Abstract:
The present invention discloses, inter alia, a device and method for correcting the shape of an infant&#39;s abnormally-shaped cranium by applying external forces over time with the growth of an infant to achieve normal shaping of the infant&#39;s head. The device applies inwardly-directed external forces only to areas of bony prominence and minimizes (or altogether eliminates) these forces on the areas of the skull that are less prominent (or flattened). Because the present invention is non-conforming to the shape of an abnormal skull, the exerted forces cause accelerated expansion of the skull in less prominent (flattened) areas coincident with brain and skull growth. This causes the cranium to return to a normal symmetric cranial shape. The material that contacts the infant&#39;s cranium is semi-rigid and relatively non-flexible, maintains its overall shape under stress.

Description:
BACKGROUND OF THE INVENTION 
       [0001]    1. Field of the Invention 
         [0002]    The present invention relates generally to a headrest in which an infant&#39;s cranium is positioned while the infant is sleeping to correct cranial deformities. More specifically, the invention relates to a headrest and method for correcting any non-synostotic deformity of the side and posterior aspects of an infant&#39;s head. 
         [0003]    2. Background of the Invention 
         [0004]    At birth, the six cranial bones comprising an infant&#39;s skull are spaced far enough apart to allow the skull to rapidly grow during the first months of the infant&#39;s life. This spacing also allows the bones to overlap so the infant&#39;s head can pass through the birth canal without compressing, and thereby damaging, the infant&#39;s brain. Eventually—some time between three and six years of age—the cranial bones will fuse and remain fused for the rest of the child&#39;s life. 
         [0005]    During an infant&#39;s normal growth, forces within the infant&#39;s skull are directed outward and are constant and equally distributed on the inner surface of the growing skull causing the skull to expand. Accordingly, a decrease of the intracranial pressure will cause a reduced head size. Similarly, an increase in intracranial pressure will cause an increased head size. 
         [0006]    Fibrous bands of tissue, called cranial sutures, fill the space between the bones and connect the bones of the skull to each other. These cranial sutures are strong and elastic, providing a flexibility to the skull to allow rapid brain growth during the first months of life. Without the sutures, a child would suffer brain damage due to constriction of the brain during the period of normal growth. 
         [0007]    During the first few months of an infants&#39; life, however, the infant is most susceptible to the formation of synostotic or non-synostotic deformities in the cranium. Synostotic deformities are a result of craniosynostosis, which is a birth defect of the skull characterized by premature closure of one or more of the cranial sutures. Craniosynostosis can be hereditary or the result of a metabolic disease, and is characterized by an abnormally-shaped skull and potential for abnormal intracranial pressure, mental retardation, seizures, and blindness. 
         [0008]    On the other hand, non-synostotic deformities, in which the cranial sutures remain open, are caused by environmental conditions, including premature birth, torticollis (twisting of the neck muscles beyond their normal position), or the preferred sleeping position of the child. In addition, neurological abnormalities, such as paralysis, cerebral palsy, or some sort of developmental delay, may predispose a child to cranial positioning problems. Non-synostotic deformities are also called positional deformities. 
         [0009]    Synostotic and non-synostotic deformities manifest themselves in a variety of ways. Plagiocephaly, for example, is a cranial deformity resulting in an asymmetric head shape. Plagiocephaly consists of a focal area of flattening in the anterior or posterior aspect of one side of the head, which also commonly produces additional compensatory deformities in adjacent areas of the skull, skull base, and face, including the orbital (eye) and mandibular (jaw) structures. This deformity most commonly occurs in the posterior aspect of the head (posterior plagiocephaly), resulting in a focal area of flattening on that side and a compensatory prominence, or bulge, on the other side. In addition, the deformity produces anterior displacement of the ear, ear canal, temporomandibular (jaw) joint, forehead and orbital structures on the same side. Cranial deformities may also be classified, inter alia, as brachycephaly (a short, wide head shape), scaphocephaly (a long, narrow head shape), and turricephaly (a pointed head shape). 
         [0010]    Non-synostotic posterior plagiocephaly is a very common problem for which parents seek evaluation and recommendations from their family physician or pediatrician. The incidence of this abnormality has increased significantly since publication of recommendations by the American Academy of Pediatrics that neonates (infants) should be put to sleep on their back rather than face down. These recommendations were made to reduce the incidence of Sudden Infant Death Syndrome (SIDS) by eliminating airway and respiratory compromise in the prone (face-down) position, which the Academy considered a possible contributor to the SIDS problem. 
