse symptoms associated with neck or spine related ailments in said patients.

Other aspects, features and advantages of the invention will be apparent in view of the accompanying description of certain embodiments thereof when considered in connection with the accompanying drawing figures. BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 A is an isometric perspective view of the Pillow 1 from front-right.

Fig. 1B is an isometric perspective view thereof showing the relationship between the user’s head and neck to the pillow when the user is in the supine position.

Fig. 1C is a right-side elevation view of the Pillow 1.

Fig. 1D is a front elevation view thereof.

Fig. 1E is a rear elevation view thereof.

Fig. 1F is a top plan view thereof.

Fig. 1G is a top plan view thereof, showing the relationship between the user’s head and neck to the pillow when the user is in the supine position.

Fig. 1H is a top plan view thereof, showing the relationship between the user’s head and neck to the pillow when the user is in the side-lying position.

Fig. II is a bottom plan view of the Pillow 1.

Fig. 2A is an isometric perspective view of the Pillow 2 from front-right.

Fig. 2B is an isometric perspective view thereof showing the relationship between the user’s head and neck to the pillow when the user is in the side-lying position.

Fig. 2C is a right-side elevation view of the Pillow 2.

Fig. 2D is a right-side elevation view thereof showing the relationship between the user’s head and neck to the pillow when the user is in the side-lying position.

Fig. 2E is a front elevation view thereof.

Fig. 2F is a rear elevation view thereof.

Fig. 2G is a top plan view thereof.

Fig. 2H is a bottom plan view of the Pillow 2.

Fig. 21 is a top plan view thereof, showing the relationship between the user’s head and neck to the pillow when the user is in the side-lying position.

Fig. 3A is an isometric perspective view of the Pillow 3 from front-right.

Fig. 3B is a plan view thereof showing the relationship between the user’s head and neck to the pillow when the user is in the supine position.

Fig. 3C is a right-side elevation view of the Pillow 3.

Fig. 3D is a right-side elevation view thereof showing the relationship between the user’s head and neck to the pillow when the user is in the supine position

Fig. 3E is a front elevation view thereof. Fig. 3F is a rear elevation view thereof.

Fig. 3G is a top plan view thereof.

Fig. 3H is a top plan view thereof, showing the relationship between the user’s head and neck to the pillow when the user is in the supine position.

Fig. 31 is a bottom plan view of the Pillow 3.

Fig. 4A, 4B and 4C are X-ray imaging studies of a patient with abnormal cervical curvature using a pillow having the design of the Pillow 3;

Fig. 5A, 5B and 5C are X-ray imaging studies of a patient with normal cervical curvature using a pillow having the design of the Pillow 3;

Fig. 6A, 6B, and 6C are X-ray imaging studies of a patient with abnormal thoracic alignment using a pillow having the design of the Pillow 2.

DETAILED DESCRIPTION

As used herein, the following terms have the following meanings:

1. “Segment” refers to the three adjacent parts of the Pillow 1 which are each designed either for use in the side-sleeping (side-lying) or back-sleeping (supine) position. The Pillow 1 comprises two side-sleeping lateral segments and one back- sleeping middle segment.

2. “Region” refers to the variations in cross-sectional form from front to back of the Pillow 1, Pillow 2 and Pillow 3. With respect to the Pillow 3, and to the middle segment of the Pillow 1, the front“first region” has a convex cross- section, the middle“second region” has a concave cross-section, and the rear “third region” has a convex cross-section. With respect to the Pillow 2, and to the lateral segments of the Pillow 1, the thickness of the regions varies along the step configuration of the upper surface of the pillow, with maximum thickness at the front edge and minimum thickness at the rear edge.

3. “Section” refers to the first convex region of the Pillow 3 and of the middle segment of the Pillow 1, wherein in cross-section, the front“first section of the first region” has an ascending concave slope and the“second section of the first region” has a descending concave slope. In some embodiments, ribs are contained only on the first section of the first region. 4. “Portion” refers to the three independent parts of the Pillow 1, comprising a (1) a“lower portion” or“base portion” which includes the entire middle segment and the lower portions of the lateral segments, and (2) two“upper portions” which are separate (left and right side) upper portions of the lateral segments.

In general, the present disclosure provides orthopedic (therapeutic) pillows having advantages over other such pillows known and used in the art. Past orthopedic pillows often have a peanut shape or other such configuration that, for a majority of people, is either uncomfortable or not therapeutic. While sleeping on one's side, such prior art pillows typically cause the neck to arch over excessively laterally. This creates pressure on the small joints in the cervical spine known as the uncinate processes. This can cause the user to awaken with neck pain and muscle spasms and may even lead to osteoarthritis of these joints over time.

Also, while lying supine, the shape of such prior art pillows often causes a forward protrusion of the head that can create an anterior weight bearing posture in the user, shortening the anterior cervical spine musculature and increasing the curve in the thoracic and lumbar spine, thereby resulting in hyper-kyphosis (increased convexity of the thoracic spine) or hyper-lordosis (increased anterior concavity of the lumbar and cervical spine). Such poor posture over time can lead to a variety of musculoskeletal problems with such symptoms as headaches, neck and/or back pain, numbness or tingling in arms or hands, etc. The poor spinal positioning and resulting poor posture caused by many prior art pillows can also irritate pre-existing problems such as arthritis and disc syndromes. Since the average person spends approximately one third of his or her life in a sleeping position, it is important to be in a biomechanical position that will accommodate and enhance this process.

In addition, since the majority of the human body’s repair work occurs during sleep, it is important to sleep on a pillow that will help encourage, rather than discourage, proper spinal alignment, to promote repair of any damage. The pillows of the present disclosure fulfill these needs and yield further advantages, as described below, by generally providing an improved ergonomic design that promotes improved alignment of the neck and spine when a person is in a supine or side-lying position.

Pillow 1: Multi-Position Pillow

Figs. 1A-1I illustrate the Pillow 1 according to a first aspect of the present disclosure, which is designed to promote improved alignment of the neck and spine when a person is in a side-lying position or in a supine position. The Pillow 1 comprises three adjacent segments having specific shapes and contours to achieve this objective. The pillow is specifically constructed to be a hybrid/multifunctional pillow in that the construction of the pillow is designed to accommodate persons that sleep in both the supine position and in the side-lying position (multi-positional sleepers). For example, many people do not maintain the same sleep position all night and instead move between different positions. Amongst this group of people, it is most common that people alternate between the supine position and the side-lying position.

As a result, it is desirable for a pillow to accommodate both positions and offer a therapeutic benefit in both positions.

In the Pillow 1, a supine sleeping position is provided in the middle segment of the pillow, while a side-lying position is provided in the two lateral segments adjacent thereto. The user thus can roll in either the left direction or the right direction from the center supine position to one of the respective side-lying positions and conversely, can move from one of the side-lying positions to the center supine position.

The middle segment of the Pillow 1 is specifically constructed to promote improved alignment of the neck and spine when a person is in a supine position.

Cervical lordosis is a curve in the cervical spine, the area of the spine which contains the neck vertebrae. This curve is entirely normal and in fact desirable because it helps to stabilize the head and spine, but when the curve straightens out, becomes too deep, or faces in the wrong direction, it can become a problem. There are several treatments available for loss of cervical lordosis, with treatment being supervised by a medical professional who specializes in spinal care.

The normal cervical lordosis (which extends from Cl to T2) should have a 17 to 24- centimeter radius. This is easily measured with the AcuArc ruler which is one of the commonly used techniques to measure the curvature of the cervical spine.

