Compliant Defect-Occluding Wire Frame for Cardiac Sealing
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Solution Overview
Problem
Existing trans-catheter delivery systems for sealing cardiac or vascular defects face challenges in efficiently accommodating a range of defect sizes and conforming to varying tissue geometries while minimizing trauma and complications associated with open-heart surgery.
Innovation Solution
A medical device featuring a wire frame with multiple wires forming occluding members and a defect-occupying portion that adapts to a wide range of defect sizes, conforming to tissue surfaces without significant deformation, and includes a sealing member for secure attachment to a delivery system.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If a trans-catheter delivery system is used to avoid open-heart surgery, then patient trauma and complications are reduced, but the system must accommodate a wide range of defect sizes (8 to 35 mm) and varying tissue geometries
Solution Approach 1:
The device incorporates a compliant defect-occupying portion that can dynamically adapt its shape and size to match the specific defect geometry. This portion is designed to be flexible enough to conform to varying tissue surfaces while maintaining the structural integrity needed for sealing defects across a wide size range (8 to 35 mm), thereby resolving the contradiction between minimizing trauma and accommodating diverse defect characteristics.
Solution Approach 2:
The device utilizes changeable physical parameters, particularly the flexibility and compliance of the defect-occupying portion, to adapt to different defect sizes and geometries. By adjusting the compliance parameter of this portion, the system can effectively seal defects from 8 mm to 35 mm without requiring multiple specialized devices, thus improving adaptability while maintaining minimal trauma through a unified delivery system.
2Adaptability or versatility
If the defect-occupying portion is made compliant to conform to tissue surfaces, then it can adapt to varying geometries, but it must not provide substantial apposition force that would cause deformation
Solution Approach 1:
The device applies local quality by differentiating the functional characteristics of its components: the defect-occupying portion is designed with high compliance to conform to tissue geometry without exerting substantial force, while the occluding members and sealing members are designed with higher strength and rigidity to provide necessary apposition force and sealing. This spatial differentiation of material properties resolves the contradiction between conformance and strength.
Solution Approach 2:
The device is segmented into distinct functional portions with different mechanical properties: a compliant defect-occupying portion for geometry adaptation, and stronger occluding and sealing portions for providing apposition force. This segmentation allows each portion to optimize its specific function without compromising the other, resolving the contradiction between needing to conform to tissue surfaces and needing to provide substantial sealing force.
3Adaptability or versatility
If the device is designed to seal defects from 8 to 35 mm using a single device, then versatility is improved, but the device complexity increases
Solution Approach 1:
The device achieves universality by incorporating a compliant defect-occupying portion that can adapt to seal defects across a wide size range (8 to 35 mm) using a single device design. This multi-functional capability allows the same device structure to serve multiple defect sizes, improving versatility while managing complexity through a unified design rather than multiple specialized devices.
Solution Approach 2:
The device manages complexity by utilizing changeable compliance parameters in the defect-occupying portion to adapt to different defect sizes. This parameter-based adaptation allows a single device structure to handle defects from 8 mm to 35 mm, achieving versatility without requiring complex mechanical adjustment mechanisms or multiple device types.
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 effectively seals defects from 8 to 35 mm in size, conforming to varying geometries and minimizing trauma, thus providing a reliable and minimally invasive sealing solution for cardiac or vascular defects.
Implementation Method 1
the defect-occupying portion deflects to an outer diameter that is less than about 60% of its nominal outer diameter when a radial pressure of about 0.04 N/mm2 is applied to the defect occupying portion
Data Source
AI summary
A medical device for sealing a defect in a body includes a wire frame that includes a plurality of wires that form a first occluding member and a second occluding member, the wire frame including a defect-occupying portion disposed between the first occluding member and the second occluding member. The defect-occupying portion is adapted to fill a wide range of potential defect sizes, such that no more than five devices of a range of sizes are required to effectively seal a range of nominal defect sizes of approximately 8 to 35 mm.