Left Ventricular Lead Active Fixation Guide Wire Tracking
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Solution Overview
Problem
Current implantable left ventricular leads face challenges in navigating complex venous anatomies and achieving precise placement at lateral and posterior basal locations of the heart, particularly in patients with small subclavian veins, due to their large diameter and difficulty in tracking around acute bends.
Innovation Solution
A downsized left ventricular lead with an active fixation configuration, featuring a tubular body and a fixed helical anchor that allows tracking over a guide wire, providing torque transfer and preventing tissue snagging, with a diameter of 3 F or less, enabling precise placement and fixation in the coronary sinus or adjacent vascular structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a guide wire is used to navigate complex venous anatomies, then navigation capability is improved, but the large diameter of the LV lead makes it difficult to track the guide wire around acute bends
Solution Approach 1:
The LV lead is divided into multiple segments with different flexibility characteristics. The distal portion has a smaller diameter and higher flexibility to track acute bends, while the proximal portion maintains sufficient diameter for structural support and electrode function. This segmentation allows the lead to navigate complex venous anatomies effectively.
Solution Approach 2:
Different portions of the LV lead have different physical properties optimized for their specific functions. The distal tip region has reduced diameter and increased flexibility for navigation, while the proximal region has larger diameter for structural integrity. This local differentiation resolves the contradiction between tracking capability and structural requirements.
2Ease of operation
If the LV lead diameter is reduced to facilitate venous access, then ease of implantation is improved, but fixation stability becomes more difficult to achieve
Solution Approach 1:
The LV lead incorporates a pre-formed helical anchor at its distal end that is designed to be deployed after venous access is achieved. This preliminary configuration allows the lead to be inserted through small veins first, then the helical anchor is expanded or deployed to provide stable fixation at the implantation site, resolving the contradiction between small diameter insertion and stable fixation.
Solution Approach 2:
The LV lead transitions from a flexible, small-diameter state during insertion to a stabilized state with deployed helical anchor at the implantation site. This dynamic transformation allows the lead to adapt its mechanical properties: flexible and compact during navigation, then stable and fixed at the target location.
3Reliability
If a helical anchor is used for active fixation, then fixation stability is improved, but the risk of tissue snagging during lead tracking increases
Solution Approach 1:
The helical anchor is designed with a protected configuration during lead tracking where the helical coils are contained or shielded. The guide wire passes through the helical anchor structure in a way that prevents the coils from catching on tissue. Only after successful navigation and positioning does the helical anchor deploy its fixation function, preventing tissue snagging during the critical tracking phase.
Solution Approach 2:
The lead is advanced through the venous system with the helical anchor in a compressed or protected state that prevents tissue interaction. The helical structure is only activated for fixation after the lead has been successfully positioned, eliminating the risk of snagging during navigation while maintaining fixation stability at the implantation site.
Data Source
AI summary
Disclosed herein is a left ventricular lead for tracking over a guide wire into a coronary sinus and providing active fixation in, or adjacent to, the coronary sinus. The guide wire is configured for coronary sinus lead implantation and has an outer diameter. In one embodiment, the lead includes a tubular body including a proximal end, a distal end and a central lumen through which the guide wire is extendable. The lead also includes a lead connector end proximally projecting from the proximal end and comprising at least one electrical contact. The lead also includes a fixed helical anchor comprising a wire member having a diameter of between approximately 0.22 mm and approximately 0.27 mm. The wire member distally extends away from the distal end in a helical arrangement including an inner helical coil diameter that is sufficient to allow the guide wire to extend through the fixed helical anchor.