U.S. patent application number 11/208229 was filed with the patent office on 2005-11-24 for cranial orthosis for preventing positional plagiocephaly in infants.
This patent application is currently assigned to INFA-SAFE, Inc.. Invention is credited to Hobar, Paul C., Sklar, Frederick H..
Application Number | 20050261616 11/208229 |
Document ID | / |
Family ID | 30444341 |
Filed Date | 2005-11-24 |
United States Patent
Application |
20050261616 |
Kind Code |
A1 |
Sklar, Frederick H. ; et
al. |
November 24, 2005 |
Cranial orthosis for preventing positional plagiocephaly in
infants
Abstract
A cranial orthosis is contoured to match the curvature of the
fronto-temporal, parietal and occipital areas of an infant's
cranial vault to provide protection against the acquisition of
postural cranial deformities as a result of the infant's sleeping
in the supine position. The orthosis is designed to be of universal
fit, as determined by the infant's fronto-occipital head
circumference (FOC) measurement. The interior dimensions of the
orthosis can be enlarged to accommodate growth of the infant's head
without requiring replacement.
Inventors: |
Sklar, Frederick H.;
(Waxahachie, TX) ; Hobar, Paul C.; (Dallas,
TX) |
Correspondence
Address: |
SCOTT T. GRIGGS
1717 MAIN STREET
SUITE 3400
DALLAS
TX
75201
US
|
Assignee: |
INFA-SAFE, Inc.
Dallas
TX
|
Family ID: |
30444341 |
Appl. No.: |
11/208229 |
Filed: |
August 19, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11208229 |
Aug 19, 2005 |
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10620070 |
Jul 14, 2003 |
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6939316 |
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Current U.S.
Class: |
602/17 |
Current CPC
Class: |
A61F 5/05891
20130101 |
Class at
Publication: |
602/017 |
International
Class: |
A61F 005/00 |
Claims
We claim:
1. A cranial orthosis for preventing positional plagiocephaly in
infants comprising a protective shell having an interior surface
that is conformed in shape to the surface curvature of a human
infant cranium and operable to expand to accommodate infant head
growth, thereby defining a cavity for receiving the head of an
infant having compliant, developing head areas to be protected, the
cavity being sized to provide a close, non-interfering fit of the
conformed interior surface in facing relation to the developing
head areas to be protected, whereby when an infant's head is
received in the protective cavity, the infant's head weight forces
are spread substantially uniformly across the conformed interior
surface that engages one or more of the developing head areas while
the infant is resting on a sleep surface in a supine position.
2. The cranial orthosis for preventing positional plagiocephaly in
infants as set forth in claim 1, wherein the protective shell
includes an interior surface means for accommodating an increase of
at least approximately a 4 cm interval of infant head growth.
3. The cranial orthosis for preventing positional plagiocephaly in
infants as set forth in claim 1, wherein the protective shell
includes interior surfaces that are smoothly contoured and
conformed in shape to the surface curvatures of the occipital,
temporal and parietal areas, respectively, of a human infant
cranium having normal size, shape and symmetry of a healthy infant
of given age and gender.
4. The cranial orthosis for preventing positional plagiocephaly in
infants as set forth in claim 1, wherein the cavity is slightly
oversized relative to the head of an infant to be protected so that
the infant's head can be turned from side-to-side on the sleep
surface without imposing binding engagement of the protective shell
against the soft developing areas of the infant's head.
5. The cranial orthosis for preventing positional plagiocephaly in
infants as set forth in claim 1, wherein the protective shell is
loosely fitted relative to the head of an infant to be protected so
that the orthosis can be worn while the infant is resting in a
supine position on a sleep surface substantially without imposing
torque forces against the soft developing areas of the infant's
head.
6. A cranial orthosis for preventing positional plagiocephaly in
infants having a relatively soft developing head area to be
protected, comprising a protective headband having an interior
surface that is conformed in shape to the surface curvature of a
human infant cranium and interior surface means operable to expand
to accommodate infant head growth, thereby defining a pocket for
receiving the head of an infant to be protected, wherein the pocket
is slightly oversized relative to the head of the infant, thereby
providing a close but non-interfering fit of the headband about the
infant's head, the contoured interior surface being disposed in
facing relation to developing head area to be protected, thereby
allowing the headband to be worn while the infant is resting on a
sleep surface in a supine position substantially without imposing
focused torque forces on the infant's head.
7. The cranial orthosis for preventing positional plagiocephaly in
infants as set forth in claim 6, wherein the interior surface means
is expandable in size to accommodate at least approximately a 4 cm
interval of infant head growth.
8. The cranial orthosis for preventing positional plagiocephaly in
infants as set forth in claim 6, the protective headband including
interior surfaces that are contoured and conformed in shape to the
surface curvatures of the occipital, temporal and parietal areas,
respectively, of a human infant cranium having normal size, shape
and symmetry of a healthy human infant of given age and gender.
9. The cranial orthosis for preventing positional plagiocephaly in
infants as set forth in claim 6, wherein the pocket is slightly
oversized relative to the head of an infant to be protected,
thereby allowing the infant to turn its head from side-to-side on
the sleep surface without imposing focused torque forces or binding
engagement of the protective headband against the infant's
head.
10. The cranial orthosis for preventing positional plagiocephaly in
infants as set forth in claim 6, wherein the protective headband is
dimensioned for a loose fit relative to the head of an infant to be
protected, thereby allowing the headband to be worn while the
infant is resting on a sleep surface in a supine position
substantially without imposing torque forces on the infant's head,
while distributing the infant's head weight forces over a large
segment its cranial vault.
11. A cranial orthosis for preventing positional plagiocephaly in a
head of an infant, the cranial orthosis comprising: a crown
portion; left and right wing portions extending bilaterally from
the crown portion, the left and right wing portions being
dimensioned to provide at least partial overlapping coverage over
the infant's parietal and temporal areas; and left and right
rostral end portions extending from the left and right wing
portions, respectively, the rostral end portions being dimensioned
to provide at least partial overlapping coverage over the infant's
fronto-parietal and temporal areas, wherein the crown portion, the
wing portions and the rostral end portions partially expose a
membranous interval of the temporal bone area, a membranous
interval of the parietal bone and temporal bone areas and a
membranous interval of the occipital bone and temporal bone
areas.
12. The cranial orthosis for preventing positional plagiocephaly in
infants as set forth in claim 11, wherein the wing portions and
rostral end portions are loosely fitted relative to the developing
head areas of the infant to be protected, thereby allowing the
helmet to be worn while the infant is resting on a sleep surface in
a supine position substantially without imposing focused torque
forces on the infant's occipital region.
13. The cranial orthosis for preventing positional plagiocephaly in
infants as set forth in claim 11, wherein the exposed membranous
intervals provide air circulation and heat transfer over a
substantial portion of the infant's head.
14. The cranial orthosis for preventing positional plagiocephaly in
infants as set forth in claim 11, wherein the crown portion, the
wing portions and the rostral end portions provide for visual
inspection of the exposed membranous intervals.
15. The cranial orthosis for preventing positional plagiocephaly in
infants as set forth in claim 11, wherein the wing portions and
rostral end portions are dimensioned to prevent direct contact
between the infant's head and a sleep surface.
16. A method for preventing postural plagiocephaly in a human
infant having a cranium that is substantially normal in size and
curvature for its age and gender, comprising the steps: (a)
providing a protective appliance in the form of a shell, headband
or helmet having an interior surface that is expandable to
accommodate at least approximately a 4 cm interval of infant head
growth, the interior surface defining a pocket for receiving the
head of the infant having a soft developing area to be protected,
wherein the pocket is sized to provide a close, non-interfering fit
about the infant's head when the appliance is worn by the infant in
a protective position in which the contoured interior surface is
disposed in facing relation to the soft developing area to be
protected; and (b) causing the infant to wear the protective
appliance while resting on a sleep surface in the supine
position.
17. The method for preventing postural plagiocephaly in a human
infant as set forth in claim 16, wherein the step of providing a
protective appliance further comprises providing an interior
surface that partially exposes membranous intervals of a temporal
bone area of the infant, parietal bone and temporal bone areas of
the infant and occipital bone and temporal bone areas of the
infant.
18. The method for preventing postural plagiocephaly in a human
infant as set forth in claim 16, further comprising the step of
exposing a membranous interval of a temporal bone area of the
infant, a membranous interval of parietal bone and temporal bone
areas of the infant and a membranous interval of occipital bone and
temporal bone areas of the infant in order to allow air circulation
and heat transfer over the infant's head.
19. The method for preventing postural plagiocephaly in a human
infant as set forth in claim 16, further comprising the step of
exposing membranous intervals of a temporal bone, parietal bone and
occipital bone areas to allow visual inspection of the infant's
head.
20. The method for preventing postural plagiocephaly in a human
infant as set forth in claim 16, including the steps: (a) providing
an inventory of the protective appliances, each of the appliances
having a pocket conforming substantially in size and shape to the
cranium of a healthy human infant of given age and gender, the
inventory comprising a plurality of the protective appliances of
various cavity sizes that are indexed according to age, gender and
average fronto-occipital circumference values tabulated for the
general infant population; (b) measuring the fronto-occipital
circumference of the infant's head; and (c) selecting for the
infant's treatment a protective appliance from the inventory that
most closely matches the infant's head size, age and gender.
