Steerable Dual-Catheter Tricuspid Valve Access Across Severe Atrial Angles
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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 difficulty in maneuvering the delivery system across a severe angle within the right atrium without engaging the atrial wall or interfering with the valve.
Innovation Solution
A medical delivery system comprising an outer guide catheter with dual deflection portions and steering mechanisms, an inner guide catheter with a single deflection portion, and an interventional catheter with a fixation device, allowing precise alignment and deployment of the fixation device at the tricuspid valve via the inferior vena cava.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a conventional delivery system is used to access the tricuspid valve via the inferior vena cava, then the procedure can be performed minimally invasively, but the delivery system cannot properly align with the valve due to the severe angle within the right atrium
Solution Approach 1:
The delivery system is divided into multiple steerable segments including an outer guide catheter with a first steerable section and an inner guide catheter with a second steerable section. Each segment can be independently deflected to navigate the severe angle within the right atrium, allowing the system to achieve proper alignment with the tricuspid valve while maintaining minimal invasiveness.
Solution Approach 2:
The inner guide catheter is nested within the outer guide catheter, creating a multi-layered delivery system. This nested configuration allows both catheters to be advanced together through the inferior vena cava, with the inner catheter providing additional steering capability to navigate the severe angle and achieve precise valve alignment.
2Manufacturing precision
If the delivery system is maneuvered to achieve proper alignment, then accurate valve repair can be performed, but the risk of engaging the atrial wall increases
Solution Approach 1:
The delivery system incorporates dynamic steering mechanisms that allow real-time adjustment of the catheter path. The steerable sections can be actively controlled to navigate around the atrial wall while maintaining proper alignment with the tricuspid valve, reducing the risk of wall engagement while achieving accurate positioning for valve repair.
3Device complexity
If a single deflection portion is used in the guide catheter, then the device complexity is reduced, but the ability to navigate severe angles and achieve proper alignment is insufficient
Solution Approach 1:
Instead of using a single deflection portion, the guide catheter is segmented into multiple steerable sections. The outer guide catheter has a first steerable section and the inner guide catheter has a second steerable section, allowing independent control of each segment to navigate the severe angle and achieve precise alignment with the tricuspid valve.
Solution Approach 2:
The nested dual-catheter configuration adds another dimension of steering control. By having both an outer and inner guide catheter with各自的steerable sections, the system gains additional degrees of freedom to navigate the complex geometry of the right atrium and achieve proper alignment with the valve.
Data Source
AI summary
Medical delivery system for accessing a tricuspid valve via an inferior vena cava, including an outer guide catheter, an inner guide catheter and an interventional catheter. The first deflection portion of the outer guide catheter is steerable to define a first outer-guide-catheter curve and the second deflection portion of the outer guide catheter is steerable to define a second outer-guide-catheter curve and the first deflection portion of the inner guide catheter is steerable to define a first inner-guide-catheter curve.