Lead-in-lead cardiac electrode positioning
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Solution Overview
Problem
Existing implantable medical devices for cardiac pacing and therapy face challenges in efficiently and effectively delivering electrodes to various locations within the heart, particularly in achieving precise positioning and depth adjustment for optimal therapy.
Innovation Solution
The lead-in-lead system allows for the translatable or rotatable positioning of leads relative to each other, enabling customized implantation by guiding a second electrode to specific depths within the heart tissue structure, facilitated by a first electrode already implanted.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a single lead is used for cardiac electrode implantation, then the device structure is simple, but the positioning precision and depth adjustment capability are insufficient
Solution Approach 1:
The patent implements a lead-in-lead configuration where a second lead is nested within or guided by a first lead. The distal portion of the second lead is delivered through or along the distal portion of the first lead, allowing the second electrode to reach deeper or more precise locations within the heart tissue while utilizing the structural support and access pathway of the first lead.
Solution Approach 2:
The patent divides the electrode delivery system into multiple segmented leads (first lead and second lead) with distinct functions. The first lead provides initial access and stabilization, while the second lead provides precise depth adjustment and additional electrode placement capability. This segmentation allows each component to be optimized for its specific function while working together as an integrated system.
2Adaptability or versatility
If electrodes are implanted at fixed positions, then the implantation process is simple, but the adaptability to different patient anatomies is reduced
Solution Approach 1:
The patent enables dynamic adjustment of electrode positions through the translatable and rotatable capabilities of the second lead relative to the first lead. After initial implantation, the second lead can be translated along its axis or rotated to achieve optimal electrode positioning tailored to the specific patient's cardiac anatomy, allowing customization without requiring complete re-implantation.
Solution Approach 2:
The first lead serves as an intermediary structure that facilitates the delivery and positioning of the second lead. The distal portion of the first lead acts as a guide or scaffold that enables precise delivery of the second lead to the target site, while the second lead's ability to translate and rotate provides the final customization capability for optimal electrode placement.
3Measurement precision
If multiple leads are used for precise electrode positioning, then the positioning accuracy is improved, but the implantation difficulty increases
Solution Approach 1:
The patent performs preliminary action by first implanting the first lead to establish a stable access pathway and reference structure. The first lead is positioned and secured before the second lead is introduced, creating a prepared framework that simplifies the subsequent delivery and positioning of the second lead. This sequential preliminary action reduces the overall implantation difficulty compared to attempting to position multiple electrodes simultaneously.
Data Source
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AI summary
A lead-in-lead system may include a first implantable lead having a first electrode and a second implantable lead having a second electrode guided by the first implantable lead to an implantation site. The second electrode may be implanted in a patient's heart distal to the first electrode at the same implantation site or at a second implantation site. Various methods may be used to deliver the lead-in-lead system to one or more implantation sites including at the triangle of Koch for ventricle-from-atrium (VfA) therapy, at the right ventricular septal wall for dual bundle-branch pacing, or in the coronary vasculature for left side sensing and pacing.