In an optimal cervical lordosis condition, all segments should be on Georges’ line (posterior body line) which is a curved line that should touch the posterior body margin of all of the segments of the spine in any of the three main curvatures. There should be an even spacing between each spinous process. Positioning of the head and spine should also be assessed for anterior head placement (also known as Forward Head Posture). As shown in Figures 1B and 1G, the design of the middle segment of the Pillow 1 allows the head to arch back over the cylindrical shaped roll portion (first region 11) of the pillow and be supported by the center second section (second region 12) of the middle segment.

The middle segment is formed such that is has several distinct regions that are designed to contact and support the neck (spine) and head of the user. More specifically, the middle segment has a first region 11 formed along the front edge 14 of the segment, a second region 12 formed centrally, and a third region 13 formed along the rear edge 15 of the segment. The second region 12 is thus located between the first region 11 and the third region 13.

As can be seen from Figure 1C, the first region 11 and the third region 13 are both generally convex shaped regions, while the center second region 12 is concave in nature. The top surface of the middle section of the Pillow 1 thus transitions from a convex surface of the first region 11 to a concave surface of the second region 12 before again transitioning to the convex surface of the third region 13. In some embodiments, the first region 11 has a more pronounced curvature compared to the third region 13, which is defined by a slight curvature.

In some embodiments, both the front edge 14 and the rear edge 15 of the middle segment are defined by rounded edges. In other embodiments, one or both of these edges are flat or substantially flat edges. In some embodiments, the rear edge 15 of the middle segment is continuous with and identical in form to the rear edges 20 of the lateral segments, optionally, wherein the said rear edge has a flat or substantially flat form.

While the first region 11 of the middle section of Pillow 1 has a generally cylindrical shape it is further defined by a plurality of ribs 18 that are strategically placed along the convex shaped first regionll. The ribs 18 are spaced from one another such that the regions between any two adjacent ribs 18 represent a valley that has a concave curvature. In some embodiments, each of the ribs 18 is a rounded rib, i.e., each rib has a semi-circular to semi-elliptical cross-section. In some embodiments, each rib 18 has a convex shape defined by a radius of curvature. The plurality of ribs can be formed such that they are uniform in radius of curvature of each of the ribs 18 is substantially equal.

The first region 11 can be thought of as being defined by a first section 16 that extends from the front edge 14 to an apex (maximum) point at which point the slope of the curve changes. A second section 17 of the first region 11 extends from the apex point to a transition

(inflection) point that marks the beginning of the concave shaped second region 12. In other words, and as shown, the first section 16 can be thought as being an upwardly sloped section (convex increasing) of the convex shaped first region 11, while the second section 17 can be thought of as being a downwardly sloped section (convex decreasing) of the convex shaped first region 11.

In some embodiments, there are three ribs 18 that are located along the first region 11 and in particular, are located along the first section 16 (convex increasing section) thereof. In other embodiments, there may be two, four, five or six ribs. In some embodiments, the ribs 18 are entirely contained within the first section 16 of the first region and are not disposed within the second section 17 of the first region (convex decreasing). In other words, the ribs are located entirely along the upwardly sloped portion (convex increasing) of the convex shaped first region and are not present along the downwardly sloped (convex decreasing) second section. In other embodiments, the ribs may be located on both the upwardly sloped and downwardly sloped portions of the convex first region 11. In some embodiments, both the second 12 and third regions 13 of the middle segment are free of ribs. In some embodiments, the most rearward rib (e.g., the third rib) is located at the apex between the first section 16 and the second section 17 of the first region 11.

The present applicant has found that the position of spaced apart ribs 18 on the upwardly sloped portion of the convex region 11, with the downwardly sloped portion thereof being free of ribs, results in a more comfortable pillow that is also therapeutic in that the strategic positioning of the ribs promotes improved alignment of the neck and spine for reasons discussed below.

As described, each of the regions 11, 12, and 13 are characterized by a curving upper surface, which surface is convex, concave, and convex, respectively. Each of said surfaces can be defined by a radius of curvature, Rl, R2, R3, respectively. In some embodiments, the convex first region 11 is defined by a first radius of curvature (Rl) having a value of about 3 to about 5 inches, for example, about 3.5 to about 4.5 inches, or about 4 inches (e.g., about 3.944 inches).

In some embodiments, the concave second region 12 is defined by a second radius of curvature (R2) having a value of about 3 to about 5 inches, for example, about 3.5 to about 4.5 inches, or about 4 inches (e.g., about 3.927 inches). In some embodiments, the convex third region 13 is defined by a third radius of curvature (R3) of about 5 to about 9 inches, for example, about 6 to about 7.5 inches, or about 6.7 inches (e.g., 6.693 inches).

Each of the ribs 18 may also be defined by a radius of curvature (R4), which may be the same for each rib, or which may be different. In some embodiments, each rib has a radius of curvature independently of a value from 0.1 to 1.0 inches, or about 0.3 to 0.7 inches, or about 0.5 inches (e.g., about 0.500 inch). The rear edge 20 of the middle section can also be defined by a fifth radius of curvature (R5) which can be from 0.1 to 1.0 inches, or about 0.3 to 0.7 inches, or about 0.5 inches (e.g., about 0.500 inch).

The spacing between the ribs 18 does not have to be uniform. For example, in an embodiment wherein there are three ribs in the first section 11, each rib may be further defined by the center point (i.e., Cl, C2, C3) of the circles that define the radii of curvature of each rib. The distances between these center points, the distances C1-C2 and C2-C3, can be the same or different.

The two lateral segments of the Pillow 1 are specifically designed to prevent rotational stress in the spine and intervertebral discs of a person sleeping in a side-lying position. This torsional stress occurs when a person’s head and/or neck are positioned on a pillow which does not produce optimal alignment between the head, neck and upper body.

The two lateral segments are identical, or substantially identical, in structure and design. The lateral segments are configured for use with side sleeping individuals. Each lateral segment is formed of two separable, independent portions, a base layer 1 and upper layer 2 or 3. The lower part of each lateral segment is thus uniform with and a continuation of the middle segment, together forming the base portion 1, as shown in Figure 1A. The upper portion of each lateral segment, upon which the user rests, comprises a foam body 2 or 3 (such as a foam body) that is defined by a top surface on which the user’s body rests, an opposing bottom surface, a rear edge, an opposing front edge, and lateral sides. The bottom surfaces of the upper portions are designed to mate with the top surfaces 5 and 6 of the base portion 1.

The upper portions 2 and 3 of each lateral segment have a step configuration from the front edge 19 to the rear edge 20, with the segment having a maximum thickness at the front edge 19 and a minimum thickness at the rear edge 20. Between these two areas, the thickness of the upper portion of the lateral segment varies with the step configuration construction.

The front edge 19 of both the upper and lower portions of each lateral segment also includes a cut-out 10 that is designed to fit a shoulder of an individual. Each cut-out 10 has a curved shape and in particular, has an arcuate shape (e.g., crescent shape). When a user’s shoulder is nestled within one of the shoulder cut-outs, it serves to properly position the user’s neck in the correct part of the pillow, ensuring optimum alignment of the vertebrae, as shown in Figure 1H. In one exemplary embodiment, the depth of the cut-out 10 is from 0.5 to 3.5 inches, or about 1 inch to 2 inches, or about 1.50 inches, as measured from the front edge 19 to a center point of the cut-out 10. The shoulder cut-outs of the two lateral segments help serve as a locating feature for locating the shoulder of the user in a side sleeping position. For optimum alignment of the spine, it is preferable for a user to position him or herself using one of the cut outs so that the user’s head is facing the outside edge of the pillow (i.e., the right shoulder is located in the left cut-out, or the left-shoulder is located in the right cut-out).

The step configuration of the lateral segments is specifically designed to relieve points of tension and pressure affecting the muscles and vertebrae of the head and neck as the individual rests his or her head on the pillow in the manner described herein.

