Biostimulator Movable Pacing Element Deep Septal Anchoring
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Solution Overview
Problem
Existing leads are not well suited for deep septal pacing, as they lack the ability to control penetration into the target tissue, often failing to penetrate beyond the fibrous endocardial tissue, and suffer from the shortcomings of conventional cardiac pacing systems.
Innovation Solution
A biostimulator with a movable pacing element relative to a fixation element, where the pacing element can be advanced longitudinally to access the deep septal area, using a telescoping pedestal mechanism to extend into the septal wall, allowing precise anchoring and pacing of the bundle branches.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional leads are used for deep septal pacing, then the structure is simple, but the ability to control penetration into target tissue is insufficient and pacing thresholds are high
Solution Approach 1:
The device is divided into distinct functional segments: a fixation element for anchoring in the endocardium, a telescoping pedestal mechanism for controlled extension, and a pacing element with helix for deep septal penetration. This segmentation allows each component to perform its specific function optimally while maintaining overall system manageability
Solution Approach 2:
The telescoping pedestal provides a dynamic extension mechanism that allows the pacing element to be advanced longitudinally from the fixation element. This dynamic structure enables controlled penetration depth adjustment, transitioning from a static lead configuration to a dynamically adjustable system that can reach the deep septal target tissue effectively
2Reliability
If conventional leads are used, then manufacturing is simple, but the leads cannot penetrate beyond fibrous endocardial tissue effectively
Solution Approach 1:
The fixation element is first anchored in the endocardial tissue to establish a secure base. Only after this preliminary anchoring is complete is the telescoping pedestal extended to advance the pacing element into the deep septal tissue. This preliminary action ensures stable positioning before attempting deep penetration, improving overall penetration effectiveness
Solution Approach 2:
The telescoping pedestal acts as an intermediary mechanism between the fixation element and the pacing element. It provides the controlled extension force needed to push the pacing element through the fibrous endocardial tissue and into the deep septal target, enabling effective penetration without requiring the entire device to be complex
3Reliability
If deep septal pacing is achieved with existing leads, then the procedure is simple, but success rates are low and pacing thresholds are high
Solution Approach 1:
The device incorporates sensing capability that provides feedback on the electrical activity of the deep septal tissue. This feedback allows the system to confirm proper positioning of the pacing element and adjust pacing parameters accordingly, improving success rates by ensuring the electrode is correctly placed in the target tissue
Solution Approach 2:
The pacing element features a helix structure with specific local geometric properties optimized for engagement with septal tissue. This localized structural quality at the pacing element tip enables effective anchoring and electrical contact in the deep septal region, improving pacing success without requiring overall procedure complexity
Data Source
AI summary
A biostimulator and a biostimulator transport system for deep septal pacing. The biostimulator includes a housing having a longitudinal axis and containing pacing circuitry in an electronics compartment. A fixation element and a pacing element are connected to the housing. The pacing element is longitudinally movable relative to the fixation element. Other embodiments are also described and claimed.