HK1165692A - Lateral support craniocervical orthosis and method - Google Patents

Description

Transverse support craniocervical orthosis and method

Cross reference to related applications

This case is a partially-continuing application claiming benefit of U.S. patent application 12/389,320, filed on 3/2009 for 2/19 and entitled "transverse Support cervical orthoses and methods", filed on 8/2006 for a Headrest and Method for correcting Non-Synostotic Cranial Deformities in Infants (Headrst and Method for correcting Non-Synostotic cervical Deformities in Infants) "for 11/446,402. Each of these applications is incorporated herein by reference.

Statement regarding federally sponsored research or development

Not applicable.

Technical Field

The present invention relates generally to a craniocervical orthosis in which an infant's cranium is positioned while sleeping to prevent and correct cranial deformities. More specifically, the present invention relates to a craniocorvical orthosis and method for preventing and correcting any non-synostotic deformity of the sides and back of an infant's head.

Background

At birth, the six cranium bones that make up the infant's cranium are spaced far enough apart to allow rapid growth of the cranium during the first months of the infant's life. This spacing also allows the bones to overlap so the infant's head can pass through the birth canal without being compressed and thereby damaging the infant's brain. Finally-sometime between three and six years-the skull will fuse and remain fused for the remainder of the child's life.

During normal growth of the infant, the forces within the infant's cranium are directed outwardly and are continuously and evenly distributed over the inner surface of the growing cranium, causing the cranium to expand. Thus, a reduction in intracranial pressure will result in a reduction in head size. Similarly, an increase in intracranial pressure will result in an increase in head size.

Tissue fiber bands (called cranial sutures) fill the spaces between bones and connect the bones of the skull to each other. These cranial sutures are strong and elastic, providing flexibility to the skull to allow rapid brain growth during the first months of life. Without the seam, the child would suffer brain damage from compression of the brain during normal growth.

However, during the first months of an infant's life, the infant is most likely to develop synostotic or non-synostotic deformities in the cranium. Synostotic deformities are the result of craniosynostosis, a birth defect of the skull characterized by premature closure of one or more of the cranial sutures. Craniosynostosis may be genetic, or the result of metabolic disease, characterized by abnormally shaped skull and potentially abnormal intracranial pressure, mental retardation, epilepsy, and blindness.

On the other hand, non-synostotic deformities, in which the cranial sutures remain open, are caused by external conditions including premature birth, torticollis (twisting of the neck muscles beyond their normal position), or a preferred sleeping position of the child. In addition, neurological abnormalities such as paralysis, cerebral palsy, or some type of developmental delay predispose children to cranial positioning problems. Non-synostotic deformities are also known as positional deformities.

Bony and non-bony connective deformities behave in different ways. For example, plagiocephaly is a cranial deformity that results in an asymmetric head shape. Plagiocephaly consists of a focal region of flattening in the anterior or posterior aspect of one side of the head, which also typically creates additional compensatory deformities in the adjacent areas of the skull, skull base, and face, including the orbital (eye) and mandibular (jaw) structures. This deformity most often occurs behind the head (posterior plagiocephaly), creating a flattened focal region on the one side and a compensatory bulge or bulge on the other side. In addition, the deformity results in anterior displacement of the ear, ear canal, temporomandibular (jaw) joint, forehead and orbital structures on the same side. Cranial deformities can be further classified into brachycephaly (short, wide head shape), navicular head deformity (long, narrow head shape), and cuspidal head deformity (pointed head shape), among others.

Non-synostotic posterior plagiocephaly is a common problem for which parents often seek assessment and advice from their family or pediatricians. The incidence of this deformity is significantly increased after the american academy of pediatrics has issued recommendations that newborns (infants) should sleep with their backs facing down rather than their faces facing down. These recommendations aim to reduce the incidence of Sudden Infant Death Syndrome (SIDS) by eliminating airway and respiratory damage in the prone position (face down), which the discipline considers as a possible cause of the SIDS problem.

Brain growth affects the growth and formation of the skull, which results from the slow and gradual separation of the bone at the cranial sutures. This separation allows the addition of new bone onto the peripheral edge of existing bone, resulting in gradual bone enlargement and reshaping of each bone. As the head expands, new bone is added to each bone in an inwardly directed manner, creating an inner surface concavity of the overall bone. Any force or pressure applied to the outer surface of the bone will redirect the growth of bone added to the rim. New bone will be added in a more linear direction, thus reducing the inner surface concavity or creating "flattening" of the bone. Bone growth does not stop; instead, it is rebooted. Thus, externally applied pressure (e.g., in contact with the orthosis) reduces or stops the outward growth or migration in the area and redirects growth to occur in a direction perpendicular to the applied force, which is tangential to the bone surface in that location. Even expansion of the remaining bone and sutures (including the cranial crown) is rare. Rather, a relatively increased growth and expansion of the region most adjacent to the "flat" region tends to occur.

Treatment may be in the form of prophylaxis or correction. With regard to prevention, focus should be placed on reducing the duration of external pressure applied to localized areas of the skull. This can be achieved by moving the same external force to different areas of the skull. This can only be achieved by repositioning the patient's head, which is not possible in large numbers of infants (e.g., those who are immobilized due to torticollis). An alternative way to achieve this is to enlarge the contact surface area, which reduces the amount of pressure on a particular area, but which still typically results in at least some degree of contact at the desired growth area. It is also important to limit compensatory overgrowth, which forms abnormally raised areas in a position perpendicular to and adjacent to the area of applied force. This allows for growth and expansion to be redirected in the proper normal direction. Devices for prophylaxis must maintain these properties, but still allow the expected gradual growth.

Prolonged immobility of the head will eventually lead to the formation of positional deformities. The cause of immobility may be neurological/developmental, muscular, skeletal (spinal) or simply due to resting/sleep preference in the absence of any known cause. Continued immobility will allow for the formation of transverse and posterior deformities.

Despite the public knowledge and education regarding the development and prevention of these deformities, it seems economically unreasonable to spend material and manpower to obtain a prophylactic device in the seemingly non-existent situation, since infants usually have normal head shapes at birth. These malformations are insidious, slowly appearing over several weeks and are easily overlooked. Often, intervention is considered only when the condition is evident.

Treatment by "repositioning" (also known as "activity"), i.e., the action of another person moving the infant's head left and right at regular intervals, is ineffective for treating or preventing these deformities due to the inherent problems associated with this treatment method. Simply put, it is very difficult to keep the child's head in the same position for a long period of time because the child's natural tendency is to return to his or her preferred sleeping position. Furthermore, since the "regimen" is ideally performed every two or three hours, it requires constant illumination of the infant overnight, and thus it is not a practical treatment option. Similarly, children with torticollis cannot be effectively "worked" due to the tendency of the head to rotate due to involuntary contraction of the neck muscles. In both cases, the resulting position of the head-whether due to preference or due to inactivity-is most likely not the desired position for correcting the deformity and, as noted above, is the cause of the deformity in the first place.

Thus, the treatment by repositioning may be effective when the above mentioned parameters are met-i.e. the child does not tend to revert to a preferred sleeping position and is not immobilized by a torticollis and it may be regularly activated once every two to three hours-in this way the child treated by prophylaxis still cannot obtain a completely normal head shape because the support device remains in contact with the skin and the head follows an abnormal shape. Thus, the force still acts on an already flattened region of the skull and inhibits growth at the region of the skull where growth should be promoted. Because of this ineffectiveness, a large number of these children require additional treatment at 5 to 10 months of age to correct persistent or progressive deformities.

The most common aids that can be used to aid repositioning are flat shaped and wedge shaped foam pads. For example, U.S. patent No. 6,473,923 (filed on 11/22/2000) (issued 11/5/2002) discloses a headrest and head positioner attached to a mattress. The device is intended to maintain the infant in a supine position-i.e. back down, face up-while reducing the risk of positional plagiocephaly by: the head is caused to rotate sideways while maintaining the supine position of the infant.

One goal of correcting existing deformities is to eliminate external forces acting on the flattened area. As with prevention, improved correction can be achieved by providing external forces acting on the compensatory raised areas of the skull, thereby reducing growth occurring in these areas and redirecting growth toward a more normal direction and shape. Correction also requires allowance for growth, and this does not compromise the mechanical ability of the device to correct an existing deformity.

