Rotating Coil Transseptal Puncture for Low-Force Septal Crossing
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Solution Overview
Problem
Transseptal puncture procedures pose risks of cardiac perforation and damage due to the need for high forward axial pressure with traditional needle puncture methods, lacking control and safety in creating openings in the septum.
Innovation Solution
The use of a transseptal puncture device with a coiled portion that applies angled force and rotates to create an opening in the septum, reducing the need for forward pressure and minimizing the risk of unexpected tissue movement, featuring a coiled portion with varying thickness and gap configurations to control the hole size and shape.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional needle puncture method is used, then puncture can be achieved, but high forward axial pressure is required causing cardiac perforation risk
Solution Approach 1:
The needle is replaced with a coiled portion having a helical curvature. This curved geometry allows the device to penetrate tissue through rotational motion rather than direct axial pressure, distributing the mechanical stress and reducing the risk of cardiac perforation while maintaining effective puncture capability.
Solution Approach 2:
The traditional direct axial mechanical puncture system is replaced with a rotational mechanical system. The coiled portion rotates during insertion, converting linear force into rotational cutting action, which reduces the forward axial pressure needed and improves safety by allowing more controlled tissue penetration.
2Manufacturing precision
If traditional needle puncture method is used, then puncture can be achieved, but control and safety in creating openings is insufficient
Solution Approach 1:
The device transitions from a static needle to a dynamic coiled structure that rotates during insertion. This rotational motion provides dynamic control over the puncture process, allowing the operator to regulate penetration depth and opening size through controlled rotation, thereby improving both precision and ease of operation.
Solution Approach 2:
The coiled portion's geometry parameters (helix angle, coil diameter, pitch) are optimized to control the puncture characteristics. By adjusting these parameters, the device achieves precise control over opening creation while maintaining ease of operation through controlled rotational motion rather than uncontrolled axial advancement.
3Reliability
If high forward axial pressure is applied, then puncture can be achieved, but unexpected tissue movement occurs causing perforation risk
Solution Approach 1:
The coiled helical structure provides predictable tissue interaction through its curved geometry. The rotation of the coil engages tissue in a controlled manner, making tissue behavior more predictable compared to sudden axial needle penetration, thereby reducing unexpected tissue movement and perforation risk.
Solution Approach 2:
Replacing axial linear motion with rotational motion changes the mechanical interaction with tissue. The rotational insertion of the coiled portion allows gradual engagement and predictable tissue displacement, reducing unexpected movements that occur with sudden axial needle penetration under high pressure.
Data Source
AI summary
Various devices, apparatuses, and methods for transseptal puncture and crossing are disclosed herein. A transseptal puncture and crossing device can include novel puncture member having a crossing coil mated to a body portion to be able to both cross a tissue and allow a wire or guard be inserted through the puncture member. Though not required, the puncture member can have one or more of novel features, including a tapered coil portion, a transition cutter, a gripper coil portion, an atraumatic guard, and a shaped cutting wire. Methods for transseptal punctures and crossing include adding rotation, oscillation and/or ultrasound to a transseptal puncture device.