Transseptal Tissue Coring Device for Atrial Shunt Creation
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Solution Overview
Problem
Current treatments for diastolic heart failure lack effective methods for pressure relief and are often invasive, with limited options for managing increased left ventricular filling pressure and atrial pressure.
Innovation Solution
A transseptal tissue coring device with a tissue incising element and a radially expandable tissue stabilizer is used to create a shunt between the left and right atria, allowing for percutaneous removal of septal tissue and establishment of a blood flow pathway that can be adjusted for pressure relief.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical procedures are used to treat diastolic heart failure, then pressure relief can be achieved, but the treatment becomes highly invasive with significant limitations
Solution Approach 1:
The patent replaces traditional surgical mechanical procedures with a percutaneous catheter-based system. The catheter delivers a coring device that creates an atrial septal defect through minimally invasive access, substituting open-heart surgery with a less invasive mechanical approach that achieves the same pressure relief function
Solution Approach 2:
The patent introduces a catheter as an intermediary delivery system that transports the tissue coring device from peripheral access points to the target site in the atrial septum. This intermediary approach enables minimally invasive delivery of the pressure relief mechanism without requiring direct surgical access to the heart
2Reliability
If a fixed shunt is created to relieve left atrial pressure, then pressure relief is achieved, but the device cannot be adjusted if clinical needs change
Solution Approach 1:
The patent employs dynamic, adjustable components including expandable balloons and repositionable catheters that allow the shunt size and position to be modified after implantation. The system transitions from a static surgical defect to a dynamic, controllable pressure relief mechanism that can be adjusted based on patient response and clinical needs
3Object-affected harmful factors
If a percutaneous approach is used to create a shunt, then invasiveness is reduced, but the ability to create a persistent shunt that prevents re-closure becomes challenging
Solution Approach 1:
The patent applies preliminary action by delivering and deploying the tissue coring device through the catheter before withdrawing the catheter itself. The coring device creates the atrial septal defect while the catheter is still in position, ensuring proper defect formation and patency maintenance before catheter removal, thereby guaranteeing shunt persistence without requiring the catheter to remain permanently in place
Data Source
AI summary
The present teachings provide devices and methods for percutaneously removing internal tissue. Specifically, one aspect of the present teachings provides a tissue incising element with a sharp cutting edge and a longitudinal lumen and a tissue stabilizer slidably disposed within the longitudinal lumen of the tissue incising element. The tissue incising element has a deployed configuration during tissue cutting and a small collapsed configuration during the percutaneous delivery and removal. The tissue stabilizer includes a tissue supporting/gripping element configured to support tissue during incising and capture the removed tissue.