Internal Pedicle Insulator with Segmented Wall for Spinal Fixation

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Solution Overview

Problem

Current pedicle screw insertion techniques face challenges with nerve root irritation and screw loosening due to limited tolerance between the pedicle screw and nerve roots, leading to malposition and instability in spinal fusion procedures.

Innovation Solution

An internal pedicle insulator implant with a cylindrical wall featuring a combination of smooth and rough surfaces, and varying thickness segments is designed to shield pedicle screws, reducing nerve root irritation and stabilizing the screw fixation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If a pedicle screw is inserted into the vertebral body, then fixation stability is improved, but nerve root irritation occurs due to limited tolerance (1-2mm) between the screw and nerve root

Engineering Contradiction:
Improvefixation stabilityVSAvoidnerve root irritation
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The patent introduces an internal insulator as an intermediary component placed between the pedicle screw and the nerve root. This insulator acts as a mediator that physically separates the screw from the nerve, preventing direct contact and irritation while maintaining the fixation stability provided by the screw.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The insulator is divided into multiple segments including a first segment with a rough surface for engagement with the screw and a second segment with a smooth surface facing the nerve root. This segmentation allows different portions of the insulator to perform different functions: securing the screw while protecting the nerve.

Inventive Principle:
Principle #1Segmentation

2Object-affected harmful factors

If the pedicle screw is repositioned to avoid nerve root impingement, then nerve root irritation is reduced, but screw loosening risk increases

Engineering Contradiction:
Improvenerve root irritationVSAvoidscrew loosening
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The internal insulator serves as a mediator that allows the screw to be positioned optimally for fixation stability without directly contacting the nerve root. This eliminates the need to reposition the screw to avoid nerve irritation, thereby maintaining both nerve protection and screw stability.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The insulator is inserted into the screw before the screw is fully implanted into the vertebral body. This beforehand cushioning protects the nerve root from potential irritation during and after implantation, while the rough surface of the insulator ensures the screw remains securely positioned.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Object-affected harmful factors

If the insulator wall thickness is increased to improve nerve protection, then nerve root irritation is reduced, but device complexity and insertion difficulty increase

Engineering Contradiction:
Improvenerve root irritationVSAvoidinsulator structure
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The insulator features local quality variations with different wall thicknesses in different segments. The first segment has a greater thickness to provide enhanced protection where needed, while the second segment has a reduced thickness to facilitate insertion and reduce overall device complexity. This localized differentiation optimizes both nerve protection and ease of insertion.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The insulator is segmented into a first portion with greater thickness for nerve protection and a second portion with reduced thickness for ease of insertion. This segmentation allows the device to meet conflicting requirements by distributing different thickness characteristics to different functional zones.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP3148458B1Internal pedicle insulator
Publication Date: 2021.11.03 CHAP-MED INC
  • EP3148458B1 patent drawingFigure 1~2H
  • EP3148458B1 patent drawingFigure 3A~5

AI summary

A pedicle insulator implant is designed to protect the nerves and surrounding tissue from injury by pedicle screws or other surgical devices and instruments. In its basic structure, the implant has a thicker section and a thinner section, the thicker section providing protection for nerves and other sensitive tissues while the thinner section can be deformable and provides grip. In one variation of the basic structure, the thinner section possess a rough surface when it is desirable in situations to provide further grip of the assembly and prevent rotation during the insertion of, for example, a pedicle screw.