PFO Closing Device Using Contact Member for Valve Alignment
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Solution Overview
Problem
Current PFO closing devices face challenges in accurately positioning the electrode and suction components, leading to potential excessive blood suction and difficulty in effectively fusing the foramen ovale valve with the atrial septum secundum, especially when the valve is distant from the septum or deformed.
Innovation Solution
A PFO closing device with a catheter equipped with a suction and hold portion, an electrode, and a negative pressure supply unit, along with a contact member and energy supply unit, which includes a hold mechanism that can protrude and bend to ensure precise alignment and suction of the foramen ovale valve towards the atrial septum secundum, allowing for efficient fusion using negative pressure and energy application.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a suction portion is provided at the distal portion of a catheter to suck and pull the foramen ovale valve, then the valve can be closed, but excessive blood may be sucked if the valve is distanced from the atrial septum secundum
Solution Approach 1:
A contact member is introduced as an intermediary element between the suction portion and the foramen ovale valve. The contact member first contacts the valve and pulls it toward the atrial septum secundum, ensuring proper positioning before the suction portion engages. This mediator prevents direct suction of excessive blood by controlling the sequence and manner of tissue engagement.
Solution Approach 2:
The contact member performs a preliminary action by contacting and pulling the foramen ovale valve toward the atrial septum secundum before the suction portion is activated. This preliminary positioning ensures that when suction is applied, the valve is already in the correct position, preventing excessive blood suction and ensuring effective closure.
2Ease of operation
If the electrode portion is positioned by a guide wire inserted into the foramen ovale, then the procedure can be performed, but the center of the suction portion or electrode portion does not always coincide with the center of the foramen ovale
Solution Approach 1:
The guide wire mechanical positioning system is replaced with a contact member that directly contacts and pulls the foramen ovale valve to the center of the atrial septum secundum. This mechanical substitution provides more accurate positioning because the contact member physically engages the valve tissue itself rather than relying on guide wire placement, ensuring the electrode portion center coincides with the foramen ovale center.
3Reliability
If conventional devices clamp the SP and SS by use of a disk-like membrane or anchor member, then the defect can be closed, but thrombi are liable to deposit on these foreign matters
Solution Approach 1:
Instead of leaving a permanent foreign body (disk-like membrane or anchor member) in the heart, the invention uses a catheter-based system where the suction portion and electrode are inserted, perform their function, and then can be removed. The foramen ovale valve itself is used as the closing structure through fusion, rather than relying on permanent artificial materials that predispose to thrombus formation.
Solution Approach 2:
The foramen ovale valve tissue itself is utilized to perform the closing function through fusion with the atrial septum secundum, rather than relying on foreign materials. The body's own tissue serves the closing function, eliminating the need for permanent artificial membranes or anchor members that would generate harmful thrombus deposition.
4Reliability
If the foramen ovale valve is sucked and pulled from the right atrium side, then the valve can be closed, but it may break the SP which is small in wall thickness
Solution Approach 1:
The contact member serves as an intermediary that distributes the pulling force on the foramen ovale valve more evenly and controls the movement toward the atrial septum secundum. This prevents concentrated forces that could break the thin septum primum, while still achieving effective closure through the fusion process.
Solution Approach 2:
The contact member performs preliminary positioning by gently pulling the foramen ovale valve toward the atrial septum secundum before the fusion process begins. This preliminary action ensures proper alignment without applying excessive force that could damage the thin septum primum, and the subsequent fusion process completes the closure safely.
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 device enables safe, accurate, and efficient closure of the PFO by preventing excessive blood suction and ensuring proper positioning for energy application, even in cases of varying septum and valve shapes, thus improving the procedure's safety, convenience, and speed.
Implementation Method 1
a negative pressure supply unit connected to the suction and hold portion for applying negative pressure to the suction and hold portion
Implementation Method 2
an energy supply unit connected to the electrode. The contact member is positionable on the other side of the foramen ovale valve and the atrial septum secundum to apply the urging force to the foramen ovale valve while the suction and hold portion is positionable on the one side of the foramen ovale valve and the atrial septum secundum so that operation of the negative pressure supply unit causes the foramen ovale valve and the atrial septum secundum to be sucked and held toward one another, and operation of the energy supply unit causes energy to be supplied to the electrode to fuse together the foramen ovale valve and the atrial septum secundum
Data Source
AI summary
A PFO closing device includes a suction and hold portion at a distal portion of a catheter for sucking and holding biological tissue of a foramen ovale valve and an atrial septum secundum from one side, an electrode portion on the side contacting the biological tissue; a negative pressure supply unit for applying negative pressure to the suctional portion and hold portion, a hold mechanism adapted to protrude from the distal tip of the catheter, and be inserted into the foramen ovale to hold the foramen ovale valve while pressing it from the other side and an energy supply unit for supplying energy to the electrode portion. Energy is supplied from the energy supply unit to the electrode portion, and the foramen ovale valve and the atrial septum secundum are mutually fused together.