Expandable Wire Frame Sealing Device for Transcatheter Defect Closure
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Solution Overview
Problem
Existing trans-catheter delivery systems for occluding devices face challenges in efficiently sealing cardiac or vascular defects without causing trauma and complications, particularly in deploying and positioning devices accurately within the body.
Innovation Solution
A sealing device with an expandable frame formed from a plurality of wires, featuring a wire frame with occluding members and a sealing member that conforms to tissue surfaces, allowing for self-centering and maintaining apposition forces, and includes fluid passageways to manage pressure differentials.
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 is reduced, but device deployment precision and positioning accuracy deteriorate
Solution Approach 1:
A delivery catheter serves as an intermediary tool to transport the occluding device to the target site through the vascular system, avoiding open-heart surgery while maintaining controlled deployment. The catheter acts as a mediator between the operator and the device, enabling precise positioning despite the minimally invasive approach
Solution Approach 2:
The occluding device is designed with self-expanding capabilities using superelastic wire structures that automatically deploy and position themselves at the target site once released from the delivery catheter, reducing the need for complex manual positioning while maintaining deployment precision
2Device complexity
If a self-expanding device is used for occlusion, then device assembly is simplified, but control over deployment timing and positioning is reduced
Solution Approach 1:
The device employs a dynamic delivery system where the catheter can be selectively retracted or advanced to control the timing and position of device deployment. The operator maintains dynamic control over the self-expanding mechanism by controlling the catheter's position relative to the target site
Solution Approach 2:
The device is pre-assembled in a compressed state within the delivery catheter, with all components ready for deployment. The superelastic wire structure is pre-configured to automatically expand upon release, eliminating the need for complex assembly steps at the target site while maintaining deployment control through catheter manipulation
3Reliability
If a sealing device is designed to conform to tissue surfaces, then sealing effectiveness is improved, but device structural complexity increases
Solution Approach 1:
The occluding device incorporates a flexible sealing member that can conform to the irregular surfaces of cardiac or vascular tissue. This flexible membrane provides effective sealing by adapting to the tissue geometry without requiring complex mechanical structures
Solution Approach 2:
The device combines superelastic wire structures with flexible sealing materials to create a composite structure. The wire frame provides structural support and expandability while the flexible membrane provides conformability and sealing, achieving effective sealing without excessive structural complexity
4Reliability
If fluid passageways are included in the sealing member, then pressure differential management is improved, but device complexity increases
Solution Approach 1:
The sealing member incorporates porous structures or fluid passageways that allow controlled fluid flow through the occluding device. This enables pressure equalization across the occlusion site, managing pressure differentials without requiring complex active control mechanisms
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 of varying sizes and shapes, maintaining position and configuration within the body, while minimizing deformation and trauma, and allowing for fluid communication to manage pressure differentials.
Implementation Method 1
an expandable frame formed from a plurality of wires... Each of the wires extend from a proximal end to a distal end of the frame
Implementation Method 2
a sealing member that conforms to tissue surfaces, allowing for self-centering and maintaining apposition forces
Data Source
Figure 1
Figure 2A~2B
Figure 3
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. In some embodiments, a sealing member is in contact with the wire frame. In some embodiments, the sealing member is configured to define one or more openings in the sealing member.