Title:
Head positioning device
Kind Code:
A1


Abstract:
The present invention relates to a head support device for the treating and prevention of plagiocephaly in infants. The device removes pressure from a desired area of an infant's head.



Inventors:
Madsen, Joseph (Newton, MA, US)
Application Number:
10/930196
Publication Date:
03/02/2006
Filing Date:
08/31/2004
Assignee:
Children's Hospital Boston (Boston, MA, US)
Primary Class:
Other Classes:
5/655, 5/733, 5/640
International Classes:
A47G9/00
View Patent Images:
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Primary Examiner:
LIU, JONATHAN
Attorney, Agent or Firm:
PROSKAUER ROSE LLP (BOSTON, MA, US)
Claims:
What is claimed is:

1. A head positioning device for preventing or treating plagiocephaly in an infant, the device comprising: (a) a first support having a first surface that is sloped relative to a second surface, and being sized and shaped to support a sideward aspect of an infant's head on said sloped first surface; and (b) a second support having at least one surface opposing said first surface of said first support when in use, and being sized and shaped to support a rearward aspect of said infant's head; wherein, while in use with said infant in a supine position, said infant's head is simultaneously supported by both of said first and second supports in a side-facing position such that gravitational pressure is at least partially distributed to said sideward aspect of said infant's head, thereby preventing or treating plagiocephaly in said infant.

2. The device of claim 1 further comprising a cap sized and shaped to receive said infant's head, and a fastener for removably attaching said cap to at least one of said supports while said device is in use.

3. The device of claim 2 wherein said fastener comprises opposing first and second members, said first member having a plurality of hooks and a second member having a plurality of loops, one of said first and second member being affixed to one of said supports, and the other of said first and second members being affixed to said cap.

4. The device of claim 2 wherein at least one of said supports comprises a surface having a plurality of loops and wherein said fastener comprises a plurality of hooks sidewardly or rearwardly positioned on said cap.

5. The device of claim 1 wherein said first and second supports are interchangeable so as to provide at least a first and a second configuration of said device, wherein, when in use in said first configuration, said infant's head is held in a left side-facing position, and, when in use in said second configuration, said infant's head is held in a right side-facing position.

6. The device of claim 1 wherein at least one of said first and second supports is optionally interchangeable with a third support.

7. The device of claim 1 wherein at least one of said first and second supports is optionally tiltable by a third support.

8. The device of claim 1 wherein said first surface of said first support slopes at a predetermined angle.

9. The device of claim 8 wherein said predetermined angle is between about 0° and about 180°.

10. The device of claim 8 wherein said predetermined angle is selected from the group consisting of 10°, 20°, 30°, 40°, 45°, 50°, 60°, 70°, 80°, 90°, 120°, 135° and 150°.

11. The device of claim 1 wherein said surface of said second support is sloped relative to a second surface of said second support.

12. The device of claim 1 wherein said first and second supports comprise a conformable but firm material.

13. The device of claim 1 further comprising a foundation, and wherein said foundation comprises both of said first and second supports.

14. The device of claim 1 further comprising a coupler for connecting said first and second supports to each other.

15. The device of claim 14 wherein, in use, said first and second supports are removably connected to each other.

16. The device of claim 14 wherein said coupler comprises opposing first and second members, said first member having a plurality of hooks and said second member having a plurality of loops, one of said first and second members being affixed to said first supports and the other of said first and second members being affixed to said second supports.

17. The device of claim 1 further comprising a mat, and wherein said first and second supports are attached to said mat.

18. The device of claim 17 wherein at least one of said first and second supports is removably attached to said mat.

19. A head positioning device for preventing or treating plagiocephaly in an infant, the device comprising (a) a mat; (b) a cap sized and shaped to receive an infant's head; and (c) a fastener for removably attaching said cap to said mat, wherein, while in use with said infant in a supine position on said mat, said fastener removably attaches said cap to the mat such that said infant's head is held in a side-facing position so as to at least partially distribute gravitational pressure to a sideward aspect of said infant's head, thereby preventing or treating plagiocephaly in the infant.

20. The device of claim 19 wherein said fastener is sidewardly positioned on said cap.

21. The device of claim 19 wherein said fastener comprises opposing first and second members; said first member having a plurality of hooks and a second member having a plurality of loops, one of said first and second member being affixed to said mat, and the other of said first and second members being affixed to said cap.