Corrective therapy is most often performed by applying a custom-made external orthosis or helmet. See, for example, U.S. patent No. 6,592,536 (filed on 7/1/2000) (issued 15/7/2003), a corrective infant helmet; united states patent No. 4,776,324 (filed on 1998 at 4/17) (published 1998 at 10/11), therapeutic and protective infant helmets. Such devices provide an area of dilation over the site of the deformity, thereby allowing the deformity to be corrected over a period of 3 to 6 months (which is associated with the growth and subsequent reshaping of the brain and skull). This long-term use is necessary because of the reduced rate of brain and skull growth during the 6 to 12 month time frame. Since the rate of brain and cranial growth decreases to about 50% of the rate during the period from birth to 6 months and the rigidity of the bones and cranial sutures increases, it is recommended to wear the helmet continuously for 23 hours a day for up to 12 months. But despite the long use of these helmets, deformities rarely return to their normal shape. In addition, many health insurance companies and programs refuse to pay for these devices, leaving a large number of infants untreated due to the relatively high cost of the helmet.

Similar to the prevention methods discussed previously, another proposed method of correcting existing cranial deformities is by using a foam pad or memory foam pillow to soften the material of the infant's head on which it rests. This method allows for the redistribution of inwardly directed forces, but does not adequately correct cranial deformities because the soft material follows an already abnormal head shape. In particular, the material still contacts the already flattened area of the head and thus applies a force to that area and reduces the force that should be applied at the abnormal cranial bulge. Preventing cranial deformities by this method is also ineffective because the force continues to act directly on the focal area of the head rather than the entire cranial crown. Since the shape of these pads and pillows is not like a normal infant skull but is generally flat, the forces acting on the skull by these devices result in flattening of the skull and thus an abnormal head shape because the head follows the shape of the material (i.e., is flat) at the point of contact.

Yet another approach is to suspend the infant's head from a flexible material, which may be, for example, a mesh with a sparse fabric that holds the infant's head slightly above the resting surface. See U.S. patent No. 6,052,849 (filed on 3/18/1999) (issued on 25/4/2000) for a method and apparatus for preventing positional plagiocephaly in infants. Although the use of elastically stretchable materials or webs may be somewhat better than conventional foams for preventing the formation of flat areas, these devices are also not effective in promoting proper formation due to the constant application of external forces directed towards the back of the infant's head. In the case of correction, the flexible material will still follow the already abnormal head shape and exert a force on the flattened area. In the case of prophylaxis, the weight of the skull on the flexible material will tend to immobilize the skull, which results in long term contact non-uniform forces around the skull, and again is just the wrong way to maintain an already normal skull shape. As with the "soft material" approach described previously, since the head follows the shape of the material, the force acting on a smaller area of the head results in a reduction in the growth and expansion of the skull, thereby resulting in an abnormal head shape in which the anterior area of the head is wider than the posterior, because the material is only applied to the posterior of the skull, resulting in the application of a compressive force.

After 10 to 12 months of age, only a small, if any, correction of cranial deformities can be achieved using non-surgical treatment due to reduced rates of brain and cranial growth, increased thickness of bone, and reduced flexibility of cranial sutures. Surgical intervention is often the only effective treatment for moderate to severe deformities in children over 12 months of age.

Alternative methods for correcting this condition without the use of a helmet do not address the cause of the problem directly and therefore do not treat the condition effectively. All other products and devices, including foams, resilient (and therefore flexible) materials or meshes, distribute or disperse forces only over focal areas of the head. Because these products and devices maintain constant contact with the skin, they conform to the skull and become abnormally shaped, including abnormally flattened areas. Thus, the prior art does not remove or eliminate external forces at the flattened area of the skull, but rather maintains an abnormal skull shape and encourages static deformities.

Finally, there are also attempts to prevent and correct such deformities in the case of the use of a headrest. Except for the present invention and united states patent No. 4,195,487 issued to ebel (ebel) (issued 5/2 1989) (hereinafter "ebel"), existing headrests are "low profile" devices that extend only a maximum of 35mm (about 30% or less of the anteroposterior distance) forward from the position of final contact with the infant's cranium and contact only the very posterior or posterior region of the head. See, for example, WO 2006/102407 (published on 9/28 2006); european patent No. EP 1665958 (filed 8/25/2004); new Zealand patent No. 510,421 (filed on 5/8/2001). However, low profile (i.e., only posterior) headrests are ineffective based on the biomechanics of such devices because of the lateral support required in order to achieve effective prevention and treatment.

These available and proposed low profile devices do not provide sufficient support and positioning to overcome the immobility problem that leads to the formation and development of positional deformities. Despite slight differences or modifications in shape, size or firmness, these deformities develop-that is, prevention or any degree of correction by means of a low profile device will require rotation of the head, and any prevention or correction achieved will be due to "repositioning" treatment as described previously, thus rendering the device unnecessary. The treatment provided in this case is repositioning rather than a low profile device. And as noted above, the ability to reposition or rotate the head is a luxury and in many cases impossible. However, lateral support allows the problem of immobility to be overcome, which is not achievable with low profile devices.

Although ebel would not be considered a "low profile device" as described previously, it also does not provide sufficient lateral support. As shown in fig. 4 and 5 of ebel, the side walls are angled outwardly from the longitudinal axis of the device, which inherently means that the ebel does not provide immediate lateral support when the infant's cranium is rotated in either direction. In this way, ebel is virtually identical to low profile devices, but has the following additional disadvantages: the ebel side walls are so high that very young infants placed on the ebel invention are prone to develop obstructive amblyopia due to obstruction of the visual field/visual pathway. In addition, the ebel is made of a soft compliant material that conforms to the unusual head shape as described with respect to foam mattresses and cushions.

Currently, for non-synostotic cranial deformities during birth to 5 months of age, there is no dedicated device available to provide effective correction and prophylactic treatment. To avoid the difficulties and deficiencies associated with currently available devices directed to treating non-synostotic cranial deformities, a corrective headrest for use just after deformity formation has been identified is disclosed. The headrest and method allow for effective treatment during rapid growth cycles of the brain and skull (from birth to six months), thereby providing rapid correction of deformities. A premonitory child may require long-term treatment. Effective treatment at an early stage is critical to provide complete correction of these deformities.

Disclosure of Invention

The present invention discloses, inter alia, a device and method for correcting and/or preventing an infant's abnormally-shaped cranium by applying external forces over time as the infant grows to achieve normal shaping of the infant's head. Different from the prior art, the invention has the following two functions at the same time: 1) preventing abnormal shaping of the infant's cranium by causing balanced growth of the infant's normally shaped head; and 2) providing a force unevenly acting on the abnormally shaped cranium to correct the existing cranial deformity. Embodiments of the present invention include a solid one-piece headrest structure of uniform firmness having depressions molded to approximate the back and sides of the skull and head, the depressions having neck or neck supports. The material that contacts the infant's skull is semi-rigid and relatively inflexible, maintains its overall shape under stress, and exhibits minimal surface focal elasticity only at the skin contact site. In a preferred embodiment, the hardness of the material contacting the infant's cranium on the OO durometer scale is between 65 and 75 (including 65 and 75).

To correct an existing cranial deformity, the present invention applies inwardly directed external forces only to areas of bony prominence and minimizes (or completely eliminates) those forces on less prominent (or flattened) areas of the skull. The present invention does not conform to the shape of an abnormal skull. The applied force allows for accelerated expansion of the skull in less prominent (flattened) areas concurrent with brain and skull growth, allowing for restoration of a normal symmetrical skull shape.

In addition, the headrest prevents the development of abnormal cranial shaping by providing a rounded normal shaped profile for contact with the back and sides of the head even if the head is turned slightly to one side or the other. Furthermore, since the surface is semi-rigid, the surface will allow for even cranial growth over this contact area, thereby maintaining the normal head shape of the infant.

Preferred embodiments of the present invention are made from impermeable high density foam, which provides easy cleaning and flame retardant properties. Other embodiments of the invention are made from other foam variants, including open cell foams covered with a vinyl or other coating or closed cell foams laminated to or applied to a relatively rigid solid or hollow plastic (e.g., PVC or nylon).

Thus, according to one aspect of the present invention, a headrest having a semi-rigid body for correcting an abnormally shaped cranium of an infant comprises: a bottom surface for contacting a resting surface; a top surface for contacting the cranium of the infant; a generally semi-ellipsoidal recess in the top surface; and a ridge at one end of the recess for supporting the neck of the infant. The shape of the depression corresponds to the shape of a normal infant skull. The top surface provides external forces acting on abnormal cranial bulges of the infant's cranium and eliminates external forces acting on abnormal cranial depressions of the infant's cranium.

Other features of the headrest include a rim defining a majority of the recess, and the headrest has a side surface between a bottom surface and a top surface. Furthermore, additional features of the headrest include a curved front surface that cradles the shoulders and further supports the neck of the infant.

