Adjustable Vascular Closure Device for Irregular Tissue Sealing
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Solution Overview
Problem
Existing closure apparatuses struggle to form an effective seal in body lumens with irregular surface topographies due to diseased areas or calcified lesions, leading to reduced sealing effectiveness and risk of dislodgment.
Innovation Solution
A closure system with a flexible sealable member and a support member that provides rigidity to the peripheral regions, combined with a locator and hydraulic pressure, to improve sealing and prevent dislodgment, accommodating varying tissue topographies and wall thicknesses.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a flexible disc closure apparatus is used to seal an aperture in the body lumen, then the lumen can be closed to allow healing, but the seal effectiveness is reduced when the tissue surface has irregular topology due to disease or calcification
Solution Approach 1:
The locator is designed with dynamic adjustability, allowing it to pivot between a delivery configuration and a deployed configuration. The adjustment mechanism enables the locator to adapt its position and orientation to accommodate varying tissue topographies and wall thicknesses, transforming a static device into a dynamic one that can respond to irregular anatomical conditions and improve seal effectiveness
Solution Approach 2:
The adjustment mechanism modifies the geometric parameters of the locator's position and orientation relative to the tissue surface. By changing these parameters dynamically during deployment, the system adapts to irregular tissue topography and varying wall thicknesses, ensuring reliable sealing across different anatomical conditions
2Reliability
If a rigid core is used to prevent disc dislodgment, then the disc maintains sealing position, but the device may inadvertently dislodge or pull out during deployment or post-implantation
Solution Approach 1:
The locator is designed as a flexible structure that can bend to fit through the aperture during deployment. This flexibility allows the device to navigate the aperture without causing tissue damage or inadvertent dislodgment, while still providing sufficient support to maintain sealing position and prevent pull-out during and after implantation
3Ease of operation
If the locator is made flexible to bend through the aperture, then the device can be deployed, but the locator must provide sufficient rigidity to push the sealable member against the tissue surface
Solution Approach 1:
The locator transitions from a flexible state during delivery (allowing it to bend through the aperture) to a more rigid state during deployment (enabling it to push the sealable member against the tissue surface with sufficient force). This dynamic transformation allows the same structure to fulfill both requirements of ease of deployment and effective sealing force application
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 system achieves unprecedented acute sealing and reduces fluid loss by ensuring a reliable and consistent closure in body lumens with irregular surfaces, providing better tactile feedback and minimizing dislodgment risk.
Implementation Method 1
The structure, in combination with a locator and the hydraulic pressure present in the body lumen (e.g., hemodynamic pressure of blood in a blood vessel), improves the tamponade formed by the device over the aperture
Data Source
Figure 1A~2C
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AI summary
The disclosed technology provides a device (10) for sealing an aperture in a tissue of a body lumen. The device includes a flexible support member (14) having a base (19) configured to engage and/or hold a sealable member (12) of the device against an interior surface of the tissue when the device is in the sealing position. The device also includes a locator (16) coupled to the support member and configured to engage with a wall of the body lumen to secure the device thereto.