22. The device of claim 19 wherein said mat comprises a surface having a plurality of loops, and wherein said fastener comprises a plurality of hooks sidewardly positioned on said cap.

23. The device of claim 19 wherein said fastener is adjustable.

24. A head positioning device for preventing or treating plagiocephaly in an infant, the device comprising first and second supports, each of said supports having a first surface that is sloped relative to a second surface, and being sized and shaped to support a sideward aspect of an infant's head on said sloped first surface, wherein, while in use with said infant in a supine position, said infant's head is simultaneously supported by both of said first and second supports in a forward-facing position such that a rearward aspect of said infant's head is elevated without contacting either of said first and second supports, thereby at least partially distributing gravitational pressure to said sideward aspects of said infant's head, thereby preventing or treating plagiocephaly in said infant.

25. The device of claim 24, further comprising a cap sized and shaped to receive said infant's head, and a fastener for removably attaching said cap to at least one of said supports while said device is in use.

26. A head positioning device for preventing or treating plagiocephaly in an infant, the head positioning device comprising: a first support comprising a first head resting surface and a first base surface, wherein the first head resting surface and the first base surface are disposed at a first acute angle relative to each other; a second support comprising a second head resting surface and a second base surface, wherein the second head resting surface and the second base surface are disposed at a second acute angle relative to each other; wherein the first support is independent of and connectable with the second support and wherein when the first support and second support are connected, the first I base surface and the second base surface are aligned substantially planar.

27. A method of preventing or treating plagiocephaly in an infant, the method comprising: (a) providing the device of claim 1; (b) positioning an infant in a supine position such that said infant's head is in a side-facing position with said sideward aspect being supported by said first support and, simultaneously, said rearward aspect being supported by said second support such that gravitational pressure is at least partially distributed to said sideward aspect of said infant's head, thereby preventing or treating plagiocephaly in the infant.

28. A method of preventing or treating plagiocephaly in an infant, the method comprising: (a) providing the device of claim 2; (b) placing said cap on said infant's head; (c) removably attaching said cap to at least one of said supports via said fastener; and (d) positioning said infant in a supine position such that said infant's head is a side-facing position with said sideward aspect being supported by said first support and, simultaneously, said rearward aspect being supported by said second support such that gravitational pressure is at least partially distributed to said sideward aspect of said infant's head, thereby preventing or treating plagiocephaly in the infant.

29. A method for treating plagiocephaly in an infant, the method comprising: (a) providing the device of claim 19; (b) placing said cap on said infant's head; and (c) removably attaching said cap to said mat via said fastener such that said infant's head is held in a side-facing position so as to at least partially distribute gravitational pressure to said sideward aspect of said infant's head, thereby preventing or treating plagiocephaly in the infant.

30. A method of using the device of claim 26, the method comprising the steps of: connecting the first support to the second support; and positioning an infant's head on the first head resting surface and the second head resting surface such that each of the first head resting surface and the second head resting surface contacts a non-flattened portion of the infant's head.

31. The method of claim 30 further comprising sliding a third support under one of the first or second support to tilt the device.

32. A kit for preventing or treating plagiocephaly in an infant, the kit comprising: (a) at least first and second interchangeable supports, each of said first and second supports having a first surface that is sloped relative to a second surface, and being sized and shaped to support a sideward aspect of an infant's head on said sloped first surface; and (b) a third support having at least one surface opposing said first surface of said first or second support when in use, and being sized and shaped to support a rearward aspect of said infant's head; wherein, said first and second supports are sloped at different predetermined angles, and wherein while in use with said infant in a supine position, said infant's head is held in a side-facing position and is simultaneously supported by (i) one of said first or second supports, and (ii) said third support, such that gravitational pressure is at least partially distributed to said sideward aspect of said infant's head, thereby preventing or treating plagiocephaly in the infant.

33. The kit of claim 32 further comprising a cap sized and shaped to receive said infant's head, and a fastener for removably attaching said cap to at least one of said supports while said device is in use.

34. A head positioning kit for preventing or treating plagiocephaly in an infant, the head positioning kit comprising: a mat; a cap sized and shaped to receive an infant's head, wherein at least one of the mat and the cap comprise a fastener such that a left or right temporal area of an infant's head can be fastened to the mat.

Description:

TECHNICAL FIELD

The present invention relates to methods and devices for treating or preventing plagiocephaly in infants. More particularly, the present invention relates to head supports and caps useful for treating or preventing positional plagiocephaly in infants.

