Preformed Stylet for Septal Lead Positioning
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Solution Overview
Problem
The placement of septal leads in cardiac stimulation devices is challenging due to the complexity of orienting the lead head perpendicularly against the cardiac septum, as existing stylets face issues with mechanical torque accumulation and sudden release, leading to imprecise positioning and deformation within the venous network.
Innovation Solution
A stylet with a specific conformation featuring a first and second curvilinear portion and a straight portion, designed to match the anatomical curvature of the venous network, allowing for self-positioning of the lead head by coinciding with the venous system's curvature and enabling precise adjustment through handle rotation, thereby avoiding mechanical torque issues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a conventional stylet is used to guide the lead, then the lead can be introduced into the venous network, but the stylet accumulates mechanical torque and deforms within the venous network, leading to imprecise positioning
Solution Approach 1:
The stylet is pre-formed with a specific curvilinear configuration that matches the anatomical curvature of the venous network before insertion. This preliminary shaping allows the stylet to follow the natural path of the veins without accumulating torque or deforming, thereby maintaining precise lead positioning throughout the procedure.
Solution Approach 2:
The stylet incorporates a curvilinear portion with a specific radius of curvature designed to match the anatomical curvature of the venous network. This curved configuration allows the stylet to smoothly navigate the venous system without sudden changes in direction that would cause torque accumulation, while still enabling precise orientation of the lead head against the septum.
2Shape
If the stylet is made rigid to maintain its shape, then the lead can be oriented perpendicularly to the septum, but the stylet cannot adapt to the curvature of the venous network
Solution Approach 1:
The stylet is designed with a curvilinear portion that has a specific radius of curvature matching the anatomical curvature of the venous network. This allows the stylet to be sufficiently rigid to maintain lead head orientation while simultaneously adapting to the curved path of the veins during insertion.
Solution Approach 2:
Different portions of the stylet have different mechanical properties: the curvilinear portion is designed with specific flexibility to match venous curvature, while other portions maintain appropriate rigidity for lead orientation. This local differentiation of mechanical properties allows the stylet to simultaneously adapt to venous anatomy and maintain precise lead positioning.
3Measurement precision
If a complex dual-stylet system is used to achieve precise positioning, then the lead can be accurately placed, but the device complexity and cost increase
Solution Approach 1:
The stylet is pre-formed with the correct curvilinear configuration during manufacturing, eliminating the need for complex adjustment mechanisms. This preliminary action achieves precise lead positioning with a simple, single-stylet design, avoiding the complexity and cost of dual-stylet systems while maintaining high positioning accuracy.
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 allows for precise and efficient placement of the septal lead head against the septum with reduced mechanical stress and deformation, facilitating easier implantation by aligning with the venous anatomy and providing a simple, cost-effective method compared to complex dual-stylet systems.
Implementation Method 1
The proximal portion is made of a permanently deformable material (so as to give a 'memory' to the shape of the stylet), which is not designed to transmit the torque due to its relative plasticity
Implementation Method 2
the proximal portion is made of a permanently deformable material (so as to give a 'memory' to the shape of the stylet)
Data Source
AI summary
Preformed guiding stylet for introducing a septal lead in contact with the septum or other intra-corporal device in contact with body tissue. This stylet includes a flexible wire to be introduced by its distal end in a central lumen of the lead, and a control handle. The wire is elastically deformable in bending and has sufficient rigidity in torsion to enable transmission by the handle rotation of a rotational movement over the entire length of the wire. Unstressed, the wire comprises successively in its distal part a first curvilinear portion a first straight portion a second curvilinear portion and optionally a second straight portion. The first and second curvilinear portions extend in respective planes making an angle between them defining a dihedral which axis comprises the first straight portion. The total length of the first curvilinear portion coincides with the anatomical curvature of the venous system.