Patient-Specific Spinal Guide for Precise Screw Placement

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Solution Overview

Problem

Current spinal fixation methods rely on anatomical landmarks and intra-operative fluoroscopy, leading to high rates of screw misplacement, radiation exposure, and increased surgical time, with existing solutions being expensive and time-consuming, and lacking in precision, which can result in neurological injuries and complications.

Innovation Solution

A customized patient-specific fixture is created using 3D modeling and additive manufacturing, providing a template with pre-defined screw paths and self-alignment members, allowing for precise screw placement and stabilization of the spine, reducing the need for complex navigation systems and minimizing foreign material in the body.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional anatomical landmarks and fluoroscopy are used for screw placement, then surgical guidance is provided, but screw misplacement rate remains high and radiation exposure increases

Engineering Contradiction:

Improvescrew placement precisionVSAvoidradiation exposure

Core Design Contradiction:

Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The system performs pre-operative CT scanning and 3D modeling to determine optimal screw trajectories before surgery. The patient-specific guide is manufactured in advance with pre-defined screw paths, eliminating the need for intraoperative fluoroscopy and navigation systems, thereby reducing radiation exposure while maintaining high placement precision.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

A patient-specific guide acts as an intermediary device between the surgeon and the vertebra. The guide incorporates pre-calculated screw trajectories and physically constrains drill and screw placement, serving as a mediator that ensures accurate screw placement without requiring continuous fluoroscopy monitoring.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Measurement precision

If intra-operative navigation and fluoroscopy are used, then screw placement accuracy improves, but surgical time and cost increase

Engineering Contradiction:

Improvescrew placement accuracyVSAvoidsurgical time

Core Design Contradiction:

Measurement precisionVSLoss of time

Solution Approach 1:

All planning and trajectory calculation are completed pre-operatively using CT scans and 3D modeling software. The patient-specific guide is manufactured before surgery with all screw paths pre-defined, eliminating time-consuming intraoperative navigation setup and fluoroscopy monitoring, thereby reducing surgical time while maintaining high accuracy.

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The patient-specific guide is a physical copy or replica of the virtual surgical plan created pre-operatively. The guide translates the digital 3D model and screw trajectories into a tangible device that physically guides screw placement, eliminating the need for complex intraoperative navigation systems and reducing surgical time.

Inventive Principle:

Principle #26Copying

3Manufacturing precision

If custom fixtures and navigation equipment are used, then placement precision improves, but device complexity and cost increase

Engineering Contradiction:

Improvescrew placement precisionVSAvoidnavigation system complexity

Core Design Contradiction:

Manufacturing precisionVSDevice complexity

Solution Approach 1:

The system extracts only the essential function needed for precise screw placement - a patient-specific guide with pre-defined trajectories - eliminating the need for complex navigation systems, cameras, infrared sensors, and continuous fluoroscopy equipment. This simplified approach achieves high precision without device complexity.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patient-specific guide is a single-use, disposable device that is manufactured economically using additive manufacturing techniques. This eliminates the need for expensive, reusable navigation equipment and allows each patient to receive a customized guide without the hospital needing to invest in costly navigation systems.

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

4Reliability

If multiple screws are placed manually, then spinal fixation is achieved, but risk of neurological injury increases

Engineering Contradiction:

Improvespinal fixation reliabilityVSAvoidneurological injury risk

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patient-specific guide serves as a protective intermediary between the surgeon's manual placement and the vulnerable neural structures. The guide's pre-defined screw trajectories ensure that screws are placed safely within the pedicle boundaries, preventing breaches that could cause neurological injuries while maintaining reliable spinal fixation.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The optimal screw trajectories and safe zones are determined pre-operatively through 3D modeling and virtual planning. The patient-specific guide incorporates these pre-calculated safe paths, allowing surgeons to place screws manually with confidence that the pre-planned trajectories will avoid neural structures, thereby reducing neurological injury risk while ensuring reliable fixation.

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS10869722B2Method and fixture for guided pedicle screw placement

Publication Date: 2020.12.22 ROCHESTER INSTITUTE OF TECHNOLOGY

AI summary

A customized patient-specific combined template and implant for spinal fixation and method for use.