Intraseptal Multi-Electrode Pacemaker for Bundle Branch Pacing
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Solution Overview
Problem
Existing cardiac pacemakers face challenges in effectively stimulating the left and right bundle branches of the heart due to uncertainty in locating conduction fibers, leading to difficulties in achieving low capture thresholds and anatomical variations among patients, which can result in under-deployment or over-deployment issues during intraseptal pacing.
Innovation Solution
A novel intraseptal multi-electrode cardiac pacemaker with a flexible elongated conduit housing multiple individual electrical wires and electrodes, allowing for precise placement and identification of optimal stimulation sites within the interventricular septum, including the use of a tissue fixation screw and optional defibrillator coils for depth limitation and sensing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If a single pacing electrode is used for intraseptal pacing, then the device complexity is reduced, but the precision of electrode placement and ability to achieve low capture thresholds deteriorates
Solution Approach 1:
The single pacing electrode is segmented into multiple individual electrodes (first plurality and second plurality) arranged in arrays. This segmentation allows precise targeting of different conduction pathways (His bundle, left bundle branch, right bundle branch) while maintaining a unified delivery system through the flexible conduit, resolving the contradiction between device simplicity and placement precision.
Solution Approach 2:
The electrodes are arranged in two-dimensional arrays extending in different directions from the conduit. This dimensional arrangement enables the electrodes to reach conduction fibers at various depths and orientations within the septum, achieving precise placement without increasing the complexity of the delivery system.
2Reliability
If the electrode is deployed deeper into the septum to reach conduction fibers, then the capture threshold is improved, but the risk of over-deployment and perforation increases
Solution Approach 1:
Multiple electrodes are pre-positioned at different depths and orientations within the flexible conduit before delivery. This preliminary arrangement ensures that when the conduit is deployed, electrodes at appropriate depths are already in place to achieve reliable capture without requiring excessive penetration depth, thereby preventing over-deployment and perforation.
Solution Approach 2:
The system changes the parameter of electrode depth by providing electrodes at multiple predetermined depths within the conduit. This allows selection of the optimal depth parameter for each patient's anatomy, achieving reliable capture thresholds while avoiding the harmful effect of over-deployment.
3Adaptability or versatility
If multiple electrodes are deployed to accommodate anatomical variations, then the adaptability to different patients is improved, but the device complexity and difficulty of deployment increase
Solution Approach 1:
The flexible conduit with multiple electrodes in arrays serves multiple functions: it can deliver electrodes to various locations (His bundle, left bundle branch, right bundle branch) and at different depths, accommodating diverse anatomical variations. This universal design achieves adaptability without proportionally increasing deployment complexity, as all electrodes are delivered through a single conduit.
Solution Approach 2:
The flexible conduit can be dynamically positioned and oriented to accommodate different anatomical configurations. The flexibility allows the conduit to adapt to various septal geometries and conduction pathway locations, providing anatomical adaptability while maintaining relatively simple deployment procedures.
4Ease of operation
If the location of conduction fibers is uncertain during deployment, then the ease of operation is reduced, but the measurement precision of fiber location is difficult to achieve
Solution Approach 1:
The conduction system is segmented into multiple targetable structures (His bundle, left bundle branch, right bundle branch) with electrodes arranged in corresponding arrays. This segmentation allows the operator to target different segments based on anatomical landmarks, improving ease of operation while achieving sufficient localization precision without requiring precise measurement of fiber locations.
Solution Approach 2:
Instead of attempting to precisely locate individual conduction fibers, the system uses partial action by targeting broader anatomical regions (bundle branches) where conduction fibers are known to be located. This approach improves ease of operation by reducing the precision requirement while still achieving effective pacing through the natural conduction pathways.
Data Source
AI summary
An intraseptal multi-electrode cardiac pacemaker has a plurality of first individual electrodes implanted at an interventricular septum at varying depths and/or lateral distances from the distal end of a flexible conduit and configured to provide a cardiac pacing therapy by stimulating left bundle branch conduction fibers. A plurality of second individual electrodes may also be implanted in the septum at suitable depths to stimulate conduction fibers of the right bundle branch. After implantation, first and second individual electrodes are interrogated to select a subset of electrodes suitable to deliver the pacing therapy according to a predetermined criterion such as capturing the left ventricle or capturing the right ventricle via normal conduction system of the heart at the lowest voltage level via corresponding bundle branches. A combination of the pacemaker with a cardioverter/defibrillator is provided by positioning a defibrillator coil near the distal end of the flexible conduit of the pacemaker.