Surgery: splint – brace – or bandage – Orthopedic bandage – Splint or brace
Reexamination Certificate
1999-11-22
2002-07-23
Lewis, Kim M. (Department: 3761)
Surgery: splint, brace, or bandage
Orthopedic bandage
Splint or brace
Reexamination Certificate
active
06423019
ABSTRACT:
TECHNICAL FIELD
This invention relates to an improved orthotic headpiece, and more specifically to a cranial remodeling orthosis.
BACKGROUND OF THE INVENTION
Abnormal head shapes, known as positional plagiocephaly, may result from forces applied to an infant's head during the birthing process. Abnormal head shapes may also result from improper postnatal positioning of the infant's head. Infants having an abnormal skull shape or positional plagiocephaly may also have multistructural asymmetry in the cranium, cranial base, or the anterior craniofacial skeleton, including the orbits and external ear. A variety of factors, such as a premature birth, restrictive intrauterine environment, birth trauma, cervical anomalies, chronic sleeping positions and torticollis or chronic malpositioning of the neck due to muscle contracture have been found to increase the incident rate for these positional craniofacial deformations. The time required to produce postnatal deformation of the cranium depends upon skull compliance and pliability, and can range from several weeks to several months depending on the child's age.
Significant skull deformities that are not craniosynostotic in nature may be addressed through surgery of the cranial vault. Alternately, non-surgical intervention, in which forces are applied to the skull to allow directed growth and/or induce deformation, may be utilized. In the latter case, external cranial orthoses may be used to form the desired skull shape.
It is known to use an external cranial headpiece to apply forces to the skull to achieve skull remodeling. This is accomplished by fabricating a therapeutic headpiece based on a plaster of paris impression of the infant's head. The impression is then filled with a plaster slurry to create a positive mold of the head. An overlying headpiece is then made over the positive mold, and internal cavities are created to provide recesses into which the skull may grow/deform in a directed manner. In addition, dynamic orthotic cranioplasty has also been developed which utilizes a headpiece having external banding. The band encircles the cranium and may be tightened or loosened as desired to adjust the applied pressure. However, the headpiece of this device is not adjustable to accommodate growth of the child's head or the changing shape of the skull. As a result, a succession of new headpieces must be fabricated as the treatment progresses.
Another disadvantage in the prior art devices is that there is no manner in which to measure the force applied by the orthosis. Thus, the pressure may be set too high and cause pressure sores under the regions of high pressure. This problem is particularly troublesome due to the fact that cranial remodeling is performed primarily on infants who are unable to communicate effectively. Furthermore, the prior art headpieces may not allow for local adjustments of the pressure applied to the skull. Accordingly, the pressure applied by the headpiece should be set to a level below that which compromises perfusion to the scalp tissue, which may result in slower remodeling and prolonged treatment.
SUMMARY OF THE INVENTION
The device of the present application is an improved cranial remodeling orthosis. Specifically, the invention uses either expandable bladders such as hydraulic or pneumatic bladders inside a headpiece or helmet encircling the cranium to exert forces on the frontal, occipital, parietal, or other bony regions of the cranium. In a preferred embodiment, the bladders and band or headpiece are clear to enable visual inspection of the child's head. This allows the care giver to ensure proper fit of the headpiece and proper circulation to the scalp.
With the device of the present invention the bladders inside the headpiece can be inflated to the highest desirable level which still permits adequate blood perfusion. The present device allows visual inspection of the scalp to detect if the pressure is too high. Additionally, the bladders utilized in the invention may be expanded to a specific level so that the pressure is applied in a more controlled and precise manner than in the prior art devices discussed above. The use of pressure gauges or blood flow gauges allow for further monitoring of the infant's condition.
In the present device, air is expanded into preferably clear pneumatic bladders as the skull remodeling occurs. This allows the scalp to be monitored continuously throughout the therapy while corrective pressure is constantly or intermittently applied. The present invention also allows for an infant's care givers to monitor and control the pressure applied by the orthosis. With the past devices, the addition of pressure involved the decreasing of internal volume, addition of internal padding, tightening of screws, clamps or adding elastics to the external banding cranial orthosis, and usually required trained medical personnel.
The present invention is a cranial remodeling orthosis for inducing directed growth and remodeling of an irregularly shaped skull. The orthosis comprises a headpiece having an outer wall and an inner wall, the inner wall being shaped to receive the skull and having at least one recess formed therein to provide a volume into which the skull may be remodeled or growth directed. The orthosis further comprises a first expandable bladder located on the interior wall of the headpiece whereby when the orthosis is placed on the skull and the bladder is expanded, the recess and the expanded bladder cooperate to cause cranial remodeling.
Other features and advantages of the present device will be come apparent from the following detailed description of the preferred embodiment made with reference to the accompanying drawings, which form a part of the specification.
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Maierson Michael M.
Papay Francis A.
Cleveland Clinic Foundation
Lewis Kim M.
Tarolli, Sundheim, Covell Tummino & Szabo L.L.P.
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