Description
PRIORITY STATEMENT & CROSS-REFERENCE TO RELATED
APPLICATIONS
[0001] This application claims priority from co-pending U.S. patent
application Ser. No. 10/620,070, entitled "Cranial Orthosis for
Preventing Positional Plagiocephaly in Infants" and filed on Jul.
14, 2003 in the names of Frederick H. Sklar and Paul C. Hobar;
which is hereby incorporated by reference for all purposes.
FIELD OF THE INVENTION
[0002] This invention is related generally to medical devices for
preventing and treating cranial deformities in infants. In
particular, the invention is related to a protective appliance or
cranial orthosis in the form of a shell, helmet or headband that
fits around a baby's head, and the use of the appliance to prevent
positional plagiocephaly by redirecting the compressive forces that
would otherwise be imposed on soft, compliant areas of the
developing cranium by the head weight of an infant lying on a sleep
surface in the supine position.
DESCRIPTION OF THE RELATED ART
[0003] Cranial asymmetry (plagiocephaly) and deformations may occur
from various congenital causes including premature closure of the
cranial vault and/or skull base sutures (craniosynostosis),
syndromal craniofacial dysostosis, intracranial volume disorders
such as hydrocephalus, microcephaly or tumor, metabolic bone
disorders such as rickets and birth trauma such as depressed skull
fractures. Cranial deformity (cranial molding) may also be acquired
in an infant as the result of compressive forces imposed by the
infant's head weight on the soft, compliant occipital areas while
the infant is lying on a sleep surface in the supine position. This
condition typically occurs during the first twelve months of
development before the cranium is fully expanded and the brain is
fully developed.
[0004] Generally, plagiocephaly is characterized by unilateral
occipital flattening with contralateral occipital bulging,
producing a flat spot at the back of the infant's head. The flat
spot and bulging make the baby's head appear to be square or
box-shaped in profile. As the deformation becomes more severe there
is ipsilateral forehead protrusion, contralateral forehead
flattening and endocranial skull base rotation with anterior
displacement of the ipsilateral ear. If not prevented or corrected
during the first twelve months of development, the deformity may
become permanent.
[0005] The number of infants diagnosed with plagiocephaly increased
substantially shortly after the onset of the "Back-to-Sleep"
campaign by the American Academy of Pediatrics (AAP) in 1992. In
that campaign, the AAP recommended that infants be placed in the
supine (lying on the back, face up) sleeping position in an effort
to decrease the incidence of sudden infant death syndrome (SIDS), a
leading cause of early infantile deaths in the United States at
that time. That campaign resulted in a substantial decrease in the
incidence of SIDS. However, the incidence of plagiocephaly was
observed to increase significantly over the same period. This
correlation suggests that positional treatment for SIDS was the
probable cause of the increased incidence of infant plagiocephaly.
The consensus of craniofacial practitioners is that plagiocephaly
may be acquired as a result of cranial postural molding that occurs
during SIDS positional treatment. That condition is now referred to
as positional plagiocephaly or acquired plagiocephaly, to
distinguish it from congenital plagiocephaly.
[0006] Postural molding of the newborn's skull is common, and this
presents clinically as occipital flattening, referred to as
acquired plagiocephaly (or brachycephaly). Although some mild
asymmetrical molding of the infant's cranial vault is likely common
as a result of back sleeping, some babies develop severe cranial
deformities that should be corrected. These deformities are
typically characterized by flattening of only one occiput. The
ipsilateral ear is displaced forward. There is compensatory bulging
of the contralateral occipital area, the ipsilateral high parietal
vertex, the ipsilateral temporal area, and occasionally the
ipsilateral forehead. Bioccipital flattening is less commonly seen.
These are acquired cranial deformities, and should be distinguished
from congenital cranial deformities that result from the premature
closure of a cranial surture (i.e., craniosynostosis). The latter
condition frequently requires craniofacial surgery in order to
correct the cranial deformity.
[0007] Positional plagiocephaly (postural molding of the cranium)
may be prevented by periodically repositioning (turning over) the
infant's head during sleeping. The "turn-over" repositioning
treatment is not difficult to accomplish. However, to be effective
this technique requires careful monitoring of the baby, diligence
and the close attention of parents during sleeping hours. Although
this seems simple in theory, in practice it is most difficult to
accomplish consistently over the treatment term, which may extend
up to 12 months, because of obligations parents may have to care
for other children and attend to other matters, while at the same
time trying to obtain the sleep and rest needed to carry on with
work and other activities.
