Patient-Specific Surgical Instrument Digital Customization

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Solution Overview

Problem

Current methods for generating patient-specific instruments (PSIs) for surgical procedures, such as joint replacements, face challenges in accurately customizing prosthetic systems to individual patient anatomy, leading to potential misfit and complications during implantation.

Innovation Solution

A computer-implemented system that uses preoperative imaging data to create a patient-specific instrument model by placing a generic implant model within a 3D representation of the patient's anatomy, allowing for customization through geometry processing operations to add or subtract features, resulting in a PSI that fits the patient's anatomy precisely.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If generic implant models are used for surgical procedures, then device complexity and manufacturing cost are reduced, but manufacturing precision and fit to patient anatomy deteriorate

Engineering Contradiction:
Improvefit to patient anatomyVSAvoidcustomization complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The system performs preoperative planning by creating a 3D model of the patient's anatomy from imaging data and virtually positioning the implant before surgery. This preliminary digital customization allows the surgical team to optimize implant fit and positioning without physical trial fittings, resolving the contradiction by achieving custom precision through preoperative digital modeling rather than complex physical customization procedures

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system creates a digital copy (3D model) of the patient's anatomy from imaging data and uses this virtual model to customize implant positioning. This digital copying approach achieves patient-specific precision without requiring complex physical modification of the implant, resolving the contradiction between manufacturing precision and device complexity

Inventive Principle:
Principle #26Copying

2Measurement precision

If patient-specific instruments are customized to individual anatomy, then manufacturing precision and surgical accuracy are improved, but device complexity and manufacturing time increase

Engineering Contradiction:
Improvesurgical accuracyVSAvoidmanufacturing time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The system replaces physical trial-and-error fitting procedures with a digital modeling and simulation system. By substituting mechanical customization processes with computer-based 3D modeling and virtual implant positioning, the system achieves high surgical accuracy while reducing the time required for instrument customization and manufacturing

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The system allows dynamic adjustment of implant positioning parameters (orientation, position, angle) in the digital model to optimize surgical outcomes. By enabling parameter optimization in the virtual environment rather than through iterative physical adjustments, the system achieves high measurement precision while minimizing the time and complexity of the customization process

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP2709540B1Generating patient specific instruments for use as surgical aids
Publication Date: 2020.11.04 THE CLEVELAND CLINIC FOUND
  • EP2709540B1 patent drawingFigure 1~4
  • EP2709540B1 patent drawingFigure 2
  • EP2709540B1 patent drawingFigure 5~6

AI summary

Systems and methods are provided for generating patient specific instruments for use as surgical guides. A region of interest within a body of a patient is scanned to provide a three-dimensional model of the region of interest. A first user is allowed to position a model of a selected implant with the three-dimensional model of the region of interest via a graphical user interface. A patient specific instrument model is generated from a generic patient specific instrument model according to the position of the model of the selected implant within the three-Dimensional model of the region of interest and the position of at least one extension of the model that is not visible to the first user. A patient specific instrument is fabricated according to the patient specific instrument model.