Multi-Axial Spinal Fixation with Adjustable Rod Connector
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Solution Overview
Problem
Current surgical treatments for spinal disorders, such as scoliosis and degenerative disc disease, often require complex procedures and multiple steps, leading to increased operating time and radiation exposure due to the need for multiple implantations and repositioning during spinal fusion and fixation surgeries.
Innovation Solution
A spinal construct system featuring a multi-axial fastener and connector design that allows for attachment to sacral and pelvic tissue, enabling adjustable fixation and revision of spinal rods without the need for extensive repositioning, utilizing a S2-alar-iliac fixation receiver and break-off setscrews for secure and adjustable attachment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional spinal fixation methods are used requiring multiple implantations and repositioning, then spinal stability is achieved, but operating time and radiation exposure increase
Solution Approach 1:
The spinal rod is pre-assembled with the connector and fastener components in a controlled preoperative setting, allowing for preliminary positioning and configuration adjustments before the actual surgical implantation. This preliminary assembly reduces intraoperative manipulation time and eliminates the need for multiple repositioning steps during surgery.
Solution Approach 2:
The spinal fixation system is divided into separable components (spinal rod, connector, fastener) that can be independently prepared and then quickly assembled during surgery. The connector serves as a modular interface that enables rapid connection between components, reducing the time required for complex intraoperative assembly and adjustments.
2Reliability
If traditional spinal fixation methods requiring multiple implantations are used, then spinal stability is achieved, but radiation exposure increases
Solution Approach 1:
The spinal rod and connector assembly is configured and positioned in advance before surgical implantation, allowing for verification of proper alignment and fit using non-radiation imaging methods in the preoperative setting. This eliminates the need for repeated intraoperative fluoroscopy and radiation exposure during multiple implantation attempts.
Solution Approach 2:
The complex assembly and repositioning operations are extracted from the surgical procedure and performed separately in the preoperative preparation phase. This separation removes the source of repeated radiation exposure (intraoperative imaging and adjustments) from the actual surgical intervention.
3Reliability
If fixed spinal constructs are used, then spinal stability is provided, but adjustability and revision capability are reduced
Solution Approach 1:
The connector design incorporates dynamic adjustment capabilities that allow the spinal rod position and orientation to be modified after initial implantation. The connector maintains stable fixation while enabling controlled adjustments through its mechanical design, which allows for postoperative revision without requiring complete removal and reimplantation of the spinal construct.
Solution Approach 2:
The system allows for selective removal and replacement of the spinal rod while retaining the implanted connector and fastener components. This enables revision surgery where only the rod needs to be exchanged (discarded and recovered) rather than the entire fixation construct, maintaining stability while providing adjustability.
Data Source
AI summary
A spinal construct includes a fastener configured for attachment with sacral and/or pelvic tissue of a body. A connector includes a mating element engageable with the fastener and includes a receiver. A spinal implant is engageable with the receiver between a capture configuration and a removable configuration. A multi-axial fastener is connected with the spinal implant. Systems, implants, instruments and methods of use are disclosed.