Fossa Ovalis Puncture Catheter with Stabilizing Wire Loop
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Solution Overview
Problem
Current methods for delivering therapeutic devices to the left ventricle of the heart, such as valve repair or replacement devices, face challenges in effectively penetrating the fossa ovalis, a region of thinner tissue, due to the need for precise and stable puncture techniques to avoid damage and ensure accurate device placement.
Innovation Solution
The development of a catheter-based apparatus with flexible longitudinal members that loop around the fossa ovalis to stabilize the catheter and facilitate puncture by a puncturing element, potentially aided by dilators, balloons, or probing elements to ensure precise positioning and minimize tissue trauma.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a puncturing element is used to penetrate the fossa ovalis, then device delivery to the left ventricle is enabled, but tissue damage and procedural risk increase due to the thinner tissue structure
Solution Approach 1:
The patent applies preliminary action by deploying flexible longitudinal members (wires) before the puncturing element to contact and stabilize the fossa ovalis tissue perimeter. This preliminary stabilization creates a controlled framework that guides the subsequent puncturing action, reducing uncontrolled tissue damage while enabling successful device delivery through the thin fossa ovalis tissue.
2Manufacturing precision
If the catheter is stabilized at the fossa ovalis perimeter, then puncture precision is improved, but device complexity increases due to additional flexible longitudinal members
Solution Approach 1:
The patent applies segmentation by dividing the catheter system into distinct functional components: the catheter body, deployable flexible longitudinal members (wires), and the puncturing element. Each component performs a specific function - the wires provide stabilization and precision guidance, while the puncturing element executes the penetration. This segmented approach achieves high puncture precision through coordinated action of specialized components.
3Stability of the object's composition
If flexible longitudinal members are deployed to contact tissue at the fossa ovalis perimeter, then catheter stability is improved, but the procedure time increases
Solution Approach 1:
The patent applies dynamics by using flexible longitudinal members that can be dynamically deployed and repositioned as needed during the procedure. The wires are made to be slidable within the catheter lumen, allowing the operator to deploy them when stabilization is required and retract or reposition them when not needed. This dynamic capability provides catheter stability only when required, minimizing unnecessary procedure time while maintaining stability during critical puncturing phases.
Data Source
AI summary
Apparatus for puncturing a fossa ovalis includes a catheter, which has a distal portion that is shaped so as to define a catheter distal end opening at a distal end of the catheter, and first and second lateral openings. The catheter is shaped so as to define a central catheter lumen open through the catheter distal end opening. A flexible longitudinal member passes from a proximal portion of the catheter to the distal portion of the catheter, out of the first lateral opening, and into the second lateral opening, so as to form a loop outside the catheter. A puncturing element is slidably disposed within the central catheter lumen, and is configured to puncture a hole through the fossa ovalis by being advanced out of the catheter distal end opening and through the fossa ovalis. Other embodiments are also described.