Leadless Pacemaker Electrode Insertion Into Cardiac Conduction System
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Solution Overview
Problem
Conventional pacemakers require a generator pocket and transvenous leads, which can cause trauma and are not physiologically aligned with the cardiac conduction system, leading to adverse outcomes such as pacing-induced cardiomyopathy and inefficient electrical pacing.
Innovation Solution
A leadless pacemaker with an implantable housing, electronic circuitry, and electrode system designed to be inserted directly into the cardiac conduction system, specifically targeting the His-bundle, right bundle branch, and left bundle branch, using a catheter-based delivery system that minimizes tissue trauma and allows for stable electrical performance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If conventional pacemakers use transvenous leads and generator pockets, then electrical pacing can be delivered to the heart, but tissue trauma increases and physiological alignment with the cardiac conduction system deteriorates
Solution Approach 1:
The patent removes the transvenous leads and generator pocket from the pacemaker system, extracting the harmful components that cause tissue trauma. The pacemaker device is extracted from its conventional external/venous positioning and relocated to direct implantation within the cardiac conduction system, eliminating the need for venous access and lead traversal through the heart chambers.
Solution Approach 2:
The patent merges the pacemaker generator and electrode system into a single integrated leadless device. The electronic circuitry, power source, and pacing electrodes are combined into one self-contained unit that can be implanted directly into the cardiac conduction system, eliminating the separate generator pocket and lead assembly required by conventional pacemakers.
2Reliability
If transvenous leads are used to deliver pacing electrodes, then electrical impulses can be delivered to the heart, but the pacing is not physiologically aligned with the cardiac conduction system
Solution Approach 1:
The patent employs preliminary action through the use of a delivery catheter system that pre-positioned the leadless pacemaker device at the target site within the cardiac conduction system before deployment. The catheter guides the device through the vasculature to the precise implantation location, ensuring the electrodes are positioned directly at the His-bundle or bundle branches prior to activation, thereby achieving physiological alignment without requiring complex surgical exposure.
3Ease of manufacture
If leadless pacemaker design is adopted, then tissue trauma is reduced and implantation is simplified, but the device must be self-contained with all components integrated
Solution Approach 1:
The patent merges the pacemaker generator and electrode system into a single integrated leadless device. The electronic circuitry, power source, and pacing electrodes are combined into one self-contained unit that can be implanted directly into the cardiac conduction system, eliminating the separate generator pocket and lead assembly required by conventional pacemakers.
Solution Approach 2:
The patent applies the nested doll principle by placing the leadless pacemaker device within a delivery catheter system during implantation. The compact pacemaker unit is nested inside the catheter, which provides a delivery pathway through the vasculature to the target site. Once positioned, the device is deployed from the catheter, leaving the catheter to be removed while the pacemaker remains implanted in the cardiac conduction system.
Data Source
AI summary
Leadless pacemakers and methods of implanting the same are provided for a cardiac conduction system. A leadless pacemaker includes an implantable housing including a mounting interface, an electronic circuitry and a power source received by the implantable housing, and an electrode system connected to the electronic circuitry via the mounting interface. The electrode system includes electrodes configured to insert into a septum and having a length to reach pathways of the cardiac conduction system.