Septal Multi-Electrode IMD for Precise His Bundle Pacing
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Solution Overview
Problem
Current implantable cardiac pacemakers and leadless pacing devices face challenges in precisely delivering pacing therapy to the bundle of His, requiring close physical placement of electrodes, which can be difficult and may not ensure adequate electric field strength for effective cardiac muscle depolarization.
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, combined with deep and shallow electrodes, allows for improved tissue fixation and precise delivery of pacing therapy to the bundle of His or other cardiac tissues.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If electrodes are placed close to the bundle of His, then pacing therapy precision is improved, but implantation difficulty and risk increase
Solution Approach 1:
The device segments the electrode system into multiple components: a helical lead electrode for deep penetration near the bundle of His, and separate fixation tines for stable anchoring. This segmentation allows the pacing electrode to be positioned precisely near the target while the fixation elements provide stable attachment, reducing implantation difficulty and risk.
Solution Approach 2:
The helical lead electrode acts as an intermediary element that can be advanced through tissue to reach the bundle of His region, while fixation tines provide indirect support by anchoring the device to the septum. This intermediary approach enables precise pacing delivery without requiring direct manipulation of the bundle of His, thereby reducing implantation risk.
2Measurement precision
If electrodes are placed close to the bundle of His, then pacing therapy precision is improved, but electric field strength may be insufficient
Solution Approach 1:
The helical configuration of the lead electrode introduces a dimensional aspect that increases the electrode's surface area and contact length with the tissue. This helical geometry allows the electrode to engage the tissue over an extended path, enhancing electric field strength while maintaining close proximity to the bundle of His for precise pacing therapy.
3Reliability
If fixation components are used as electrodes, then tissue fixation is improved, but device complexity increases
Solution Approach 1:
The fixation tines are designed to serve dual functions: providing mechanical anchoring of the device to the septum and serving as electrodes for pacing and sensing. This multi-functionality reduces the need for separate fixation and electrode components, thereby reducing overall device complexity while maintaining reliable tissue fixation.
Solution Approach 2:
The device merges the fixation function and electrode function into a unified structure where the same tines that anchor the device also deliver electrical therapy. This merging of functions simplifies the device architecture by eliminating the need for distinct fixation mechanisms and electrode assemblies, reducing device complexity while ensuring reliable tissue attachment.
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.