Dual-Chamber Pacing Catheter Tip for Fast, Atraumatic Positioning
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Solution Overview
Problem
Existing temporary pacing catheters are difficult to position correctly, often cause endothelial injury and fibrotic processes, and can lead to complications such as cardiac tamponade, infection, and limited mobility due to their mobility during procedures, failing to maintain atrio-ventricular synchrony effectively.
Innovation Solution
A self-positioning, quick-deployment transvenous electrode system with insulated wires and atraumatic tips, featuring a domed head connected to a cylindrical sidewall with a sloped edge and tapered coupling, allowing for easy insertion and positioning of both atrial and ventricular leads, minimizing tissue damage and entanglement, and enabling dual chamber pacing without extensive training.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing temporary pacing catheters are used, then pacing function can be provided, but they cause endothelial injury and fibrotic processes
Solution Approach 1:
The catheter tip is designed with a curved, rounded geometry rather than a sharp or angular structure. This curvature allows the tip to conform to the cardiac chamber wall smoothly, distributing contact forces and preventing focal points of endothelial injury while maintaining effective pacing contact.
Solution Approach 2:
The catheter incorporates a flexible, compliant outer coating that changes the mechanical parameters of the lead surface. This coating reduces friction and contact pressure against the endothelium, minimizing shear forces and mechanical injury while preserving electrical conductivity for pacing function.
2Reliability
If existing temporary pacing catheters are used, then pacing function can be provided, but they lead to cardiac tamponade and infection risks
Solution Approach 1:
The catheter is designed with a segmented, multi-layer structure where the tip portion is separable from the main body. This allows the tip to be independently positioned and secured in the cardiac chamber without penetrating the pericardium, while the main body remains in the vein for easy removal if tamponade occurs.
Solution Approach 2:
A flexible, biocompatible coating acts as an intermediary layer between the catheter and the cardiac tissue. This intermediate layer prevents direct contact and potential perforation while maintaining electrical conductivity, thereby reducing the risk of cardiac tamponade and infection.
3Reliability
If existing temporary pacing catheters are used, then pacing function can be provided, but they are difficult to position correctly
Solution Approach 1:
The catheter incorporates a self-positioning mechanism where the tip geometry and flexibility allow it to automatically conform to the cardiac chamber wall upon insertion. The curved tip and compliant coating enable the catheter to find its own optimal position without requiring complex manipulation or extensive operator training.
Solution Approach 2:
The catheter is designed with dynamic flexibility, allowing the tip to adapt its shape and position in response to the cardiac chamber geometry. This dynamic compliance enables easy positioning across different patient anatomies while maintaining consistent pacing contact.
4Reliability
If existing temporary pacing catheters are used, then pacing function can be provided, but they cause limited patient mobility
Solution Approach 1:
The pacing function is extracted from a bulky, restrictive catheter design and concentrated in a thin, flexible tip. This allows the majority of the catheter body to be removed or made collapsible, minimizing the burden on the patient and allowing mobility while maintaining effective pacing through the slender, compliant tip.
Data Source
AI summary
The embodiments described herein relate to a self-positioning, quick-deployment low profile transvenous electrode system for sequentially pacing both the atrium and ventricle of the heart in the “dual chamber” mode having an atraumatic tip comprising a domed head connected to a cylindrical sidewall, said cylindrical sidewall having a sloped proximal edge connected to a tapered coupling, said tapered coupling forming a smooth transition to an outer diameter of the insulated wire, and methods for deploying the same.