         [0011]    The usual method of attempting to treat these deformities involves trying to reposition the child during sleep. The most common adjuncts available to assist with this treatment are flat- and wedge-shaped foam pads. For example, U.S. Pat. No. 6,473,923 (filed Nov. 22, 2000) (issued Nov. 5, 2002) discloses a body pillow and head positioner attached to a mat. The device is intended to maintain the infant&#39;s supine position while reducing the risk of positional plagiocephaly by causing the head to rotate to the side while maintaining the infant&#39;s supine position. 
         [0012]    Simply put, repositioning, even with foam padding, is ineffective for treating or preventing these deformities, and even after treatment most children do not obtain a perfectly normal head shape. Repositioning merely distributes or disperses the forces over a larger area of the head. The foam padding remains in contact with the skin and conforms the head to an abnormal shape. Due to this ineffectiveness, a large number of these children require additional treatment from five to ten months of age due to persistent or progressive deformities. 
         [0013]    The additional treatment most often is by application of a custom-made external orthosis, or helmet. See, e.g., Corrective Infant Helmet, U.S. Pat. No. 6,592,536 (filed Jan. 7, 2000) (issued Jul. 15, 2003); Therapeutic and Protective Infant Helmets, U.S. Pat. No. 4,776,324 (filed Apr. 17, 1998) (issued Oct. 11, 1998). Such devices provide an expanded area over the site of the deformity, thereby allowing for correction of the deformity over a three to six month period of time related to brain and skull growth and subsequent reshaping. This prolonged time of use is necessary because of the reduced rate of brain and skull growth during the six- to twelve-month time frame. Due to a decrease in the rate of brain and skull growth to approximate fifty percent of the rate from birth to six months and increased stiffness of bones and cranial sutures, the recommendation is to wear the helmet continuously for twenty-three hours each day for up to twelve months. But despite extended use of these helmets, deformities rarely return to a normal shape. In addition, many health insurance companies and programs refuse to pay for these devices, leaving a large number of infants with no available treatment because of the relatively high cost of the helmets. 
         [0014]    Another approach to correcting cranial deformities is to soften the material on which the infant&#39;s head rests by using a foam pad or memory foam pillow. This method allows the redistribution of inwardly directed forces over a slightly larger surface area, but fails to adequately correct cranial deformities because the softened material conforms to the head shape. The material still contacts, and therefore applies forces to, flattened areas instead of only the abnormal cranial bulges. Preventing cranial deformities with this approach is also ineffective because forces continue to act directly on a focused area of the head. Forces acting on a smaller area of the head results in cranial flattening, and therefore an abnormal head shape, because the head conforms to the shape of the material at the point of contact. 
         [0015]    Still another approach is to suspend the infant&#39;s head on a flexible material, which, for example, may be a net with an open weave that keeps the infant&#39;s head slightly elevated over the resting surface. See Method and Apparatus to Prevent Positional Plagiocephaly in Infants, U.S. Pat. No. 6,052,849 (filed Mar. 18, 1999) (issued Apr. 25, 2000). Although the use of an elastic stretchable material or netting may be slightly better than regular foam for preventing the development of flattened areas, these devices do not promote normal shaping due to the continuous application of external forces directed at a smaller posterior aspect of the infant&#39;s head. As with the “softened material” approach previously described, forces acting on a smaller area of the head results in cranial flattening because the head conforms to the shape of the stretched material, thus resulting in an abnormal head shape in which the frontal areas are wider than the posterior aspect of the head. 
         [0016]    After ten to twelve months of age, little, if any, correction of a cranial deformity can be accomplished with non-operative treatment because of reduced velocity of brain and skull growth, increased thickness of bone, and reduced flexibility of the cranial sutures. Surgical intervention is typically the only effective treatment for moderate to severe deformities in children over twelve months of age. 
         [0017]    The prior art for treating this condition does not directly address the cause of the problem, and therefore does not effectively treat the condition. All other products and devices, including foam, elastic (and therefore flexible) material or netting, merely distribute or disperse forces over a larger area of the head. Because these products and devices remain in contact with the skin, they therefore conform the cranium to the abnormal shape. Thus, the prior art does not remove or eliminate the external forces at flattened areas of the cranium, but rather maintains an abnormal cranial shape and promotes a static deformity. 
