Flexible Tip Introducer with EGM Feedback for Epicardial Access
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for puncturing tissue, particularly in epicardial access, face challenges such as inadvertent laceration and puncture of the heart wall due to the use of stiff introducers, which can lead to complications like cardiac effusion and tamponade, and lack precision in confirming the correct positioning of the puncture device relative to the target tissue.
Innovation Solution
The use of an elongate device with a tip electrode configured for collecting electrograms (EGMs) to indirectly measure and monitor pressure applied to the tissue, combined with an introducer having a stiff main body and a flexible tip, allowing for tangential approach and reducing the risk of damage, and employing a method that includes collecting EGMs to confirm the tip's location relative to the target tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a stiff introducer is used to provide access to the pericardium, then the physician can control the advancement of the introducer, but there is a risk of inadvertent laceration to the heart surface or puncture of the heart wall
Solution Approach 1:
The introducer is designed with spatially varying properties: the proximal portion is rigid to provide control during advancement, while the distal portion is flexible to conform to the heart surface and reduce laceration risk. This local differentiation of mechanical properties resolves the contradiction between controllability and safety.
Solution Approach 2:
The introducer is divided into distinct segments with different mechanical characteristics - a rigid proximal segment for operator control and a flexible distal segment for safe tissue interaction. This segmentation allows each portion to fulfill its specific function without compromising the other.
2Ease of operation
If a stiff introducer is used, then the physician can control the advancement, but precision in confirming the correct positioning of the puncture device relative to the target tissue is lacking
Solution Approach 1:
The system incorporates electrogram sensing capability that provides real-time feedback on the introducer tip's position relative to the target tissue. By detecting electrical signals from the heart, the system confirms correct positioning with high precision while maintaining the controllability benefits of the rigid proximal portion.
Solution Approach 2:
The introducer combines multiple functions in a single device: mechanical advancement control through the rigid proximal portion and positional confirmation through electrogram sensing. This multi-functionality eliminates the need for separate positioning verification steps while maintaining operational control.
3Adaptability or versatility
If the second polymer flexible tip segment length is greater than the flexible tip portion cap length, then the flexible tip can better conform to the heart surface, but the structural integrity may be compromised
Solution Approach 1:
The flexible tip is constructed as a composite structure with an inner core of first polymer providing structural integrity and an outer layer of second polymer providing enhanced flexibility and conformability. This composite construction allows the distal portion to be longer and more flexible without compromising the overall structural strength of the introducer.
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
This approach enhances the safety and predictability of tissue puncture by providing real-time feedback on the tip's position and pressure, reducing the risk of inadvertent damage and improving the precision of epicardial access procedures.
Implementation Method 1
The method uses an elongate device (e.g. a radiofrequency (RF) guidewire) having a tip electrode, which is configured for collecting electrograms (EGMs) and for delivering electrical energy for puncturing the tissue, and the method including collecting EGMs to indirectly measure and monitor the pressure applied against the target tissue by the elongate device
Implementation Method 2
The elongate device (e.g. a radiofrequency (RF) guidewire) having a tip electrode, which is configured for collecting electrograms (EGMs) and for delivering electrical energy for puncturing the tissue
Data Source
AI summary
An elongated medical sheath is configured to be movable and positionable proximate to a biological feature of a patient. An expandable-and-collapsible support structure is configured to be selectively movable, at least in part, between an interior of the elongated medical sheath and an exterior of the elongated medical sheath. An energy-emitting assembly is supported by the expandable-and-collapsible support structure.