According to another characteristic of the invention, it is evident that the antero-lateral support provided by the invention is innovative in its capacity to: provides treatment from birth to ten months of age without requiring any enlargement, alteration or modification during this period. In particular, according to this feature of the invention, lateral support is provided in combination with an anatomically correct shape. The elevated lateral support surfaces allow for continued growth from birth to about ten months of age while maintaining or creating a normal head shape without the need to change, modify or enlarge within about the first year. Due to the lateral bearing surfaces, the present invention is not only able to correct deformities, but also to prevent them from occurring.

Drawings

Fig. 1 shows a perspective view of a preferred embodiment of the present invention.

Fig. 2 shows a front view of a preferred embodiment of the present invention.

Fig. 3 is a cross-sectional view of the craniocervical orthosis along line 3-3 of fig. 2.

Fig. 4 is a cross-sectional view of the craniocervical orthosis along line 4-4 of fig. 2.

Fig. 5 and 6 depict the dimensions of a preferred embodiment of the orthosis.

Fig. 7A and 7B are rear and top elevation views, respectively, of a normally shaped infant's cranium, showing a surface area contacting the headrest when the infant's head is positioned supine in the orthosis.

Fig. 8A is a chart showing the head circumference age of men from birth to 36 months.

Fig. 8B is a chart showing the head circumference age of women from birth to 36 months.

Fig. 9A and 9B show an infant's cranium with a circumference of about 36.5cm and 46.5cm, respectively, positioned in a preferred embodiment.

Fig. 10 is a partial sectional view of a preferred embodiment of the invention with an infant having a normally shaped cranium positioned on the contact surface of the headrest.

Fig. 11 is a partial sectional view of the headrest through the inclined first plane of fig. 10.

Fig. 12 is a partial sectional view of the headrest through the inclined first plane of fig. 10 with the normal infant's cranium rotated 30 degrees clockwise about its longitudinal axis to contact the lateral support surfaces of the headrest.

Fig. 13 is a partial cross-sectional view of an orthosis of a navicular cranium through the first plane of fig. 10.

Fig. 14 is a partial sectional view of the headrest through the first plane of fig. 10 with the navicular cranium rotated 30 degrees clockwise about its longitudinal axis to contact the lateral support surface of the headrest.

Fig. 15 is a partial cross-sectional view of an orthosis of a plagiocephalic skull extending through the oblique first plane of fig. 10.

Fig. 16 is a partial sectional view of the headrest through the angled first plane of fig. 10, with the angled cranium rotated 30 degrees clockwise about its longitudinal axis to contact the lateral support surface of the headrest.

Fig. 17 is a partial sectional view through the inclined first plane of fig. 10 of a headrest for use with a cranium with a brachycephaly.

Fig. 18 is a partial sectional view of the headrest through the inclined first plane of fig. 10 with the brachycephalic cranium rotated 45 degrees clockwise about its longitudinal axis to contact the lateral support surfaces of the headrest.

Fig. 19 is a perspective view of an alternate embodiment of the present invention.

Fig. 20 is a front view of the craniocervical orthosis shown in fig. 22.

Fig. 21 is a cross-sectional view taken along line 21-21 of fig. 19.

Fig. 22 is a perspective view of another alternate embodiment of the present invention.

Fig. 23 is a cross-sectional view taken along line 23-23 of fig. 22.

Fig. 24 is yet another embodiment of the present invention.

Fig. 25 is a sectional view taken along line 25-25 of fig. 24.

FIG. 26 is a front perspective view of yet another alternative embodiment of the present invention including two spacing members positioned on the rim.

Fig. 27 is a side cross-sectional elevation through line 27-27 of fig. 26.

Fig. 28 is a cross-sectional elevation through line 28-28 of fig. 26.

FIG. 29 is a front perspective view of yet another embodiment of the present invention in which the lateral support surface is laterally adjustable.

Fig. 30 is a rear cross-sectional view through plane 30-30 of fig. 29.

Detailed Description

When referring to the figures, standard anatomical location terminology is used. For example, the sagittal plane is a plane parallel to the sagittal suture 5 and divides the torso into left and right parts. The coronal plane divides the torso into a posterior portion and an anterior portion. The transverse plane divides the torso into an upper portion and a lower portion.

Fig. 1-4 show a headrest 10 that is a preferred embodiment of the present invention. The headrest 10 includes a bottom surface 12 for contacting a resting surface 14 and a top surface 16 for contacting the infant's cranium. The top surface 16 includes a generally semi-ellipsoidal recess 18, a contact surface 19 that corresponds to the shape of a normal infant's cranium, and a rim 22 that defines a substantial portion of the recess 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 an open cell foam material covered with a vinyl coating or other surface coating, a closed cell foam laminated to a higher density foam, an open cell foam laminated to a higher density foam, or a closed cell foam laminated to a more rigid solid or hollow plastic.

The front surface 24, which is preferably curved, is positioned to rest the shoulders of the infant and support the neck of the infant when the infant's cranium is in contact with the top surface 16. A side surface 26, preferably curved, extends between the rim 22 and the bottom surface 12. In this preferred embodiment, the headrest 10 is a continuous, uniform solid body. However, variations in the uniformity or continuity of the body are contemplated and may be utilized.

During normal operation to correct an abnormally shaped infant cranium, the headrest 10 is placed on the resting surface 14 such that the bottom surface 12 is in contact with the resting surface 14. The infant's head is then placed in the depression 18 with the infant's cranium resting on the contact surface 19. Initially, the back and a portion of the sides of the infant's head contact the contact surface 19, but during a sleep stage, the infant's head may roll to one side or the other. Throughout the sleep stage, the neck of the infant is supported by the spine 20. The shoulders of the infant are aligned along and supported by the curved front surface 24. The contact surface 19 provides external forces acting on any abnormal bulges of the infant's cranium and reduces or eliminates external forces acting on abnormal depressions (flattened areas) of the infant's cranium as the infant's head makes contact with the top surface 16. This contact reduces the net outward force from brain and skull growth at these projections and redirects growth in areas of the skull where the infant's head is not in contact with the top surface 16.

It should be noted that the amount of contact of the infant's cranium with the contact surface 19 varies depending on the size of the infant's cranium. For example, the cranium of a newborn infant will contact relatively few contact surfaces 19 and in a non-rotating position, contact will occur primarily at the occiput and adjacent areas of the left and right parietal bones. As the infant grows over time, the size of the skull will approach the size of the depression 18, making the contact area larger and larger.

The headrest 10 operates in a similar manner to prevent cranial deformities. The infant's head is placed in the recess 18 with the contact surface 19 of the recess 18 matching the rounded normal contoured profile of the back and sides of the head, causing the head to "grow" into the properly shaped contact surface 19 over time. As the skull grows, any existing deformities will follow the normal shape of the contact surface 19 of the concavity 18. Due to its semi-rigid nature, the contact surface 19 allows the infant's cranium to grow evenly and maintain its normal shape. Typically, this occurs when the headrest is used from 2 to 7 months of age, but due to statistical variations in the circumference of the infant's head, this is more appropriately a function of circumference (i.e., until the head grows to the same size as the depression 18).

Fig. 7A and 7B are rear and top elevation views, respectively, of a normally shaped infant cranium 400 having a circumference of less than 46.5cm and a left parietal bone 402 connected to a right parietal bone 404 by a sagittal suture 406. The left and right parietal bones 402, 404 are connected to the frontal bone 412 via a coronal seam 414 and to the occiput 416 by a herringbone seam 418. The sagittal suture 406 joins the coronal suture 414 at the anterior fontanel 420. The herringbone seam 418 joins the sagittal seam 406 at the posterior fontanel 422. When positioned in the preferred embodiment of the headrest 10, the cranial surface area 424, including a portion of the occiput 416 and the posterior portions of the left and right parietal bones 402, 404, makes contact with the contact surface 19 of the depression 18, as previously discussed.

Fig. 8A shows the head circumference age of a male from birth to 36 months. Fig. 8B shows the head circumference age of women from birth to 36 months. As can be seen from these figures, less than 5% of all infants had a head circumference of less than 36.5cm at two months of age. At 7 months, at least 95% of all infants had a head circumference of less than 46.5 cm. Thus, a preferred embodiment of an orthosis having features of the present invention is configured to address at least a head circumference in the range of 36.5cm to 46.5cm in circumference. However, it is contemplated that the present invention will accommodate headbands ranging from thirty-two (32) to forty-eight (48) centimeters and still provide the benefits described herein.

Fig. 9A and 9B depict side elevation views of two infants of a normally shaped cranium of different circumference positioned in the same preferred embodiment of the cranial orthosis 10, and show the location of the predetermined coronal plane relative to the orthosis 10. The circumference of the infant's head is the maximum distance around the head and generally exists in a plane 47 that intersects the forehead and the rearmost point 54 of the cranium of the infant.