BACKGROUND

A major concern in the development of an infant child is the flattening of his or her head brought about by the repeated positioning of the infant's head in the same position against a flat surface during sleep or rest. During development, an infant's skull is extremely soft and malleable to allow for the fast growth rate of the brain. As the brain develops, the skull must retain its malleability in order to accommodate the rapid growth. When an infant is repeatedly allowed to sleep or rest with its soft head laying against a flat surface (such as in cribs, strollers, playpen, or car seats), the force of gravity causes the infant's head to mold to the shape of the surface at the contact region between the head and surface. The infant's head flattens, and, thus, develops what is known as positional plagiocephaly, or flattened head syndrome.

The need for effective treatment and prevention of plagiocephaly has become particularly compelling due to current medical recommendations from the American Academy of Pediatrics that infants sleep in a supine position (laying on their backs) to help prevent sudden infant death syndrome (SIDS). Although the incidence of SIDS has greatly decreased because of this recommendation, the incidence of plagiocephaly has consequently risen.

Several devices to treat and prevent positional plagiocephaly exist in the art. These devices include a number of caps and pillow-like head supports designed to angle or support an infant's head or body. Helmets and caps that are available are, by design, thick and bulky to allow the cushioning of the infant's head in preventing positional plagiocephaly. Because of their design, these helmets and caps place the infant's head in an unnatural and uncomfortable position and can become uncomfortably hot when worn for extended periods. Similarly, available pillows include those having a sloped surface that causes the tilting of an infant's head. These devices, however, lack sufficient counter-support to allow natural positioning of the infant child's head without excessive effort or discomfort on the part of the infant. Furthermore, these caps and head supports fail to provide for adjustment or customization of treatment. For example, once employed, a pillow of the prior art cannot be adjusted to increase or decrease the slope angle in order to accommodate the growth of the infant's head or gradual improvement in the shape of the infant's head.

It is, therefore, an object of the present invention to provide improved devices and methods that can be used to allow adequate positioning capabilities of an infant's head to prevent or treat positional plagiocephaly, while offering comfortable and natural positioning of the infant's head.

SUMMARY OF THE INVENTION

The present invention relates to head support devices useful in treating and preventing plagiocephaly in infants. Devices according to the invention, when used with an infant lying in the supine position, support a first predetermined area of an infant's head, for example, a right or left sideward aspect or a temporal area, such that pressure on the infant's skull caused by gravity pressing it against a surface (“gravitational pressure”) is at least partially removed from a second predetermined area of the infant's head, for example, a rearward or an occipital area, thereby preventing or treating plagiocephaly or any deviations in the natural curvature of the infant's head. While typically plagiocephaly results in the flattening of the posterior region of an infant's head, the devices and methods of the invention are useful in treating or preventing plagiocephaly, whether such disorder has resulted or would result in the flattening of the posterior region or any other region of an infant's head.

In one aspect, the invention provides a head positioning device comprising a first support having a first surface that is sloped relative to a second surface, and being sized and shaped to support a sideward aspect of an infant's head on the sloped first surface, and a second support having at least one surface opposing the first surface of the first support when in use, and being sized and shaped to support a rearward aspect of the infant's head. According to this embodiment, while in use with the infant in a supine position, the infant's head is simultaneously supported by both the first and second supports in a side-facing position such that gravitational pressure is at least partially distributed to the sideward aspect of the infant's head, thereby preventing or treating plagiocephaly in the infant. In one embodiment, the first and second supports are interchangeable so as to provide at least a first and a second configuration of the device wherein, when in use in the first configuration, the infant's head is held in a left side-facing position, and when in use in the second configuration, the infant's head is held in a right side-facing position.

In another embodiment, the first surface of the first support is a head resting surface, and the second surface of the first support is a first base surface. Likewise, the second support has a first surface being a second head resting surface, and a second surface being a second base surface. The first head resting surface and the first base surface are disposed at a first acute angle relative to each other, and the second head resting surface and the second base surface are disposed at a second acute angle relative to each other. The first support is independent of and connectable with the second support. When the first support and second support are connected, the first base surface and the second base surface are aligned substantially planar.

The device may also include a third support. The third support can be capable of replacing at least one of the first or second supports when the device is assembled. The third support may be adapted to slide underneath at least one of the first or second supports to tilt the device.