[0008] Infants more than three months of age and those who have not
responded to repositioning may be treated with a custom-made
cranial torque helmet. The torque helmet, which is precisely
manufactured from an exact mold of the infant's head, continuously
applies pressure or torque to the cranium to correct asymmetric
deformities. The corrective forces have proven effective in some
cases to restore cranial symmetry by helping the growing brain to
reshape the cranium while it is still soft and compliant. The
torque helmet is worn continuously, day and night, and is removed
only for bathing until the child is twelve months of age or older.
After twelve months of age or if the deformity is severe, torque
helmets are of limited value and surgical cranial re-contouring may
be required.
[0009] Custom-fitted, conventional torque devices have treated
these acquired cranial deformities with varying degrees of success.
The success has depended in large part on the age of the patient at
the time torque treatment is begun. Clinical improvement occurs
most rapidly in young infants (3 to 5 months of age). Treatment
with these torque devices typically requires more time in older
infants. As a child's age approaches 12 months, torque treatment
becomes less effective. Many craniofacial physicians feel that
little is gained with a cranial orthotic device after 12 months of
age. Moreover, the acquired distortion of the base of the skull, as
evidenced by the forward displacement of the ear on the side of the
occipital flattening, does not generally improve with torque
treatment devices. The petrous pyramids of the base of the skull
tend to rigidly reinforce the skull base and resist external
torsion/correction of the acquired cranial deformity.
[0010] Not infrequently, infants undergoing cranial torque
treatment require re-fitting and replacement of the cranial
orthosis to accommodate head growth as the child develops and the
cranial deformity changes (responds). Because each orthosis is
custom manufactured from an exact mold of the child's head, and
because each device requires follow-up and modification as the
child grows and the deformity responds, these devices are expensive
and beyond the reach of many families, in particular those without
effective insurance coverage. Some commercial insurance companies
do not reimburse for the manufacture and use of such cranial
orthotic devices, because the cranial deformities are acquired and
are not the result of craniosynostosis (suture fusion).
[0011] It is therefore evident that a protective appliance is very
much needed for all newborns and infants, in order to prevent the
development of occipital flattening as a result of postural
molding. Moreover, such a protective appliance should be
universally available to all infants without requiring costly
procedures to custom-fit the device to the individual infant.
Rather, the protective appliance should be available on an
"off-the-shelf" basis, using simple measurements such as head
circumference to determine appropriate sizing. Finally, the
protective appliance should be safe, simple to understand and use,
relatively inexpensive and easily within the means of all families,
even those without insurance coverage, so that preventive care and
treatment can begin immediately after birth and continue at home
without professional assistance other than the usual well baby
check-ups.
BRIEF SUMMARY OF THE INVENTION
[0012] The protective appliance of the present invention is a
cranial orthosis that is positioned around the head of a newborn or
infant under one year of age, providing a protective shell that
overlaps the occiput (os occipitale), left and right temporals (os
temporale) and left and right parietals (os parietale). The
protective shell has a concave profile with bilateral symmetry, and
its interior surface is smoothly contoured to conform to the
curvature and symmetry of the underlying occiput, temporal and
parietal areas of the baby's head. Positional plagiocephaly
(postural molding of the cranium) is prevented by redirecting the
head weight forces that would otherwise compress the soft,
compliant areas of the baby's head against the sleep surface and
spreading those forces substantially uniformly over the smooth,
conforming interior surface of the protective shell. The
compressive forces imposed by the sleep surface (e.g., a mattress)
are decoupled from the soft, vulnerable areas of the baby's head
and are reacted through the protective shell. This prevents the
development of a deformity and allows the developing areas of the
infant's head to expand freely into the smooth, contoured cavity of
the protective shell and thereby obtain normal cranial symmetry
during the critical first twelve months of cranial development.
[0013] The concave pocket or cavity is sized to provide a close
fit, to redistribute the compressive forces of the mattress over a
large surface area of the baby's cranial vault. In the preferred
embodiment, the protective appliance is in the form of a concave
shell made of a durable, lightweight plastic material, having a
head receiving pocket bounded by a smooth interior surface that is
contoured to match the complex curvature and symmetry of the
occipital, parietal and temporal regions of a normal human infant
of the same age and gender.
