Left Bundle Branch Stimulation for Physiological Ventricular Activation
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Solution Overview
Problem
Existing cardiac rhythm management systems lack medically approved components for smooth implantation and stimulation of the left bundle branch area, leading to non-physiological activation patterns and potential exacerbation of 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 cardiac rhythm can be managed, but non-physiological activation patterns occur leading to dyssynchronous ventricular contraction and potential heart failure
Solution Approach 1:
The patent uses the left bundle branch as an intermediary structure to deliver electrical stimulation directly to the septum, which then naturally propagates activation to both ventricles. This mediator approach restores physiological activation patterns by utilizing the heart's own conduction system rather than directly stimulating ventricular muscle, thereby eliminating dyssynchronous contraction while maintaining reliable rhythm management.
Solution Approach 2:
The patent replaces the mechanical/electrical stimulation of ventricular muscle (traditional pacing) with stimulation of the conduction system (left bundle branch). This substitution allows the heart's natural electrical conduction mechanisms to propagate the stimulus physiologically through the septum to both ventricles, eliminating the harmful dyssynchronous activation patterns while maintaining effective rhythm management.
2Reliability
If epicardial leads or transvenous leads are used for CRT, then left ventricle stimulation can be achieved, but the activation pattern is indirect and less physiological
Solution Approach 1:
The patent extracts the stimulation from indirect pathways (epicardial or transvenous leads) and applies it directly to the left bundle branch via a transseptal approach. This extraction of the stimulation delivery point eliminates the need for complex lead positioning in the coronary sinus or epicardial placement, simplifying the implantation procedure while achieving more physiological activation and reliable ventricular resynchronization.
Solution Approach 2:
Instead of approaching the left ventricle from the outside (epicardial) or through the venous system (transvenous), the patent inverts the approach by accessing the left bundle branch from the right atrium through the septum. This inverted transseptal approach simplifies implantation by using existing access routes while achieving direct conduction system stimulation for physiological resynchronization.
3Ease of operation
If direct left bundle branch area pacing is performed, then more synchronized ventricular activation can be achieved, but medically approved systems covering all implantation components are lacking
Solution Approach 1:
The patent merges multiple previously separate components (transseptal access device, electrode catheter, fixation mechanism, and pulse generator) into a single integrated system that has received medical approval. This combination allows the entire implantation process for direct left bundle branch pacing to be performed with approved components, maintaining the ease of achieving synchronized ventricular activation while ensuring regulatory compliance and reliability.
Solution Approach 2:
The patent creates a universal system that combines multiple functions into single components: the electrode catheter serves both as a delivery vehicle and stimulation electrode, the fixation mechanism provides both anchoring and positioning guidance, and the integrated system works across different patient anatomies. This multi-functionality maintains ease of operation for achieving synchronized activation while ensuring the system meets medical approval standards for reliability.
Data Source
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AI summary
The present disclosure relates to a system (100) 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 (10); at least one electrode (30) 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 (50) 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.