Semi-Rigid Bone Fixation with Flexible Segment
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Solution Overview
Problem
Current methods for stabilizing the distal tibia and fibula following a syndesmotic injury provide overly rigid fixation, leading to discomfort and limited flexibility, and often require additional recovery points and inconsistent stability, making it difficult for patients to return to weight-bearing activities and necessitating secondary surgeries for hardware removal.
Innovation Solution
A semi-rigid fixation system using a flexible segment between anchors on the fibula and tibia, allowing for controlled shear and rotational motion, which maintains the pre-injury distance between bones under dynamic loading, reducing displacement and the need for additional holes in the tibia.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If cortical screws are placed across the syndesmosis to stabilize the fibula and tibia, then the bones are rigidly fixed in proper orientation, but the fixation is overly rigid preventing natural shear motion and rotation, causing discomfort and limited flexibility
Solution Approach 1:
The patent changes the fixation parameter from rigid (cortical screws) to semi-rigid (flexible segment with controlled elasticity), allowing the fixation device to maintain stability while permitting natural physiological motion during gait
Solution Approach 2:
The patent employs a flexible segment (such as a suture or elastic band) instead of rigid screws to connect the fibula and tibia, providing the necessary flexibility to allow shear motion and rotation while maintaining bone stabilization
2Reliability
If cortical screws are used for fixation, then the ligaments can heal, but secondary surgery is required to remove the screws after healing
Solution Approach 1:
The flexible segment is designed to be temporary and biocompatible, allowing it to serve its stabilization function during healing and then be naturally absorbed or easily removed, eliminating the need for complex secondary removal surgery
Solution Approach 2:
The patent uses a disposable flexible segment that serves its purpose during the healing period and can be discarded or removed without requiring complex surgical intervention, reducing overall treatment complexity
3Ease of operation
If a flexible internal segment is used to reduce rigidity, then some motion is allowed, but through or bore holes through the medial wall of the tibia are required, providing additional recovery points and requiring access from multiple sides
Solution Approach 1:
The patent extracts or eliminates the need for through-holes in the medial wall of the tibia by using an alternative fixation approach that accesses the syndesmosis through a single lateral approach, reducing the number of surgical access points required
Solution Approach 2:
The flexible segment is designed to perform multiple functions (stabilization, allowing motion, and eliminating need for additional holes) through a single implementation, reducing overall procedural complexity
4Stability of the object's composition
If cortical screws provide rigid fixation, then the bones are held stable, but return to weight-bearing is more difficult due to prevention of natural shear motion
Solution Approach 1:
The patent transitions from static rigid fixation to dynamic semi-rigid fixation, where the flexible segment adapts its stiffness to allow natural physiological motion during weight-bearing activities while maintaining adequate stabilization
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enables earlier weight-bearing and potentially reduces the number of follow-up surgeries by providing stable, flexible fixation that maintains the pre-injury bone distance and reduces displacement under repetitive loading, improving clinical outcomes.
Implementation Method 1
A semi-rigid fixation system using a flexible segment between anchors on the fibula and tibia, allowing for controlled shear and rotational motion
Implementation Method 2
maintains the pre-injury distance between bones under dynamic loading, reducing displacement
Data Source
AI summary
An example method is provided for maintaining stability to an injury defined by a separation of two bones (e.g., the tibia and fibula), the separation being an injured distance greater than a pre-injury distance between the two bones in a first human patient. The method may include delivering a first apparatus for approximation of the two bones in the first human patient comprising the injury, the first apparatus including a flexible segment disposed between a first anchor and a second anchor. The method may further include maintaining, by the first apparatus, a restored distance between the two bones in the first human patient after a repetitive dynamic loading, the restored distance approximately equal to the pre-injury distance.