[0014] The nominal dimensions (i.e., fronto-occipital
circumference) and surface curvatures that characterize the cranium
of a normal human infant are well known and documented in pediatric
practice. It is also well known and universally recognized that the
fronto-occipital circumference measurement (forehead to occiput) in
a healthy human infant varies predictably in the population
according to the infant's age and gender. Thus the protective
appliance of the present invention can be provided in standard,
universal sizes (e.g., small, medium and large) and fitted
effectively according to the age, gender and fronto-occipital
circumference measurement of the infant as determined by
traditional pediatric procedures.
[0015] In the preferred embodiment, the protective appliance
includes a crown portion, left and right wing portions and rostral
end portions. The appliance is sized to cover substantially all of
the underlying occipital area. The left and right wing portions
extend bilaterally from the crown portion, overlapping the left and
right parietal and the left and right temporal bones. Preferably,
the upper parietal and frontal regions are only partially covered
by the appliance in the protective position, thus allowing good air
circulation and heat transfer over most of the infant's head, while
protecting the compliant occiput from focused deformation forces
applied by the sleep surface.
[0016] The wing portions are terminated by rostral end portions
that are spaced apart and overlap the forehead (os frontale) area.
The appliance is placed on the infant's head by spreading the
rostral end portions slightly and inserting the baby's head into
the protective pocket, and then allowing the rostral end portions
to return to their resting (un-spread) position. Because the
cranium is wider across the occiput than it is across the forehead,
the appliance will be retained in the protective position by the
rostral end portions, which yieldably oppose separation from the
relaxed, protective position. The appliance includes a stretch band
of soft woven fabric material, bridging the rostral ends of the
appliance across the forehead region (os frontale) in order to help
stabilize the appliance in the protective position.
[0017] According to another aspect of the invention, multiple
layers of soft, spongy material or fabric material cover the
contoured interior surface of the protective shell. The layers can
easily be peeled away and removed at intervals to allow the
appliance to accommodate normal head growth.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] The accompanying drawing figures are incorporated into and
form a part of the specification to illustrate the preferred
embodiments of the present invention. Various advantages and
features of the invention will be understood from the following
detailed description taken with reference to the drawing figures in
which:
[0019] FIG. 1 is a top plan view of the cranial orthosis of the
present invention fitted over the head of an infant in the
protective position;
[0020] FIG. 2 is a left side elevation thereof, the right side
elevation being the mirror image thereof;
[0021] FIG. 3 is a front elevation view thereof;
[0022] FIG. 4 is a front elevation view thereof showing a stretch
headband attached to the orthosis and bridging across the forehead
of the infant;
[0023] FIG. 5 is a lateral view of a human infant skull at birth
showing the bones that make up the cranium and indicating in
phantom the operative protective position of the cranial orthosis
of the present invention;
[0024] FIG. 6 is a simplified elevation view of an infant's
unprotected head resting on a sleep surface in the supine position,
illustrating occipital flattening that occurs as the result of
forces imposed by the infant's head weight and the reaction forces
imposed by the sleep surface acting to compress a relatively soft,
compliant occiput;
[0025] FIG. 7 is a simplified elevation view of an infant's
protected head resting on a sleep surface in the supine position,
illustrating the operative position of the cranial orthosis as it
shields the infant's occiput;
[0026] FIG. 8 is a view similar to FIG. 7 showing the infant's head
in nesting engagement with cranial orthosis as it distributes the
head forces uniformly over the conformed interior surface;
[0027] FIG. 9 is a perspective view, partially broken away, of the
cranial orthosis with its conformed interior surface covered by
multiple layers of soft material that can be removed independently
and sequentially to accommodate head growth;
[0028] FIG. 10 is a perspective view of the cranial orthosis of the
present invention;
[0029] FIG. 11 is a chart that illustrates tabulated average and
two standard deviation values of fronto-occipital circumference
measurements for infant boys in the population age group from birth
to age 24 months;
[0030] FIG. 12 is a chart that illustrates tabulated average and
two standard deviation values of fronto-occipital circumference
measurements for infant girls in the population age group from
birth to age 24 months;
[0031] FIG. 13 is a perspective view of a flexible measuring tape
used for determination of fronto-occipital circumference
measurement;
[0032] FIG. 14 is a side elevation view of the tape being applied
in a fronto-occipital circumference measurement; and
[0033] FIG. 15 is a top plan view of a color chart used as a
reference for comparison with colored lining layers.
DETAILED DESCRIPTION OF THE INVENTION
[0034] The specification which follows describes a cranial orthosis
intended for use by newborns and infants less than one year of age
that will prevent the development of postural cranial deformities
as a result of the child's sleeping on his or her back. Preferred
embodiments of the invention will now be described with reference
to various examples of how the invention can best be made and used.