In a particular embodiment, the step configuration consists of three steps 21, 22, and 23, from front to back. Each step is planar, or substantially planar. In some embodiments, the step configuration may consistent of two steps or of four steps. Figures 1A-1I show an embodiment wherein each lateral segment has three steps. In this particular embodiment, the first step 21 and the third step 23 are planar, while the middle step 22 is slightly curved (concave). As used herein, the term planar means that the thickness of the step is uniform or substantially uniform from the front of the step (towards edge 19) to the rear of the step (towards edge 20).

In some embodiments having a three-step configuration, there is a sloped“riser” between the first and second steps, or between the second and third steps, or both. For example, in the three- step configuration as shown in Figure 1C, there is a sloped riser 24 which connects the second step 22 to the third step 23. Unlike the steps, the sloped riser is neither planar, nor substantially planar, and it instead shows a significant slope. The presence of such a riser divides the top surface of each lateral segment into four regions from front to back.

For example, as shown in Figure 1C, a first region 21 begins at the front edge 19 of the upper portion of the lateral segment and it is a planar region in which the thickness of the lateral segment is uniform or substantially uniform. A second region 22 is adjacent to the first region

21, and it is slightly sloped in the forward direction and it has a slight concave shape (i.e., it descends slightly from front to rear). Optionally, the slope of the second region 22 is variable, such that the forward part of the second region has a greater slope than the rearward part of the second region. The second region 22 is the second step of the three-step step -configuration. The third region 24 is adjacent to the second region 23, and it has a sharp incline (downward slope) in the direction of the rear of the pillow. The third region 24 thus has significantly variable thickness and a much more significant slope than the other regions, making it a“riser” rather than a“step” in the three-step configuration.

The fourth region 23 is adjacent to the third region 24 and reaches the rear edge 20 of the upper portion of the lateral segment. The fourth region 23 is a planar section in that the thickness of the fourth region 23 is uniform, or substantially uniform throughout the fourth region 23. The first and fourth regions are thus both planar sections that lie in different planes (i.e., parallel planes). The fourth region is the third step of the three-step configuration.

Taken together, the front edges 19 and 25 of the upper and lower portions of the lateral segment, respectively, can form a curved edge (e.g., rounded edge (convex edge)) or can form a flat (e.g., vertical) or substantially flat edge. Similarly, the rear edges 20 and 26 of the upper and lower portions of the lateral segment, respectively, can form a curved edge (e.g., rounded edge (convex edge)) or a flat (e.g., vertical) or substantially flat edge. As shown in Figures 1A and 1C, front edges of the upper and lower portions of the lateral segments preferably form a rounded edge, preferably a convex edge, while the rear edge of the upper and lower portions of the lateral segment preferably form a flat or substantially flat edge.

As previously mentioned, the lateral segments have a construction that relieves points of tension and pressure affecting the muscles and vertebrae of the head and neck, and more particularly, the stepped construction allows for compression of the pillow such that the spine is maintained in a neutral position. When a user rests his or her head on the lateral segment, the top of the head will be seated on and be supported by the fourth region 23. The user’s head extends along the fourth region 23, the third region 24 and at least the rear portion of the second region 22. The neck of the user rests on the first region 21 and at least partially on the second region 22.

The first region 21 has increased thickness compared to the other regions and thus represents a higher structure since in a side sleeping position, the natural shape of the neck includes an inward taper since the head has a greater width than the neck.

The stepped construction provides different thicknesses of material and therefore, has a complex compression profile across the width of the lateral segment. However, the compression profile is designed such that when the lateral segment is in use, the spine is maintained in a substantially neutral position. In other words, the stepped construction of the lateral segment is configured such that the head and neck (spine) are supported evenly across the width of the lateral segment. In other words, the different compression profiles of the different regions of the lateral segment based on the thickness of the lateral segment in the region and based on the contour of the pillow in the region cause the pillow to compress so as to maintain the user’s spine in the neutral position.

The upper portions 2 and 3 are designed to mate with the corresponding parts 5 and 6 of the base portion 1 to form the complete Pillow 1. In a preferred embodiment, the top surface of the lower parts 5 and 6, and the bottom surface of the upper portions 2 and 3 are each flat or substantially flat such that these opposing surfaces mate in a planar junction. The use of a planar mating surface, as opposed to any kind of irregular mating surface, results in easier adherence of the surfaces together. The opposing surfaces may further comprise a means of joining and securing the two portions together. In one embodiment, the means of joining and securing the portions together is one or more sets or strips of hook and loop fasteners, or of adhesive strips, or of snap closure or button closures. For example, in a particular embodiment, in each lateral segment, each upper portion can be joined to the base portion by means of a plurality of rows of hook and loop fasteners running from front to back of the lateral segment (e.g., along the short axis of the pillow). In another embodiment, the two portions can be joined by means of a plurality of rows of hook and loop fasteners running from side to side of the segment (e.g., along the long axis of the pillow). In either embodiment, the number of rows of hook and loop fasteners may be selected from the group consisting of one, two, three, four or five rows. In some embodiments, there may be both front-to-back and side-to-side rows of hook and loop fasteners, thus resulting in a crisscrossed or grid-like arrangement. Likewise, instead of hook and loop fasteners, each of the above embodiments can be emulated using any other means of attachment, such as adhesive strips, snap closure or button closures.

Junction between adjacent segments. The transition between each lateral segment and the middle segment can have any number of different structures, such as a straight junction, an angled (beveled) junction, or a curved junction, depending on the shape inner edge of the lateral segment portions 2 and 3. In some embodiments, the inner side edge of portions 2 and 3 are straight (e.g., perpendicular to the base of the pillow), which results in a straight junction between the lateral and middle segments. This is shown in Figures 1A to II. In other

embodiments, the inner side edges of the portions 2 and 3 can be in the form of beveled edges.

The Pillow l’s design with three independent portions, 1, 2 and 3, permits the easy customization of the thickness of the side-sleeping segment without similarly changing the thickness of the back-sleeping segment. One or more inserts 7 can be inserted between the base portion 1 and the upper portion 2 in order to increase the thickness of the right-side side-sleeping segment of the pillow. Likewise, one or more inserts 8 can be inserted between the base portion 1 and the upper portion 3 in order to increase the thickness of the left-side side-sleeping segment of the pillow. Often, the user will insert one or more inserts 7 and 8 in equal numbers or equal net thickness to produce a pillow having side-sleeping segments of equal thickness. In either instance, the addition of inserts 7 and/or 8 does not affect the thickness of the middle back- sleeping segment of the pillow 4. In addition, or alternatively, a user can insert one or more inserts 9 underneath the base portion 1 of the pillow. A user could add any one or more of inserts 7, 8, or 9, in order to adjust the thickness of the different segments of the pillow in a multitude of ways to suit the user’s needs. In some embodiments, the pillow portions 1, 2 and 3 are used without any inserts.

Each of the inserts 7, 8 and 9 has a plan form that matches, or substantially matches, the plan form of the portions 2, 3 and 1, respectively. That is, the shape of the inserts 7, 8 and 9 differ from the shape of the portions 2, 3 and 1, respectively, only in their thickness profiles.

Pillow 2: Side-Sleeping Pillow

Figs. 2A-2I illustrate the Pillow 2 according to a second aspect of the present disclosure, which is designed to promote improved alignment of the neck and spine when a person is in a side-lying position. The Pillow 2 comprises a single main foam body having specific shapes and contours to achieve this objective. The Pillow 2 is specifically designed to prevent sagging or bulging of the cervico-thoracic area and to prevent rotational stress in the spine and intervertebral discs of a person sleeping in a side-lying position. This torsional stress occurs when a person’s head and neck are positioned on a pillow which does not produce optimal alignment between the head, neck and upper body.

