Guiding Sheath Tip Location Using Electrical Catheter Sensing
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Solution Overview
Problem
Existing guiding sheaths for medical procedures lack improved deflection characteristics and rely on fluoroscopy for precise catheter positioning, exposing healthcare providers to radiation during transseptal punctures.
Innovation Solution
A guiding sheath assembly with electrically conductive elements and proximity sensing mechanisms on the control handle and catheter to confirm engagement without radiation, using electrically conducting elements or proximity sensing elements on the control handle and diagnostic or treatment catheter to provide visual or audio confirmation of contact.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If fluoroscopy is used to locate the distal end of the catheter, then positioning accuracy is improved, but radiation exposure increases
Solution Approach 1:
The patent replaces the fluoroscopy-based visual localization system with an electrical sensing system. Electrical conductive elements are embedded in the catheter and guiding sheath to create an electrical circuit that detects engagement status, substituting the mechanical/optical fluoroscopy method with an electrical field-based detection method that eliminates radiation exposure while maintaining positioning information.
Solution Approach 2:
The patent introduces electrical conductive elements as intermediaries between the catheter and guiding sheath. These conductive elements serve as mediators that transmit engagement information through electrical contact, allowing the system to detect catheter positioning without direct visual observation via fluoroscopy, thereby eliminating radiation exposure.
2Reliability
If electrically conductive elements are added to the guiding sheath and catheter, then engagement detection is improved, but device complexity increases
Solution Approach 1:
The patent merges the engagement detection function with the existing structural components of the guiding sheath and catheter. Electrical conductive elements are integrated into the walls of the guiding sheath and the surface of the catheter, combining the structural integrity function with the electrical sensing function in a single integrated system rather than adding separate detection mechanisms.
Solution Approach 2:
The electrical conductive elements serve multiple functions: they provide structural integrity as part of the guiding sheath wall, enable electrical engagement detection, and can potentially serve as grounding paths. This multi-functionality reduces the need for additional separate components, offsetting the increase in complexity with functional consolidation.
3Ease of operation
If the guiding sheath deflection mechanism is improved, then maneuverability is enhanced, but device complexity increases
Solution Approach 1:
The patent implements a dynamic deflection mechanism where the guiding sheath can change its shape and orientation in response to external forces applied at the proximal end. The sheath includes deflection sections with varying rigidity that allow controlled bending and steering, enabling the distal end to navigate complex vascular paths dynamically rather than maintaining a fixed rigid structure.
Solution Approach 2:
The guiding sheath is divided into multiple sections with different mechanical properties: a proximal section with higher rigidity for stability, and distal deflection sections with lower rigidity for maneuverability. This segmentation allows each section to perform its specific function optimally while reducing the overall complexity compared to a uniformly complex structure throughout.
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 precise catheter positioning without radiation exposure, enhancing safety and operational smoothness during medical procedures.
Implementation Method 1
adding electrically conductive elements or other proximity sensing elements to each of the guiding sheath and the diagnostic or treatment catheter that, upon contact with one another, complete a circuit and provide a visual or audio confirmation of contact
Implementation Method 2
The proximity sensing elements can detect the proximity of each other using electrical, optical, physical and magnetic sensing
Implementation Method 3
The proximity sensing elements can detect the proximity of each other using electrical, optical, physical and magnetic sensing
Implementation Method 4
The proximity sensing elements can detect the proximity of each other using electrical, optical, physical and magnetic sensing
Data Source
AI summary
A guiding sheath has a hemostatic valve and a central lumen into which a diagnostic or treatment catheter can be introduced and guided into a patient. The hemostatic valve also includes an electrically conducting element or proximity sensing element on its proximal end that interacts with a second electrically conducting element or proximity sensing element on a proximal end of the diagnostic or treatment catheter that can be passed through the central lumen of the guiding sheath and into the patient's heart. The interaction between the two electrically conducting elements or proximity sensing elements enables the location of the distal end of the diagnostic or treatment catheter in the patient's heart without the need for irradiating the patient.