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.
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.
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.
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.
FIGS. 4A-D show a schematic view of a system involving a head positioning device according to
FIGS. 5A-C show a schematic perspective view of certain embodiments of a mat and head positioning device.
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.
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
In this embodiment shown in
As shown in
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 (
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.
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.