Patient-Specific Tibial Wedge for Osteotomy Alignment

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Solution Overview

Problem

Current surgical systems for high tibial osteotomy lack precision and accuracy in correcting deformities like varus and valgus deformities, as they rely on non-locked shims or wedges, leading to uneven loading and potential complications.

Innovation Solution

A custom, patient-specific wedge designed using pre-operative planning software and 3D modeling, which optimizes wedge parameters for precise correction, combined with a reusable wedge system that can be adjusted for optimal angle and load distribution, allowing for accurate alignment and load distribution without pinning.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Device complexity

If non-locked shims or wedges are used in high tibial osteotomy, then the surgical system is simpler to implement, but precision and accuracy in correcting deformities deteriorates

Engineering Contradiction:
Improvesurgical system complexityVSAvoiddeformity correction precision
Core Design Contradiction:
Device complexityVSManufacturing precision

Solution Approach 1:

The patent applies preliminary action by performing pre-operative planning and 3D modeling to design custom patient-specific wedges before surgery. The wedge parameters are optimized in advance based on patient-specific anatomy and deformity characteristics, ensuring precise correction without requiring complex intraoperative adjustments.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent implements local quality by creating patient-specific custom wedges tailored to each individual's anatomical characteristics and deformity profile. Each wedge has unique dimensions, angles, and geometries optimized for that specific patient's tibial plateau and mechanical axis requirements, rather than using universal non-locked shims.

Inventive Principle:
Principle #3Local quality

2Ease of manufacture

If non-locked shims or wedges are used in high tibial osteotomy, then the device is easier to manufacture, but load distribution becomes uneven causing complications

Engineering Contradiction:
Improvewedge manufacturing easeVSAvoidload distribution uniformity
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent applies parameter changes by optimizing wedge parameters including angle, dimensions, and geometry based on patient-specific deformity characteristics. The custom wedges are designed with precise parameters that ensure even load distribution across the tibial plateau, preventing complications associated with uneven loading from standard non-locked shims.

Inventive Principle:
Principle #35Parameter changes

3Manufacturing precision

If custom patient-specific wedges with optimized parameters are used, then precision and accuracy of deformity correction is improved, but device complexity and manufacturing complexity increase

Engineering Contradiction:
Improvedeformity correction precisionVSAvoidcustom wedge system complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The patent replaces complex mechanical adjustment systems with pre-designed custom wedges whose correction parameters are determined through computational 3D modeling and pre-operative planning. This substitution of mechanical trial-and-error adjustment with computer-aided design simplifies the intraoperative procedure while maintaining high precision.

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

4Adaptability or versatility

If reusable wedge systems with adjustment capabilities are used, then adaptability to different patients is improved, but device complexity increases

Engineering Contradiction:
Improvepatient-specific adaptabilityVSAvoidadjustable wedge system complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent applies dynamics by designing reusable wedge systems with adjustment capabilities that allow intraoperative modification of wedge parameters. The wedges can be adjusted to accommodate different patient anatomies and deformity characteristics, providing versatility while maintaining a standardized base design that reduces overall system complexity.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentUS20230190376A1Surgical System
Publication Date: 2023.06.22 FORMUS LABS LTD
  • US20230190376A1 patent drawing
  • US20230190376A1 patent drawing
  • US20230190376A1 patent drawing

AI summary

A removable wedge for high tibial osteotomy surgery, comprising: a truncated wedge configured to provide a patient specific correction to the weight bearing axis based on 3D data for that patient’s tibia, femur and/or fibula; and an anterior flange configured to locate the partial wedge in a predetermined location on the tibia of that patient. Also a method for pre-operative planning, a method of designing a wedge, a method of printing a wedge a reusable wedge and a prosthetic implant.