Leadless Pacemaker Snare Catheter for Secure Retrieval
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Solution Overview
Problem
Conventional pacemakers face issues such as bulging under the skin, infection at the implant site, complex connections leading to malfunctions, and difficulties in navigating patient anatomy due to long delivery catheters, which increase the risk of spontaneous release and complicate retrieval procedures, often requiring surgical intervention.
Innovation Solution
A catheter system with a snare assembly and handle portions that allow for the reliable delivery and retrieval of leadless pacemakers using a single system, reducing the risk of spontaneous release and enabling tool-less bed-side loading, while providing torque transmission and secure engagement with the pacemaker.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional delivery catheter systems are used to deliver leadless pacemakers, then the pacemaker can be delivered to the implant site, but the long catheter length makes navigation difficult and increases the risk of spontaneous release
Solution Approach 1:
The delivery system is divided into multiple components: a delivery catheter, a retrieval catheter, and a snare assembly. The snare assembly can be advanced through the delivery catheter to engage the pacemaker, allowing the pacemaker to be securely held during navigation through the vasculature without requiring an excessively long delivery catheter.
2Ease of repair
If conventional retrieval systems are used, then the pacemaker can be retrieved, but surgical intervention is often required which increases procedure complexity and recovery time
Solution Approach 1:
The catheter system is designed to perform multiple functions: delivery of the pacemaker, securement during implantation, and retrieval if needed. The snare assembly can engage the pacemaker's docking projection and maintain secure attachment throughout the procedure, eliminating the need for separate surgical retrieval procedures.
3Reliability
If tether-based attachment is used to secure the pacemaker to the delivery catheter, then the pacemaker can be held during delivery, but loss of tether alignment causes spontaneous release
Solution Approach 1:
The snare assembly acts as an intermediary mechanism between the delivery catheter and the pacemaker. Instead of relying on direct tether alignment, the snare loops engage the docking projection from multiple directions, providing redundant attachment points that maintain secure connection even if one tether loses alignment.
4Reliability
If conventional connector systems are used to connect leads to the pulse generator, then electrical connection can be established, but the complex connection interface provides multiple opportunities for malfunction
Solution Approach 1:
The leadless pacemaker design extracts the connector interface entirely from the system. The pacemaker is self-contained with no external leads or connectors required, eliminating the complex male-female connector mating interface and setscrew mechanisms that are prone to malfunction in conventional systems.
5Ease of manufacture
If subcutaneous pulse generator placement is used, then the generator can be implanted, but it creates skin bulge that patients find unsightly and can lead to erosion and infection
Solution Approach 1:
The leadless pacemaker extracts the pulse generator from the subcutaneous space and places it directly inside the heart chamber. This eliminates the skin bulge problem and removes the generator from exposure to external pathogens, thereby preventing erosion, infection, and other skin-related complications while maintaining implantation feasibility through catheter delivery.
Data Source
AI summary
Systems and methods for delivering and retrieving a leadless pacemaker are described. A leadless pacemaker retrieval system includes a catheter system having a snare assembly to capture the leadless pacemaker. The catheter system includes sheaths extending distally from a shaft, and the snare assembly includes several snare legs, such as segments of snare loops, that extend from one sheath to connect to another sheath. The snare loops can have bights that connect to opposing sheaths to form a docking space between the legs of the snare loops and radially between the sheaths. The snare assembly is movable between an engaged position and a disengaged position by translating the snare legs within lumens of the corresponding sheaths. In the engaged position, the snare assembly tightens around the leadless pacemaker to allow the leadless pacemaker to be retrieved. Other embodiments are also described and claimed.