In one embodiment, the first surface of the first support slopes at a predetermined angle. The predetermined angle can be between about 0° and about 180°, or may be selected from the group consisting of about 10°, 20°, 30°, 40°, 45°, 50°, 60°, 70°, 80°, 90°, 120°, 135° and 150°. Additionally or alternatively, a first surface of the second support may slope relative to a second surface of the second support. The sloping angles of the first and second supports may be the same or different, and each angle may be acute, right or obtuse.

In still other embodiments, the first and second supports are made of a conformable but firm material. In one embodiment, the supports are separate units, while in another embodiment, the device is a single unit comprising a foundation that includes both of the first and second supports.

In yet another embodiment, the device includes a coupler for connecting the first and second supports to each other. In use, the first and second supports may be permanently or removably attached to each other. Furthermore, the coupler may comprise, for example, opposing first and second members, the first member having a plurality of hooks and the second member having a plurality of loops, one of the first and second members being affixed to the first support and the other of the first and second members being affixed to the second support.

In still another embodiment, the device may include a mat, wherein the first and/or second supports are permanently or removably connected to the mat. In one aspect, at least one of the first and second supports may be removably attached to the mat via, for example, a coupler.

In another embodiment, the device comprises a cap sized and shaped to receive the infant's head. According to the invention, the cap may be used with or without a head support of the invention. According to one aspect, the cap includes a fastener for removably attaching the cap to a mat or at least one of the supports of the head positioning device while the device is in use. By adhering the cap to a mat or at least one of the supports, the desired position of the infant's head can be maintained. In one embodiment, a fastener comprises, for example, opposing first and second members, the first member having a plurality of hooks and a second member having a plurality of loops, one of the first and second member being affixed to the mat or one of the supports, and the other of the first and second members being affixed to the cap. In another embodiment, the mat or at least one of the supports may contain a surface having a plurality of loops capable of fastening to a plurality of hooks sidewardly or rearwardly positioned on the cap. In various embodiments of the foregoing aspect, the fastener is sidewardly positioned on the cap. In another embodiment, the fastener is adjustable.

According to the invention, a mat may comprise a cushioned pad, mattress, mattress pad, sheet, or any other suitable material for adhering a support or cap in place. For example, in one embodiment, a mat comprises a fitted sheet suitable for use with a standard crib or bassinet mattress. In this embodiment, the fitted sheet may be outfitted with a plurality of loops capable of fastening to a plurality of hooks located on one or more of the supports or the cap. In another embodiment, a mat comprises a mattress with built-in supports. Such a mat may be sized and shaped for use in a crib or bassinet in lieu of a standard mattress and may further comprise a form-fitted sheet, pad or other covering.

As practiced, the invention provides for a method of preventing or treating plagiocephaly in an infant. According to the invention, an infant is placed on the head positioning device in a supine position such that the infant's head is in a side-facing position with the sideward aspect being supported by the first support and, simultaneously, the rearward aspect being supported by the second support such that gravitational pressure is at least partially distributed from the posterior of the infant's head to the sideward aspect of the infant's head, thereby preventing or treating plagiocephaly in the infant. In another aspect, the invention provides for connecting the first support to the second support and positioning an infant's head on the first head resting surface and the second head resting surface such that each of the first head resting surface and the second head resting surface contacts a non-flattened portion of the infant's head.

In another embodiment, the cap may be used in conjunction with the head positioning device by placing the cap on the infant's head, removably attaching the cap to at least one of the supports via the fastener, and positioning the infant in a supine position such that the infant's head is a side-facing position with the sideward aspect being supported by the first support and, simultaneously, the rearward aspect being supported by the second support such that gravitational pressure is at least partially distributed to the sideward aspect of the infant's head.

Alternatively, while in use with the infant in a supine position, the infant's head is simultaneously supported by both of the first and second supports in a forward-facing position. In one such embodiment, a rearward aspect of the infant's head is elevated without contacting either of the first and second supports, thereby at least partially distributing gravitational pressure to the sideward aspects of the infant's head.

In another embodiment, the cap may be used in conjunction with a mat by placing the cap on the infant's head and removably attaching the cap to the mat via the fastener such that the infant's head is held in a side-facing position so as to at least partially distribute gravitational pressure to the sideward aspect of the infant's head.

