Shunt Delivery Wire Deflection for Tissue Capture Confirmation
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Solution Overview
Problem
Existing shunt devices for treating elevated pressure in the left atrium of the heart face challenges in ensuring proper placement and anchoring, leading to risks of embolization and paradoxical stroke, with limited methods for confirming accurate tissue capture during implantation.
Innovation Solution
A delivery device equipped with a flexible wire that can be slidably received in a tube and extended through a side opening, featuring a tip that deflects upon contact with tissue, allowing for tactile and imaging confirmation of proper shunt device placement by advancing the wire through the catheter and proximal arm, ensuring the distal and proximal arms are correctly positioned on opposite sides of the tissue wall.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a shunt device is implanted to reduce left atrial pressure, then the therapeutic effect is improved, but the risk of embolization and paradoxical stroke increases due to improper placement
Solution Approach 1:
The flexible wire is advanced through the delivery catheter and proximal arm before final deployment of the shunt device. This preliminary action allows confirmation of proper tissue capture and arm positioning on opposite sides of the tissue wall, ensuring correct placement before the device is fully implanted and released.
Solution Approach 2:
The deflection of the flexible wire tip upon contact with tissue provides tactile feedback to the operator. Additionally, fluoroscopic imaging provides visual feedback to confirm the wire's position and the shunt device's placement, allowing real-time verification of proper tissue capture and reducing the risk of improper implantation.
2Ease of operation
If traditional implantation methods are used, then the implantation process is simple, but confirmation of accurate tissue capture is limited
Solution Approach 1:
The flexible wire serves as an intermediary tool between the operator and the tissue. It transmits tactile information about tissue contact to the operator and can be visualized via fluoroscopy, providing both tactile and imaging confirmation of proper tissue capture without complicating the overall implantation procedure.
Solution Approach 2:
The patent replaces reliance solely on mechanical sensation with a combination of tactile feedback from the flexible wire and visual confirmation via fluoroscopic imaging. This substitution enhances measurement precision for tissue capture confirmation while maintaining ease of operation through the use of standard imaging equipment.
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
Enhances the reliability of shunt device implantation by providing tactile and fluoroscopic confirmation of proper tissue capture, reducing the risk of embolization and improving the safety and effectiveness of the implantation process.
Implementation Method 1
The flexible wire includes a tip at a distal end configured to deflect upon contact with human tissue
Implementation Method 2
imaging, by fluoroscopy, the advancement of the flexible wire
Data Source
AI summary
A device for delivering a shunt device within a human body, the shunt device having a central flow tube, a proximal arm, and a distal arm, the proximal arm and distal arm configured to capture a tissue wall therebetween. The delivery device includes a catheter that includes a tube and a side opening. The delivery device further includes a flexible wire slidably receivable in the tube and extendable into the side opening. The flexible wire includes a tip at a distal end configured to deflect upon contact with human tissue. The flexible wire is disposed outside of the central flow tube of the shunt device.