Fossa Ovalis Puncture Catheter with Stabilizing Members
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Solution Overview
Problem
Current methods for delivering therapeutic devices to the left ventricle of the heart, particularly through the fossa ovalis, face challenges in accurately puncturing this region due to its thin tissue and the need for precise apparatus and techniques to stabilize the catheter and facilitate safe penetration.
Innovation Solution
The development of a catheter-based apparatus with flexible longitudinal members that loop around the fossa ovalis to stabilize the catheter and guide a puncturing element, along with radially-expandable elements and probing/sensor systems to identify and puncture the site accurately, ensuring precise and controlled access.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If a puncturing element is used to penetrate the fossa ovalis, then access to the left ventricle is achieved, but tissue damage and procedural risk increase due to the thin tissue structure
Solution Approach 1:
The flexible longitudinal members are deployed before the puncturing element to contact and stabilize the fossa ovalis tissue perimeter. This preliminary stabilization prepares the tissue to withstand the subsequent puncturing action, reducing unintended damage while maintaining access capability
Solution Approach 2:
The flexible longitudinal members act as intermediary elements between the catheter and the fossa ovalis tissue. They provide a stabilizing interface that allows controlled puncturing while minimizing harmful effects to the thin tissue structure
2Adaptability or versatility
If the catheter is made flexible to navigate cardiac anatomy, then delivery capability is improved, but stability during puncturing deteriorates
Solution Approach 1:
The catheter system is segmented into a flexible catheter body for navigation and deployable flexible longitudinal members for stabilization. This segmentation allows the catheter to exhibit different mechanical characteristics (flexibility vs. stability) at different operational stages
Solution Approach 2:
The catheter system transitions from a purely flexible state during navigation to a stabilized state during puncturing through deployment of the flexible longitudinal members. This dynamic reconfiguration allows the system to adapt its stability characteristics based on operational requirements
3Manufacturing precision
If the puncture site is precisely targeted in the thin tissue region, then device delivery accuracy is improved, but the difficulty of detecting and measuring the correct site increases
Solution Approach 1:
The flexible longitudinal members serve as intermediary indicators that visually or tactilely mark the correct puncture site location on the fossa ovalis. They facilitate detection and measurement of the optimal puncture position while enabling precise targeting
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
This approach enables safe and precise puncturing of the fossa ovalis, facilitating the delivery of therapeutic devices while minimizing tissue damage and improving procedural accuracy.
Implementation Method 1
By contacting tissue at the perimeter of the fossa ovalis, the flexible longitudinal members facilitate the puncturing of the fossa ovalis by the puncturing element, e.g., by stabilizing the catheter prior to the puncturing
Implementation Method 2
a puncturing element slidably disposed within the catheter lumen, the puncturing element configured to be deployed from a distal portion of the catheter and to puncture the fossa ovalis
Data Source
AI summary
Apparatus and methods are described, including apparatus for puncturing a fossa ovalis of a heart. The apparatus comprises a catheter shaped to define a catheter lumen. A puncturing element is slidably disposed within the catheter lumen, and is configured to be deployed from a distal portion of the catheter and to puncture the fossa ovalis. One or more flexible longitudinal members are configured to be deployed from the distal portion of the catheter, and upon being deployed, facilitate the puncturing of the fossa ovalis by the puncturing element, by contacting tissue at a perimeter of the fossa ovalis. Other applications are also described.