Bone Anchor Swaging Mechanism for Tension Control
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Solution Overview
Problem
Prior art medical implants lack accurate provisional tensioning capabilities, leading to issues with maintaining consistent tension in sutures and cables, especially in soft tissues, where initial tension can settle and become excessive, and there is no effective method to trial tension and re-tension as needed.
Innovation Solution
A modular orthopedic device and implant system that includes a bone anchor with a housing, collet, and sleeve configuration, allowing for swaging of tensile members under controlled tension, enabling provisional and permanent tensioning with minimally invasive access and intuitive instrumentation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If standard suture anchors are used with hand-tightened slipknots, then the tensile member can be tensioned, but the tension cannot be accurately controlled and will settle into soft tissue losing tension after implantation
Solution Approach 1:
The patent changes the physical state and parameters of the tensile member by applying controlled heat and/or chemical treatment to melt or bond the suture within the anchor body, transforming it from a loose state to a permanently tensioned state. This ensures accurate initial tensioning and prevents subsequent settling in soft tissue.
Solution Approach 2:
The patent replaces the mechanical hand-tightened slipknot system with a thermal and/or chemical bonding system. Instead of relying on friction and knot tension, the suture is permanently fixed through melting or chemical adhesion, providing more reliable and accurate tension control.
2Ease of operation
If excessive tension is applied during implantation, then the tensile member appears tight, but it may experience loads greater than its failure load during cyclic loading in-situ
Solution Approach 1:
The patent incorporates a feedback mechanism where the surgeon can visually inspect the tensile member tension after implantation and perform load cycling to observe how the tissue responds. This allows adjustment of tension parameters to ensure they remain within safe limits during cyclic loading conditions.
Solution Approach 2:
The patent allows for preliminary tensioning and load cycling before final permanent setting. The surgeon can apply initial tension, test the construct through load cycling, and then make final adjustments to the tension parameters before the suture is permanently bonded, ensuring safety margins are maintained.
3Manufacturing precision
If a modular anchor system with swaging mechanism is used, then accurate and repeatable tensioning is achieved, but the device complexity increases
Solution Approach 1:
The patent combines multiple functions into a single integrated anchor body: the swaging mechanism, heating element, and suture retention features are all incorporated into one component. This merging of functions achieves precise and repeatable tensioning while minimizing the number of separate parts and overall device complexity.
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
This solution provides accurate and repeatable tensioning of tensile members, allowing for load cycling and re-tensioning before setting final tension, reducing the risk of excessive tension and improving surgical precision.
Implementation Method 1
a breakaway structure which is configured to retain structural integrity under a first predetermined tensile load and to separate under a second predetermined tensile load which is greater than the first predetermined tensile load
Implementation Method 2
the collet is configured to be swaged around and against the tensile member
Data Source
AI summary
A method for anchoring one or more tensile members to bone includes: providing an anchor, including: a housing including a body portion and an extension portion interconnected by a breakaway structure which is configured to retain structural integrity under a first predetermined tensile load and to separate under a second predetermined tensile load which is greater than the first predetermined tensile load; a collet disposed in the hollow interior; and a sleeve movable parallel to the central axis between first and second positions; passing one or more tensile members through a central bore of the collet; seating the housing into a bore formed in the bone; and driving the sleeve from the first position towards the second position under the first predetermined tensile load, so as to swage the collet around the one or more tensile members.