Steerable Catheter Alignment for Precise Paravalvular Leak Closure
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Solution Overview
Problem
Existing methods for treating paravalvular leakage (PVL) in prosthetic heart valves are hazardous for high-risk patients and require elaborate imaging technology, lacking a cost-effective and reliable solution for precise leak identification and closure.
Innovation Solution
A catheter system with a bendable and steerable extension arm and a guiding sheath, equipped with an alignment component that expands radially to stabilize the catheter tip, allowing for precise leak identification and deployment of an occluding member without elaborate imaging, using guidewires and occluding members like coils or stents.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If a catheter with distal cardioscope and elaborate imaging technology is used for PVL detection and repair, then measurement precision of leak detection is improved, but device complexity and cost increase
Solution Approach 1:
The patent extracts the essential function of leak detection from complex imaging systems by using a simple wire-based mechanical detection method. The wire is passed through the leak and its movement detected manually or with minimal instrumentation, eliminating the need for elaborate imaging technology while maintaining detection precision.
Solution Approach 2:
The patent employs simple, inexpensive wires as the detection and guidance element. These wires can be easily manipulated and discarded after use, replacing expensive imaging equipment and providing a cost-effective solution for PVL detection and closure.
2Reliability
If surgical intervention is used for PVL treatment, then reliability of leak closure is improved, but loss of time and surgical risk increase
Solution Approach 1:
The patent replaces open surgical intervention with a minimally invasive transcatheter approach. A catheter system is inserted through blood vessels to deliver the closure device, eliminating the need for open surgery while maintaining reliable leak closure. This substitution reduces surgical time and risk significantly.
Solution Approach 2:
The patent introduces a catheter as an intermediary device that facilitates the delivery of the closure device through the vascular system. This intermediary approach allows reliable leak closure to be achieved without direct surgical access, reducing both time loss and surgical risk.
3Manufacturing precision
If a rigid catheter tip is used for PVL closure, then manufacturing precision of positioning is improved, but ease of operation decreases due to lack of flexibility
Solution Approach 1:
The patent divides the catheter into multiple segments or sections with different degrees of flexibility. The proximal portion can be stiffer for precise positioning, while the distal portion remains flexible for maneuverability through the vascular system. This segmentation allows both positioning precision and ease of operation to be achieved simultaneously.
Solution Approach 2:
The patent incorporates dynamic flexibility into the catheter design, allowing it to adapt its rigidity based on operational needs. The catheter can be made slightly flexible for easy navigation through blood vessels, then stabilized in position once the target area is reached, providing both ease of operation and positioning precision.
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
Enables reliable and efficient closure of PVLs with reduced risk to patients and lower costs by providing precise leak detection and minimally invasive placement of occluding members, stabilizing the catheter tip for accurate positioning.
Implementation Method 1
at least one alignment component has a collapsed state and is configured to expand into an expanded state... Each strut of the plurality of struts preferably runs at least sectionwise into radial direction and/or is inclined with regard to the longitudinal axis in the expanded state thereby producing a force directed radially outwardly and supporting the alignment component on the patient's heart, vasculature and/or implant
Implementation Method 2
The extension arm has an inner lumen through which a guidewire can be maneuvered and defines a longitudinal axis. At least one guidewire is within the inner lumen of the extension arm
Implementation Method 3
an occluding member is in contact with a distal guidewire section and/or a distal guidewire end of the at least one guidewire
Data Source
AI summary
A catheter system for a interventional procedure includes a bendable and/or steerable extension arm and a guiding sheath. The extension arm is movable along the sheath or fixed at the distal end so that it projects in an operation position from the distal end. The extension arm has an inner guidewire lumen. At least one alignment component having a collapsed state and being configured to expand into an expanded state is advanceable to or attached to the guiding sheath at a pre-defined position within the distal section but proximally from its distal end. The alignment component includes a plurality of struts distributed on the circumference. Each strut of the struts runs at least sectionwise into radial direction and/or is inclined with regard to the longitudinal axis in the expanded to produce a force directed radially outwardly and to support the alignment component on the patient's heart, vasculature and/or implant.