Implantable apparatus, matrix and method for correction of crani

Surgery – Instruments – Orthopedic instrumentation

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606 57, 606 70, A61B 1756

Patent

active

059934484

DESCRIPTION:

BRIEF SUMMARY
BACKGROUND OF THE INVENTION

1. Field of the Invention
The invention relates to bone distractive and contractive movements and more particularly, to apparatus and methods for the correction of craniofacial bone deformities.
2. Description of Related Technology
Human children born with skull and facial (craniofacial) bone growth disorders known as craniosynostosis develop profound abnormalities in the shape and function of the craniofacial skeleton. The underlying causative factor is the congenital absence of anatomically normal sutures (lines of open bone) between the various segments of craniofacial bone. This fusion of the normal bone lines, or synostosis, leads to unbalanced bone growth and subsequent deformation. The traditional treatment for these disorders has been surgical exposure, and transfer of the bones to create a more normal architecture. Such surgery requires neurosurgical exposure of the brain and its surrounding tissues. Also, bone grafts, plating, wires, and other rigid fixation implants are required to stabilize the repositioned bones.
Alternative methods for correcting synostotic deformities in young infants without the risk of major intracranial surgery and bone grafts have been introduced. For example, Remmler, U.S. Pat. No. 5,147,358 discloses an apparatus which was utilized to gradually reposition the cranial and fronto-facial bones in a rabbit model by mechanical means to a degree proportionate to that required in humans with craniosynostosis. Stainless steel fixation plates with threaded tubes were attached with screws to the craniofacial bones. Next, threaded percutaneous (through the skin) pins were attached to the plates. The bones were then gradually repositioned over a period of approximately one and one-half months to the desired position using an external jackscrew mechanism.
The device disclosed in U.S. Pat. No. 5,147,358 has been used to successfully distract bone segments primarily in one dimension. However, congenital craniofacial anomalies are frequently asymmetric in three dimensions, requiring simultaneous distractive and contractive movements of multiple major bone segments. Thus, a need exists for a versatile, multi-axial apparatus, system, and method for moving multiple bone segments in various directions.


SUMMARY OF THE INVENTION

It is an object of the invention to overcome one or more of the problems described above. Further objects of the invention include providing subcutaneous craniotatic apparatus and matrix which offers the advantages of complete implantation under the skin and multi-axial distraction capability, and including a method for guiding bones during their transit, preferably with computer aided accuracy.
An apparatus of the invention for relative movement of first and second bone segments, such as portions of a skull, includes first and second nodes attachable to first and second bone segments, respectively, and a first rod mechanism flexibly attached to both the first and second nodes. The rod mechanism is either extendible or retractable along an axis thereof. The rod mechanism axis is pivotable with respect to the first and second nodes in at least a first plane parallel to a plane tangent to the skull. The rod mechanism axis also is pivotable with respect to the first and second nodes in a second plane perpendicular to the first plane.
Also according to the invention, a matrix for correcting craniofacial bone deformities includes a first node disposed on a first bone segment; a second node disposed on a second bone segment; and a first rod mechanism flexibly attached to both the first node and the second node. The first rod mechanism is extendible and/or retractable along an axis thereof. The matrix also includes a third node which is disposed on one of the first bone segment, the second bone segment, or a third bone segment neighboring the first bone segment. A second rod mechanism is attached to both the first node and the third node. The second rod mechanism is either extendible, retractable, extendible and retractable, or static along

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Cohen et al., "Distraction Osteogenesis of the Human Craniofacial Skeleton: Initial Experience with a New Distraction System," J. Craniofacial Surgery, vol. 6. No. 5, pp. 368-374, Sep. 1995.
Rachmiel et al., "Multiple Segmental Gradual Distraction of Facial Skeleton: An Experimental Study," Analysis of Plastic Surgery, vol. 36, No. 1, pp. 52-59, Jan. 1996.
Cohen et al., "Maxillary-Midface Distraction in Children with Cleft Lip and Palate: A Preliminary Report," Plastic and Reconstructive Surgery, pp. 1421-1428, Apr. 1997.
International Seach Report, Application No. PCT/US96/15716, mailed Dec. 27, 1996.

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