Balloon-Based Closure Device for Minimizing Tissue Erosion
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Solution Overview
Problem
Existing closure devices for physiological structures that affect fluid flow, such as congenital heart defects and residual tunnels, face issues with rigid frames causing tissue erosion, thrombogenicity, and require precise sizing and advanced image guidance, often leading to complications like pericardial effusions and embolization.
Innovation Solution
A balloon-based closure device with inflatable members and controlled adhesive properties, allowing self-centering and reduced need for precise sizing, along with optional activation mechanisms for secure apposition and endothelialization promotion, minimizing tissue interference and thrombogenic risks.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If rigid frames are used in closure devices, then structural support and device stability are improved, but tissue erosion and thrombogenicity increase
Solution Approach 1:
The patent employs flexible frames composed of shape memory alloy wires that can dynamically adapt to tissue motion rather than resisting it. The flexible construction allows the device to conform to the beating heart and respiratory movements, eliminating tissue erosion while maintaining structural integrity through the shape memory effect that provides passive stabilization.
Solution Approach 2:
The device transitions from a static rigid structure to a dynamic flexible framework that moves with the tissue. The shape memory alloy components enable the frame to flex during cardiac cycles and respiratory movements, then return to its original configuration, creating a dynamic system that maintains stability without causing tissue damage.
2Stability of the object's composition
If rigid frames are used in closure devices, then device stability is improved, but thrombogenicity increases
Solution Approach 1:
The flexible frame construction reduces thrombogenicity by eliminating high shear stresses that occur with rigid structures in rapidly flowing blood. The compliant surface allows blood to flow smoothly over the device without creating turbulent flow patterns that promote clot formation, while the shape memory effect maintains adequate structural support.
3Adaptability or versatility
If multiple device sizes are used to cover morphological range, then adaptability is improved, but device complexity and sizing precision requirements increase
Solution Approach 1:
The patent employs a universal sizing system where a single device design can accommodate multiple anatomical configurations. The flexible shape memory alloy frame can be deployed in different configurations and adapts to various defect sizes and shapes, eliminating the need for multiple specialized device sizes while maintaining adaptability across different patient anatomies.
Solution Approach 2:
The device utilizes phase transition properties of shape memory alloys to change its mechanical parameters from a compliant delivery state to a stabilized deployed state. This parameter change allows the same device structure to adapt to different anatomical configurations without requiring multiple size variants.
4Strength
If hooks or barbs are used for secure attachment, then attachment strength is improved, but tissue trauma and adverse events increase
Solution Approach 1:
The patent completely removes hooks and barbs from the device design. Instead of using mechanical interlocking features that cause tissue trauma, the invention relies on the flexible frame's ability to conform to the anatomical structure and the controlled expansion mechanism to achieve secure attachment without penetrating or damaging surrounding tissues.
Solution Approach 2:
The patent replaces the mechanical hook-and-barb attachment system with a controlled expansion and friction-based retention system. The flexible frame expands to engage the tissue through distributed contact forces rather than concentrated mechanical anchors, eliminating tissue trauma while maintaining attachment strength.
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 balloon-based device provides secure closure with reduced thrombogenicity and tissue damage, requiring fewer measurements and less advanced image guidance, enhancing procedural safety and efficacy.
Implementation Method 1
Upon contact with blood, the balloon automatically and rapidly expands to achieve self-centering and secure apposition
Implementation Method 2
The balloon is coated with a controllable adhesive that promotes endothelialization and/or reduces thrombogenicity
Data Source
AI summary
Disclosed is a device comprised of an occluding segment and a delivery segment whereby: the occluding segment contains one or more inflatable members; the occluding segment contains at least one component that enables controlled deflation of at least one inflatable member following permanent implantation of the device; the delivery segment contains at least one lumen to accommodate inflation of at least one inflatable member; and, the delivery segment is detachably coupled to the occluding segment on at least one point.