The main foam body of Pillow 2 is defined by a top surface on which the user’s body rests, an opposing bottom surface, a rear edge, an opposing front edge, and lateral sides. The upper surface of the pillow has a step configuration from the front edge 31 to the rear edge 32, with the pillow having a maximum thickness at the front edge 31 and a minimum thickness at the rear edge 32. Between these two areas, the thickness of the pillow varies with the step configuration construction.

The front edge 31 of includes two cut-outs 35 that are designed to fit a shoulder of an individual. Each cut-out 35 has a curved shape and in particular, has an arcuate shape (e.g., crescent shape). These shoulder cut-outs help position the user’s neck in the correct part of the pillow, ensuring optimum alignment of the vertebrae, as shown in Figure 2B. In some embodiments, the two cut-outs are identical, or substantially identical. In some embodiments, the two cut-outs are positioned symmetrically along the long axis of the pillow, e.g., equidistant from the centerline of the pillow.

In one exemplary embodiment, the depth of each cut-out 35 is from 0.5 to 3.5 inches, or about 1 inch to 2 inches, or about 1.50 inches, as measured from the front edge 31 to a center point of the cut-out 35. The shoulder cut-outs help serve as a locating feature for locating the shoulder of the user in a side sleeping position. For optimum alignment of the spine, it is preferable for a user to position him or herself using one of the cut-outs so that the user’s head is facing the outside edge of the pillow (i.e., the right shoulder is located in the left cut-out, or the left- shoulder is located in the right cut-out).

The step configuration of the Pillow 2 is specifically designed to provide equal pressure across the head and neck areas of the individual as the individual rests his or her head on the pillow in the manner described herein.

In a particular embodiment, the step configuration consists of three steps 36, 37, and 38, from front to back. Each step is planar, or substantially planar. In some embodiments, the step configuration may consistent of two steps or of four steps. Figures 2A-2I show an embodiment the Pillow 2 has three steps. In this particular embodiment, the first step 36 and the third step 38 are planar, while the middle step 37 is slightly curved (concave). As used herein, the term planar means that the thickness of the step is uniform or substantially uniform from the front of the step (towards edge 31) to the rear of the step (towards edge 32).

In some embodiments having a three-step configuration, there is a sloped“riser” between the first and second steps, or between the second and third steps, or both. For example, in the three- step configuration as shown in Figure 2C, there is a sloped riser 39 which connects the second step 37 to the third step 38. Unlike the steps, the sloped riser is neither planar, nor substantially planar, and it instead shows a significant slope. The presence of such a riser divides the top surface of the Pillow 2 into four regions from front to back.

For example, as shown in Figure 2C, a first region 36 begins at the front edge 31 of the upper portion of the lateral segment and it is a planar region in which the thickness of the lateral segment is uniform or substantially uniform. A second region 37 is adjacent to the first region

36, and it is slightly sloped in the forward direction and it has a slight concave shape (i.e., it descends slightly from front to rear). Optionally, the slope of the second region 37 is variable, such that the forward part of the second region has a greater slope than the rearward part of the second region. The second region 37 is the second step of the three-step step -configuration. The third region 39 is adjacent to the second region 37, and it has a sharp incline (downward slope) in the direction of the rear of the pillow. The third region 39 thus has significantly variable thickness and a much more significant slope than the other regions, making it a“riser” rather than a“step” in the three-step configuration.

The fourth region 38 is adjacent to the third region 39 and reaches the rear edge 32 of the Pillow 2. The fourth region 38 is a planar section in that the thickness of the fourth region 38 is uniform, or substantially uniform throughout the fourth region 38. The first and fourth regions are thus both planar sections that he in different planes (i.e., parallel planes). The fourth region is the third step of the three-step configuration.

The front edge 31 of the Pillow 2 can form a curved edge (e.g., rounded edge (convex edge)) or can form a flat (e.g., vertical) or substantially flat edge. Similarly, the rear edge 32 of the pillow can form a curved edge (e.g., rounded edge (convex edge)) or a flat (e.g., vertical) or substantially flat edge. As shown in Figures 2A and 2C, the front edge preferably forms a rounded edge, preferably a convex edge, while the rear edge preferably forms a flat or substantially flat edge.

The Pillow 2 has a construction that provides for equal pressure across the neck and head of the user and more particularly, the stepped construction allows for compression of the pillow such that the spine is maintained in a neutral position. As shown in Figure 2D, when a user rests his or her head on the lateral segment, the top of the head will be seated on and be supported by the fourth region 38. The user’s head extends along the fourth region 38, the third region 39 and at least the rear portion of the second region 37. The neck of the user rests on the first region 36 and at least partially on the second region 37.

The first region 36 has increased thickness compared to the other regions and thus represents a higher structure since in a side sleeping position, the natural shape of the neck includes an inward taper since the head has a greater width than the neck. The stepped construction provides different thicknesses of material and therefore, has a complex compression profile across the width of the lateral segment. However, the compression profile is designed such that when the pillow is in use, the spine is maintained in a substantially neutral position. In other words, the stepped construction is configured such that the head and neck (spine) are supported evenly across the width of the pillow. In other words, the different compression profiles of the different regions of the pillow based on the thickness of the pillow in the region and based on the contour of the pillow in the region cause the pillow to compress so as to maintain the user’s spine in the neutral position.

A user can insert one or more inserts 34 underneath the foam body of the Pillow 2 in order to uniformly change the thickness of the pillow. In some embodiments, the pillow is used without any inserts. The inserts include matching cut-outs 35 so that when combined two uniform cut-outs are formed in the pillow to receive the shoulder of the user in a side-lying position. Each of the inserts 34 has a plan form that matches, or substantially matches, the plan form of the pillow body 30 (i.e., the shape of the insert 34 differs from the shape of the pillow body 30 only in its thickness profile).

Pillow 3: Back-Sleeping Pillow

Figs. 3A-3I illustrate the Pillow 3 according to a third aspect of the present disclosure, which is designed to promote improved alignment of the neck and spine when a person is in a supine position. As shown in Figures 3B, 3D and 3H, the design of the Pillow 3 allows the head to arch back over the cylindrical shaped roll portion (first region 51) of the pillow and be supported by the center second section (second region 52) of the pillow.

The pillow is comprised of a main foam body defined by a top surface upon which the user’s body rests, an opposing bottom surface, a rear edge and an opposing front edge, and lateral sides. The foam body is formed such that is has several distinct regions that are designed to contact and support the neck (spine) and head of the user. More specifically, the pillow has a first region 51 formed along the front edge 54, a second region 52 formed centrally, and a third region 53 formed along the rear edge 55 of the segment. The second region 52 is thus located between the first region 51 and the third region 53.

As can be seen from Figure 3C, the first region 51 and the third region 53 are both generally convex shaped regions, while the center second region 52 is concave in nature. The top surface of the Pillow 2 thus transitions from a convex surface of the first region 51 to a concave surface of the second region 52 before again transitioning to the convex surface of the third region 53. In some embodiments, the first region 51 has a more pronounced curvature compared to the third region 53, which is defined by a slight curvature. In some embodiments, both the front edge 54 and the rear edge 55 of the Pillow 3 are defined by rounded edges. In other embodiments, one or both of these edges are flat or substantially flat edges.

While the first region 51 of the Pillow 3 has a generally cylindrical shape it is further defined by a plurality of ribs 58 that are strategically placed along the convex shaped first region 51. The ribs 58 are spaced from one another such that the regions between any two adjacent ribs 58 represent a valley that has a concave curvature. Each rib 58 can thus be defined by a radius of curvature. The plurality of ribs can be formed such that they are uniform in radius of curvature of each of the ribs 58 is substantially equal.

The first region 51 can be thought of as being defined by a first section 56 that extends from the front edge 54 to an apex (maximum) point at which point the slope of the curve changes. A second section 57 of the first region 51 extends from the apex point to a transition (inflection) point that marks the beginning of the concave shaped second region 52. In other words, and as shown, the first section 56 can be thought as being an upwardly sloped section (convex increasing) of the convex shaped first region 51, while the second section 57 can be thought of as being a downwardly sloped section (convex decreasing) of the convex shaped first region 51.

In some embodiments, there are three ribs 58 that are located along the first region 51 and in particular, are located along the first section 56 (convex increasing section) thereof. In other embodiments, there may be two, four, five or six ribs. In some embodiments, the ribs 58 are entirely contained within the first section 56 of the first region and are not disposed within the second section 57 of the first region (convex decreasing). In other words, the ribs are located entirely along the upwardly sloped portion (convex increasing) of the convex shaped first region and are not present along the downwardly sloped (convex decreasing) second section. In other embodiments, the ribs may be located on both the upwardly sloped and downwardly sloped portions of the convex first region 51. In some embodiments, both the second 52 and third regions 53 of the pillow are free of ribs. In some embodiments, the most rearward rib (e.g., the third rib) is located at the apex between the first section 56 and the second section 57.

The present applicant has found that the position of spaced apart ribs 58 on the upwardly sloped portion of the convex region 51, with the downwardly sloped portion thereof being free of ribs, results in a more comfortable pillow that is also therapeutic in that the strategic positioning of the ribs promotes improved alignment of the neck and spine for reasons discussed below. As described, each of the regions 51, 52, and 53 are characterized by a curving upper surface, which surface is convex, concave, and convex, respectively. Each of said surfaces can be defined by a radius of curvature, Rl, R2, R3, respectively. In some embodiments, the convex first region 51 is defined by a first radius of curvature (Rl) having a value of about 3 to about 5 inches, for example, about 3.5 to about 4.5 inches, or about 4 inches (e.g., about 3.944 inches).

In some embodiments, the concave second region 52 is defined by a second radius of curvature (R2) having a value of about 3 to about 5 inches, for example, about 3.5 to about 4.5 inches, or about 4 inches (e.g., about 3.927 inches). In some embodiments, the convex third region 53 is defined by a third radius of curvature (R3) of about 5 to about 9 inches, for example, about 6 to about 7.5 inches, or about 6.7 inches (e.g., 6.693 inches).

In some embodiments, each of the ribs 58 is a rounded rib, i.e., each rib has a semi circular to semi-elliptical cross-section. In some embodiments, each rib 58 has a convex shape defined by a radius of curvature. The radius of curvature may be the same for each rib, or may be different. In some embodiments, each rib has a radius of curvature independently of a value from 0.1 to 1.0 inches, or about 0.3 to 0.7 inches, or about 0.5 inches (e.g., about 0.500 inch).

The rear edge 55 of the pillow can also be defined by a fifth radius of curvature (R5) which can be from 0.1 to 1.0 inches, or about 0.3 to 0.7 inches, or about 0.5 inches (e.g., about 0.500 inch).

The spacing between the ribs 58 does not have to be uniform. For example, in an embodiment wherein there are three ribs in the first section 51, each rib may be further defined by the center point (i.e., Cl, C2, C3) of the circles that define the radii of curvature of each rib. The distances between these center points, the distances C1-C2 and C2-C3, can be the same or different.

A user can insert one or more inserts 59 underneath the foam body of the Pillow 3 in order to uniformly change the thickness of the pillow. In some embodiments, the pillow is used without any inserts. Each of the inserts 59 has a plan form that matches, or substantially matches, the plan form of the pillow body 50 (i.e., the shape of the insert 59 differs from the shape of the pillow body 50 only in its thickness profile).

Pillow Material

The pillows of the present disclosure comprise one or more foam bodies, as well as optional foam inserts, as described further below. As used herein, the term“foam” means any material having the consistency and density of resilient foam. This requires a minimum amount of stiffness so that the material does not simply collapse or completely compress under the weight of the user’s body. While such“foam” material may be traditional aerated foamed synthetic polymers, such as polyurethane foam, other materials such as cotton, may be used, as well as air- filled, pressurized bladders.

In some embodiments, the pillows are formed of a material, such as a polyurethane foam. The foam is preferably of sufficient hardness such that when a user sleeps on the pillow, the user’s spine will conform to the shape of the pillow, rather than the pillow conforming to the shape of the user (i.e., by collapsing under the pressure of the user).

Any number of different foam materials are commercially available and can be selected for use in the present disclosure so long as they are suitable for the intended application and use as a pillow material. Generally, there are several important considerations when selecting a suitable foam material. Two of the main factors are the thickness and density. Foam comes in a wide range of densities ranging from 1 to lOpounds per cubic foot. Most standard bedding foam has a density of about 1 to 5 lb/ft ³ (16-80 kg/m ³ ), and most topper pads and comfort layers in mattresses and pillows, have a foam density of between about 3 to 4.5 lb/ft ³ . Very high densities, such as 5.3 lb/ft ³ (85 kg/m ³ ), are used infrequently in mattresses. The pillows of the present disclosure can be formed of materials that have densities from about 1 to about 5 lbs/ft ³ , for example about 3 to 5 lbs/ft ³ ; about 4 to 5 lbs/ft ³ ; about 3 to 4.5 lbs/ft ³ ; or about 4 to 4.5 lbs/ft ³ , etc. More preferably, the foam of the present disclosure has an average density of about 3.5-4.5 lbs/ft ³ . In some embodiments, the foam bodies of the present disclosure are comprised of layers of foam with varied densities.

In addition to the foam density, another important aspect of foam is its resiliency or compressibility. This is commonly measured by the 25% Indentation Foam Deflection test (IFD test, see ASTM D3574). This test, also known as the indentation load deflection test, consists of measuring the number of pounds of force it takes to compress the foam by 25% of its original thickness. 25% IFD is a measure of surface firmness. The related 65% IFD test measures the force needed to compress foam by 65% of its original thickness, and this is a measure of deep firmness. In a preferred embodiment of the present disclosure, the foam has a 25% IFD of 8-20 lbs, more preferably 11-17 lbs. Another useful test is the Ball Rebound Test (BRT), which involves dropping a steel ball onto foam from a fixed height and measuring the rebound height of the ball as a percentage of its initial height. In a preferred embodiment, the foam of the present disclosure has a resiliency as measured by the BRT of about 40 to 75%, more preferably about 50 to 65%. For some bedding, foam typically comes in slab form from which products, such as a mattress component, can be made and the slabs can have different thicknesses, typically in various thicknesses ranging from about 1 inch to about 5 inches. However, these are merely exemplary dimensions and properties and are not limiting of the present disclosure.

Foam products can be formed using any number of different processes including but not limited to pouring the liquid foam into a mold or the like to form a block which is then removed from the mold when cooled. More advanced technology creates the foam in a vacuum chamber. Called vacuum injection, this process of manufacturing creates a foam product of uniform density and ultimately, a high-quality mattress topper, pad, or pillow. Various finishing techniques can be used to form the foam product having the desired shape and in particular, various cutting techniques (e.g., a laser cut) can be used to transform the block of foam material into the end-use product.

