Anchored Coronary Sinus Occlusion Catheter for Stable PICSO
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Solution Overview
Problem
Current PICSO catheters face issues with instability during occlusion, require time-consuming setup, and have low-fidelity pressure sensing, making them difficult to operate efficiently and effectively in coronary sinus procedures.
Innovation Solution
A catheter assembly with a steerable and deflectable distal end, an optical pressure sensor, and an anchoring device, an anchoring device for stable positioning, and a design that includes a smaller occlusion balloon and optical pressure sensing, eliminating the need for fluid-filled lines and reducing procedural time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If an anchored catheter design is used, then stability during occlusion is improved, but device complexity increases
Solution Approach 1:
The catheter is divided into distinct functional segments: a shaft with multiple lumens, a separate occlusion device (balloon) with diameter 5-15mm, and a proximal handle. This segmentation allows each component to be optimized independently while reducing overall complexity management.
Solution Approach 2:
The occlusion device is fixed to the distal tip of the shaft and nested within the catheter structure, while the anchoring mechanism integrates the occlusion device into the coronary sinus ostium. This nested arrangement provides stable positioning without requiring separate external anchoring systems.
2Measurement precision
If optical pressure sensing is used, then measurement precision is improved, but device complexity increases
Solution Approach 1:
The patent replaces traditional mechanical fluid-filled pressure sensing lines with an optical pressure sensor. This substitution eliminates the need for fluid-filled lumens connected to external pressure transducers, reducing setup time and improving measurement fidelity while integrating the sensing capability directly into the catheter structure.
3Ease of operation
If a smaller occlusion balloon is used, then ease of operation is improved, but occlusion effectiveness may worsen
Solution Approach 1:
The occlusion balloon diameter is specifically designed to be 5-15mm, optimizing the balance between ease of delivery and occlusion effectiveness. This parameter change allows the balloon to be small enough for straightforward catheter navigation while remaining large enough to effectively occlude the coronary sinus ostium and generate the required pressure rise throughout the coronary vasculature.
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
The new design provides reliable and fast intermittent occlusion with improved stability, reduced procedural time, and high-fidelity pressure measurement, enhancing the efficacy of PICSO procedures.
Implementation Method 1
means of measuring the pressure at the distal tip of the catheter assembly and distally to the occlusion device, preferably using an optical pressure sensor
Data Source
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AI summary
The invention relates to a catheter assembly for the intermittent occlusion of the coronary sinus (CS, 60). The catheter assembly comprises a shaft (17, 126). The shaft (17, 126) has a plurality of lumens (7A, 7B, 35, 38, 40, 40A, 40B), a distal end (22) with a distal tip (20A, 20B, 20C), an occlusion device (24, 56, 142) fixed to the distal tip (20A, 20B, 20C) and operable through at least one of the plurality of lumens (7A, 7B, 35, 38, 40, 40A, 40B) and a proximal handle (10). The catheter assembly further having at least one of the following: - the occlusion device (24, 142) having a diameter of 5 20 mm and adapted to occlude the coronary sinus ostium, - means of measuring the pressure at the distal tip (20 a, 20B, 20C) of the catheter assembly and distally to the occlusion device (24, 142), preferably using an optical pressure sensor (28), - an anchoring device (30, 54, 65, 80, 90A, 122) for anchoring the occlusion device (24, 142) in a predefined position in the coronary sinus (CS, 60), preferably in the ostium, - the distal end (22) being deflectable/steerable with deflection being controlled by an actuator arranged at the proximal handle (10).