Leadless Catheter Conductive Pathway Navigation
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Solution Overview
Problem
Current medical devices and delivery systems for leadless cardiac pacing devices face challenges in navigation and communication due to tortuous anatomy and potential tissue trauma, with existing systems lacking efficient conductive pathways for electrical signals.
Innovation Solution
A catheter system with a tubular member and a distal holding structure that includes an electrical port and an electrically conductive insert or segments, providing a conductive pathway for electrical signals to and from the leadless pacing device, and a delivery device with a steerable and deflectable design to navigate through the vasculature effectively.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a leadless pacing device is delivered through tortuous anatomy using conventional catheters, then the device can be implanted, but navigation difficulty and tissue trauma increase
Solution Approach 1:
The catheter system employs a flexible distal holding structure with a compliant design that can navigate tortuous vasculature. The holding structure includes a flexible body portion and hub that can bend and conform to anatomical pathways, reducing mechanical stress on blood vessel walls during delivery while maintaining device stability at the implantation site.
Solution Approach 2:
The catheter system incorporates a steerable and deflectable design with the ability to dynamically adjust its configuration. The distal holding structure can change its shape and orientation during navigation, allowing operators to steer through complex anatomical pathways and position the device accurately while minimizing contact forces on vessel walls.
2Reliability
If conventional delivery systems are used without dedicated conductive pathways, then device delivery is simplified, but electrical signal transmission reliability deteriorates
Solution Approach 1:
The catheter system incorporates an electrically conductive insert or coating within the distal holding structure that serves as an intermediary conductive pathway. This dedicated conductive element facilitates reliable electrical signal transmission between the leadless pacing device and external programming/monitoring equipment during the delivery and implantation process, ensuring accurate device communication without requiring complex external lead connections.
3Ease of operation
If the distal holding structure is made more flexible to navigate tortuous anatomy, then navigation improves, but structural stability at implantation site may deteriorate
Solution Approach 1:
The distal holding structure is divided into distinct functional segments: a flexible body portion for navigation through tortuous anatomy, and a more stable hub region for device retention. This segmentation allows each portion to be optimized independently - the body portion provides compliance and steerability for navigation, while the hub provides structural stability and secure device holding at the implantation site.
Solution Approach 2:
The leadless pacing device is nested within the distal holding structure during delivery, with the device contained inside the holding structure's cavity. This nesting arrangement provides stable containment and protection during navigation, while the holding structure's design allows for controlled release at the target site, maintaining stability throughout the delivery process and enabling secure implantation.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Enhances the navigation and deployment of leadless pacing devices through tortuous anatomy while minimizing tissue trauma and ensuring reliable electrical communication, improving the efficiency and safety of the delivery process.
Implementation Method 1
an electrical port extending through the tubular distal holding structure at a location proximal of the proximal electrode of the leadless pacing device. The electrical port may provide a conductive pathway for an electrical signal traveling through the tubular distal holding structure
Data Source
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AI summary
Catheter and implantable leadless pacing devices, systems, and methods utilizing catheters and implantable leadless pacing devices are disclosed. An example catheter system may include a holding structure extending distally from a tubular member. An implantable device, such as a leadless pacing device, may be located within a cavity of the holding structure. The holding structure may include one or more electrical ports adjacent the proximal end of the holding structure and adjacent or proximal of the proximal end of the implantable device. The electrical ports may provide a conductive pathway extending through the distal structure to allow electrical signals to pass through the distal structure to and/or from the implantable device.