Like reference numerals are used throughout the description and
several views of the drawing figures to indicate like or
corresponding parts.
[0035] Referring to FIG. 1, FIG. 2, FIG. 3 and FIG. 10, the cranial
orthosis of the present invention is in the form of a molded
plastic appliance 10, for example a shell, headband or helmet, made
of a unitary plastic molding or shell for protecting the soft,
compliant skull base, occiput, left and right parietal bones and
left and right temporal bones from deformation as the result of
compressive forces caused by head weight while the infant is
sleeping in the supine (face up) position on a sleep surface, for
example a mattress. The protective appliance includes a crown
portion 12 covering the left and right occipital areas, left and
right wing portions 14 and 16 partially overlap the parietal,
temporal and frontal areas. Rostral portions 18, 20 partially
overlap the infant's forehead and help hold the appliance 10 in the
operative protective position.
[0036] The crown portion 12 is centrally disposed for substantially
complete overlapping coverage of the left and right sides of the
occipital bone. The left and right wing portions 16, 18 extend
bilaterally from the crown portion and the rostral end portions 18,
20 for terminal end portions on the wings. Preferably, the wing
portions 14, 16 and rostral portions 18, 20 are dimensioned to
provide limited overlapping coverage, whereby the upper parietal
aspects of the bones 28, temporal bones 26 and frontal area 30 are
only partially overlapped by the appliance in the protective
position, thus allowing good air circulation and heat transfer over
most of the infant's head, while shielding the soft, compliant
occiput from direct contact against the sleep surface.
[0037] The protective, overlapping positions of the various
protective elements of the appliance 10 can best be understood with
reference to FIG. 5 that shows a cranium 22 of a normal human
infant. The infant cranium includes an occipital bone area 24, a
temporal bone area 26, parietal bone area 28 and frontal bone area
30 that encase the brain. These bones are separated by membranous
intervals 32, 34 and 36 for several months and open cranial sutures
until brain growth is complete, typically until teenage years. For
the first year of life, an infant's skull is soft and pliable and
can be deformed or flattened by the head weight of the infant as a
result of the child's sleeping on his or her back.
[0038] This flattening deformity F, sometimes referred to as the
"bean bag" effect, is shown in FIG. 6. Here, the soft occipital
area 24 and temporal area 26 are compressed against the sleep
surface 38 of a mattress 40. These soft, compliant areas deflect
and are deformed inwardly along the line F, while the ipsilateral
ear (and that side of the skull base) is displaced forwardly, with
compensatory bulging of the contralateral occiput, the ipsilateral
high parietal vertex and the ipsilateral frontal area.
[0039] This acquired postural deformity is prevented by the cranial
orthosis 10 that includes an interior surface 42 that is conformed
in shape to the surface curvature of a normal human infant cranium,
thereby defining a cavity or pocket 44 for receiving the head of an
infant having compliant, developing head areas to be protected. In
one embodiment of the invention, the cavity 44 is sized to provide
a close, non-compressive fit of the conformed interior surface 42
in facing relation to the soft developing head areas to be
protected, as shown in FIG. 7 and FIG. 8.
[0040] According to another arrangement, the conformed surface 42
and protective pocket 44 are slightly oversized relative to the
head of the infant, thereby providing a close but non-interfering
fit of the orthosis 10 about the infant's head. In this embodiment,
the contoured interior surface is positioned in facing relation to
the soft developing head areas to be protected, thereby allowing
the orthosis to be worn while the infant is resting on a sleep
surface in a supine position substantially without focusing torque
forces on one particular part of the infant's head. This
arrangement allows the infant's head to turn from side-to-side
without imposing binding engagement of the orthosis against the
soft, developing head areas.
[0041] According to yet another arrangement, the protective pocket
44 is dimensioned to allow nesting engagement of the infant's head
against the conformed interior surface 42, as shown in FIG. 8.
According to this embodiment, when the infant's head is received in
the protective pocket 44, the infant's head weight forces are
distributed substantially uniformly across the conformed interior
surface 42 that nests in engagement against one or more of the soft
developing head areas while the infant is lying on a sleep surface
in the supine resting position.
[0042] The orthosis 10 is placed on the infant's head by spreading
the rostral end portions 18, 20 slightly and inserting the baby's
head into the protective pocket 44, and then allowing the rostral
end portions to return to their resting (un-spread) position.
