His Bundle Pacing Lead With Linear Electrode Array
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Solution Overview
Problem
Current methods for His bundle pacing are technically challenging due to the limitations of existing tools, which make it difficult to efficiently activate the native conduction system of the heart, leading to inefficient heart contraction and potential pacing-induced cardiomyopathy.
Innovation Solution
The development of pacing leads and leadless pacemakers with an approximately linear array of electrodes, fixated to the His bundle using tines or an extendible helix, allowing for improved sensing and pacing of the atrium, His bundle, and ventricle, and featuring multiple electrodes for enhanced fixation and functionality.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a single distal electrode is used to directly engage the His bundle, then the target region can be accessed, but the procedure becomes difficult and time-consuming due to the small target area
Solution Approach 1:
The single distal electrode is segmented into multiple electrodes (at least four, preferably at least eight) arranged in an approximately linear array. This segmentation increases the probability of engaging the small target region (approximately one square centimeter) by providing multiple potential contact points, thereby reducing procedure time while maintaining precision.
Solution Approach 2:
The electrodes are arranged in an approximately linear array that extends along a portion of the lead, transitioning from a point contact (single electrode) to a line contact (multiple electrodes). This dimensional change increases the effective target area for engagement while maintaining precise positioning at the His bundle.
2Reliability
If standard right ventricular pacing is used, then the heart rate can be sustained, but it results in pacing-induced cardiomyopathy and heart failure due to inefficient activation
Solution Approach 1:
The linear array of electrodes at the distal section of the lead acts as an intermediary structure that enables His bundle pacing. By providing multiple electrodes in a linear arrangement, the system can more reliably engage the His bundle and activate the native conduction system, thereby sustaining heart rate while avoiding the harmful effects of standard right ventricular pacing.
3Reliability
If multiple electrodes are arranged in a linear array at the distal section, then the success rate of His bundle pacing increases, but the device complexity increases
Solution Approach 1:
The linear array of electrodes serves multiple functions: it provides fixation to the myocardium through the extendible helix, enables His bundle pacing through multiple potential contact points, and allows for sensing and stimulation. This multi-functionality increases the success rate of His bundle pacing while the modular design helps manage device complexity.
4Stability of the object's composition
If the helix is deployed perpendicular to the endocardial surface, then fixation is achieved, but the target region engagement becomes more difficult due to the small target area
Solution Approach 1:
The single fixation point is segmented into multiple electrodes in a linear array, increasing the probability of successful target engagement. The extendible helix provides additional fixation points along the lead body, distributing the fixation load and maintaining stability while facilitating easier target engagement through the multi-electrode approach.
Data Source
AI summary
The present disclosure relates to devices and methods for cardiac pacing therapy. Disclosed herein are methods for His bundle cardiac pacing; cardiac leads and leadless cardiac pacemakers that enables pacing and sensing of the His bundle as well as the right atrium and right ventricle; and delivery sheaths for placing the cardiac lead or leadless cardiac pacemaker in the heart. The devices and methods disclosed increase the success at which His bundle pacing can be implemented.