More specifically, FIG. 9A depicts an APD having a perimeter of 46.5cm and having a front-to-back distance₁First infant skull 49, anteroposterior distance APD₁Is the distance between the rearmost point 54 on the infant's head and the foremost point 57 on the infant's forehead. A first coronal plane 51 is defined as being positioned at an anteroposterior distance APD₁About forty percent (40%) (approximate the position of the height of the ear opening 52 of an infant having this head size). With respect to the orthosis 10, the first coronal plane 51 is positioned about 4.8cm to 5.3cm above the nadir 23 (i.e., the lowest point) of the concavity 18. The third coronal plane 21 is defined as the coronal plane located at the forwardmost point of contact 27 between the infant's cranium 49 and the headrest 10. The third coronal plane 21 is positioned approximately 8.0cm to 8.6cm from the bottom surface relative to the headrest 10. Similarly, fig. 9B depicts a second infant skull 55 having a circumference of 36.5 cm. The second coronal plane 56 is defined as an APD positioned on an infant having this head size₂About seventy percent (70%) of the coronal plane. Relative to the orthosis 10, the second coronal plane is positioned approximately 8.0cm to 9.0cm above the nadir 23 of the concavity.

As shown in fig. 3, in a preferred embodiment, the contact surface 19 is defined as the following surface area of the recess 18: (1) above an inclined first plane 47 that is at an angle between 10 and 20 degrees from vertical in the upward direction and intersects the bottom point 23, and (2) behind the third coronal plane 21. At a minimum, however, the contact surface 19 is at least the following surface area of the recess 18: (1) above a diagonal plane that is at a 45 degree angle to the vertical in the upward direction and intersects the bottom point 23, and (2) behind the third coronal plane 21.

Fig. 5 and 6 depict preferred dimensions of a particular embodiment of orthosis 10. As shown, the length of the orthosis 10 from its lowermost point to its uppermost point is 23.3 cm. The height of the ridge 20 above the bottom surface 12 (where it intersects the longitudinal axis) is 2.9 cm. At its highest point, the edge 22 is 9.4cm from the bottom surface 12. The ridge 20 is 6.5cm from the cranial transverse plane 70, the cranial transverse plane 70 being the transverse plane that intersects the base point 23 of the depression 18. The cranial transverse plane is 7.5cm from the uppermost contact point 27. In a preferred embodiment, the upper point 27 is 8.3cm from the bottom surface 12.

In a preferred embodiment, as shown in FIG. 6, where the shading has been removed for clarity, the width of the curved front surface 24 is 23.3cm and the width of the ridge 20 is 13.3 cm. The depression has a front portion 37 extending 2.3cm from the ridge 20 along the horizontal longitudinal axis 31 and is coterminous on either side with the symmetrical projections 33. Intermediate portion 25 is immediately adjacent to front portion 37, wherein inner boundary 29 of rim 22 adjacent to intermediate portion 25 is substantially straight. The curved rear portion 35 is adjacent the intermediate portion 25 with the inner boundary 29 of the rim being symmetrically curved to connect one side of the intermediate portion 25 to the other. The maximum depth of the curved rear portion 35 along the horizontal longitudinal axis 31 from the intermediate portion 25 to the inner boundary 29 of the rim 22 is 3.9 cm. The maximum width of the middle portion 25 at the boundary with the front portion 37 (line B) is 16.3 cm. The mid-section 25 is 12.7cm narrowest immediately adjacent the curved rear section 35 (line a). The depth of the middle portion 25, i.e., the distance between the front portion 37 and the curved rear portion 35, is about 8.0 cm. The upper-to-lower widening of the middle portion 25 provides space for the ears of an infant that is resting in the headrest 10 in a supine position, which is important to avoid poor shaping of the ears. The depth of the depression 18 along the horizontal longitudinal axis from the peak of the ridge 20 to the inner boundary of the rim 22 is 14.2 cm. The thickness C of the rim 22 around the arcuate portion 35 is about 2 cm. While the dimensions of the preferred embodiment are given by way of specific measurements, it is understood that the measurements may vary slightly without altering the effectiveness of the device. In this respect, the dimensions provided are to be understood as substantial approximations of the preferred embodiments of the device.

Returning now to the description of the invention, fig. 10 and 11 depict a preferred embodiment of the invention in which an infant 60 having a normally shaped cranium 62 with a circumference of about forty (40) centimeters is positioned supine on the headrest 10. The first coronal plane 51, as defined above with respect to a predetermined circumference of 46.5cm, extends longitudinally and is parallel to the second coronal plane 56. The cranial transverse plane 70 is oriented perpendicular to the first coronal plane 51 and extends through the nadir 23, with the rearmost point 54 of the skull 62 resting in the nadir 23. An inclined first plane 74, representing a typical plane in which the circumference of the head is measured, is positioned and inclined upwardly relative to the cranial transverse plane 70 and intersects the nadir 23 and forwardmost point on the forehead.

As described with respect to fig. 1-4, the headrest 10 (or orthosis) includes a bottom surface 12 that contacts the resting surface 14 and a contact surface 92 that contacts the infant's cranium 62 during use. The top surface 16 has formed therein a generally semi-ellipsoidal depression 18 having at least one contact surface 19 (see fig. 3), the contact surface 19 having the shape of a portion of a normal infant cranium 62. In a preferred embodiment, and as previously described with respect to fig. 3, the contact surface 19 has a posterior surface area that generally corresponds to the left and right parietal bones in addition to a majority of the occipital bone area, as discussed with reference to fig. 5. The top surface 16 is semi-rigid and relatively inflexible, maintains its overall shape under stress, and exhibits minimal surface focal elasticity at the skin contact site. The ridge 20 at the end of the depression 18 supports the infant's neck 86 and is contoured to the shape of the infant's neck 86.

At least the contact surface 19 of the preferred embodiment has a hardness of between 65 and 75 as measured with an OO scale durometer, which is a preferred hardness required for both positional deformity prevention and correction as described herein. However, since the headrest 10 preferably has a uniform firmness, it is expected that the entire outer surface of the headrest 10 will have the same firmness. It should be noted that with a hardness between 25 and 35 on the same scale, only prevention may be achieved, not both prevention and correction.

Still referring to fig. 10 and 11, the contact surface 19 further includes at least a portion of the first and second lateral support surfaces 88, 92. A portion 90 of first and second lateral support surfaces 88, 92 is positioned forward of first coronal plane 51 and above cranial transverse plane 70. To prevent obstructive amblyopia, the first and second lateral support surfaces 88, 92 do not extend in front of the second coronal plane 56, as a complete unobstructed field of view must be provided to eliminate the risk of iatrogenically induced neuroophthalmic injury (i.e., obstructive amblyopia).

Fig. 11 is a partial sectional view of the normal infant cranium 62 taken along the angled first plane 74 of fig. 10. In a preferred embodiment, the first and second lateral support surfaces 88, 92 are substantially perpendicular at their upper ends with a slight curvature before the first coronal plane 51. When the infant's cranium 62 is in a supine position, the contact force 96 is applied at the posterior of the cranium 62 proximate the occiput 98 with only minimal application at the posterior-most ends of the parietal bones 100, 102. As growth occurs, the left and right parietal bones 100, 102 expand laterally and eventually contact substantially the entire contact surface 19 as the infant's cranium 62 grows to a circumference of 46.5cm, as shown in FIG. 9A. In this way, the shape of the parietal and occipital regions on the infant's skull 62 follows the shape of the contact surface 19 over time (i.e., over the month).

Fig. 12 depicts the normal infant cranium 62 shown in fig. 11 rotated 30 degrees clockwise about the longitudinal axis 94. This rotation causes a contact area of the skull 62 with the contact surface 19 and thus a corresponding displacement of where the external force 96 is applied to the skull 62. Contact force 96 still contacts a greater portion of occiput 98 and posterior right parietal bone 102. In addition, second lateral support surface 92 contacts skull 62 at frontal bone 104 prior to coronal suture 106.

As overall growth of the skull 62 occurs, a smaller rotation of the skull 62 is allowed, which results in further maintenance of the normal head shape. The additional expansion and overall growth causes the skull 62 to eventually counter-rotate back to 20 degrees of rotation or less, with the contact surface 19 and the first and second lateral support surfaces 88, 92 limiting the lateral expansion of the parietal bones 100, 102. In other words, as the infant continues to grow and the circumference of the skull 62 approaches the size of the depression 18, the head is progressively constrained to a smaller rotation, resulting in the head "growing" into the properly shaped contact surface 19. For example, if the size of the skull 62 is equal to the size of the recess 18, rotation of the skull 62 will be completely inhibited. Thus, as the skull 62 grows, any existing deformities will follow the normal shape of the contact surface 19 of the recess 18.