In yet another aspect, the invention provides a kit for preventing or treating plagiocephaly in an infant, the kit comprising at least first and second interchangeable supports. In another embodiment, a kit according to the invention comprises a third interchangeable support. In yet another embodiment, the kit includes a cap according to the invention.

In still another embodiment, a kit according to the invention provides a third support that comprises a third head resting surface and a third base surface, with the third head resting surface and the third base surface disposed at a third angle relative to each other. A third support may be slid under one of the first or second support to tilt the device, or may be used in the place of the first or second support.

These and other objects, along with advantages and features of the present invention herein disclosed, will become apparent through reference to the following description, the accompanying drawings, and the claims. Furthermore, it is to be understood that the features of the various embodiments described herein are not mutually exclusive and can exist in various combinations and permutations.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention. In the following description, various embodiments of the present invention are described with reference to the following drawings.

FIG. 1A shows a schematic perspective view of one embodiment of a head positioning device with a first and second support.

FIG. 1B shows a schematic perspective view of the embodiment of FIG. 1A having the first and second supports assembled.

FIG. 1C shows a schematic perspective view of the embodiment of FIGS. 1A and 1B having the first and second supports assembled and having a third support positioned under the first support to tilt the assembly.

FIG. 2 shows a schematic perspective view of an infant using the head positioning device of FIGS. 1A and 1B.

FIG. 3 shows a schematic rear view of the infant and head positioning device of FIG. 2.

FIGS. 4A-D show a schematic view of a system involving a head positioning device according to FIGS. 1A and 1B, a cap, and a fastener.

FIGS. 5A-C show a schematic perspective view of certain embodiments of a mat and head positioning device.

FIG. 6 is a schematic perspective view of an infant using one embodiment of a mat and cap.

FIG. 7 is a schematic perspective view of an infant using the mat, head positioning device, and cap of FIGS. 4A-D and 5.

FIG. 8 is a schematic view of a system encompassing the components shown in the preceding figures.

DETAILED DESCRIPTION OF THE INVENTION

The present invention provides head positioning devices, mats, and caps that are useful in treating or preventing plagiocephaly in infants and/or treating or preventing any deviations in the natural shape of the infant's head. When devices according to the invention are used with an infant lying in the supine position, the infant's head is supported in such that gravitational pressure on the infant's skull is decreased in a predetermined area of the infant's head. For example, the infant's head may be supported on a sideward aspect such that gravitational pressure on a posterior or occipital region of the head is decreased.

FIGS. 1-3 show various views of an embodiment of the invention comprising a first support 1 and a second support 2. As shown in FIG. 1A, the first support 1 comprises a first sloped surface 3, and the second support 2 comprises a second sloped surface 4 that is positioned in use so as to oppose the first sloped surface 3. The first sloped surface 3 is angled at a desired degree 50 relative to a second surface 52. Likewise, the opposing sloped surface 4 is angled at a desired degree 56 relative to a second surface 54 of the second support 2. The angles relative to the first and second base surfaces can be between about 0° and 180°, or may be selected from the group consisting of about 10°, 20°, 30°, 40°, 45°, 50°, 60°, 70°, 80°, 90°, 120°, 135° and 150°. The two angles can be the same or different.

In one embodiment, surface 52 is a first base surface, and surface 54 is a second base surface. Surfaces 52 and 54 typically are substantially planar. The head resting surfaces, surfaces 3 and 4 in FIG. 1A, may be planar, or may be any other shape, such as concave, convex, or angular. The supports 1 and 2 may be separate units or may be separate regions of a single foundation. The supports can be manufactured according to known methods using various materials of varying densities and softness. Typically, these materials will be resilient but soft enough to be comfortable. The supports may also include a disposable or a washable cover which may be made of, for example, an open-weave fabric. The materials useful for the supports include open and closed cell polymeric foams. For example, a polyethylene foam such as ETHAFOAM (Dow Plastic, Midland, Mich.) or an open cell urethane foam. Exemplary materials for the supports and cover include those in U.S. Pat. No. 6,684,437, the disclosure of which is incorporated herein by reference.

