Segmented Thermoplastic Augmentation Element for Bone Anchoring
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Solution Overview
Problem
Existing medical devices face challenges in achieving stable anchoring in bone tissue, particularly in trabecular bone, due to insufficient bone stability and load-bearing capabilities, especially in osteoporotic or osteopenic conditions.
Innovation Solution
A method and assembly for augmenting hard tissue using a thermoplastic augmentation element, where energy is applied to liquefy the material, allowing it to penetrate and harden within the bone tissue, creating an augmented opening for improved implant anchoring, with segmentation and asymmetry to enhance stability and flexibility.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Strength
If a screw is anchored in trabecular bone tissue, then the screw can be inserted, but the anchoring stability and load-bearing capability are insufficient
Solution Approach 1:
The augmentation element is segmented axially into multiple sections (first section, second section, third section) with different properties. The first section has first material properties, the second section has second material properties, and the third section has third material properties. This segmentation allows different regions to provide different functions: some regions provide strong anchoring while others allow controlled movement or expansion, thereby improving both anchoring stability and long-time reliability in trabecular bone.
Solution Approach 2:
Different sections of the augmentation element are assigned different material properties and structural characteristics. The first section may have higher density for initial anchoring, the second section may have intermediate properties for transition, and the third section may have lower density for bone integration. This local differentiation of material properties optimizes the anchoring stability and load distribution across different regions of the bone-implant interface.
2Strength
If thermoplastic augmentation element is compressed between tool and counter element, then material is liquefied and pressed into surrounding tissue, but the tool requires large initial opening access
Solution Approach 1:
The augmentation element is divided into multiple axially spaced sections that can be independently compressed or expanded. This segmentation allows the element to be delivered through a narrower initial opening in a compressed state and then expanded or activated in situ within the bone, improving accessibility while maintaining the ability to provide bone stability.
Solution Approach 2:
The augmentation element transitions from a compressed, low-volume state during delivery to an expanded, high-volume state during function. The element can be compressed between the tool and counter element for delivery through narrow access, then the compression is released or additional force is applied to expand the element and press material into the surrounding tissue, achieving both accessibility and bone stabilization.
3Strength
If augmentation element is segmented axially into sections with different material properties, then anchoring stability is improved, but device complexity increases
Solution Approach 1:
The augmentation element is segmented into multiple axially spaced sections (first section, second section, third section) where each section has different material properties. The first section has first material properties optimized for initial anchoring, the second section has second material properties for intermediate functions, and the third section has third material properties for bone integration. This segmentation improves anchoring stability by creating optimal conditions in different regions while maintaining a relatively simple overall structure that can be manufactured as an integrated piece with varying material compositions or densities.
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
The solution provides enhanced anchoring stability and resistance to torsional movement, easing screw insertion while maintaining additional stability, suitable for various bone conditions and anatomical shapes.
Implementation Method 1
energy is coupled into the tool and while a periphery of a liquefaction interface of the tool and the augmentation element is within the opening; thereby liquefying material of the augmentation element at the liquefaction interface(s) to yield liquefied material
Data Source
Figure 1~2b
Figure 2c~2g
Figure 3a~4
AI summary
An augmentation method is provided, wherein a thermoplastic augmentation element is subject to mechanical energy impact and mechanical pressure by a tool so that augmentation material of the augmentation element is liquefied and pressed into hard tissue to augment the hard tissue, wherein in at least one axial depth, the augmentation element is segmented as a function of the circumferential angle so that at this axial depth the circumferential wall of the initial opening in first regions is in contact with the augmentation element and in second regions is not in contact with the augmentation element.