Fig. 13 depicts a partial cross-sectional view of the inclined first plane 74 of fig. 10 with the navicular cranium 134 of the infant positioned supine in the recess 18 in the top surface 16 of the orthosis 10. In this supine position, the contact surface 19 of the recess 18 causes the force 46 to act on the scaphocephalic skull 134 at the occiput 144. If this non-rotated supine position can be maintained, the absence of forces acting on the parietal bones 147, 149 will allow the parietal bones 147, 149 to grow laterally into a normally shaped skull.

Fig. 14 depicts the navicular cranium 134 shown in fig. 11 rotated 30 degrees clockwise about its longitudinal axis 148. In this rotational position, the second lateral support surface 92 contacts the frontal bone 150 and thereby prevents contact between the middle or upper right parietal bone 149 and the contact surface 19 of the recess 18 and allows only minimal contact with the right parietal bone 149 at its rearmost point. Again, the contact surface 19 of the recess 18 contacts the occiput 144 and provides a force thereon. The absence of contact and the force 146 acting on the left parietal bone 147 and almost all of the right parietal bone 149 allows for expansion and development of parietal bones toward the normal head shape. Rotation in the counterclockwise direction results in similar contact of the skull 134 with the orthosis 10 on the opposite side of the skull 134.

Fig. 15 is a partial cross-sectional view through the first plane 74 of fig. 8 of the preferred embodiment, wherein an infant with a plagiocephalic skull 170 has abnormal bulge growth at the right side of the left parietal 196 and frontal 198 bones in addition to the flattened configuration at the right parietal 202 and occipital 200 bones. In the supine position shown, initial force 194 is concentrated on the lower ends of left parietal bone 196 and left occipital bone 200. It should be noted, however, that this is an unstable configuration that will inevitably result in rotation-in this case clockwise-about the longitudinal axis 192.

Fig. 16 is a partial sectional view in the oblique first plane 74 of fig. 10, depicting an infant with a cranium 170 having a plagiocephaly deformity rotated 30 degrees clockwise about its longitudinal axis 192. In this rotational position, the contact surface 19 contacts and provides a force 194 on the raised left parietal bone 196, thereby limiting further lateral growth of the raised bone. In addition, the second lateral support surface 92 contacts the right side of the frontal bone 198 and provides a force 199 acting thereon and also limits growth in the raised area. Contact with the second lateral support surface 92 further removes all external forces from the flat occiput 200 and right parietal bone 202, thus redirecting the growth of those bones by allowing those bones to expand. In this way, the infant's plagiocephalic skull 170 is allowed to grow into a normal shape.

Fig. 17 depicts a preferred embodiment for use with a cranium brachycephaly 204 resting in a supine position, the cranium brachycephaly 204 having a flat occiput 216 and convex left and right parietal bones 208, 210 of the tympanum. The contact surface 19 contacts the two parietal bones 208, 210 and provides a force 206 acting thereon to limit lateral growth of these parietal bone projections. The normal cranial shape of the contact surface 19 eliminates any contact to and forces on the occiput 216. This re-directs growth and expansion in a more anterior direction and allows the flat occiput 216 to grow outward, thereby allowing deformities to be corrected over time as they grow.

Fig. 18 shows the same brachiocephalic skull 204 depicted in fig. 17 resting on a preferred embodiment of the orthosis 10 and rotated 40 degrees about the longitudinal axis of the headrest 10. The contact surface 19 of the depression 18 contacts the raised right parietal bone 210 and provides a force thereon and thereby limits the growth of the bone. At the same time, the first lateral support surface 88 contacts the raised left parietal bone 208 and provides a force 206 acting thereon, and again restricts growth of the bone 208. The normal cranial shape of the contact surface 19 provides clearance between the contact surface 19 of the depression 18 and the flat occiput 216, thereby eliminating forces acting on the occiput 216 and again allowing for ingrowth in that area. The lack of contact force on the frontal bone 211 also allows for forward growth of the skull 204. In this manner, the orthosis 10 effects correction of a brachycephalic cranium 204 resting in a rotated position.

Although the invention has so far been described with reference only to term infants, the principles and concepts also apply to the cranium of premature infants, albeit on a smaller scale. Indeed, the cranial vertex of premature infants is more prone to positional deformity than full-term infants, as the skull is much weaker and more malleable and the skin is more fragile.

According to industry data, the average head circumference of a 26 week infant is about 23.5 cm, the average head circumference of a 36 week infant is about 33cm, and the two standard deviations on either side of this 26 week growth curve and 36 week growth curve are slightly greater than ± 2 cm. Thus, by simply "collapsing" the preferred embodiment described herein to accommodate this curve, the same principles operate to correct and prevent positional deformities in premature infants in the same manner. Due to the weaker and more malleable skull of the premature infant, the top surface should be softer than the top surface described with reference to the preferred embodiments herein. The inventors have found that the hardness of the surface when used in premature infants is between 20 and 30 on the OO scale.

Fig. 19-21 show an alternative embodiment of the invention that requires less material to manufacture. The headrest 300 includes two beams 302 for contacting a resting surface 304 and a top surface 306 for contacting the infant's cranium. Elongated cross members 302 are positioned along opposite sides of the headrest 300. The front and rear of the headrest 300 are open, forming openings 308 bounded on either side by the cross-member 302.

The top surface 306 of the headrest 300 includes: a generally semi-ellipsoidal depression 310 having a top surface 306 corresponding to the shape of a normal infant's cranium; and a rim 312 defining a majority of the recess 310. At one end of the recess 310, a ridge 314 is positioned to support the neck of the infant. The top surface 306 is preferably made of a closed cell foam material, although other materials as described above may be used. A pair of side surfaces 316 (only one of which is shown in fig. 5) adjoin the rim 312 to the beam 302.

As shown more clearly in fig. 21, the cross beams 302 are positioned at opposite sides of the headrest 300 and along the perimeter thereof, thereby forming openings 308 between the cross beams 302. However, in another embodiment, the opposing cross beams 302 may be positioned at the front and rear of the headrest 300.

After the headrest 300 is placed on the resting surface 304 such that the cross beam 302 is in contact with the resting surface 304, the head of the infant is placed in the depression 310, with the head of the infant resting in the depression 310. Correction and/or prevention of an infant's abnormally shaped cranium is then achieved in the same manner as in the preferred embodiment.

Fig. 22 and 23 (fig. 23 is a cross-sectional view along line 23-23 of fig. 22) show another embodiment of the invention. The apparatus of this embodiment includes a mattress or padded surface 340 and a generally semi-ellipsoidal depression 342 in a portion of the mattress surface 340. The top surface 344 in the recess 342 corresponds to the shape of a normal infant skull. In this embodiment, the top surface 344 of the depression 342 is semi-rigid, resilient and made of a closed cell foam material, thereby providing external forces acting on the abnormal cranial bulge of the infant and minimizing or eliminating external forces acting on the abnormal cranial depression. However, it is contemplated that other materials may be utilized, such as open cell foams with vinyl coatings. In this embodiment, a ridge 346 at one end of the top surface 344 is shaped and positioned to support the neck of the infant when the infant's head rests on the top surface 344 of the apparatus. In another version of this embodiment, it is contemplated that ridges 346 will be eliminated.

The embodiment shown in fig. 22 and 23 is disclosed as having a generally flat mattress or pad surface 340. However, it is contemplated that the mattress or pad surface 32 may be contoured to prevent tumbling of the infant. It is further contemplated that the area of the mattress or padding surface 340 surrounding the depression 342 may be raised to provide support for the baby's head in a slightly raised position.

As with the embodiment already described, the infant's head is placed in the depression 342 formed in the mattress 340 such that the infant's head is in contact with the top surface 344. The infant's neck is supported by the spine 346 while the infant's torso is supported by the mattress 340 in a generally supine position in a comfortable resting position. Correction and/or prevention of an infant's abnormally shaped cranium is then achieved in the same manner as in the preferred embodiment.

Fig. 24 and 25 (fig. 25 is a cross-sectional view along line 25-25 of fig. 24) show another embodiment of the present invention: a device consisting of a semi-rigid body 360 having a semi-ellipsoidal depression 362, the semi-ellipsoidal depression 362 having a contact surface 364 in the shape of a normal infant skull. A plurality of legs 366 support semi-rigid body 360 in a position to allow the head of an infant to rest on contact surface 364. In this embodiment, there are four legs 366 as shown in fig. 24 and 25. However, it is contemplated that more or fewer legs may be used to support the body 360. The contact surface 364 is resilient and made of closed cell foam, but in alternative embodiments of the invention, the contact surface 364 can be made of other materials including open cell foam covered with a vinyl coating, and other materials as described above. Further, a ridge 368 at one end of the contact surface 364 is shaped and positioned to support the neck of the infant when the infant's head rests on the contact surface 364 of the apparatus.

