Abstract:
A device for treating or preventing plagiocephaly includes a head strap, pair of shoulder straps and a crotch strap which hold a patient&#39;s head correctly in a depression in a pillow section. The device can be custom fit to the characteristics of any person&#39;s head.

Description:
BACKGROUND 
       [0001]    1. Field of the Invention 
         [0002]    The invention is a device to be worn by infants and newborn children, for example, during sleep in order to prevent plagiocephaly. 
         [0003]    2. Background of the Invention 
         [0004]    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&#39;s head in the same position against a flat surface during sleep or rest. During development, an infant&#39;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 can cause the infant&#39;s head to mold to the shape of the surface at the contact region between the head and surface. The infant&#39;s head flattens, and, thus, develops what is known as positional plagiocephaly, or flattened head syndrome. 
         [0005]    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. 
         [0006]    Several devices to 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&#39;s head or body. One of these devices is described by U.S. Pat. No. 6,968,586, herein incorporated by reference in its entirety. Helmets and caps (such as described by U.S. Pat. No. 6,393,316, herein incorporated by reference in its entirety) that are available are, by design, thick and bulky to allow the cushioning of the infant&#39;s head in preventing positional plagiocephaly. Because of their design, these helmets and caps place the infant&#39;s head in an unnatural and uncomfortable position and can become uncomfortably hot when worn for extended periods. 
         [0007]    Similarly, available pillows include those having a sloped surface that causes the tilting of an infant&#39;s head. These devices, however, lack sufficient counter-support to allow natural positioning of the infant child&#39;s head without excessive effort or discomfort on the part of the infant. These pillow-type devices may be provided with one or more indentation regions. 
         [0008]    Furthermore, conventional caps and head supports fail to provide for adjustment or customization of treatment, particularly once plagiocephaly has been diagnosed. 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&#39;s head or gradual improvement in the shape of the infant&#39;s head. 
         [0009]    Although commercial devices currently on the market are designed to prevent instances of plagiocephaly, once such a condition is found in a child, none of these devices can be used to correct the problem with a customized solution. 
       SUMMARY OF THE INVENTION 
       [0010]    In order to solve the problems of conventional systems, the head snuggler of the present invention includes a pillow section for receiving and supporting the rear of a child&#39;s head and a head strap to hold the child&#39;s head on the pillow section. 
         [0011]    In one embodiment, the snuggler is provided with one or more shoulder straps, designed to be worn around the shoulders of the child. These shoulder straps can be used to further secure the device to the child. Additional elements, such as crotch supports, and clips can also be included, to form what is known in the art as a five-point harness. 
         [0012]    In one preferred embodiment, in order to correct a condition of plagiocephaly, the device may be customizable. For example, once plagiocephaly has been diagnosed in a child, a mold can be taken, and a properly fitting device be manufactured therefrom. 
         [0013]    In other embodiments, the device can be used as a treatment or preventive for other conditions. Examples of such conditions include:
       a. A child or an adult with an injury or illness that would benefit from midline head support while in a supine position, e.g., for children in a car seat or stroller;       
 
         [0015]    b. Children or adults with significant cranial burns in need of pressure relief;
       c. Children or adults with head trauma and/or brain injuries, cranial surgeries; craniotomies, locked in syndrome, edema, stroke, bone plate removal positioning, shunt placement;   d. Individuals with Cerebral palsy; positioning for upright feeding, wheel chair positioning, and/or sleeping;   e. Individuals with occipital pressure sores or soft tissue ear sore from sidelying;   f. Individuals with tortocollis or for prevention thereof;       
 
         [0020]    g. Infants in the Neonatal Intensive Care Unit; to avoid airway complication from intubation, support head in midline and in sidelying;
       h. Dolicephaly prevention by supporting head in a midline position; encouraging age appropriate development in the hospital and/or at home;   i. Individuals in the Intensive Care Unit in a coma, sedated and/or chemical paralyzed and are unable to relieve pressure from their heads; and   j. Infants born with chromosomal defects that would benefit from support while sleeping in the hospital and/or at home.       
 
         [0024]    Other objects, features and advantages of the present invention will become apparent from the following detailed description. It should be understood, however, that the detailed description and the specific examples, while indicating preferred embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description. 
     
