Aortic Valve No Exchange Catheter Tip Shape Control
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Solution Overview
Problem
Current catheter devices for transcatheter aortic valve replacement (TAVR) procedures are cumbersome, requiring multiple device exchanges, increasing procedural risks and complexity, and lack efficient means for precise tip shape change and differential pressure measurement.
Innovation Solution
A dual-member catheter system with an inner and outer tubular member, controlled by a handle mechanism, allowing for precise and repeatable shape changes without fluoroscopic guidance, integrated pressure measurement, and minimizing the need for device exchanges.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple device exchanges are performed during TAVR procedures, then diagnostic and therapeutic functions can be achieved, but procedural risks increase and procedure time increases
Solution Approach 1:
The patent combines multiple catheter functions (diagnostic pressure measurement and therapeutic valve delivery) into a single integrated catheter system. The inner catheter can remain in place throughout the procedure while the outer catheter is exchanged, eliminating the need for complete device exchanges and reducing procedural risks associated with multiple interventions.
Solution Approach 2:
The patent employs a nested catheter configuration where an inner catheter is positioned within an outer catheter. The inner catheter serves as a permanent access route that remains stationary, while the outer catheter can be exchanged or manipulated independently. This nesting allows functional versatility without requiring complete device removal and reinsertion.
2Adaptability or versatility
If multiple device exchanges are performed during TAVR procedures, then diagnostic and therapeutic functions can be achieved, but procedure time increases
Solution Approach 1:
The integrated catheter system combines diagnostic and therapeutic functions in one device, allowing both functions to be performed without removing the catheter from the patient. The inner catheter remains in place for continuous access while the outer catheter provides therapeutic functionality, eliminating repeated insertion and removal cycles.
Solution Approach 2:
The inner catheter is positioned and secured in place before the therapeutic outer catheter is introduced. This preliminary establishment of access route allows subsequent therapeutic interventions to be performed through the already-positioned inner catheter, avoiding the need to re-establish access for each function.
3Ease of operation
If catheter tip shape is changed using embedded control wire, then tip shape can be manipulated, but catheter complexity increases and space efficiency decreases
Solution Approach 1:
The catheter is divided into distinct segments: an inner catheter and an outer catheter. The outer catheter can be exchanged or manipulated independently while the inner catheter remains stationary. This segmentation allows shape control functionality to be distributed, with the outer catheter providing the shape-changing capability without requiring complex internal wiring throughout the entire catheter length.
4Ease of operation
If catheter tip shape is changed using stiff insertable member, then tip shape can be changed, but additional procedural steps are required
Solution Approach 1:
The outer catheter is nested within the inner catheter, with the outer catheter's distal tip extending beyond the inner catheter. The outer catheter is pre-shaped to provide the desired tip configuration, eliminating the need for additional shape-changing maneuvers or insertable members during the procedure. The nested configuration allows the outer catheter to be exchanged without affecting the inner catheter's position.
Data Source
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AI summary
A medical device used to percutaneously gain access to a targeted site within a living body, for example the left ventricle of the heart. The device is comprised of an inner tubular member, outer tubular member, and an adjustable control handle. The control handle can precisely control the relative position of the inner tubular member relative to the outer member by providing feedback to the operator. This feedback provided by the control handle allows the operator to precisely maneuver the catheter within a body and change the shape of the catheter system without taking his/her eyes off the task that he/she is performing. The control handle is designed to precisely change the catheter system from one tip shape to another tip shape and back. Described herein is a method to perform a catheter tip shape change without the need to observe manipulations of a control system to change catheter tip configurations.