After the apparatus is placed on the resting surface such that the legs 366 are in contact with the resting surface, the head of the infant is placed in the recess 362 with the head of the infant resting on the contact surface 364 and the neck of the infant supported by the ridge 368. Correction and/or prevention of an infant's abnormally shaped cranium is then achieved in the same manner as in the preferred embodiment.

It should be noted that the smaller the infant's cranium, the more angular rotation of the cranium about the longitudinal axis is required to contact one of the lateral support surfaces. In other words, in general, a smaller infant cranium placed in a given headrest and depression will require greater rotation about a longitudinal axis than a larger similarly shaped cranium positioned in the same headrest and depression. However, it is desirable that the rotation of the infant's cranium within the depression be limited to about the angular rotation range described with reference to the previous figures. While this concern can be addressed by manufacturing the headrest in various sizes to correspond to the range of expected skull sizes as set forth above, it is desirable to produce fewer variations of the invention to take advantage of manufacturing economies of scale for cost reduction purposes.

However, by enabling adjustability of the position of the lateral support surface, thus allowing for limiting rotation of the skull as needed based on the size of the skull, this conflict between manufacturing preferences and patient treatment preferences may be addressed. For example, fig. 26-28 show another embodiment of a headrest 510 having features of the invention in which the position of the lateral support surface is adjustable to accommodate various skull sizes (i.e., to limit the range of possible rotations of the skull within the recess). Fig. 26 is a front perspective view of the embodiment. Fig. 27 and 28 are cross-sectional views through line 27-27 and line 28-28, respectively, of fig. 26.

As mentioned with respect to the previously described embodiment, the headrest 510 of this alternative embodiment includes a bottom surface 512 and a top surface 516 for contacting the infant's cranium. The top surface 516 includes a generally semi-ellipsoidal recess 518, a contact surface 519 that corresponds to the shape of a normal infant's cranium, and a rim 522 that defines a majority of the recess 518. At one end of the recess 518 is located a ridge 520 to support the neck of the infant. The top surface 516 is preferably made of a closed cell foam material, but may alternatively be made of an open cell foam material covered with a vinyl coating or other surface coating, a closed cell foam laminated to a higher density foam, an open cell foam laminated to a higher density foam, or a closed cell foam laminated to a more rigid solid or hollow plastic. The curved front surface 524 is positioned to rest the shoulders of the infant and support the neck of the infant when the infant's cranium is in contact with the top surface 516. Preferably curved side surfaces 526 extend between rim 522 and bottom surface 512.

Two attachable spacing members 550 are positioned on rim 522 and are preferably centered to be preferably about 60 degrees from longitudinal axis 531. Preferably, the spacer members 550 are generally U-shaped and sized to fit snugly over the rim 522, and each have a first leg 551 that extends into the recess 518 and contacts the lateral support surfaces 588, 592 and a second leg 552 that extends downward adjacent the side wall 526 of the headrest 510 and contacts the side wall 526. The spacing member 550 is made of a closed cell foam material, but may alternatively be made of an open cell foam material covered with a vinyl coating or other surface coating, a closed cell foam laminated to a higher density foam, an open cell foam laminated to a higher density foam, or a closed cell foam laminated to a more rigid solid or hollow plastic.

As shown in fig. 28, in the embodiment specifically described herein, the outer portion 552 of the spacer member 550 is removably attached to the body of the headrest 510 by way of hook and loop fasteners 554. Alternate embodiments contemplate other fastening hardware and adhesives. Placing the spacer member 550 on the rim 522 provides the ability to alter the range of rotation of the infant's head when placed in the headrest 510.

Normal operation of correction of an abnormally shaped infant cranium is as mentioned with respect to the previously described embodiments. The headrest 510 is placed on a resting surface (not shown) such that the bottom surface 512 is in contact with the resting surface. The infant's head is then placed in the depression 518 with the infant's cranium resting on the contact surface 519. The effective distance between the lateral support surfaces 588, 592 may be altered by attaching one or more of the spacer members 550 to properly fit the infant's cranium within the headrest 510. In this particular embodiment, the maximum thickness T1 of the leg 551 of the spacer component 550 extending into the recess 518 and along the sagittal axis is preferably about 8 millimeters.

Initially, the back and a portion of the sides of the infant's head contact the contact surface 519, but during the sleep stage, the infant's head may roll over to one side or the other. When this occurs, the side of the baby's head will contact the interior surface 553 of the first leg 551 of one of the spacer members 550. In this way, the inner surface 553 acts as an adjusted lateral support surface. Throughout the sleep stage, the neck of the infant is supported by the ridge 520. The shoulders of the infant are aligned along and supported by the curved front surface 524. Contact surface 519 provides external forces on any abnormal bulging of the infant's cranium and reduces or eliminates external forces on abnormal depressions (flattened areas) of the infant's cranium as the infant's head makes contact with top surface 516. As mentioned with respect to the previously described embodiments, this contact reduces the net outward force from brain and skull growth at these projections, and redirects growth of the cranial region where the infant's head is not in contact with the top surface 516. As the infant's cranium grows, the spacer member 550 may be removed or replaced with a spacer member having a thinner first leg 551.

While the spacer member 550 is described in the embodiments as being generally U-shaped, it is contemplated that the spacer member 550 may have varying shapes and attachment locations on the headrest 510. For example, the spacing member 550 may be a circular or rectangular pad having a flat interior surface to serve as an adjusted lateral support surface and a flat exterior surface for adhering to a lateral support surface of the headrest.

Fig. 29 and 30 show an alternative embodiment of a "low profile" headrest 610 having first and second laterally adjustable side rails 626. Fig. 29 is a perspective view of the embodiment and fig. 30 is a rear sectional view through plane 30-30 of fig. 29. As previously described, the "low-profile" headrest 610 is provided to otherwise have some of the features of the present invention, such as the top surface 616, the recess 618, and the like. However, as previously discussed, this "low-profile" headrest 610 by itself does not provide lateral support by way of a lateral support surface.

As shown in fig. 29 and 30, the laterally adjustable side rail 626 may be secured to the top surface 616 of the "low profile" headrest 610 by a carabiner 630 or other snap-fit method and positioned to provide lateral support to an infant's cranium resting in the headrest 610 by lateral support surfaces 688, 692 on the interior side wall of the side rail 626. The laterally adjustable side rail 626 is positioned such that the lateral support surfaces 688, 692 are positioned forward of the first coronal plane and above the mid-cranial lateral plane, as described with reference to other embodiments. The first and second lateral support surfaces 688, 692 do not extend in front of the second coronal plane, as a complete unobstructed field of view must be provided to eliminate the risk of iatrogenically induced neuroophthalmic injury (i.e., obstructive amblyopia). In addition, the laterally adjustable side rail 626 allows the distance between the lateral support surfaces 688, 692 to be adjusted by repositioning both laterally adjustable side rails 626 towards the infant's cranium and reattaching them to the top surface 616.

The invention has been described above with reference to a preferred illustrative embodiment of the headrest and an alternative embodiment of the invention, which have been specifically described. Those skilled in the art will recognize that alternative configurations of such a headrest may be used to implement the present invention. Other aspects, features and advantages of the present invention can be obtained from a study of the disclosure and the drawings, together with the appended claims.

The claims (modification according to treaty clause 19)

1. An orthopedic headrest for promoting normal shaping of a cranium of an infant, the headrest comprising:

a bottom surface for contacting a resting surface;

a top surface;

a generally semi-ellipsoidal recess in the top surface, the recess having a nadir;

a contact surface in the recess having the shape of at least a portion of a normal infant cranium;

a ridge at one end of the depression for supporting the neck of the infant; and

first and second lateral support surfaces having at least a portion positioned anterior to the first coronal plane and above a cranial medial lateral plane;

the contact surface comprises at least a portion of the first and second lateral support surfaces.

2. The orthopedic headrest of claim 1, wherein the top surface is semi-rigid.

3. The orthopedic headrest of claim 2, wherein the top surface has a hardness between 65 and 75 (including 65 and 75) on an OO durometer scale.

4. The orthopedic headrest of claim 1, wherein the contact surface has the shape of a portion of a normal infant cranium having a circumference between 36.5 and 46.5 centimeters and including 36.5 and 46.5 centimeters.