According to an optional embodiment as shown in FIG. 4, a stretch
band 46 of soft flexible material may be connected to the rostral
end portions 18, 20 and bridge across the forehead 30 of the infant
when the infant's head is received in the protective pocket 44. The
stretch band 46 is formed by a strip of soft, resilient material,
for example woven 100% cotton fabric, broadcloth of 65% polyester
and 35% cotton or open cell foam material, and is reinforced by
elastic. Other materials that can be used include knitted goods,
velvet-like goods, and water resistant and water-proof fabrics,
such as GORE-TEX.RTM. brand fabric. The stretch band is preferred
for stabilizing the slightly oversized cavity embodiment of the
orthosis 10 in the protective position.
[0043] The stretch band is optional and usually is not needed
because of the retaining action of the rostrals 18, 20. Because the
cranium 22 is wider across the occiput than it is across the
forehead, the orthosis 10 will be retained in the protective
position by the rostral end portions. The rostral end portions are
resilient and yieldably oppose separation, but are spreadable to
allow insertion and will return automatically to the relaxed,
protective position shown in FIG. 1-FIG. 3 upon release.
[0044] According to another aspect of the invention, multiple
layers of soft, spongy material or fabric material 48, 50, 52 and
54 cover the contoured interior surface 42 of the protective shell
12, as illustrated in FIG. 9. With the exception of the innermost
base layer 54 which is permanently bonded to shell 12, the
remaining layers are releasably bonded to each other by contact
adhesive that permits independent release and removal of the strips
one at a time. By this arrangement, the remaining layers 48, 50 and
52 can easily be peeled away and removed sequentially to
accommodate normal head growth. Thus, the protective pocket 44 can
be enlarged to accommodate normal growth of the infant's head,
usually without requiring early replacement of the cranial orthosis
10, at least during the first three or four months. Typically, only
two orthoses may be required for most infants, to accommodate
normal head growth up to 12 months of age. Premature birth infants
may require three orthoses.
[0045] The protective shell 10 is molded with smooth interior
surfaces that are contoured and conformed in shape to the surface
curvatures of the occipital, temporal and parietal areas,
respectively, of a human infant cranium having normal size, shape
and symmetry of a healthy infant of a given age and gender. The
nominal dimensions (i.e., fronto-occipital circumference) and
surface curvatures that characterize the cranium of a normal human
infant are well known and documented in pediatric practice. See,
for example, the mean and standard deviation circumference values
for boy infants shown in FIG. 11 and the mean and standard
deviation circumference values for girl infants shown in FIG. 12,
as tabulated by G. Nellhaus in Composite International and
Interracial Graphs, Pediatrics 41: 106, 1968.
[0046] It is also well known and universally recognized that the
fronto-occipital circumference measurement (forehead to occiput) in
a healthy human infant varies predictably in the population
according to the infant's age and gender, as shown in FIG. 11 and
FIG. 12. For example, during the first eighteen months of age, the
mean head circumference 22 increases from about 34 to about 48 cm
for boys, and from about 34 to about 47 cm for girls. Thus the
protective appliance 10 can be provided in standard, universal
sizes (e.g., small, medium and large) and fitted effectively
according to the age, gender and fronto-occipital circumference
measurement of the infant as determined by traditional pediatric
procedures.
[0047] According to the method of the invention, an inventory of
protective appliances 10 is established, with each appliance having
a pocket conforming substantially in size and shape to the cranium
of a healthy human infant of given fronto-occipital circumference
(FOC) measurement. The inventory includes protective appliances of
various cavity sizes that may be indexed according to age, gender
and average fronto-occipital circumference values tabulated for the
general infant population.
[0048] Preferably, the inventory includes multiple cranial orthosis
10 in a range of cavity sizes that may be indexed according to age,
gender and average fronto-occipital circumference values
corresponding to male and female mean value circumference
tabulations for the general infant population. For example, the
standard sizes may range in maximum circumference from about 31
centimeters (corresponding to the 2nd percentile FOC of newborn
females) to about 49.5 centimeters (corresponding to 98th
percentile FOC of boys at twelve months), in four or six centimeter
intervals. Three or four standard or universal sizes in six or four
centimeter intervals, respectively, are sufficient to span the
range from birth to twelve months for a given boy or girl. A
closely conforming, non-binding initial fit is easily accomplished
by selecting an oversized orthotic shell 10 and lining its
conformed interior surface 42 with multiple release layers 48, 50
and 52. A satisfactory fit is maintained as the infant's head grows
by removing one or more of the layers from time-to-time as
discussed above.
