Steerable Snare Catheter for Leadless Pacemaker Retrieval
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Solution Overview
Problem
Existing catheter devices struggle to navigate easily and reliably to previously implanted leadless pacemakers, recapture them, and either reposition or explant them within the patient's anatomy, particularly when the implantation site is no longer suitable for proper function.
Innovation Solution
A catheter device comprising a steerable catheter with a snare catheter and mandrel system, allowing for axial movement and relative positioning to establish a connection with the implantable medical device, featuring a snare that can be retracted to secure the connection, a protective cup for safe removal, and a handle for control and navigation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If a catheter device is designed to navigate to and recapture an implanted leadless pacemaker, then the ability to reposition or explant the device is improved, but the device complexity increases due to multiple axially movable catheters and mandrel systems
Solution Approach 1:
The catheter device employs a nested structure where an outer catheter contains a steerable catheter, which in turn contains a snare catheter with a mandrel. This nested doll configuration allows multiple functional components to be integrated within each other, enabling complex operations (navigation, capture, repositioning) through a unified device while managing structural complexity through hierarchical organization
Solution Approach 2:
The device incorporates multiple axially movable components including the outer catheter relative to the steerable catheter, and the mandrel within the snare catheter. These dynamic elements allow the device to adapt its configuration during the procedure - extending for navigation and capture, then retracting for repositioning or explantation, providing versatility without requiring permanently complex structures
2Reliability
If the snare is made retractable into the snare catheter to secure connection to the pacemaker, then the connection reliability is improved, but the ease of operation deteriorates due to the additional axial movement required
Solution Approach 1:
The device merges the snare catheter and mandrel into a single integrated unit that moves together axially. This combination eliminates the need for separate control mechanisms for snare deployment and catheter positioning, allowing the operator to control both functions through a single axial movement, thereby maintaining ease of operation while achieving reliable connection
Solution Approach 2:
The mandrel acts as an intermediary element that transmits axial movement from the operator to the snare, converting linear motion into the cinching action needed for secure capture. This mechanical mediation simplifies the operation by providing a direct, intuitive control mechanism rather than requiring complex actuation systems
Data Source
AI summary
A catheter device for repositioning or explanting an implantable medical device comprises an outer catheter, and a steerable catheter extending through the outer catheter, wherein the outer catheter is axially movable with respect to the steerable catheter. A snare catheter extends through the steerable catheter, wherein the snare catheter is axially movable relative to the steerable catheter. A mandrel may extend through the snare catheter and comprising a distal end, wherein the mandrel is axially movable relative to the snare catheter. A snare may be arranged on the distal end of the mandrel for establishing a connection to the implantable medical device, wherein the snare, by moving the mandrel with respect to the snare catheter, is at least partially retractable into the snare catheter.