5. The orthopedic headrest of claim 1, wherein the first and second lateral support surfaces do not extend forward of a second coronal plane.

6. The orthopedic headrest of claim 1, wherein at least a portion of the first and second lateral support surfaces are substantially perpendicular.

7. The orthopedic headrest of claim 1, wherein the contact surface comprises at least the following areas of the top surface: (1) contacting a surface region of a normally shaped cranium having a maximum size of the recess resting supine in the recess; and (2) above a diagonal plane that is at a 45 degree angle to vertical in an upward direction and intersects the bottom point; and (3) behind the third coronal plane.

8. The orthopedic headrest of claim 1, wherein the contact surface comprises areas of the top surface that: (1) contacting the surface region of a normally-shaped skull having a maximum size of the recess resting supine in the recess; and (2) above an inclined first plane that is angled between 10 and 20 degrees upward from the cranial transverse plane and intersects the nadir; and (3) behind the third coronal plane.

9. The orthopedic headrest of claim 1, wherein the first and second lateral support surfaces are positioned such that rotation of a properly positioned normal infant cranium about a longitudinal axis causes a frontal bone of the normal infant cranium to contact one of the first and second lateral support surfaces above the cranium lateral plane.

10. The orthopedic headrest of claim 9, wherein the contact with the frontal bone of the normal infant cranium occurs when the circumference of the cranium is between 36.5cm and 46.5cm and including 36.5cm and 46.5 cm.

11. The orthopedic headrest of claim 10, wherein the contact surface of the depression is shaped and positioned such that it contacts an occiput and a parietal bone closest to a point of contact with the frontal bone.

12. The orthopedic headrest of claim 1, wherein the headrest prevents the formation of plagiocephaly and brachycephaly in the normal cranium of the infant resting in a supine position by: limiting lateral expansion of the parietal bone with the first and second lateral support surfaces and the contact surface underlying the first and second lateral support surfaces.

13. The orthopedic headrest of claim 1, wherein the headrest prevents formation of brachycephaly in the infant's normal cranium resting in a rotational position about a longitudinal axis by: limiting lateral growth of left and right parietal bones with the first or second lateral support surfaces and the contact surface of the recess below the first and second lateral support surfaces.

14. The orthopedic headrest of claim 1, wherein the headrest prevents plagiocephaly from forming in the infant's normal cranium resting in a rotational position about a longitudinal axis by: lateral growth on the parietal bone is limited by the contact surfaces of the recesses below the first and second lateral support surfaces on a side of the skull opposite the direction of rotation, and lateral and anterior growth of the frontal bone is limited by the lateral support surfaces on a side same as the direction of rotation.

15. The orthopedic headrest of claim 1, wherein:

the contact surface provides an external force acting on an abnormal cranial bulge of the infant's cranium; and is

The contact surface eliminates external forces acting on abnormal cranial depressions of the infant's cranium.

16. The orthopedic headrest of claim 1, wherein the headrest corrects brachycephaly in an infant's skull resting in a non-rotating supine position within the headrest by:

limiting lateral growth of the left and right parietal bones of the bulge; and

promoting posterior growth of the occiput by eliminating contact between the headrest and the occiput of the infant's cranium.

17. The orthopedic headrest of claim 1, wherein the headrest corrects plagiocephaly in an infant's cranium resting in a rotational position about a longitudinal axis by: growth of the flat occiput and parietal bones is promoted by eliminating contact between the headrest and the flat occiput and parietal bones, and growth of the raised frontal bones is limited by contact between the raised frontal and parietal bones and one of the first and second lateral support surfaces, and growth of the raised parietal bones is limited by contact between the raised parietal bones and the contact surface below the first and second lateral support surfaces.

18. The orthopedic headrest of claim 1, wherein the headrest corrects navicular deformities in an infant's cranium resting in a rotational position about a longitudinal axis by: growth of the flat left and right parietal bones is promoted by eliminating contact between the contact surface and the flat parietal bones, and growth of the convex occiput is limited by contact between the convex occiput and the contact surface.

19. The orthopedic headrest of claim 1, wherein the headrest corrects brachycephaly in an infant's cranium resting in a rotational position about a longitudinal axis by:

promoting growth of the flat occiput and the flat posterior ends of the left and right parietal bones by eliminating contact between the contact surface and the flat occiput and the flat posterior ends of the left and right parietal bones; and

growth of bulge neutral and anterior parietal bone is limited by contact between bulge neutral and anterior parietal bone opposite the direction of rotation and one of the first and second lateral support surfaces and between bulge neutral and anterior parietal bone along the direction of rotation and the contact surface below the first and second lateral support surfaces.

20. The orthopedic headrest of claim 1, wherein the depression further comprises a middle portion that gradually widens from an upper end of the middle portion to a lower end thereof, thereby providing space for normally shaping the ears of an infant's cranium.

21. The orthopedic headrest of claim 1, wherein the contact surface comprises at least the following surface areas of the depression: (1) above an inclined first plane angled 20 degrees upward from the cranial plane and intersecting the nadir, and (2) behind a third coronal plane.

22. The orthopedic headrest of claim 1, wherein the cranial medial transverse plane is 7cm to 8cm from an uppermost contact point of an infant normally-shaped cranium having a circumference of 46.5cm when positioned supine in the headrest.

23. The orthopedic headrest of claim 1, further comprising at least one spacer member attachable to the headrest, the spacer member having a portion of the spacer member extending into the semi-ellipsoidal recess adjacent at least one of the first and second lateral support surfaces.

24. The orthopedic headrest of claim 23, wherein the at least one spacing member is removably attached and includes a first leg extending into the recess and contacting the lateral support surface and a second leg extending downward adjacent to and contacting a side wall of the headrest.

25. The orthopedic headrest of claim 24, wherein the at least one spacing member comprises two spacing members centered about 60 degrees from the longitudinal axis.

26. The orthopedic headrest of claim 1, further comprising at least one laterally adjustable side rail having at least one interior side wall, the at least one laterally adjustable side rail securable to the top surface to provide lateral support to an infant cranium resting in the headrest.

27. The orthopedic headrest of claim 26, wherein the at least one laterally adjustable side rail includes at least a portion of each of the first and second lateral support surfaces on the at least one interior side wall.

28. A craniocervical orthosis for promoting normal shaping of a cranium of an infant, the craniocervical orthosis comprising:

a bottom surface for contacting a resting surface;

a top surface having a contact surface for contacting the cranium of the infant, the contact surface shaped like at least a portion of the curvature of a normal infant cranium;

first and second lateral support surfaces each having at least a portion extending in front of the first coronal plane at a location above the cranial lateral plane;

the contact surface comprises at least a portion of the first and second lateral support surfaces;

a ridge at one end of the top surface for supporting the neck of the infant, the ridge following the curvature of the rear neck region of a healthy infant and having a ridge peak;

wherein the contact surface has a semi-rigid surface; and

a nadir at an intersection of the cranial transverse plane and the contact surface.

29. The craniocervical orthosis of claim 28, wherein the contact surface is shaped like at least a portion of a curvature of a normal infant's cranium having a circumference between 36.5cm and 46.5cm and including 36.5cm and 46.5 cm.

30. The craniocervical orthosis of claim 28, wherein the first coronal plane is between 4.8 centimeters and 5.3 centimeters from the nadir and includes 4.8 centimeters and 5.3 centimeters.

31. The craniocervical orthosis of claim 28, wherein the first and second lateral support surfaces do not extend before the second coronal plane.

32. The craniocervical orthosis of claim 31, wherein the second coronal plane is between 8.0 centimeters and 9.0 centimeters from the nadir and includes 8.0 centimeters and 9.0 centimeters.

33. The craniocervical orthosis of claim 28, wherein an uppermost contact point of a normally shaped infant's cranium of 46.5cm circumference resting in a supine position is between 8.0cm and 8.6cm from the bottom surface.

34. The craniocervical orthosis of claim 28, wherein the contact surface comprises at least the following surface areas: (1) above a diagonal plane that is at a 45 degree angle to vertical in the upward direction and intersects the bottom point, and (2) behind a third coronal plane.

35. The craniocervical orthosis of claim 28, wherein the contact surface comprises at least the following surface areas: (1) above an inclined first plane angled 20 degrees upward from the cranial transverse plane and intersecting the nadir, and (2) behind a third coronal plane.

36. The craniocervical orthosis of claim 28, wherein the cranial transverse plane is 7cm to 8cm from an uppermost contact point of a normally shaped cranium of an infant having a circumference of 46.5cm when the cranium is positioned supine in the orthosis.

37. The craniocervical orthosis of claim 28, wherein the base point measured along a longitudinal axis of the orthosis is between 6cm and 7cm from a midpoint of the spine.

