Multilumen Sheath for Simultaneous Ablation and Fluid Removal
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Solution Overview
Problem
Current methods for pericardial access during cardiac ablation face challenges in efficiently removing accumulated fluid while maintaining the ablation catheter in place, due to limited lumen capacity and the need for multiple catheter withdrawals and reinsertions, which complicates fluid removal and ablation procedures.
Innovation Solution
A sheath design with multiple lumens allows simultaneous tissue ablation and fluid removal without withdrawing the catheter, utilizing fenestrations for fluid withdrawal, navigation, and adherence to tissue, enabling effective fluid management and stabilization during procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Quantity of substance
If a single-lumen sheath is used to accommodate the ablation catheter, then the sheath structure is simple, but fluid removal capability is severely limited
Solution Approach 1:
The sheath is divided into multiple lumens (first lumen and second lumen) that are separate and independent. The first lumen accommodates the ablation catheter while the second lumen is dedicated to fluid removal, allowing simultaneous independent operation of ablation and fluid evacuation without interference between functions
Solution Approach 2:
The sheath structure is designed to perform multiple functions simultaneously: the first lumen provides catheter access and fluid irrigation, while the second lumen provides fluid suction and removal. This multi-functional design eliminates the need for separate catheters for each function
2Quantity of substance
If the sheath diameter is enlarged to allow fluid flow around the catheter, then fluid removal capability improves, but puncture size and procedural risk increase
Solution Approach 1:
Instead of enlarging the overall sheath diameter, the fluid removal function is segmented into a separate second lumen. This allows the sheath to maintain a smaller outer diameter suitable for safe puncture while internal segmentation provides dedicated fluid evacuation pathways
Solution Approach 2:
The second lumen for fluid removal is nested within the sheath structure alongside the first lumen containing the ablation catheter. This nested configuration allows multiple functional lumens to coexist within a compact sheath diameter, avoiding the need for oversized sheaths
3Quantity of substance
If fluid is removed by withdrawing and reinserting the ablation catheter, then fluid can be evacuated, but procedural time and complexity increase
Solution Approach 1:
The sheath is designed with a second lumen that provides continuous fluid removal capability independent of the ablation catheter. This allows fluid evacuation to occur simultaneously with ablation procedures without requiring catheter withdrawal or repositioning
Solution Approach 2:
The second lumen enables continuous fluid removal throughout the ablation procedure. Fluid can be evacuated continuously via the second lumen while the ablation catheter remains in place and continues its ablation function, eliminating intermittent interruptions for fluid management
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
Enables efficient and continuous fluid removal and tissue ablation without catheter withdrawal, improving procedural efficiency and reducing the need for oversized sheaths, thus facilitating more effective pericardial access and ablation.
Implementation Method 1
Applying pressure (positive or negative) to fenestrations in the sheath may allow one to withdraw fluid from the space
Data Source
AI summary
In an embodiment a sheath allows one to simultaneously ablate tissue, using a catheter located in the sheath, and remove fluid from a patient's pericardial space, via the same sheath, all without withdrawing the ablation catheter from the sheath. Applying pressure (positive or negative) to fenestrations in the sheath may allow one to withdraw fluid from the space, navigate the sheath within the space, and/or adhere the sheath to tissue in the space. Other embodiments are described herein.