Nested Steerable Catheters for Tricuspid Valve Access
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Solution Overview
Problem
Existing medical devices face challenges in properly positioning and aligning repair devices with the tricuspid valve, particularly when approaching via the inferior vena cava, due to the severe angle and maneuverability issues within the right atrium, making it difficult to deploy the repair device effectively.
Innovation Solution
A medical delivery system comprising an outer guide catheter with dual steering mechanisms and an inner guide catheter with a single steering mechanism, allowing for precise alignment and deployment of an implantable fixation device at the tricuspid valve via the inferior vena cava, utilizing preformed curves and pull wires for steering control.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a single guide catheter is used to approach the tricuspid valve via the inferior vena cava, then the device structure remains simple, but the ability to properly position and align the repair device at the valve is insufficient due to severe angles and maneuverability issues
Solution Approach 1:
The patent employs a nested catheter configuration where an inner guide catheter is positioned within an outer guide catheter. This allows the delivery system to navigate the severe angles of the inferior vena cava approach while providing precise positioning capability at the tricuspid valve. The nested structure enables sequential deployment and independent steering of each catheter layer.
Solution Approach 2:
The guide catheter system is divided into multiple segments with independent steering capabilities. The outer guide catheter has a first steering mechanism for navigating the inferior vena cava, while the inner guide catheter has a second steering mechanism for final positioning at the tricuspid valve. This segmentation allows complex maneuvering to be broken down into manageable steps.
2Ease of operation
If the delivery system is made more maneuverable to navigate the severe angle in the right atrium, then access to the tricuspid valve is improved, but the device complexity increases
Solution Approach 1:
The catheter system incorporates dynamic steering mechanisms that allow real-time adjustment of the catheter path. The outer guide catheter can be steered to navigate the inferior vena cava entry, while the inner guide catheter can be independently adjusted to reach the tricuspid valve. This dynamic control enables the system to adapt to anatomical variations and achieve proper positioning.
3Manufacturing precision
If a dual-catheter system with multiple steering mechanisms is used, then precise alignment at the tricuspid valve is achieved, but the device complexity and operational difficulty increase
Solution Approach 1:
The outer guide catheter is first positioned and steered to navigate the inferior vena cava and establish a stable foundation. Only after this preliminary positioning is achieved is the inner guide catheter deployed and steered for final alignment at the tricuspid valve. This sequential approach breaks down the complex operation into manageable steps, reducing operational difficulty.
Data Source
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AI summary
Medical delivery system (1) for accessing a tricuspid valve via an inferior vena cava, including an outer guide catheter (1000), an inner guide catheter (1020) and an interventional catheter (302). The first deflection portion (1015A) of the outer guide catheter is steerable to define a first outer- guide-catheter curve and the second deflection portion (1015B) of the outer guide catheter is steerable to define a second outer-guide-catheter curve and the first deflection portion (1025) of the inner guide catheter is steerable to define a first inner-guide-catheter curve.