         [0018]    Currently there is no specific apparatus available to provide effective corrective and preventative treatment for non-synostotic cranial deformities in the age range of birth to five months. To avoid the difficulties and pitfalls associated with currently available devices aimed at treating non-synostotic cranial deformities, the present invention discloses a corrective headrest for use at the very first recognition of development of a deformity. The headrest and method allow effective treatment during the rapid period of brain and skull growth (birth to six months), thereby providing rapid correction of the deformity. Children with predisposing conditions possibly require prolonged treatment. Early effective treatment is the key to providing complete correction of these deformities. 
       SUMMARY OF THE INVENTION 
       [0019]    The present invention discloses, inter alia, a device and method for correcting and preventing the shape of an infant&#39;s abnormally-shaped cranium by applying external forces over time with the growth of an infant to achieve normal shaping of the infant&#39;s head. Unlike the prior art, the present invention both 1) prevents abnormal shaping of an infant&#39;s cranium by causing even growth of the infant&#39;s normally shaped head and 2) provides forces that act unevenly across an abnormally shaped cranium to correct existing cranial deformities. The embodiments of the present invention include a solid, one-piece headrest structure of uniform consistency, which is molded to approximate the posterior and side aspects of the skull and head, with cervical, or neck, support. The material that contacts the infant&#39;s cranium is semi-rigid and relatively non-flexible, maintains its overall shape under stress, and demonstrates minimal superficial focal elasticity only at the site of cutaneous contact. 
         [0020]    To correct existing cranial deformities, the present invention applies inwardly-directed external forces only to areas of bony prominence and minimizes (or altogether eliminates) these forces on the areas of the skull that are less prominent (or flattened). The present invention is non-conforming to the shape of an abnormal skull. The forces exerted allow for accelerated expansion of the skull in the less prominent (flattened) areas coincident with brain and skull growth, allowing for return to a normal symmetric cranial shape. 
         [0021]    In addition, the headrest prevents development of abnormal cranial shaping by providing a round, normally-shaped contour for the posterior and side aspects of the head, even if the head is turned slightly to one side or the other. Because the contour is normally shaped, the entire surface area of the head that rests in the depression contacts the surface of the headrest. Moreover, because the surface is semi-rigid, the surface will allow for even cranial growth over this area of contact, thereby maintaining the infant&#39;s normal head shape. 
         [0022]    The preferred embodiment of the present invention is made from an impermeable high-density foam, which provides ease of cleaning as well as flame retardant properties. Other embodiments of the present invention are made from other foam variants, including open cell foam covered with a vinyl or other coating or closed cell foam layered over or applied to more rigid solid or hollow plastic (e.g., PVC or nylon). 
         [0023]    Therefore, in accordance with one aspect of the present invention, a headrest having a semi-rigid body for correcting the shape of an infant&#39;s abnormally-shaped cranium includes a bottom surface for contact with a resting surface; a top surface for contact with the cranium of the infant; a generally hemi-ellipsoidal depression in the top surface; and a ridge at one end of the depression for supporting the neck of the infant. The shape of the depression corresponds to the shape of a normal infantile cranium. The top surface provides external forces acting on abnormal cranial bulges of the infant&#39;s cranium and eliminates external forces that act on abnormal cranial depressions of the infant&#39;s cranium. 
         [0024]    Other features of the headrest include a rim that defines a substantial portion of the depression, as well as the headrest having a side surface between the bottom surface and the top surface. Furthermore, an additional feature of the headrest includes a curved front surface that cradles the shoulders and further supports the neck of the infant. 
