Low Profile Spinal Tethering Device for Deformity Correction
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Solution Overview
Problem
Current rod-based systems for correcting spinal deformities are cumbersome, requiring complex surgical procedures, are rigid, and can hinder spinal growth, while also often necessitating fusion of multiple spine levels, leading to reduced spinal flexibility.
Innovation Solution
A spinal anchoring device comprising a staple body, a fastening element, and a locking assembly, which allows for the secure attachment of a tether to the spine, enabling correction of spinal deformities without fusion, and allowing for growth on one side of the deformity to self-correct the curvature.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If rod-based systems are used to correct spinal deformities, then correction effectiveness is improved, but device complexity and surgical procedure complexity increase
Solution Approach 1:
The rod-based system is divided into multiple modular components including segmented rods with adjustable curves, modular connectors, and separate fixation elements. This segmentation allows for simplified surgical assembly while maintaining correction effectiveness, as each component can be independently positioned and adjusted without requiring complex integrated structures.
Solution Approach 2:
The system incorporates dynamic adjustment capabilities allowing intraoperative modification of rod curvature and positioning. The rods can be bent and adjusted during surgery to achieve optimal spinal alignment, and the fixation elements allow for positional adjustments, enabling correction effectiveness to be optimized without requiring overly complex pre-planned rigid structures.
2Stability of the object's composition
If rigid rod-based systems are used for spinal correction, then structural stability is improved, but spinal growth and flexibility are hindered
Solution Approach 1:
The fixation system employs dynamic fixation elements that allow controlled motion and adjustment. The connectors between rods and vertebrae permit limited degrees of freedom, providing structural stability while accommodating natural spinal movements and growth. This dynamic capability allows the spine to maintain flexibility and adaptability during growth periods while still achieving correction stability.
Solution Approach 2:
The system allows for parameter adjustments in rod curvature, diameter, and fixation strength to balance stability and flexibility requirements. By varying these parameters across different spinal levels and patient age groups, the system can provide appropriate structural support while preserving necessary spinal flexibility and growth potential.
3Reliability
If multiple spine levels are fused using rod-based systems, then correction permanence is improved, but spinal flexibility is reduced
Solution Approach 1:
The spinal correction is divided into segmented fusion levels rather than extensive continuous fusion. By identifying and fusing only the critical deformity segments while leaving adjacent levels mobile, the system achieves permanent correction of the deformity while preserving spinal flexibility in non-fused regions. This selective segmentation reduces the overall impact on spinal mobility.
Solution Approach 2:
The system applies different fixation qualities to different spinal levels based on local requirements. Highly rigid fixation is applied only where necessary for correction stability, while more flexible fixation or no fixation is used in regions where flexibility is prioritized. This localized approach maintains correction permanence at critical levels while preserving spinal flexibility overall.
4Strength
If high-profile rod-based devices are used, then structural strength is improved, but patient mobility and comfort are reduced
Solution Approach 1:
The system employs thin-profile rod structures and low-profile fixation elements that maintain necessary structural strength through optimized geometry and material properties rather than increased size. The slender rod design with appropriate cross-sectional moments of inertia provides sufficient strength while presenting a low profile that does not interfere with patient mobility or cause discomfort during daily activities.
Data Source
AI summary
Methods and devices for treating spinal deformities are provided. In one exemplary embodiment, a low-profile spinal anchoring device is provided for receiving a spinal fixation element, such as a tether, therethrough. The device generally includes a staple body that is adapted to seat a spinal fixation element, a fastening element for fixing the staple body to bone, and a locking assembly for coupling a spinal fixation element to the staple body. In one embodiment, the locking assembly includes a washer that is adapted to couple to the staple body such that the spinal fixation is disposed therebetween, and a locking nut that is adapted to engage the staple body to mate the washer to the staple body.