Coronary Stimulation Lead with Adjustable Microcable
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Solution Overview
Problem
Existing medical devices for endocardial stimulation and defibrillation of the left ventricle face challenges in establishing a reliable electrical connection, accurately adjusting microcable length, guiding the microcable through the septum, and avoiding kinking, while requiring simple and fast surgical gestures without specialized tools or training.
Innovation Solution
A system comprising a deformable lead body with a lumen and a conductive microcable, where the microcable is anchored to the heart chamber or coronary vein, and a connector with a coupling mechanism to secure the microcable, allowing for adjustable length and secure electrical connection, facilitated by a stylet for pushing the microcable and a stop ring to limit its sliding, ensuring mechanical and electrical stability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a guide catheter is used to establish communication between the right ventricle and the left ventricle, then the puncture diameter can be sufficient to introduce the lead, but the device complexity and surgical difficulty increase
Solution Approach 1:
The patent removes the guide catheter from the system entirely. Instead of using a guide catheter to establish communication between ventricles, the invention uses a screw lead that directly punctures the septal wall and extends into the left ventricle, eliminating the need for the complex guide catheter system while maintaining sufficient puncture diameter for lead introduction
Solution Approach 2:
The screw lead performs multiple functions: it anchors itself in the septal wall, creates the puncture pathway, and serves as the support structure for the microcable extension. This multi-functional design replaces the separate guide catheter and lead system, reducing overall device complexity
2Device complexity
If a microcable is pushed through the septum without RF energy, then the system is simpler, but the microcable cannot penetrate the tissue and butts at the contact point
Solution Approach 1:
The patent introduces RF energy as an intermediary to facilitate microcable penetration. The RF energy applied to the microcable tip creates a localized thermal effect that allows the thin microcable to gradually penetrate the septal tissue without mechanical force, solving the penetration problem while keeping the system relatively simple
Solution Approach 2:
The patent utilizes thermal phase transition (heating) of the tissue at the microcable tip through RF energy application. This thermal effect softens and facilitates the penetration path through the septal wall, enabling the microcable to pass through without mechanical pushing force
3Force
If the microcable is made thinner to minimize axial force, then the required force decreases, but the microcable cannot penetrate the tissue without RF assistance
Solution Approach 1:
The patent replaces the mechanical penetration system with a thermal system. Instead of relying on mechanical force to push the thin microcable through tissue, RF energy creates a thermal pathway that the microcable follows, enabling penetration without excessive axial force while maintaining reliability
4Reliability
If a coupling mechanism is added to secure the microcable in the lead body, then the electrical connection reliability improves, but the device complexity increases
Solution Approach 1:
The patent uses a nested structure where the microcable is housed within the lead body lumen and secured by a coupling mechanism that interfaces between the microcable and lead body. This nested arrangement provides secure mechanical and electrical connection while maintaining a compact, integrated design that doesn't significantly increase overall 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
The system provides a simple, reliable, and adjustable electrical connection, allowing for effective endocardial or coronary stimulation with reduced risk of kinking and easy repositioning, enhancing the efficiency and safety of the implantation process.
Implementation Method 1
a stylet for pushing the microcable
Implementation Method 2
the drilling in the interventricular septum is preferably assisted by a RF puncture technique, which involves applying a localized radio frequency energy (RF) produced by a suitable electronic generator to create a very small size opening in the tissue of the septal wall
Implementation Method 3
Note also that the RF puncture technique advantageously provides a cauterizing of the traversed tissues, and thus prevents significant bleeding
Data Source
AI summary
A system for stimulation/defibrillation of the left ventricle endocardially or from a vein in the coronary system including: a lead body (10) having a lumen, a distal end (12) with an anchor (14) connectable to a wall of a heart chamber or of a vein of the coronary system, and a proximal side with a connector (22) having a first terminal (26). The lumen of the lead houses a microcable (28) with an active free part (30) that emerges from the distal end. An insert (38) formed on the lead body includes a first electrical connection to the first terminal (26) of the connector, and a coupler selectively movable between (i) a released position wherein the microcable is free to slide in lumen of the lead body, and (ii) a closed position, wherein the microcable is both mechanically immobilized in the lead body and electrically connected to first electrical connection.