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0025]      FIG. 1  shows a device according to the invention, as worn by a child. 
           [0026]      FIG. 2  shows a preferred embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0027]      FIG. 1  shows a head snuggler device  10 , as worn about a forehead  12  of a child  14 . In one embodiment, the device  10  includes a pillow section  16  and a single strap  18  that holds the device in place. 
         [0028]    The strap  18  can be any conventional strap. For example, the strap  18  may include hook-and-loop pads, and/or may be formed from an elastic-type material (permitting stretching), allowing for a great deal of adjustability in the length of the strap  18 . Typically, the strap  18  has a cushioning element  18   a  which can be as simple as a soft pad (e.g., cotton or gauze), where the strap  18  meets the forehead. 
         [0029]    The strap  18  is preferably positioned to hold the back of the child&#39;s head  20  in place over the pillow section  16 . In a preferred embodiment (shown in  FIG. 2 ), the pillow section  16  is provided with an indentation  22  into which the back of the child&#39;s head  20  is to be placed. Although the indentation  22  is preferably centered in the pillow section  16 , such that an upper ledge  24 , of equal length L, is about the indentation, such is not required. 
         [0030]    Although  FIG. 2  shows the indentation  22  has a hole, it is within the scope of the invention to provide the indentation  22  with a bottom  22   a  (not shown). In such a configuration, the bottom  22   a  is typically at a different elevation as compared to the upper ledge  24 , in order to form the indentation  22 . 
         [0031]    If the strap  18  is positioned correctly, it is possible to have a reversible device  10 , wherein the bottom is not positioned centrally in the indentation. When the device  10  is in one orientation, the bottom  22   a  would be at a first distance from the (effective) upper ledge  24 , and when flipped over, the bottom  22   a  could be at a different distance from the (effective) upper ledge  24 . 
         [0032]    Positioned between the upper ledge  24  and the indentation  22  (or bottom  22   a ) is a transition  26 .  FIG. 2  shows the transition  26  as being a straight section, forming a singe sharp angle (such as an approximate right angle) with the upper ledge. However, the transition may be rounded (preferably convex), tapered or connect through a number of angles and lengths (which may be equal or different). 
         [0033]    The material for the pillow section  16  may be any type of material, but is typically soft. In one embodiment, the pillow section  16  is formed from a wire-type frame and is covered by a soft fabric covering. The covering can be removed for cleaning or replacement. The pillow section  16  can also be formed from a foamed material which would allow for a varying degree of deformation under pressure. The specific type of foam, e.g., open cell, etc., would be determined depending upon the desired properties. 
         [0034]    It is also considered within the scope of the invention to form the pillow section  16  from an inflatable structure. In this embodiment, a port  16 a (not shown) would be present on the pillow section  16  to allow for inflation, which can be performed manually (e.g., by mouth) or automatically (e.g., a pump). If the port  16 a were not present, the pillow section  16  can be inflated by a gas cartridge (e.g., a carbon dioxide cartridge), configured to release its gas into the pillow section. 
         [0035]    The device  10  typically includes other securing elements. In one embodiment, two shoulder straps  30  are positioned on opposite sides of the pillow section  16  to help prevent the child from moving off the device  10  in a lateral direction. If further securing is desired, a crotch strap can be provided, attached at a lower extension, or a chest clip can be used (which can connect to each shoulder strap). Padding and other elements can also be included, as described by U.S. Pat. No. 6,968,586. 
         [0036]    Although the device  10  may be purchased “off the shelf,” typically the device  10  is custom designed to ensure the correct fit. Typically, this is accomplished by having the head of the child measured and the measurements transmitted to the manufacturer by, e.g., telephone, U.S. mail, electronic mail, facsimile, and the internet. For example, the manufacturer can maintain provide a website, giving both instructions for taking the measurements (which instructions can include a template) and a form for inputting the measurements and ordering the device. 
         [0037]    The measurements can also be determined with a mold. For example, a parent or doctor can place a deformable mold on the head of the child, such that the mold mimics the shape of the child&#39;s head. The mold is then sent to the manufacturer who determines the characteristics of the child&#39;s head from the mold. In such an embodiment, the mold can be purchased at a retailer, eliminating the need for a doctor. 
         [0038]    In one embodiment, the mold is a flexible plastic structure, such as a B-stage resin. When formed into the correct shape, the mold can be rigidified by any method known in the art. This method is similar to that which is disclosed by U.S. Pat. No. 5,874,141, herein incorporated by reference in its entirety. 
         [0039]    It is considered within the scope of the invention to provide a number of devices in accordance with the invention. For example, if a device is purchased when a child is at a young age (such as 1 or 2 months), the device will likely not fit once the child reaches 4 or 5 months. Therefore, multiple devices, of various sized can be sold in a single package or retailers can stock devices of various sizes. 
         [0040]    Similarly, when a device is custom designed, the manufacturer can form multiple devices of different sizes for when the child ages. Statistical information and current characteristics (e.g., measurements of different areas) can be used to anticipate or hypothesize as to the size and shape of devices for when the child ages. 
         [0041]    In addition to correcting plagiocephaly in a child, the device of the invention can be used to treat plagiocephaly. Particularly because the device can be custom designed for use with a specific child with the child&#39;s particular condition, unlike conventional devices, the device of the invention can be formed to apply pressure in certain areas, and relieve pressures in other areas to correct plagiocephaly. 
         [0042]    It should be apparent that embodiments other than those specifically described above may come within the spirit and scope of the present invention. Hence, the present invention is not limited by the above description.