In this embodiment shown in FIG. 1A-C, the supports 1, 2 are connectable. Couplers 7a, 7b on each of the supports 1, 2, respectively, take the form of posts which slide into apertures 8a, 8b in the opposing support. FIG. 1B shows the supports 1, 2 assembled together such that they contact each other. Once assembled, the first base surface 52 and the second base surface 54 of the supports 1, 2 combine to form a foundation 21. The supports may be connected by other alternative methods. For example, a hook and loop system such as VELCRO® (a fastening system consisting of at least two opposing members, one with a plurality of hooks and the other having a dense looped pile that interlock when pressed together) may be used to position the supports in physical communication with each other, or the two supports can be connected by tying, pinning, zippering, gluing, snapping, locking, taping, them together. The supports 1, 2, once connected, can be disconnected such that the couplers 7a, 7b slide out of their respective apertures 8a, 8b. In this instance, one or both of the supports 1, 2 can be replaced with an another support (for example, one with a different slope of the head resting surface). In an alternative embodiment, the device is a single piece that forms a “V” shape towards the central portion of the device. This device would look similar to the two-part device shown in FIG. 1B.

As shown in FIG. 1C, the head positioning device 26 may be tilted by an optional third support 25. The third support 25 slides under one of the supports 1, and tilts the assembly. Alternatively, a third support can slide under the other of the supports. Additionally, two or more additional supports can be used to tilt the assembly. For example, after a first additional support is added, and additional tilting of the support is desired, another additional support can be added in series with the first additional support. Also, additional supports can be used on both sides of the device. Alternatively, the third support can replace the first or second support 1,2 altogether. Additionally, the supports (and/or the additional supports) may include built-in compartments for holding or containing baby objects such as bottles, toys, musical devices, and pacifiers.

FIG. 2 shows an infant 8 using the head positioning device 26. The infant's 8 head is supported by the first head resting surface 3 and the second head resting surface 4, causing the infant's 8 head to tilt to one side. The infant's 8 head is tilted by a certain amount (represented by a tilt angle 20 between lines 27 and 28). This tilt angle 20 is formed between line 27 (the midline of the infant's head) and line 28 (a line perpendicular to the foundation 21 and located at the intersection of the supports 1,2). The tilt angle 20 is a result of the slope of the two head resting surfaces 3,4, where slope is governed, for example, by angles 50 and 56. The tilt angle can have any value, for example, between about 0° to about 180°, or may be selected from the group consisting of about 10°, 20°, 30°, 40°, 45°, 50°, 60°, 70°, 80°, 90°, 120°, 135° and 150°. However, the tilt angle is capable of having any value that corresponds with the degree to which an infant's head can be turned. Furthermore, the angle may also reflect a three dimensional aspect and provide tilt in the X, Y and/or Z axes.

FIG. 3 shows a rear view of the infant 8 and device 26 shown in FIG. 2. This view shows that the first head resting surface 3 on the first support 1 provides support for a sideward aspect 10 of the infant's 8 head, and, similarly, the second head resting surface 4 on the second support 2 provides support for a rearward aspect 11 of the infant's 8 head, causing the infant's 8 head to assume a side-facing position. The degree of the tilt angle is based on the slope of the two surfaces 3 and 4. As mentioned, due to the particular slope of the head resting surfaces 3, 4, portions of the sideward and rearward aspects 10, 11 of the infant's 8 head are in physical contact with the supports 1, 2. In the embodiment shown in FIG. 3, with the infant 8 in a supine position such that the infant's 8 head is in a side-facing position with the right sideward aspect 10 being supported by the first support 1 and, simultaneously, the rearward aspect 11 being supported by the second support 2, the infant's 8 head is allowed to tilt to the side such that gravitational pressure is at least partially distributed to the right sideward aspect 10 of the infant's 8 head, thereby preventing or treating plagiocephaly in the infant.

To the extent the tilt angle of the infant's head is desired to be changed, the first support and/or the second support can be replaced with another support having a different angle relative to the base surface. The angle relative to the base surface also can be a compound angle. Not only does the head resting surface form an angle with the base surface, but also the head resting surface is sloped toward or away from the infant such that the head resting surface is lower in the rear of the device than in the front of the device (i.e., sloped away from the infant) or is higher in the rear of the device than in the front of the device (i.e., sloped toward the infant).

In certain embodiments, the tilt angle may be 0° such that the infant's head lies in a forward facing position. In this instance, the line through the midline of the infant's head and the line perpendicular to the foundation and located at the intersection of the supports coincide. The first support and the second support simultaneously provide support to the left and right temporal areas of the infant's head, thus elevating the occipital area of the infant's head without the occipital area substantially contacting the first and second supports. This configuration distributes gravitational pressure to the left and right temporal areas of the infant's head.