38. The craniocervical orthosis of claim 28, wherein the ridge apex is between 2.5cm and 3.5cm from the inferior surface and includes 2.5cm and 3.5 cm.

39. The craniocervical orthosis of claim 28, wherein the nadir is between 0.3cm and 0.7cm from the bottom surface and includes 0.3cm and 0.7 cm.

40. The craniocervical orthosis of claim 28, wherein the ridge is between 12.8cm and 13.8cm in width.

41. The craniocervical orthosis of claim 28, further comprising an arcuate posterior portion and an intermediate portion adjacent the arcuate portion, wherein:

the maximum width of the arc-shaped rear part is between 12.2cm and 13.2 cm;

the maximum width of the middle portion is between 15.8cm and 16.8 cm; and is

The depth of the middle portion is between 7.7cm and 8.3 cm.

42. The craniocervical orthosis of claim 41, wherein a maximum distance between the middle portion and a rim measured along the longitudinal axis is between 3.4cm and 4.4 cm.

43. The craniocervical orthosis of claim 42, wherein a maximum distance between the arc portion and an edge apex measured along the longitudinal axis is between 9.8cm and 10.5 cm.

44. The craniocervical orthosis of claim 28, further comprising at least one spacer member attachable to the orthosis, the spacer member having a portion of the spacer member extending into a semi-ellipsoidal recess adjacent at least one of the first and second lateral support surfaces.

45. The craniocervical orthosis of claim 44, wherein the at least one spacing member is removably attached and includes a first leg extending into the recess and contacting the lateral support surface and a second leg extending downwardly adjacent a sidewall of the orthosis and contacting the sidewall.

46. The craniocervical orthosis of claim 44, wherein the at least one spacing member comprises two spacing members centered about 60 degrees from the longitudinal axis.

47. The craniocervical orthosis of claim 28, further comprising at least one laterally adjustable side rail having at least one interior side wall, the at least one laterally adjustable side rail being securable to the top surface to provide lateral support to an infant's cranium resting in the orthosis.

48. The craniocervical orthosis of claim 47, wherein the at least one laterally adjustable side rail includes at least a portion of each of the first and second lateral support surfaces on the at least one interior side wall.

49. A method of preventing abnormal shaping of a normally shaped infant's cranium, comprising:

placing the infant in a substantially supine position;

supporting the normal-shape infant cranium in a generally semi-ellipsoidal recess in a top surface of a headrest, the semi-ellipsoidal recess having a contact surface comprising at least a portion of first and second lateral support surfaces, wherein the contact surface has the shape of at least a portion of a normal infant cranium;

positioning the first and second lateral support surfaces in front of a first coronal plane and behind a second coronal plane;

contacting the infant's cranium with the contact surface;

limiting rotation of the head about the longitudinal axis with the first and second lateral support surfaces;

allowing growth of the infant's cranium to conform to the contact surface.

50. A method of correcting an infant's abnormally shaped cranium, comprising:

placing the infant in a substantially supine position;

supporting the normal-shape infant cranium in a generally semi-ellipsoidal recess in a top surface of a headrest, the semi-ellipsoidal recess having a contact surface comprising at least a portion of first and second lateral support surfaces, wherein the contact surface has the shape of at least a portion of a normal infant cranium;

positioning the first and second lateral support surfaces in front of a first coronal plane and behind a second coronal plane;

contacting the infant's cranium with the contact surface;

limiting rotation of the head about the longitudinal axis with the first and second lateral support surfaces;

limiting growth of cranial bulge by contact between the contact surface and a region of cranial bulge;

promoting growth of a flattened area of the skull by eliminating contact between the contact surface and the flattened area of the skull.

51. The method of claim 50 wherein the abnormal shape is a brachycephaly and the step of limiting growth of cranial bulges further comprises limiting lateral expansion of the parietal bone with the contact surface.

52. A method of correcting an infant's abnormally-shaped cranium, wherein the infant's head is resting in a rotational position about a longitudinal axis, the method comprising:

supporting the normal-shape infant cranium in a generally semi-ellipsoidal recess in a top surface of a headrest, the semi-ellipsoidal recess having a contact surface comprising at least a portion of first and second lateral support surfaces, wherein the contact surface has the shape of at least a portion of a normal infant cranium;

positioning the first and second lateral support surfaces in front of a first coronal plane and behind a second coronal plane;

contacting the infant's cranium with the contact surface;

limiting rotation of the head about a longitudinal axis with the first and second lateral support surfaces;

limiting growth of cranial bulge by contact between the contact surface and a region of cranial bulge;

promoting growth of a flattened area of the skull by eliminating contact between the contact surface and the flattened area of the skull.

53. The method according to claim 52, wherein the abnormal shape is a plagiocephaly, and the step of limiting growth of a cranial bulge further comprises limiting growth of a parietal region opposite to the direction of rotation and a frontal region on the same side as the direction of rotation.

54. The method of claim 52, wherein the abnormality is shaped as a brachycephaly, and the step of limiting further comprises limiting growth of left and right parietal bones with one of the first and second lateral support surfaces and the contact surface of the recess below the first and second lateral support surfaces.

55. The method of claim 54 wherein the step of promoting growth of a flattened area of the cranium further comprises promoting posterior growth by eliminating contact between the headrest and the occiput of the infant's cranium.

56. The method according to claim 52, wherein the abnormal shape is a plagiocephaly, and the step of limiting the growth of a cranial bulge further comprises:

limiting growth of a convex parietal bone on a side of the skull opposite the direction of rotation with the contact surfaces of the recess below the first and second lateral support surfaces; and

limiting growth of a convex frontal bone by one of the first and second lateral support surfaces on a same side as the direction of rotation.

57. The method of claim 56, wherein the step of promoting growth of a flattened area of the skull further comprises promoting growth of the flattened occiput and parietal bones by eliminating contact between the headrest and the flattened occiput and parietal bones.

58. The method of claim 52, wherein the abnormal shape is a navicular deformity, and wherein:

the step of promoting growth of a flattened area of the skull further comprises eliminating contact between the contact surface and the flattened parietal bone; and is

The step of limiting growth of a cranial bulge further comprises limiting growth of a convex occipital bone with the contact surface and limiting growth of the convex frontal bone with one of the first and second lateral support surfaces.

59. The method of claim 52, wherein the abnormal shape is a brachycephaly, and wherein:

the step of promoting growth of a flattened area of the skull further comprises promoting growth of posterior ends of the flat occiput and the left and right parietal bones through contact between the contact surface and the posterior ends of the flat occiput and the left and right parietal bones; and is

The step of limiting growth of cranial protrusions further comprises limiting growth of the middle and anterior parietal bones in protrusions on a side of the infant's cranium opposite the rotational direction with one of the lateral support surfaces, and limiting growth of the middle and anterior parietal bones in protrusions on a side of the infant's cranium in the rotational direction with the contact surfaces under the first and second lateral support surfaces.

Claims (4)

1. An orthopedic headrest for promoting normal shaping of a cranium of an infant, the headrest comprising:

a bottom surface for contacting a resting surface;

a top surface;

a generally semi-ellipsoidal recess in the top surface, the recess having a nadir;

a contact surface in the recess having the shape of at least a portion of a normal infant cranium;

a ridge at one end of the depression for supporting the neck of the infant; and is

The contact surface comprises at least a portion of first and second lateral support surfaces, each of the first and second lateral support surfaces having at least a portion positioned anterior to a first coronal plane and superior to a cranial lateral plane.

2. The orthopedic headrest of claim 1, further comprising at least one spacer member attachable to the headrest, the at least one spacer member having a portion extending into the semi-ellipsoidal recess adjacent at least one of the first and second lateral support surfaces.

3. A craniocervical orthosis for promoting normal shaping of a cranium of an infant, the craniocervical orthosis comprising:

a bottom surface for contacting a resting surface;

a top surface having a contact surface for contacting the cranium of the infant, the contact surface shaped like at least a portion of the curvature of a normal infant cranium;

the contact surface comprises at least a portion of first and second lateral support surfaces each having at least a portion extending in front of a first coronal plane at a location above a cranial lateral plane;

a ridge at one end of the top surface for supporting the neck of the infant, the ridge following the curvature of the rear neck region of a healthy infant;

wherein the contact surface has a semi-rigid surface; and

a nadir point located in the depression at an intersection of the cranial transverse plane and the contact surface.

4. The craniocervical orthosis of claim 3, further comprising at least one spacer member attachable to the headrest, the at least one spacer member having a portion extending into the semi-ellipsoidal recess adjacent at least one of the first and second lateral support surfaces.