Patient-Specific Alignment Guide Manufacturing for Orthopedic Surgery

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Solution Overview

Problem

Current orthopedic surgery planning methods face challenges in accurately pre-operatively planning and manufacturing customized alignment guides and implants due to insufficient medical image data, leading to inefficiencies in surgical procedures.

Innovation Solution

A pre-operative planning method that constructs three-dimensional digital models of joint portions from medical image data, allowing for the creation of patient-specific alignment guides when sufficient data is available, or selecting non-custom implants and instruments based on two-dimensional images when data is insufficient, thereby assembling a tailored surgical kit for each patient.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If three-dimensional digital models are constructed from medical image data to create patient-specific alignment guides, then surgical precision and customization are improved, but the requirement for sufficient image data becomes a limiting factor when data is insufficient

Engineering Contradiction:
Improvealignment guide precisionVSAvoidinsufficient image data
Core Design Contradiction:
Manufacturing precisionVSLoss of information

Solution Approach 1:

The system performs preliminary assessment of image data sufficiency before committing to a manufacturing path. By evaluating whether the medical image data contains sufficient information for 3D model construction upfront, the system can plan alternative approaches (2D image-based sizing) in advance, preventing workflow disruptions when data is insufficient

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

Instead of requiring sufficient 3D image data to proceed with patient-specific alignment guides, the system inverts the approach by using 2D medical images to determine implant sizes and select from non-custom implants when 3D data is unavailable. This reversal allows surgical planning to continue with lower-quality imaging data

Inventive Principle:
Principle #13The other way round (Inversion)

2Productivity

If patient-specific alignment guides are manufactured from three-dimensional digital models, then surgical efficiency and patient-specific tailoring are improved, but the complexity of the manufacturing process increases

Engineering Contradiction:
Improvesurgical efficiencyVSAvoidmanufacturing complexity
Core Design Contradiction:
ProductivityVSDevice complexity

Solution Approach 1:

The system dynamically adjusts the manufacturing approach based on the quality and sufficiency of available medical image data. When 3D data is sufficient, it proceeds with patient-specific alignment guide manufacturing; when insufficient, it transitions to 2D image-based implant selection. This dynamic adaptation optimizes surgical efficiency while avoiding the complexity of patient-specific manufacturing when unnecessary

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The system changes the parameter of image data quality threshold to determine the manufacturing path. By establishing criteria for sufficient versus insufficient image data, the system can switch between high-precision patient-specific manufacturing and standard implant selection, balancing surgical efficiency with manufacturing complexity

Inventive Principle:
Principle #35Parameter changes

3Measurement precision

If the system requires sufficient image data for constructing three-dimensional digital models, then manufacturing accuracy is improved, but the applicability of the system decreases when image data is insufficient

Engineering Contradiction:
Improvedigital model accuracyVSAvoidsystem applicability
Core Design Contradiction:
Measurement precisionVSAdaptability or versatility

Solution Approach 1:

The system achieves multi-functionality by supporting two distinct workflows: (1) 3D image data-based patient-specific alignment guide manufacturing for high-precision cases, and (2) 2D image data-based non-custom implant selection for cases with insufficient 3D data. This universality ensures the system remains applicable across different imaging scenarios while maintaining measurement precision where possible

Inventive Principle:
Principle #6Universality (Multi-functionality)

Data Source

PatentUS9757238B2Pre-operative planning and manufacturing method for orthopedic procedure
Publication Date: 2017.09.12 BIOMET MFG LLC
  • US9757238B2 patent drawing
  • US9757238B2 patent drawing
  • US9757238B2 patent drawing

AI summary

A pre-operative planning and manufacturing method for orthopedic surgery includes obtaining pre-operative medical image data representing a joint portion of a patient. The method also includes constructing a three-dimensional digital model of the joint portion and manufacturing a patient-specific alignment guide for the joint portion from the three-dimensional digital model of the joint portion when the image data is sufficient to construct the three-dimensional digital model of the joint portion. The patient-specific alignment guide has a three-dimensional patient-specific surface pre-operatively configured to nest and closely conform to a corresponding surface of the joint portion of the patient in only one position relative to the joint portion. The method further includes determining, from the image data, a size of a non-custom implant to be implanted in the patient and assembling a surgical kit including the non-custom implant when there is insufficient image data to construct the patient-specific alignment guide therefrom.