Internal craniofacial distraction with biodegradable devices: Early stabilization and protected bone regeneration

Internal craniofacial distraction has several advantages over distraction w ith external devices. The scars may be less conspicuous; the devices are bu ried and therefore easier for patients to tolerate; and the devices are mor e rigidly secured to bone, preventing uncontrolled rotation of the advancin g segments. There are several types of internal devices. The Modular Intern al Distraction System developed by one of the authors (S.R.C.) and Stryker- Leibinger, Inc. has had widespread use for midface distraction, but require s a substantial surgical procedure for device removal. This is justified in selected children with syndromic craniosynostosis, who frequently need sec ondary orbitocranial reconstruction at the conclusion of distraction with a ny type of device. It would be preferable to develop a device that would re tain the positive characteristics of the Modular Internal Distraction syste m, while allowing easy removability. Moreover, the entire distraction proce dure would benefit from a technique that would assist in bone regeneration within the distraction gap. Such a biodegradable, stabilizing device may en able early explantation, accelerating the recovery period, while providing fixation of the distraction gap and protected bone regeneration. Accordingl y, we have developed a new, biodegradable distraction device with Macropore , Inc. that may be used with the Modular Internal Distraction system to per mit easy removability of the device without the need for a large operation for exposure. Second, we have developed a biodegradable stabilizer that per mits earlier removal of the distraction device while providing simultaneous fixation and protected bone regeneration. Last, we have demonstrated the f easibility of midcourse correction of the distraction procedure, should thi s be necessary for whatever reason.