Leadless Cardiac Stimulation via Epicardial Stent Extraction
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Solution Overview
Problem
Current cardiac resynchronization therapy (CRT) technologies face limitations due to the need for multiple leads, which increase the risk of vascular complications, lead displacement, and limited multisite pacing capabilities, particularly in patients with left bundle branch block (LBBB), and are invasive and prone to complications such as thrombosis and infection.
Innovation Solution
A leadless cardiac stimulation system using self-powered stent electrodes positioned at the origin of the coronary sinus for both atrial and ventricular sensing, with remote communication to stimulation stents placed in veins around the heart, enabling multisite pacing and defibrillation without the need for leads, thereby reducing invasive procedures and complications.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple leads are implanted through veins leading to the heart for CRT, then biventricular pacing capability is improved, but the risk of vascular complications increases
Solution Approach 1:
The patent extracts the lead from the traditional transvenous implantation approach and positions it directly on the epicardial surface of the heart. This eliminates the need for multiple transvenous leads and their associated vascular complications while maintaining biventricular pacing capability through direct cardiac contact
Solution Approach 2:
The patent introduces an intermediary delivery system (catheter with balloon) that facilitates the placement of the epicardial lead without requiring permanent transvenous leads. The balloon-based delivery mechanism allows temporary positioning during implantation, eliminating the need for long-term vascular access points
2Adaptability or versatility
If multiple leads are implanted for CRT, then pacing coverage is improved, but the potential for lead displacement increases
Solution Approach 1:
The patent removes the lead from the transvenous pathway and places it directly on the epicardial surface, eliminating the mechanical interface between lead and vein that causes displacement. This direct epicardial contact prevents the lead from migrating through vascular tissue
Solution Approach 2:
The patent employs preliminary fixation measures during implantation, where the lead is secured to the epicardial surface using a delivery system with balloon inflation before final positioning. This preliminary anchoring ensures stable lead placement and prevents subsequent displacement
3Duration of action of stationary object
If leads are implanted long-term for CRT, then therapeutic benefit is improved, but the risk of infection increases
Solution Approach 1:
The patent extracts the lead from the transvenous implantation approach, eliminating the chronic foreign body presence in vascular tissue that predisposes to infection. By placing the lead directly on the epicardial surface with no transvenous component, the infection risk is significantly reduced while maintaining long-term therapeutic benefit
Solution Approach 2:
The patent converts the potential harm of invasive lead implantation into a benefit by using a minimally invasive epicardial approach. The direct cardiac contact provides stable pacing while the absence of transvenous leads eliminates the vascular infection pathway, turning a high-risk procedure into a lower-risk alternative
4Ease of operation
If traditional transvenous lead implantation is used for CRT, then pacing function is achieved, but the procedure is invasive and complex
Solution Approach 1:
The patent extracts the complex transvenous lead implantation procedure and replaces it with a simpler epicardial approach. By eliminating the need to navigate leads through multiple veins and chambers, the procedure becomes less invasive and technically simpler while achieving the same pacing function
Solution Approach 2:
The patent segments the pacing system into a separate epicardial lead component and a delivery system, allowing the lead to be implanted as a standalone element rather than as part of a complex transvenous assembly. This segmentation simplifies the implantation process and reduces procedural complexity
Data Source
Figure 1A~1B
Figure 2
Figure 3A~3B
AI summary
A system for artificial stimulation of the heart of a subject comprises a controller comprising a receiver for receiving signal data, a processor for processing received signal data, and a transmitter for transmitting signal data; a sensing stent for location in the proximal coronary sinus of the subject and comprising a sensing electrode assembly for sensing atrial and/or ventricular signals from the heart of the subject and a transmitter for transmitting signal data to the receiver; a stimulation stent for location in a vein of the subject distal of the sensing stent and comprising a receiver for receiving signal data from the transmitter and an electrode assembly for providing a stimulating electrical signal to the heart in response to the data received; and a defibrillator assembly for providing stimulation to the heart sufficient to defibrillate the heart in response to a signal received from the controller assembly.