     
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0025]    The present invention, as well as further objects and features thereof, are more clearly and fully set forth in the following description of the preferred embodiment, which should be read with reference to the accompanying drawings, wherein: 
           [0026]      FIG. 1  is a perspective view of the preferred embodiment of the present invention; 
           [0027]      FIG. 2  is a frontal view of the preferred embodiment of the present invention; 
           [0028]      FIG. 3  is a sectional view of the headrest along Line  3 - 3  of  FIG. 2 ; 
           [0029]      FIG. 4  is a sectional view along Line  4 - 4  of  FIG. 2 ; 
           [0030]      FIG. 5  is perspective view of an alternative embodiment of the present invention; 
           [0031]      FIG. 6  is a frontal view of the headrest shown in  FIG. 5 ; 
           [0032]      FIG. 7  is a sectional view along Line  7 - 7  of  FIG. 5 ; 
           [0033]      FIG. 8  is a perspective view of another alternative embodiment of the present invention; 
           [0034]      FIG. 9  is a sectional view along Line  9 - 9  of  FIG. 8 ; 
           [0035]      FIG. 10  is yet another embodiment of the present invention; and 
           [0036]      FIG. 11  is a sectional view along Line  11 - 11  of  FIG. 10 . 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
       [0037]      FIG. 1  through  FIG. 4  show a headrest  10  that is the preferred embodiment of the present invention. The headrest  10  comprises a bottom surface  12  for contacting a resting surface  14 , and a top surface  16  for contacting an infant&#39;s cranium. The top surface  16  comprises a generally hemi-ellipsoidal depression  18 , which corresponds to the shape of a normal infantile cranium, and a rim  22  defining a substantial portion of the depression  18 . At one end of the depression  18 , a ridge  20  is positioned to support the neck of the infant. The top surface  16  is preferably made of a closed cell foam material, but may alternatively be made of open cell foam material covered with a vinyl or other surface coating, closed cell foam layered over higher density foam, open cell foam layered over higher density foam, or closed cell foam layered over a more rigid solid or hollow plastic. 
         [0038]    A front surface  24 , preferably curved, is positioned to cradle the infant&#39;s shoulders and support the neck of the infant while the infant&#39;s cranium is in contact with the top surface  16 . A preferably-curved side surface  26  extends between the rim  22  and the bottom surface  12 . In this preferred embodiment, the headrest  10  is a continuous, uniform, solid body. However, it is anticipated that variations of the uniformity or continuity of the body could occur and be utilized. 
         [0039]    In normal operation for correction of an abnormally shaped infant cranium, the headrest  10  is placed on the resting surface  14  so that the bottom surface  12  is in contact therewith. The infant&#39;s head is then placed in the depression  18  with the infant&#39;s head resting on the top surface  16 ; Initially, the posterior and part of the side aspects of the infant&#39;s head contacts the top surface  16 , although during the sleep period the infant&#39;s head may roll to one side or the other. Throughout the sleep period, the infant&#39;s neck is supported by the ridge  20 . The infant&#39;s shoulders are aligned in and cradled by the curved front surface  24 . As the infant&#39;s head makes contact with the top surface  16 , the top surface  16  provides external forces acting on any abnormal bulges of the infant&#39;s cranium and eliminates external forces that act on abnormal depressions of the infant&#39;s cranium. This contact reduces the net outward forces from brain and skull growth at these prominences, and redirects the growth to areas of the cranium where the infant&#39;s head is not in contact with the top surface  16 . 
         [0040]    The headrest  10  works similarly to prevent cranial deformities. The infant&#39;s head is placed in the depression  18 , which matches the round, normally-shaped contour of the posterior and side aspects of the head. This normally-shaped semi-rigid contour allows for the development of normal cranial shaping regardless of the head&#39;s resting position by preventing growth in the areas of contact. Forces from the top surface  16  act on the areas of the cranium in contact therewith, which in an already normally-shaped head is the totality of the surface area resting in the depression  18 . Because of its semi-rigid character, the top surface  16  allows the infant&#39;s cranium to grow evenly and maintain its normal shape. 
         [0041]      FIG. 5  through  FIG. 7  show an alternative embodiment of the present invention that requires less material to manufacture. The headrest  11  comprises two beams  31  for contacting a resting surface  15 , and a top surface  17  for contacting an infant&#39;s cranium. The elongated beams  31  are positioned along opposite sides of the headrest  11 . The front and back of the headrest  11  are open, forming an opening  29  defined on either side by the beams  31 . 
         [0042]    The top surface  17  of the headrest  11  comprises a generally hemi-ellipsoidal depression  19  that corresponds to the shape of a normal infantile cranium and a rim  23  that defines a substantial portion of the depression  19 . At one end of the depression  19 , a ridge  21  is positioned to support the neck of the infant. The top surface  17  is preferably made of a closed cell foam material, although other materials may be used as described hereinabove. A pair of side surfaces  27 , only one of which is shown by  FIG. 5 , adjoin the rim  23  to the beams  31 . 