In the Pillow 1, each pillow portion 1, 2 and 3, may be made from a different foam material or from the foam material. Preferably, pillow portions 2 and 3 are made of the same foam material, and further preferably the pillow portion 1 is also made of the same foam material. Each of the one or more inserts 7, 8 and/or 9, may be made of a different foam material than the foam body portions 1, 2 and 3. For example, either a stiffer (more rigid) foam or a softer (more compressible) foam may be used in the insert(s) compared to the foam of the portions 1, 2 and 3. In some embodiments, the various foam inserts are made of the same foam material, while in other embodiments, any of the foam inserts may be made of a different foam material from any other foam insert or from any of the portions 1, 2 or 3.

Likewise, in the Pillow 2 and Pillow 3, each of the one or more inserts 34 or 59, may be made of a different foam material than the foam body 30 or 50, respectively. For example, either a stiffer (more rigid) foam or a softer (more compressible) foam may be used in the insert(s) compared to the foam body. In some embodiments, the various foam inserts are made of the same foam material, while in other embodiments, any of the foam inserts may be made of a different foam material from any other foam insert or from the foam body.

Locator member

Any one of the pillows described and illustrated herein can include a locator member that easily permits the user to determine the positioning of the pillow within a pillowcase. For example, the pillow can have a tab (protrusion) that extends outwardly from one section of the pillow, such as at a front edge in order to easily to provide a tactile indicator to a user to allow the position of the pillow to be easily determined especially when the pillow may be covered with a pillowcase or the like.

Enclosures

In some embodiments, the pillows described herein are intended to fit within a traditional commercial pillowcase, such as a standard- sized, queen-sized or king-sized pillow case. In some embodiments, the pillows are designed such that each portion of the pillow is to be fitted with a custom case or enclosure that is cut to the shape of the underlying pillow, e.g., a tightly-fitting case. In some embodiments of the Pillow 1, each of the foam portions 1, 2, and/or 3 is enclosed in a separate case. In other embodiments of the Pillow 1, portions 1, 2, and/or 3 are enclosed in a single case.

In some embodiments of any of Pillow 1, 2 or 3, both the main pillow foam body or bodies (i.e., portions 1, 2 and/or 3 for Pillow 1; body 30 for Pillow 2; body 50 for the Pillow 3) are enclosed in a case along with any and all optional foam inserts (e.g., 7, 8, and/or 9; 34; 59).

In some embodiments, said case is open, i.e., does not have a means for sealing all foam bodies within the case. In other embodiments, the case is closed, i.e., it is open on at least one edge with a means for reversibly closing the case to seal the foam bodies within. Any suitable means of closure is contemplated, including one or more zippers, one or more sliding fasteners, one or more snap closures, one or more button closures, one or more hook-and-loop fastener closures, or any combination thereof. Preferably, any such opening is located along the long-axis of the pillow enclosure in order to permit easy insertion and removal of any of the foam inserts 7, 8, and/or 9; and/or 34; and/or 59.

The enclosures as described above can be made of any suitable material, including but not limited to, natural or synthetic fabrics, or combinations thereof. Non-limiting examples include polyester, cotton and blended fabric. Such fabric will be chosen to optimize the desired comfort, resilience, softness and support. Optionally, such fabric can include enhancements such as antimicrobial additives, cooling agents, fragrances, enhanced fire retardants, or exotic fiber materials. The material may be of a quilted form, and may further comprise padding such that the enclosure itself has negligible thickness. In some embodiments, the enclosure is comprised of at least one elastic material such that the enclosure can be stretched when insert the main body foam piece and/or foam inserts, but upon release of tension, the material relaxes to form a tight fit upon the foam materials. In some embodiments, only the side walls of the enclosure are elastic, but the horizonal surfaces of the enclosure are non-elastic, to enable a tight fit between the pillow and the enclosure regardless of the number or thickness of foam inserts added.

Customizing inserts

Each of the inserts 7, 8 and/or 9, and 34 or 59, has a thickness that is uniform from front to back and from side to side. In some embodiments, each of the inserts 7, 8 and/or 9, 34 or 59, has a thickness not more than the maximum thickness of the Pillow 1, 2 or 3, respectively, measured at whichever point of the pillow has maximum thickness. In some embodiments, each of the inserts 7, 8 and/or 9, 34 or 59, has a minimum thickness of ¼ inch (6.35 mm). In some embodiments, each of the inserts 7, 8 and/or 9, 34 or 59, has a maximum thickness of 3 inches.

In some embodiments, each of the one or more inserts 7, 8 and/or 9, 34 or 59, has a thickness selected from the group consisting of about ¼ inch (6.35 mm), about 1/3 inch (8.47 mm), about ½ inch (12.7 mm), about 2/3 inch (16.94 mm), about ¾ inch (19.05 mm), about 1 inch (25.4 mm), about 1.25 inches (31.75 mm), about 1.5 inches (38.1 mm), about 1.75 inches (44.45 mm), about 2 inches (50.8 mm), about 2.25 inches (57.15 mm), about 2.5 inches (63.5 mm), about 2.75 inches (69.85 mm), and about 3 inches (76.2 mm). In some embodiments, the Pillow 1 comprises any combination of: (1) from zero to six inserts 7, (2) from zero to six inserts 8, and/or (3) from zero to six inserts 9. In some embodiments, the Pillow 2 or Pillow 3 comprises from zero to six inserts 34 or 59, respectively.

In some embodiments of the Pillow 1, any one or more of the inserts 7, 8 and/or 9, is designed with a means to affix the inserts to each other and/or to the base portion 1 or upper portions 2 or 3 of the pillow. Likewise, in some embodiments of the Pillow 2 or 3, any one or more of the inserts 34 or 59, respectively, is designed with a means to affix the inserts to each other and/or to the main body foam 30 or 50, respectively. For example, the opposing surfaces between any inserts or between any insert and any portion may be fitted with hook-and-loop fasteners, adhesive strips, snap closures, button closures, interlocking or mating parts, or other suitable means of attachment. Alternatively, or additionally, any of these means of attachment may operate by way of the side walls of the inserts and/or portions. For example, by pieces of fabric attached to one or both of the adjacent side walls and having a means of attachment between the fabric pieces, such as by a button or snap closure, or adhesive or hook-and-loop fasteners. In some embodiments, there are no direct connections or affixations between any inserts or between any insert and any portion, and the inserts and portions are instead held together by fitting into a tightly-fitting fabric enclosure. In such a case, customization of the thickness of any segment of the pillow is affected by opening the enclosure and adding or removing any desired inserts to adjust the thickness of any segment of the pillow.

In any of the above embodiments, one or more of the foam inserts may be made of a foam that is considerably firmer and less compressible than the main foam body or bodies of the pillow. For example, the insert may be composed of a foam with a 25% IFD of greater than 20 lbs, or greater than 30 lbs, or greater than 40 lbs, and preferably 40-50 lbs., and/or a Ball Rebound Test value of about 40-60%, and preferably about 45%.

Other Aspects

It will also be understood that an accessory can be provided for use with the middle segment of the Pillow 1. The underside (bottom) surface of the accessory has a shape that is a mirror image of the top surface of the middle segment of the pillow, which permits the accessory to mate with the middle section such that a clean, intimate mating (flush fit) results between the accessory and the middle segment. The accessory thus transforms the Pillow 1 into a complete side-lying pillow without provision for back-sleeping usage. The accessory preferably is sized in its thickness to provide a uniform thickness along both longitudinal dimensions of the pillow.

The accessory may be made of foam as described above. In addition, the accessory can have different material foam characteristics compared to the main foam bodies. For example, the density (e.g., foam density) can be different than the main foam body densities to provide a different feel in the middle segment compared to the lateral segments. The accessory can be freely removed from the pillow, to return the pillow to a combination side-sleeping and back- sleeping use. The accessory can be contained in a separate enclosure, e.g., any type of enclosure as described in each of the enclosure embodiments above. Alternatively, the enclosure of the base portion of the pillow can be designed with sufficient flexibility and elasticity such that the accessory foam body can be inserted into the main enclosure along with the main foam body of the base portion. One or more fasteners, such as hook and loop material can be provided on the bottom surface of the accessory and the top surface of the middle segment to secure the accessory in place.

