Self-Positioning Transvenous Pacing Catheter with Atraumatic Tip
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Solution Overview
Problem
Current temporary pacing catheters fail to establish and maintain atrio-ventricular (AV) synchrony, leading to complications such as cardiac tamponade, infection, myocardial damage, and limited patient mobility, and cause endothelial injury due to their difficulty in correct positioning and mobility during procedures.
Innovation Solution
A self-positioning, quick-deployment transvenous electrode system with an atraumatic tip comprising a domed head connected to a cylindrical sidewall, featuring a sloped proximal edge and tapered coupling, which forms a smooth transition to an insulated wire, allowing easy insertion and positioning of atrial and ventricular leads to maintain AV synchrony without causing tissue damage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If existing temporary pacing catheters are used, then pacing function can be provided, but AV synchrony cannot be maintained and complications occur
Solution Approach 1:
The catheter is divided into separate atrial and ventricular leads that can be independently positioned and deployed. The ventricular lead is delivered through a ventricular sheath while the atrial lead is delivered through an atrial sheath, allowing independent placement in respective chambers to ensure proper AV synchrony without the complications of single-chamber pacing
Solution Approach 2:
The ventricular sheath is nested within the atrial sheath, creating a concentric structure where the inner ventricular sheath can be independently deployed after the outer atrial sheath is positioned. This nested configuration enables sequential deployment of leads in the correct anatomical sequence while maintaining a compact delivery system
2Reliability
If epicardial wires are used for pacing, then pacing can be established, but removing them causes cardiac tamponade and other serious complications
Solution Approach 1:
The catheter system serves as an intermediary device that replaces the need for epicardial wires. Instead of directly suturing wires to the epicardium and removing them later (which causes tamponade and infection risks), the catheter provides a temporary pacing function through transvenous lead placement that can be removed without direct tissue trauma, eliminating the harmful removal complications
Solution Approach 2:
The invention replaces the mechanical suture-attachment system of epicardial wires with a transvenous catheter system that uses a soft, atraumatic tip to gently engage cardiac tissue. This substitution eliminates the need for surgical suturing and wire removal, replacing a traumatic mechanical system with a safer, less invasive alternative
3Ease of operation
If balloon positioning is used, then catheter placement can be achieved, but the catheter moves to block the right ventricle outflow tract and pulmonary artery
Solution Approach 1:
The catheter system employs self-positioning features including a self-expanding balloon mechanism and atraumatic tip design that automatically engages with the cardiac chamber geometry. The ventricular lead self-positions in the right ventricle apex while the atrial lead self-positions in the right atrium, eliminating the need for manual balloon manipulation that causes outflow tract blockage
Solution Approach 2:
Instead of using a rigid balloon-tipped catheter that requires forceful positioning (which blocks outflow tracts), the invention uses a soft, flexible catheter with an atraumatic tip that gently engages the cardiac tissue. The positioning is achieved through the natural compliance of the tip and the geometry of the delivery sheath rather than through balloon inflation, inverting the traditional approach
4Reliability
If conventional leads are used, then pacing can be provided, but leads move (dislodge) during procedures and patient mobility is limited
Solution Approach 1:
The catheter system incorporates dynamic, flexible leads with memory shape capabilities that can adapt to patient movement. The leads are designed with sufficient flexibility to accommodate patient ambulation while maintaining electrical contact, allowing the patient to be mobile during temporary pacing without lead dislodgement, unlike rigid conventional leads
5Reliability
If conventional leads are used, then pacing can be established, but endothelial injury and fibrotic processes occur
Solution Approach 1:
The catheter tip and lead surfaces are coated with biocompatible materials and have modified surface parameters (smoothness, chemistry) to reduce endothelial activation. The atraumatic tip geometry and biocompatible coating parameters are specifically optimized to minimize friction and chemical irritation to the endothelium, preventing the fibrotic encapsulation and thrombotic obstruction that occur with conventional leads
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.