         [0043]    As shown more clearly by  FIG. 7 , the beams  31  are positioned at opposing sides of the headrest  11  and along the perimeter thereof, thereby forming an opening  29  between the beams  31 . In another embodiment, however, the opposed beams  31  are positioned at the front and rear of the headrest  11 . 
         [0044]    After placement of the headrest  11  on the resting surface  15  so that the beams  31  are in contact therewith, the infant&#39;s head is placed in the depression  19  with the infant&#39;s head resting on the top surface  17 . Correction and/or prevention of the infant&#39;s abnormally shaped cranium is then accomplished in the same manner as in the preferred embodiment. 
         [0045]      FIG. 8  and  FIG. 9 , which is a sectional view along Line  9 - 9  of  FIG. 8 , show another embodiment of the present invention. The apparatus of this embodiment comprises a mattress or padded surface  32  and a generally hemi-ellipsoidal depression  34  in a portion of the mattress surface  32 . The depression  34  corresponds to the shape of a normal infantile cranium, and has a semi-rigid top surface  36  that is defined by the depression  34 . In this embodiment, the top surface  36  is resilient and made of a closed cell foam material, providing external forces acting on abnormal cranial bulges and minimizing external forces acting on abnormal cranial depressions of the infant. However, it is anticipated that other materials could be utilized, such as open cell foam with a vinyl coating. In this embodiment, a ridge  38  at one end of the top surface  36  is shaped and positioned to support the neck of the infant while the infant&#39;s head rests on the top surface  36  of the apparatus  30 . In another version of this embodiment, it is anticipated that the ridge  38  will be eliminated. 
         [0046]    The embodiment shown by  FIG. 8  and  FIG. 9  is disclosed with a substantially flat mattress or padded surface  32 . However, it is anticipated that the mattress or padded surface  32  could be contoured to prevent an infant from rolling. It is further anticipated that the area of the mattress or padded surface  32  surround the depression  34  could be raised to provide support for the infant&#39;s head in a slightly raised position. 
         [0047]    As with the already-described embodiments, the infant&#39;s head is placed in the depression  34  formed in the mattress  32  such that the infant&#39;s head is in contact with the top surface  36 . The infant&#39;s neck is supported by the ridge  38 , while the infant&#39;s body is supported in a comfortable resting position by the mattress  32  in a generally supine position. Correction and/or prevention of the infant&#39;s abnormally shaped cranium is then accomplished in the same manner as in the preferred embodiment. 
         [0048]      FIG. 10  and  FIG. 11 , which is a sectional view along Line  11 - 11  of  FIG. 10 , show another embodiment of the present invention, an apparatus  33  comprised of a semi-rigid body  44  with a hemi-ellipsoidal top surface  40  that is in the shape of a normal infantile cranium. A plurality of legs  42  support the semi-rigid body  44  in a position to allow an infant&#39;s head to rest on the top surface  40 . In this embodiment, there are four legs  42 , as shown in  FIG. 10  and  FIG. 11 . However, it is anticipated that more or fewer legs could be used to support the body  44 . The top surface  40  is resilient and made of closed cell foam, although in alternative embodiments of the present invention the top surface  40  may be made of other material, including open cell foam covered with a vinyl coating and other materials as described hereinabove. Furthermore, a ridge  46  at one end of the top surface  40  is shaped and positioned to support the neck of the infant while the infant&#39;s head rests on the top surface  40  of the apparatus  33 . 
         [0049]    After placement of the apparatus  33  on a resting surface so that legs  42  are in contact therewith, the infant&#39;s head is placed in the depression  48  with the infant&#39;s head resting on the top surface  40  and the infant&#39;s neck being supported by the ridge  46 . Correction and/or prevention of the infant&#39;s abnormally shaped cranium is then accomplished in the same manner as in the preferred embodiment. 
         [0050]    The present invention is described above in terms of a preferred illustrative embodiment of a specifically described headrest, as well as alternative embodiments of the present invention. Those skilled in the art will recognize that alternative constructions of such a headrest can be used in carrying out the present invention. 
         [0051]    Other aspects, features, and advantages of the present invention may be obtained from a study of this disclosure and the drawings, along with the appended claims.