Compression and Tension Instruments for Measured Ligament Reinforcement
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Solution Overview
Problem
Current implants and methods for reinforcing ligaments to promote healing and normal joint function face challenges, particularly in injuries such as high ankle sprains, where syndesmosis ligaments are often compromised.
Innovation Solution
A clamp for compressing bone portions with a directional force vector and a tension instrument for knotlessly locking flexible strands are used to reinforce ligaments, allowing precise application of compression and tension forces using gauges for measurement and adjustment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If current implants and methods are used to reinforce ligaments, then ligament reinforcement is achieved, but precision in applying compression and tension forces is insufficient
Solution Approach 1:
The patent replaces traditional mechanical implant systems with a sophisticated mechanical instrument system that includes a clamp with force gauge and a tension instrument with adjustable tensioning mechanism. This substitution enables precise control of compression and tension forces through mechanical means while maintaining the ability to reinforce ligaments effectively.
Solution Approach 2:
The patent incorporates force gauges in both the clamp and tension instrument that provide real-time feedback on the magnitude of compression and tension forces being applied. This feedback mechanism allows the surgeon to precisely control and monitor the forces applied to the ligament, ensuring optimal reinforcement while avoiding excessive stress.
2Manufacturing precision
If traditional compression methods are used without directional control, then bone portions can be compressed, but precise alignment and force direction cannot be achieved
Solution Approach 1:
The patent introduces directional control by defining a specific longitudinal clamp axis and orienting the force vector along this axis. This adds a dimensional aspect to the compression operation, transforming it from simple radial compression to controlled axial compression, thereby achieving precise alignment and force direction.
Solution Approach 2:
The clamp is designed with multiple functions: it can compress bone portions, control the direction of compressive forces through its longitudinal axis, and interface with the tension instrument. This multi-functionality consolidates several operations into a single device, improving ease of operation while maintaining precision.
3Reliability
If flexible strands are used for ligament reinforcement, then ligament flexibility is maintained, but knotless locking mechanism is complex
Solution Approach 1:
The patent extracts the knot-tying function from the traditional ligament reinforcement process by implementing a dedicated knotless locking mechanism in the tension instrument. This separate locking component eliminates the need for manual knot tying, thereby maintaining reliability while reducing operational complexity.
Solution Approach 2:
The knotless locking mechanism is designed to automatically secure the flexible strand within the tension instrument without requiring external knot-tying actions. The mechanism self-locks when the strand is tensioned to the desired level, providing reliable fixation while simplifying the surgical procedure.
4Measurement precision
If force measurement is not integrated, then simple instruments can be used, but measurable compression and tension forces cannot be applied
Solution Approach 1:
The patent merges the force measurement function with the compression and tension instruments by integrating force gauges directly into the clamp and tension instrument. This combination allows simultaneous application of force and measurement of that force, achieving measurement precision without significantly increasing overall device complexity.
Solution Approach 2:
The force gauge acts as an intermediary element between the mechanical force application system and the surgeon's control system. It translates mechanical forces into measurable readings that can be observed and used to adjust the applied forces, thereby enabling precise control while keeping the overall system manageable.
Data Source
AI summary
The disclosure provides apparatus and methods of use pertaining to syndesmosis reinforcement. Embodiments include a clamp having two jaws that extend toward each other to clamp two bone portions therebetween. The clamp may include an angle gauge and an adjustment mechanism having a force gauge that combine to enable the compression of the two bone portions in an optimal direction or angle and at an optimal, measurable compression force. Embodiments also include a tension instrument configured to knotlessly lock a flexible strand construct between two anchors at the same optimal direction and tension applied by the clamp. Further embodiments include an exemplary syndesmosis reinforcement procedure that employs the clamp and the tension instrument to construct a ligament reinforcement construct that achieves optimal anatomic positioning in both directional alignment and the reduction force applied by the construct. Other embodiments are disclosed.