Septal Multi-Electrode IMD for Precise His Bundle Pacing
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Solution Overview
Problem
Current implantable cardiac pacemakers face challenges in precisely delivering pacing therapy to the bundle of His, requiring leads to be placed as close as possible physically, which can be difficult and may not ensure optimal electrode contact and tissue fixation.
Innovation Solution
The use of fixation components as electrodes, such as helical fixation components and tines, positioned in the interatrial or interventricular septum to steer pacing therapy, with deep and shallow electrodes configured to penetrate and engage cardiac tissue for precise delivery to the bundle of His.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If lead electrodes are placed as close as possible physically to the bundle of His, then pacing therapy delivery precision is improved, but implantation difficulty and risk increase
Solution Approach 1:
The device segments the electrode system into multiple components: fixation electrodes positioned in the septum and pacing electrodes positioned distally. This segmentation allows the fixation electrodes to provide stable anchoring while the pacing electrodes deliver therapy precisely to the bundle of His, resolving the contradiction between implantation ease and therapy precision.
Solution Approach 2:
The fixation electrodes serve as an intermediary structure that anchors the device in the septum, enabling the pacing electrodes to reach the bundle of His without requiring direct manipulation in that difficult-to-access location. This intermediary fixation system simplifies the implantation process while maintaining therapy delivery precision.
2Reliability
If fixation components are used as electrodes, then tissue fixation and electrode contact are improved, but device complexity increases
Solution Approach 1:
The device merges the fixation function and electrode function into a single integrated structure. The fixation components that anchor the device to the tissue also serve as electrodes for pacing therapy, eliminating the need for separate fixation mechanisms and reducing overall device complexity while improving reliability.
Solution Approach 2:
The fixation components are designed with multi-functionality, serving both as mechanical anchors for tissue fixation and as electrical electrodes for pacing therapy. This universal design reduces the number of separate components needed, simplifying the device while enhancing its reliability through improved tissue contact.
3Measurement precision
If deep penetration into septum is achieved, then pacing therapy precision to bundle of His is improved, but tissue damage risk increases
Solution Approach 1:
The electrode system is segmented into fixation electrodes that penetrate the septum for anchoring and pacing electrodes that deliver therapy from a distal position. This segmentation allows deep septal penetration for stable fixation while the actual pacing therapy is delivered from a position that minimizes direct tissue damage risk at the penetration site.
Solution Approach 2:
The fixation electrodes act as intermediaries that penetrate the septum to provide stable anchoring, while the pacing electrodes deliver therapy from a protected distal position. This intermediary fixation system enables the necessary deep penetration for precision while isolating the therapy delivery function from the penetration trauma.
Data Source
AI summary
An implantable medical device (IMD) comprises a plurality of deep tines configured to be advanced into a septum of a heart of a patient in different directions that are not parallel to a longitudinal axis of the implantable medical device, wherein each deep tine of the plurality of deep tines is configured to deliver cardiac pacing to cardiac tissue distal to a chamber of the heart in which the IMD is implanted, and one or more shallow electrodes engageable with the septum, wherein the one or more shallow electrodes are configured to deliver cardiac pacing to the chamber of the heart in which the IMD is implanted.