FIGS. 4A-D show kit comprising a cap and a fastener to be used with a head positioning device 26. The kit includes the head positioning device 26 having a fastener 17 (such as the hooks or the loops of a hook and loop fastening system) disposed on the first head resting surface (FIG. 4A). Additionally, the kit includes a cap 15 having a fastener 16 (such as the loops or the hooks of a hook and loop fastening system) complementary to the fastener 17 on the head positioning device 26. The cap 15 is sized and shaped to receive the infant's 8 head (FIG. 4D). In the embodiment shown in FIGS. 4B and 4C, the fastener 16 is located such that it corresponds to the temporal area of the infant's 8 head. The fastener 16 allows the cap to be removably fastened to the support 1. Typically, the placement of the fastener on the cap is dictated by the maximum curvature of the individual infant's head. The fastener is generally located on the cap on the side of the infant's head containing the larger curvature as opposed to being on a misshapened or flatten aspect of the infant's head.

In alternative embodiments, the cap may have a fastener system on both sides of the cap, a fastening system covering the entire cap, one hemisphere of the cap, or one or more quadrants or other regions of the cap. The fastener may be adjustable and may be located in various locations on the cap, such as areas that correspond to the occipital and temporal areas of the infant's head. Additionally, the complementary part of the fastening system to the part on the cap may be located on both supports. The fastening system on the support or supports can be over all or a portion of the head resting surface of the support or supports. Other than hook and loop systems, the fastening systems can accomplish fastening the infant's head in a desired position by tying, pinning, zippering, gluing, snapping, locking, taping, and suction.

The cap may be constructed from any of a variety of textiles, and these materials typically are soft and flexible. Useful materials include those that do not retain heat to such a degree that the cap is uncomfortable for the infant and/or those materials that would allow an infant to breathe should the infant's mouth or nose become covered. Such materials include mesh and other porous materials. The cap may be washable and reusable or, alternatively, may be disposable.

FIG. 5A shows a head positioning device 26 on a flat pad-type mat 23, while FIG. 5B shows the head positioning device 26 on a mattress-type mat 23. The first support 1 and the second support 2 of the head positioning device are each either permanently or removably attached to the mat. The first support 1 and/or second support 2 can be attached by using a hook and loop system, tying, pinning, zippering, gluing, snapping, locking, taping, and suction. As shown in FIG. 5B, the first and second supports 1, 2 may be permanently built into the mat 23. In the embodiment of FIG. 5B, the mat 23 comprises a mattress that may be used instead of a standard mattress in a crib. FIG. 5C shows a view from the top of an infant's head 28 of the device 26 of FIG. 5B in use. In the embodiment shown, support 1 comprises an obtuse angle 30, and support 2 comprises an acute angle 32, and the infant's head is held in a side-facing position with the posterior portion elevated without coming into contact with any surface. FIG. 7 shows an infant using the head positioning device 26 attached to a flat mat 23, as shown in FIG. 5A. The cap 15 is used in conjunction with the head positioning device 26 as described for FIGS. 1A-D, 2, 3, and 4A-D.

FIG. 8 is a view of a kit encompassing the items shown in FIGS. 1A-C, 2, 3, 4A-D, 5, and 7. The kit includes the first and second supports 1 and 2, an additional support such as the third support 25, the mat 23 (shown with the assembled head positioning device attached to it), and the cap 15 (shown with an addition patch of fastener on the side that did not have the fastener in FIG. 4C).

FIG. 6 is another embodiment of a mat 23 for use without a head positioning device. The cap 15 can be removably attached to the mat 23 using any fastening system, such as any of the fastening systems described for FIGS. 4A-4D. For example, the mat has an area 23a that contains hooks or loops of a hook and loop fastening system and the cap 15 has the complementary loops or hooks of the fastening system. As shown in use, the infant 8 is positioned in a supine position with the infant's 8 head fastened and held in a side-facing position by the mat 22 such that gravitational pressure is at least partially distributed to the left temporal area 10 of the infant's 8 head, thereby preventing or treating plagiocephaly in the infant. An infant's head can be positioned in any desired position, and the cap can be designed in any of the manners described for the system FIGS. 4A-D.

The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting on the invention described herein. Scope of the invention is thus indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are intended to be embraced therein.

Each of the patent documents and scientific publications disclosed above is incorporated by reference herein.