[0049] The standard size protective appliances 10 are made from
control prototypes fabricated from head molds of healthy control
infants having normal head size, curvature and symmetry. A control
infant's head should be symmetrically shaped and free of
plagiocephaly. Head growth is monitored and a set of control molds
are fabricated for each control infant to provide the 2-cm FOC size
increments spanning the desired range, for example from 31
centimeters to 49 centimeters for an infant boy at the 50th
percentile FOC. Optionally, an overall FOC span of 18 cm can be
provided by a set of two control prototypes, from which two
standard over-sized protective appliances 10 are fabricated, each
fitted with four or five removable layers thereby providing
adjustable fit in 2-cm FOC increments over an approximate range of
9 cm each (18 cm total per set), as described below.
[0050] Plastic molds are fabricated with reference to carefully
selected control infants, and from these molds control prototypes
are made in two or more standard or universal sizes. The standard
size protective appliances 10 are then fabricated using the control
prototypes as templates and using conventional mass production
manufacturing techniques, for example by pneumatic thermoforming.
In the preferred embodiment of the invention, the cranial orthosis
is a shell molding 10 in the form of a head band fabricated of a
light weight, high impact resistant plastic such as polypropylene,
high density polyethylene, acetyl or polycarbonate resin having a
sidewall thickness in the range of {fraction (1/16)}-{fraction
(3/32)} inch.
[0051] The age and gender of the infant are known, and the
fronto-occipital circumference of the infant's head is measured.
With this information, a protective appliance is selected from the
inventory that most closely matches the infant's head size, age and
gender, which accommodates normal head growth over a specified time
period. Thus a physician can prescribe a protective cranial
orthosis 10 from the established inventory of standard sizes based
on the simple measurement of the infant's occipital-frontal
circumference (FOC) measurement.
[0052] Preferred materials for molding manufacture of the cranial
orthosis 10 include engineering plastic materials such as ABS,
polycarbonate, rigid polyvinyl chloride, polypropylene, acetyl,
cellulose acetate butyrate, polystyrene or other high impact
resistance plastic polymer resin material. For many applications
more flexible plastic resins such as medium or low density
polyethylene, plasticized polyvinyl chloride, polypropylene,
ethylene vinyl acetate, butadiene styrene, vinyl acetate-ethylene
or other suitable flexible plastic may be employed. Rigid or
semi-rigid polyurethane, polyvinyl chloride, ethylene vinyl
acetate, polyethylene or other suitable expandable plastic resins
may also be utilized.
[0053] Referring now to FIG. 9, FIG. 13, FIG. 14 and FIG. 15, the
removable layers 48, 50, 52 and 54 of soft fabric that cover the
inner shell surface are provided in different colors, for example W
(white), P (pink), B (blue) and G (green), to simplify the parents'
understanding of when to remove a given layer to accommodate head
growth. A flexible measuring tape 56 is fitted in a loop about the
infant's head, as shown in FIG. 14 and FIG. 15, with the loop
closure position of the tape buckle 58 determining the FOC. The FOC
measurement is indexed with reference to colored zones on the tape,
for example W (white), P (pink), B (blue) and G (green).
Preferably, each colored tape segment is 2 cm in length,
corresponding with the expected growth range over a predetermined
interval. Alternatively, the FOC measurement is taken with
reference to an external color chart 60 having color zones W, P, B
and G that cross-reference the FOC increments with the colors of
the various fabric lining layers. The tape measurement is taken at
weekly intervals to monitor the FOC and thus determine when to
remove the current lining layer. By this method the parent can
easily determine the most appropriate (best fit) lining layer by
matching the color indicated by the FOC tape measurement with the
color of the outer-most lining layer.
[0054] It will now be appreciated that a protective cranial
orthosis has been described that is capable of preventing postural
plagiocephaly in infants, can be mass produced at a nominal cost
per unit, and can be made universally available to all infants
without requiring costly procedures to custom-fit the orthosis to
the individual infant. The protective appliance 10 of the present
invention can be stocked and made available on an "off-the-shelf"
basis, using simple FOC head circumference measurements to select
the appropriate orthosis size from an inventory of standard size
appliances. Because of its simple design and construction, the
protective appliance is safe, easy to understand and use,
relatively inexpensive and easily within the means of all families,
even those without insurance coverage, so that preventive care and
treatment can begin immediately after birth and continue at home
without professional assistance other than the usual well-baby
check-ups. With such early treatment, disfiguring cranial
deformities that are so costly to treat and sometimes impossible to
correct can easily be prevented by the cranial orthosis of the
present invention.
[0055] Although the invention has been described with reference to
certain exemplary arrangements, it is to be understood that the
forms of the invention shown and described are to be treated as
preferred embodiments. Various changes, substitutions and
modifications can be realized without departing from the spirit and
scope of the invention as defined by the appended claims.
* * * * *