Steerable Guiding Sheath for Tracking Modular Catheter Inserts
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Solution Overview
Problem
Existing catheter-based medical procedures face challenges in efficiently navigating and tracking multiple catheters during procedures like pulmonary vein isolation, particularly in managing intralumenal devices such as guiding sheaths and catheters, which complicate the process and increase the risk of complications.
Innovation Solution
A modular catheter system comprising a steerable guiding sheath and interchangeable catheter inserts, equipped with navigation sensors and electrical connectors, allowing for real-time tracking and exchange of diagnostic and therapeutic catheters, enabling precise positioning and ablation of cardiac tissue.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple catheters are used during cardiac arrhythmia procedures, then the ability to perform both diagnostic mapping and ablation is improved, but the complexity of navigating and tracking multiple intralumenal devices increases
Solution Approach 1:
The patent employs a nested configuration where multiple catheters and intralumenal devices are positioned within a single guiding sheath. The guiding sheath serves as a master conduit that houses multiple functional catheters (diagnostic, ablation, dilator, needle) in a nested arrangement, allowing them to be delivered through a single access point while maintaining the ability to perform multiple procedures simultaneously or sequentially.
Solution Approach 2:
The system segments the catheter assembly into functionally independent modular components, each with specific capabilities (diagnostic mapping, ablation, dilation, needle delivery). These segmented catheters can be independently controlled and tracked while sharing the common guiding sheath structure, enabling complex procedures without proportionally increasing overall system complexity.
2Adaptability or versatility
If a guiding sheath with multiple lumens is used to accommodate multiple catheters, then the versatility of the system is improved, but the difficulty of tracking the position of each catheter increases
Solution Approach 1:
The patent introduces navigation sensors as intermediary devices that mediate between the catheters and the tracking system. These sensors are positioned at the distal ends of catheters and guiding sheath components, serving as reference points that the external navigation system can detect and track. The sensors convert the physical position of intralumenal devices into detectable signals, solving the tracking difficulty.
Solution Approach 2:
The system replaces purely mechanical tracking methods with electromagnetic or optical navigation systems. Instead of relying on mechanical linkages or visual tracking through transparent materials, the patent uses sensors that emit or detect electromagnetic fields to determine the three-dimensional position and orientation of catheters and sheath components in real-time.
3Measurement precision
If navigation sensors are integrated into the guiding sheath, then the precision of catheter positioning is improved, but the complexity of the guiding sheath structure increases
Solution Approach 1:
The guiding sheath is designed as a multi-functional device that simultaneously serves as a structural conduit, a navigation reference framework, and a sensor housing. The same sheath structure that provides mechanical protection and catheter guidance also incorporates navigation sensors and serves as a reference for position tracking, eliminating the need for separate navigation components and reducing overall system complexity.
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
Facilitates seamless navigation and tracking of multiple catheters during procedures, reducing procedural complexity and improving the accuracy of cardiac tissue ablation by allowing for real-time position determination and electrical signal transmission.
Implementation Method 1
navigation sensors coupled to a distal portion of the shaft... electrical signals from the navigation sensors on the distal portion of the guiding sheath
Implementation Method 2
electrical connector configured to couple to an electrical connector of the modular catheter insert so that electrical signals measured at, and/or delivered to a target area pass through the handle of the guiding sheath
Implementation Method 3
Irreversible electroporation (IRE) is an alternative approach to RF ablation. To achieve IRE, short pulses of high voltage electrical signals (pulse field ablation electrical signals) are delivered to tissues; the electrical signals generate an unrecoverable permeabilization of cell membranes.
Data Source
AI summary
A modular catheter system includes a guiding sheath and multiple catheter inserts configured to couple to the guiding sheath. The guiding sheath can include a navigation sensor coupled to a distal portion of the guiding sheath shaft. A location of a distal portion of a respective catheter insert can be determined based on electrical signals from the navigation sensor. The catheter insert can be electrically coupled to the guiding sheath to provide electrical connection to an electrode assembly on the distal portion of the respective catheter insert. The guiding sheath may include a deflection mechanism that deflects the distal portion of the guiding sheath and a distal portion of a catheter shaft of the catheter insert. The modular catheter system may be configured to be tracked and moved without the catheter inserts requiring a navigation sensor or a deflection mechanism.