Septal Punch Device With Steerable Guide
Find Innovative SolutionsGenerate Solutions
Solution Overview
Problem
Current methods for accessing the left side of the heart through transseptal puncture are challenging due to difficulties in precise and accurate targeting, stability issues during cardiac procedures, and increased risks associated with misalignment and inadvertent punctures, especially in abnormal anatomies.
Innovation Solution
A septum puncture device with a steerable platform that includes a side catheter guide and a guide stabilizer/actuator, allowing for lateral deflection and stabilization of a septum penetrator to facilitate precise and safe access to the left atrium by transitioning between delivery and deployed configurations.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If a traditional catheter assembly with a long, stiff-wire needle is used for transseptal puncture, then the needle can reach the fossa ovalis, but the catheter is unstable in the SVC and easily maneuvered out of position during cardiac activity
Solution Approach 1:
The catheter assembly is divided into distinct segments: a flexible catheter body for navigation, a separate needle component for puncture, and a stabilizing mechanism. This segmentation allows each component to be optimized independently - the catheter remains flexible for stability while the needle provides puncture capability when needed.
Solution Approach 2:
The catheter assembly incorporates dynamic elements that allow it to adapt to cardiac motion. The flexible catheter material and adjustable positioning mechanisms enable the device to move with the heart rather than resist it, maintaining stable positioning throughout the cardiac cycle.
2Ease of operation
If the catheter assembly is withdrawn from the SVC too far to reposition, then the operator can adjust positioning, but time-intensive procedural steps must be repeated because the device cannot be moved cephalad
Solution Approach 1:
The catheter incorporates dynamic positioning mechanisms that allow for incremental adjustment in both directions (cephalad and caudad). This eliminates the need for complete withdrawal and repositioning, enabling fine-tuning of the needle position relative to the fossa ovalis without repeating procedural steps.
Solution Approach 2:
A flexible connection mechanism serves as an intermediary between the operator's control and the needle tip position. This allows for smooth, continuous adjustment of the needle angle and position without discrete movements that would require procedural repetition.
3Stability of the object's composition
If the needle is not fixed to the catheter, then the catheter remains flexible, but accidental needle exposure and inadvertent cardiac puncture can occur
Solution Approach 1:
The needle-catheter connection is designed to be dynamically adjustable. During normal navigation, the needle remains sheathed and flexible for safe catheter movement. When puncture is intended, the system transitions to a fixed configuration that secures the needle to the catheter, preventing accidental exposure while maintaining flexibility during non-puncture phases.
Solution Approach 2:
Different sections of the catheter assembly have different fixation properties. The needle is firmly secured at the puncture site where stability is critical, while other portions of the catheter remain flexible for navigation. This localized quality differentiation resolves the contradiction between flexibility and containment.
4Reliability
If a blunt needle electrified by radiofrequency is used for puncture, then puncture can be achieved, but the procedure becomes difficult to learn and prone to premature, misaligned, and inadvertent puncturing
Solution Approach 1:
The system performs preliminary positioning and stabilization actions before needle deployment. The catheter is first positioned with the needle sheathed, then stabilized against the fossa ovalis, and only then is the needle advanced for puncture. This sequence of preliminary actions prevents premature or misaligned puncturing by ensuring proper positioning before the puncture function is activated.
Data Source
AI summary
In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum.