Left Bundle Branch Area Pacing System for Physiological Activation
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Solution Overview
Problem
Existing cardiac rhythm management systems face challenges in smoothly performing implantation and stimulation of the left bundle branch area of the heart, lacking medically approved components and resulting in non-physiological activation patterns that can exacerbate heart failure.
Innovation Solution
A system comprising a stimulation pulse generator, electrode with a fixing portion, and a sheath with a three-dimensional opening, designed for combined use to facilitate easy implantation and stimulation of the left bundle branch area, enhancing cardiac function and treating various cardiac conditions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional pacing systems stimulate the right atrium and/or right ventricle, then electrical stimulation can be provided to the heart, but non-physiological activation patterns occur that can lead to or exacerbate heart failure
Solution Approach 1:
The patent uses the left bundle branch area as an intermediary structure to deliver electrical stimulation more physiologically. By pacing through the natural conduction pathway (left bundle branch) rather than directly stimulating the ventricle, the system achieves more physiological activation patterns while maintaining reliable cardiac function. The sheath with three-dimensional opening also acts as an intermediary tool to facilitate precise positioning of the electrode in the septum.
Solution Approach 2:
The patent replaces the traditional mechanical approach of right ventricular pacing with a more physiological electrical conduction pathway by stimulating the left bundle branch area. This substitution allows electrical energy to travel through the heart's natural conduction system rather than forcing activation from the right ventricle, thereby improving physiological compatibility while maintaining effective cardiac stimulation.
2Reliability
If epicardial leads or transvenous leads are used for CRT, then left ventricle stimulation can be achieved, but the implantation process becomes complex and requires off-label usage of components
Solution Approach 1:
The patent combines multiple components (generator, electrode with fixing portion, and sheath with three-dimensional opening) into an integrated system specifically adapted for left bundle branch area pacing. This merging of components into a coordinated system simplifies the implantation process compared to using separate epicardial leads or transvenous leads, while ensuring reliable left ventricle stimulation through the natural conduction pathway.
Solution Approach 2:
The sheath with three-dimensional opening is designed to pre-establish the correct positioning and orientation for electrode implantation in the septum. By preparing the implantation pathway in advance with the sheath, the actual electrode placement becomes simpler and more accurate, reducing the overall complexity of the implantation process while ensuring reliable stimulation of the left bundle branch area.
3Reliability
If a combined set of components (generator, electrode, sheath) is used for left bundle branch area pacing, then medically approved systems can be provided, but device complexity increases
Solution Approach 1:
The patent designs each component (generator, electrode, sheath) to perform multiple functions within the integrated system. The electrode serves both as a stimulation source and has an integrated fixing portion for secure attachment. The sheath provides both guidance during implantation and structural support. This multi-functionality reduces the need for additional separate components, thereby managing system complexity while ensuring medically approved, reliable left bundle branch area pacing.
Data Source
AI summary
A system for providing stimulation to a patient, in particular stimulation to a left bundle branch area of the heart of the patient, the system comprising: a stimulation pulse generator; at least one electrode having a distal end for being engaged with the patient and a proximal end for being engaged with the generator, the electrode being configured to be implanted at least partially in the septum of the heart of the patient, and to provide stimulation to the patient, wherein the distal end comprises a fixing portion configured to facilitate implanting in the septum; a sheath having a three-dimensional opening for guiding the at least one electrode for implanting of the electrode; wherein the generator, the electrode and the sheath are adapted for use in combination with each other.