Compliant Balloon Occlusion Device for Complex Anatomies
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Solution Overview
Problem
Current occlusion devices for cardiovascular defects and gaps between medical devices and body tissue are inadequate in high-pressure and complex geometries, lacking conformability and intra-device sealing, leading to suboptimal outcomes and complications.
Innovation Solution
A compliant balloon occlusion device with a fluid-tight chamber, distal and proximal elements, and a locking mechanism, allowing for adjustable expansion to fit complex anatomies, using a guidewire and delivery system for precise deployment and sealing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If currently used occlusion devices are implanted in high-pressure and complex geometry environments, then they can treat paravalvular leaks and LAA occlusion, but they lack conformability and intra-device sealing leading to suboptimal outcomes
Solution Approach 1:
The device transitions from a static, rigid structure to a dynamic, adjustable system. The frame can be compressed and expanded along its longitudinal axis, and the sealing element can be inflated to different volumes, allowing the device to adapt to various anatomical geometries and pressure conditions in real-time
Solution Approach 2:
The invention changes physical parameters of the device to improve adaptability. The sealing element's volume can be adjusted through inflation, and the frame's longitudinal dimension can be modified by compressing it along its axis, enabling the device to conform to complex geometries while maintaining occlusion effectiveness
2Reliability
If an expandable frame with sealing membrane is used to block body passageways, then occlusion can be achieved, but the device cannot adapt to complex geometries and high-pressure environments
Solution Approach 1:
The device is divided into distinct functional components: a frame structure and a separate sealing element. This segmentation allows each component to be optimized independently - the frame provides structural support and adaptability, while the sealing element provides reliable occlusion through controlled inflation
Solution Approach 2:
The device incorporates dynamic adjustment capabilities through the inflatable sealing element and compressible frame. These features allow the device to adapt to complex geometries and maintain stable occlusion in high-pressure environments by adjusting to the specific anatomical conditions
3Ease of operation
If self-expandable devices are used for LAA occlusion, then deployment is simplified, but they lack adaptability to anatomy resulting in complications
Solution Approach 1:
The device maintains deployment simplicity while adding adaptability through dynamic features. The frame can be compressed and expanded along its longitudinal axis, and the sealing element can be inflated to different volumes, allowing the device to adapt to various anatomical geometries without complicating the deployment process
Solution Approach 2:
The invention enables parameter adjustments after deployment - the sealing element volume can be modified through inflation, and the frame's longitudinal dimension can be changed by compression. This allows the device to adapt to the specific anatomy while maintaining ease of initial deployment
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 provides improved adaptability and sealing in high-pressure environments, reducing complications by conforming to complex geometries and ensuring a secure occlusion.
Implementation Method 1
expanding the balloon in a radial or a lateral direction by shortening a distance between a distal tip element and a proximal base element
Implementation Method 2
a compliant balloon defining a fluid-tight balloon chamber
Data Source
AI summary
An occlusion device (20) includes a compliant balloon (5) including an inflation port (3) for filling and unfilling a fluid into and from a balloon chamber (26). A distal tip element (10) and a proximal base element (4) are disposed at distal and proximal sides (28B, 28A) of the balloon (5), respectively. An elongate actuating element (9) is disposed longitudinally slidable in a balloon lumen (6) forming a longitudinal passage (27) from the proximal side (28A) to the distal side (28B) of the balloon (5), connected to the distal tip element (10), and longitudinally moveable with respect to the proximal base element (4) so as to set a distance between the distal tip element (100 and the proximal base element (4). A locking mechanism (2) is configured to maintain, between the distal tip element (10) and the proximal base element (4), the distance set using the elongate actuating element (9).