Concentric Catheter Shape Control for TAVR Access
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Solution Overview
Problem
Current catheter technologies for accessing the left ventricle in procedures like TAVR are inefficient due to the need for multiple device exchanges, which increases procedural risks and complexity, and existing solutions are costly, complex, and space-inefficient.
Innovation Solution
A concentric two-tube catheter system with an inner and outer tubular member that can change shape by sliding one relative to the other, allowing for different tip configurations without the need for multiple device exchanges, using a control handle mechanism to easily switch between shapes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If multiple device exchanges are performed to access the left ventricle and perform TAVR procedures, then the ability to perform different procedural steps is improved, but procedural complexity and risk increase
Solution Approach 1:
The patent combines multiple catheter functions into a single integrated catheter device that can perform both access to the left ventricle and delivery of the TAVR valve. The catheter includes an inner catheter for ventricle access and an outer catheter for valve delivery, allowing both functions to be performed without exchanging devices between steps.
Solution Approach 2:
The catheter device is designed with multi-functionality to perform multiple procedural steps including ventricle access, valve delivery, and potential emboli removal. The device can adapt its configuration during the procedure to serve different purposes without requiring exchange with separate specialized devices.
2Adaptability or versatility
If multiple device exchanges are performed during TAVR procedure, then different procedural needs can be met, but procedural time and patient risk increase
Solution Approach 1:
The catheter is pre-configured with both the inner and outer catheters in place before the procedure begins. The distal tip of the inner catheter is pre-shaped to facilitate ventricle access, and the entire assembly is ready for immediate deployment, eliminating the need for sequential device exchanges during the procedure.
3Shape
If stiffening inserts are used to change catheter tip shape, then catheter configuration can be changed, but procedural steps and complexity increase
Solution Approach 1:
The catheter tip is designed with dynamic shape-changing capability through the interaction between the inner and outer catheters. The distal tip of the inner catheter can be extended beyond the outer catheter to provide a pre-formed curved shape for ventricle access, or retracted to allow the outer catheter to assume its shape, enabling shape change without additional procedural steps.
4Ease of operation
If pull wires and control mechanisms are embedded in catheter, then catheter shape can be controlled, but space efficiency and cost decrease
Solution Approach 1:
The catheter is divided into functional segments with the inner catheter providing shape control through its distal tip configuration rather than through embedded pull wires. This segmentation allows the inner catheter itself to serve as the control element, eliminating the need for additional space-consuming pull wire mechanisms within the catheter shaft.
Data Source
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 are methods to use such devices.