Transcatheter Occluder Frame for Conformal Cardiac Defect Sealing
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Solution Overview
Problem
Existing trans-catheter sealing devices for cardiac and vascular defects, such as patent foramen ovale (PFO), are difficult to visualize, cumbersome to load, and do not conform well to heart anatomy, making them challenging to position, reposition, and retrieve.
Innovation Solution
A sealing device with an expandable frame formed from a plurality of wires, featuring proximal and distal eyelets, and a handle with a linear actuator that allows independent advancement and retraction of components for easy deployment, repositioning, and retrieval.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Extent of automation
If self-expanding devices are used for trans-catheter delivery, then deployment is automated, but the devices are difficult to visualize, cumbersome to load, and difficult to position and reposition
Solution Approach 1:
The device transitions from a compressed state during delivery to an expanded state at the target site, allowing dynamic adjustment of size and shape. The expandable frame can be manipulated between compressed and expanded configurations, enabling easy positioning, repositioning, and retrieval while maintaining automated deployment capabilities
Solution Approach 2:
The device is divided into separable components including the expandable frame, sealing member, and delivery system elements. This segmentation allows the device to be loaded in a compressed state within the catheter and then expanded at the target site, resolving the contradiction between automated deployment and ease of positioning
2Ease of manufacture
If self-expanding devices are used, then deployment is simplified, but the devices do not conform well to heart anatomy leading to tissue erosion
Solution Approach 1:
The sealing member is designed with specific local properties including biocompatible materials and tailored geometric configurations that conform to the local anatomy of the heart defect. The sealing surface is optimized to match the contours of the atrial septum or vascular wall, distributing forces evenly and preventing tissue erosion while maintaining deployment simplicity
Solution Approach 2:
The device allows for parameter adjustments in size, shape, and expansion force to match specific anatomical variations. The expandable frame can be configured with different diameters and geometries to conform to different defect sizes and locations, eliminating tissue erosion while preserving ease of deployment
3Ease of operation
If traditional occluding devices are used, then trans-catheter delivery is achieved, but assembly is required at the site of the tissue opening
Solution Approach 1:
The device is pre-assembled in a compressed, deliverable configuration before reaching the target site. All components including the expandable frame, sealing member, and attachment mechanisms are prepared and integrated in advance, eliminating the need for complex assembly procedures at the tissue opening while maintaining trans-catheter delivery capabilities
4Ease of manufacture
If devices require threading or buttoning of discrete elements, then deployment is achieved, but the process is cumbersome and time-consuming
Solution Approach 1:
Multiple discrete components are merged into an integrated, pre-assembled device structure. The expandable frame, sealing member, and delivery mechanisms are combined into a single unified device that can be deployed as one unit, eliminating time-consuming threading and buttoning operations while maintaining effective deployment capability
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 provides improved conformity to heart anatomy, enabling easy deployment, repositioning, and retrieval with minimal force, enhancing sealing effectiveness and reducing tissue erosion.
Implementation Method 1
a linear actuator located within the slot and the linear actuator capable of independently advancing and retracting at least three separate components by advancing and retracting the actuator along the slot length
Implementation Method 2
an expandable frame formed from a plurality of wires extending from a proximal end to a distal end of the frame
Data Source
AI summary
The invention relates to a sealing device for repair of cardiac and vascular defects or tissue opening such as a patent foramen ovale (PFO) or shunt in the heart, the vascular system, etc. and particularly provides an occluder device and trans-catheter occluder delivery system. The sealing device would have improved conformity to heart anatomy and be easily deployed, repositioned, and retrieved at the opening site.