It will be appreciated that the relative dimensions, such as the width and length, of each pillow section can be varied depending upon the particular application, such as the pillow size (e.g., standard, queen, king, etc.).

In some embodiments of the Pillow 1, the overall length of the pillow is about 26 to 27 inches, while the width is about 14 inches. In some embodiments, the length of the two lateral segments is equal to the length of the middle segment. In other embodiments, the two lateral segments have the same length, and this length is larger or smaller than the length of the middle segment. Preferably, all segments have the same width. In some embodiments of the Pillow 2 or 3, the overall length of the pillow is about 16 to 18 inches, while the width is about 11 inches.

The present disclosure also includes like pillows of similar proportions but different dimensions for use by children. In some embodiments, a children’s pillow according to the present disclosure will have a lower length, width, thickness radii of curvature R1-R4.

The foam bodies which comprise the pillow can be formed using any number of conventional techniques known to those skilled in the art. In one embodiment, each main foam body is formed as a single piece construction (a single unitary, integral construction).

The pillows of the present disclosure may be further defined as follows:

1.1. An adjustable-thickness pillow.

1.2. An adjustable thickness pillow comprising at least one main foam body and one or more foam inserts having a plan form that matches, or substantially matches, the plan form of the main foam body (i.e., the shape of the insert differs from the shape of the pillow body only in its thickness profile).

1.3. An adjustable thickness pillow according to any preceding embodiment, wherein the pillow comprises a single main foam body.

1.4. An adjustable thickness pillow according to any preceding embodiment, wherein the main foam body is defined by a top surface on which the user’s body rests, an opposing bottom surface, a rear edge, an opposing front edge, and lateral sides, wherein the upper surface of the pillow has a step configuration from the front edge to the rear edge, with the pillow having a maximum thickness at the front edge and a minimum thickness at the rear edge.

1.5. The adjustable thickness pillow according to embodiment 1.4, wherein the front edge of the pillow comprises one or more arcuate- shaped cut-outs to receive the user’s shoulder.

1.6. An adjustable thickness pillow according to any preceding embodiment, wherein the main foam body is defined by a top surface on which the user’s body rests, an opposing bottom surface, a rear edge, an opposing front edge, and lateral sides, wherein the pillow has a convex first region formed along the front edge of the pillow, a concave second region formed centrally, and a convex third region formed along the rear edge of the pillow.

An adjustable thickness pillow according to embodiment 1.6, wherein convex first region comprises a plurality of ribs.

An adjustable thickness pillow according to embodiment 1.7, wherein each rib is a rounded rib, optionally, a convex rib.

An adjustable thickness pillow according to any preceding embodiment, wherein the pillow comprises three adjacent segments comprising a middle segment for sleeping in the supine position and two flanking lateral segments for sleeping in the side-lying position.

. An adjustable thickness pillow according to embodiment 1.9, wherein the pillow comprises three independent main foam bodies consisting of a lower base portion comprising the middle segment and the lower parts of each lateral segment, and two upper portions forming the upper part of each lateral segment.

. The adjustable thickness pillow according to embodiment 1.9, wherein the pillow optionally comprises independently (1) one or more foam inserts placed between the base portion and the left upper portion for adjusting the height of the left-side lateral side-lying segment, (2) one or more foam inserts placed between the base portion and the right upper portion for adjusting the height of the right-side lateral side-lying segment, and (3) one or more foam inserts placed below the base portion for adjusting the thickness of the entire pillow.

. The adjustable thickness pillow according to any preceding embodiment, wherein the foam inserts have a thickness selected from the group consisting of about ¼ inch (6.35 mm), about V ₃ inch (8.47 mm), about ½ inch (12.7 mm), about 2/3 inch (16.94 mm), about ¾ inch (19.05 mm), about 1 inch (25.4 mm), about 1.25 inches (31.75 mm), about 1.5 inches (38.1 mm), about 1.75 inches (44.45 mm), about 2 inches (50.8 mm), about 2.25 inches (57.15 mm), about 2.5 inches (63.5 mm), about 2.75 inches (69.85 mm), and about 3 inches (76.2 mm).

. The adjustable thickness pillow according to any preceding embodiment, wherein the opposing surfaces between any inserts or between any insert and any main foam body is fitted with hook-and-loop fasteners, adhesive strips, snap closures, button closures, interlocking or mating parts, or any other suitable means of attachment, to affix said inserts and bodies together.

1.14. The adjustable thickness pillow according to any preceding embodiment, wherein main foam body or bodies and any inserts are enclosed within a tightly-fitting fabric enclosure.

1.15. The adjustable thickness pillow according to embodiment 1.14, wherein the

enclosure comprises an opening that is reversibly sealed with a zipper, or a sliding fastener, or with one or more snap or button closures, or with one or more strips of hook-and-loop fasteners or adhesive, or by any other suitable means.

1.16. The adjustable thickness pillow according to any embodiment of Pillow 1, Pillow 2, or Pillow 3, as described herein.

1.17. The adjustable thickness pillow as shown, or substantially as shown, in Figures 1A to II.

1.18. The adjustable thickness pillow as shown, or substantially as shown, in Figures 2A to 21.

1.19. The adjustable thickness pillow as shown, or substantially as shown, in Figures 2A to 21.

In another aspect, the present disclosure provides a method (Method 1) of maintaining or improving the curvature and/or alignment of the cervical and/or thoracic vertebrae of a human, the method comprising sleeping with the head and neck supported by a pillow according to any one of the embodiments described herein, e.g., Pillow 1, Pillow 2, Pillow 3 or any of the Pillows 1.1-1.19. In a further embodiment, the person is suffering from an ailment of the neck or cervical vertebrae, such as a misalignment of the cervical vertebrae, and the method is applied to a person in need of treatment therefor. Due to its unique design, sleeping with the head and neck supported by the pillows as disclosed herein results in the cervical and/or thoracic vertebrae adopting a clinically improved curvature and/or alignment, and continued use of these pillows during sleep will result in gradual improvement of curvature and alignment of the vertebrae during waking hours. In one embodiment, the method is effective for treating or ameliorating

(e.g., reducing or eliminating the symptoms of) ailments of the spine, neck or cervical vertebrae, for example: misalignment of the cervical vertebrae, chronic or acute neck pain, back pain, or shoulder pain, headache, numbness of the extremities, excessive abnormal curvature of the cervical or thoracic vertebrae (e.g., kyphosis or lordosis), cervical or lumbar arthritis, or disorders of the intervertebral discs (e.g., disc inflammation, disc prolapse, disc herniation).

The inventors have discovered that even persons who appear without identifiable spinal injury or disease, and who have cervical or thoracic curvature or alignment considered within the normal range, when sleeping on traditional commercial pillows, can have their vertebrae forced into an unnatural or unhealthy alignment. While this improper alignment usually does not persist after waking, having spent many hours sleeping with such improper alignment, users can experience neck or back pain of apparently unknown cause. By sleeping on pillows of the present disclosure, however, normal users without spinal injury or disease can avoid the above problems because the pillows of the present disclosure will maintain optimal cervical alignment during sleep. Thus, in some embodiments, the pillows of the present disclosure help maintain healthy cervical and/or thoracic curvature and/or alignment in persons without apparent spinal injury or disease.

In a particular embodiment, the method may comprise sleeping on said pillow for a period of time from 2 hours to 10 hours per night, preferably from 6 to 8 hours, and doing so on a regular basis (e.g., every night) for a sufficient period of time to result in reduction or resolution of symptoms (e.g., at least 2 weeks, or at least 4 weeks or at least 8 weeks). In another embodiment, the method comprises sleeping on said pillow on a regular basis for an extended period of time (e.g., several months or years, or an indefinite period of time) in order to maintain healthy spinal curvature and alignment.

In a particular embodiment, the user (e.g. patient) has been diagnosed, for example, by X- ray radiography, as having an abnormal curvature or alignment of the cervical or thoracic vertebrae, and when the user lies on a pillow of the present disclosure, the pillow supports the user’s neck into a healthier alignment or curvature. For example, where a patient suffers from hypo-lordosis (insufficient anterior concavity of the cervical vertebrae), use of the pillow during sleep may result in the user’s neck being supported into a more concave arch. Over time, this may result in improved neck curvature during waking hours, and consequently, reduced adverse symptoms associated with the cervical condition (e.g., reduced pain).

As used herein, the term“alignment” refers to both the curvature of the cervical or thoracic vertebrae as viewed from the side, or the alignment of the cervical or thoracic vertebrae as viewed from the front or back. As used herein,“abnormal alignment” refers to abnormal curvature of the cervical spine (e.g., outside of the normal lordotic range), abnormal alignment of the spinal processes of the vertebra (where the vertebrae are not aligned substantially along the midline of the spine), or any other deviation of the orientation of the cervical or thoracic vertebrae, with respect to each other or to the rest of the body, that is considered abnormal.

The invention is described in detail with reference to particular embodiments thereof, but the scope of the invention is to be gauged by the claims that follow and also by those

modifications that provide equivalent features to those that are claimed as such modifications are still within the spirit and scope of the invention.

EXAMPLES

X-ray radiographic studies are conducted to compare the effects of pillows having the surface contour design of the pillows of the present disclosure versus a standard polyester-filled pillow, or other commercial pillows, on the curvature or alignment of the cervical spine of patient presenting with hypo-lordosis. The normal lordotic curvature of the cervical spine is +17 to +24 centimeters degree of arc, with curvature being concave when viewed from the side, with respect to the line formed between the occiput and the sacrum. Normal alignment of the spine consists of the spinous process of each cervical vertebra forming a substantially straight line when viewed from the back, and in each spinous process being positioned approximately at the midpoint of the spine. Patients are first assessed in a standing position, followed by assessment in the supine position using various types of pillows.

Example 1 (cervical curvature):

Multiple patients presenting with abnormal cervical curvature (Cases 1-4) are assessed using a pillow having the design of the Pillow 3, without optional inserts, versus one or more pillows, including standard down-filled pillows, contoured polyester-filled pillows, commercial therapeutic interlocking-fill pillows or commercial contoured memory foam pillows. Standing curvatures range from -130 centimeter-degrees (nearly straight) to -26 centimeter-degrees (strongly convex). Upon lying supine on conventional pillows, the patients’ abnormal cervical curvatures are either only slightly improved or worsened. In contrast, when lying supine on the pillow of the present disclosure, all patients showed markedly improved curvature of the cervical spine (curvature became positive, i.e. lordotic, for each patient).

Results are shown in Table 1 below (curvature measured in centimeters degree of arc):

Figures 4A to 4C show the corresponding X-ray images for case study 1. In Figure 4A, the patient is imaged standing. The dashed line A marks normal lordotic curvature (+17 to +24 centimeter-degree arc), while line B traces the actual curvature of the patient’s spine (-68 cm degree), which is reversed (also known as kyphotic). In Figure 4B, the patient is imaged lying supine on the pillow of the present disclosure. Dashed line A shows normal curvature, while solid line B shows the patient’s curvature. The patient’s curvature is shown to be +26 cm degrees, which, while just outside the normal range of lordotic curvature, is significantly improved from the patient’s standing baseline. In contrast, as shown in Figure 4C, when the patient lies supine on a contoured polyester- filled pillow, the patient’s cervical curvature (line B) remains highly abnormal (-150 degrees of curvature, still kyphotic) compared to normal curvature (line A).

Table 1 shows similar results for patients 2, 3 and 4. Patient 2, who began with even worse kyphotic curvature than patient 1 (-26 cm degrees), improves only slightly when lying supine on a standard down pillow (-66 cm-degrees, still kyphotic), but achieves nearly normal lordotic curvature on a Pillow 200 (+30 cm-degrees). Likewise, patient 3 has nearly straight curvature standing (-130 cm-degrees) and improves to almost normal lordotic curvature using Pillow 200 (+28 cm-degrees). In contrast, on a therapeutic interlocking-fill pillow, this patient shows no change from standing, while on a commercial contoured memory foam pillow, this patient shows a very shallow lordotic curvature (+50 cm-degrees). Patient 4, also with nearly straight standing curvature (-130 cm-degrees), improves to within the normal lordotic range using Pillow 200 (+24 cm-degrees), but becomes even more kyphotic on a standard down pillow (-55 cm-degrees). These studies demonstrate the effectiveness of the pillows of the present disclosure in reversing abnormal curvature of the cervical spine during sleep.

Also shown in Table 1 are the results from two patients who have cervical curvatures within the normal range (patients 5 and 6). Figure 5A shows patient 5’s standing curvature of +17 cm degrees of arc (solid line B). When lying on a Pillow 200 of the present disclosure, the patient’s cervical curvature remains substantially the same (+ 21 cm-degrees of arc, still within the normal range), as shown in Figure 5B (solid line B). In contrast, as shown in Figure 5C, when lying on a commercial therapeutic interlocking-fill pillow, which lacks the kind of support provided by the pillow of the present disclosure, it is observed that the patient’s neck becomes substantially straight (+500 cm-degrees of arc, solid line B). This curvature is well outside the normal lordotic range (line A in each figure), and could result in significant adverse effects. Similarly, patient 6 presents with +20 cm degrees of arc curvature while standing, and this remains substantially the same when lying supine on the pillow of the present disclosure (+21 cm-degrees). In contrast, this patient’s neck loses curvature (straightens) on both a contoured polyester pillow (+100 cm-degrees) and on a contoured memory foam pillow (+43 cm-degrees). These examples demonstrate the efficacy of the pillows of the present disclosure in maintaining healthy curvature of the neck during sleep in persons considered to have normal neck curvature.

Example 2 (thoracic alignment):

Patient 6 is assessed using a pillow having the design of the Pillow 2, without optional inserts, versus a commercial contoured memory foam pillow. Figure 6A shows the patient’s standing cervical alignment. The solid lines mark the edges of the patient’s spinal column, and dotted line A marks the midpoint line. Ideally, the tip of each spinous process (white carets) should be located on or substantially close to the midpoint line. While most of the patient’s spinous processes show proper alignment, the spinous process of vertebra T3 (marked C) is out of alignment (it is greater than 2.5 centimeters from the midpoint line). In Figure 6B, patient 6 is shown side-lying on the pillow of the present disclosure. Lying on this pillow causes the patient’s deviant T3 vertebra (white caret B) to become properly aligned along the midline of the spine (dashed line A). In contrast, lying on the commercial contoured memory foam pillow, the patient’s T3 vertebra (black caret C) remains out of alignment, and in addition, several more vertebrae also fall out of alignment with the spinal midpoint line (dashed line A). On this pillow, only the C5 and C6 vertebrae are in proper alignment, while the C7 and Tl-4 vertebrae are all misaligned (black carets). This study demonstrates that the side-lying pillow of the present disclosure is effective at correcting spinal misalignment, and that a commercial contoured memory foam pillow actually can cause increased misalignment of the spine during sleep.