Absorbable Cardiac Closure Device with Elastic Restorability
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Solution Overview
Problem
Existing closure devices for cardiac holes or ducts, such as those with mesh structures made of metal wires, often face challenges in effectively closing irregularly shaped holes or ducts due to mechanical damage leading to erosion and cardiac tamponade risks.
Innovation Solution
A closure system comprising a catheter-delivered closure device with a first plate having elastic restorability and a waist part, where the first extension part can unfold to securely cover the hole or duct, and optionally a second plate for enhanced sealing, both designed using a learning model for personalized dimensions and materials based on the specific cardiac disease and patient anatomy.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a mesh structure made of metal wires is used to close a hole or duct in cardiac tissue, then the closure device can be delivered through a catheter and expanded to seal the defect, but the metal wires may cause mechanical damage leading to erosion and cardiac tamponade
Solution Approach 1:
The patent removes the harmful metal wire mesh structure from the closure device, extracting only the essential function of sealing the defect. The closure device is replaced with a soft, biocompatible material that eliminates erosion risk while maintaining closure effectiveness through a different mechanism (physical occlusion with absorbable material).
Solution Approach 2:
The closure device uses an absorbable material that is intended to be temporary, providing structural support during the healing process and then being naturally absorbed by the body. This disposable approach eliminates long-term presence of foreign material that could cause erosion, while still achieving the closure function during the critical healing period.
2Adaptability or versatility
If a mesh structure is used to close a hole or duct, then the device can be delivered through a catheter, but the planar shape is limited making it difficult to properly close irregularly shaped holes or ducts
Solution Approach 1:
The closure device utilizes the physical and chemical properties of absorbable materials that allow it to change shape and conform to irregular defect geometries. The material can be delivered in a compressed state through the catheter and then expands or molds itself to match the irregular shape of the hole or duct, achieving adaptability through material property changes rather than rigid structural design.
3Reliability
If a closure device with elastic restorability is used, then the device can unfold to securely cover the hole or duct, but the device complexity increases with multiple components
Solution Approach 1:
The patent combines multiple functions into a single integrated closure device made of absorbable material. The device simultaneously provides structural support, secure coverage through elastic restorability, and eventual absorption by the body. This merging eliminates the need for separate metal wire meshes and other components, reducing overall device complexity while maintaining reliability.
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 closure system provides a higher degree of freedom in planar shape, reduces erosion risk, and effectively closes cardiac defects without mesh structures, thereby minimizing the risk of cardiac tamponade and allowing for quick, custom-made device production using 3D printing.
Implementation Method 1
a first extension part extending around the first center part and containing a resin having elastic restorability; the elastic restorability is a property by which the first extension part returns from a state in which the first extension part is folded such that surface portions of the first extension part face to each other, to a state in which the first extension part is extended around the first center part
Data Source
AI summary
A closure system includes a catheter having an internal diameter D1 [mm]; and a closure device to be delivered to the hole or duct in the tissue through the catheter. The closure device includes: a first plate including a first center part, and a first extension part extending around the first center part and containing a resin having elastic restorability; and a waist part connected to the first center part. The first extension part has a thickness A1 [mm]. The waist part has a maximum dimension T1 [mm] in a plan view. The internal diameter D1 of the catheter is larger than 2×A1+T1.