Compliant Balloon Occlusion for Adaptive Left Atrial Appendage Sealing
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Solution Overview
Problem
Existing left atrial appendage occlusion devices lack adaptability to the unique anatomy of the LAA, leading to complications and suboptimal outcomes due to poor conformability and inadequate sealing.
Innovation Solution
The development of a compliant balloon occlusion device with an actuating shaft that allows for adjustable longitudinal distance between its end portions, enabling inflation and radial expansion to conform to the LAA geometry, along with a valve and locking mechanism for sealing and secure anchoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Device complexity
If self-expandable occlusion devices are used, then the device structure is simplified, but the adaptability to LAA anatomy and sealing performance deteriorate
Solution Approach 1:
The occlusion device incorporates an adjustable length mechanism that allows the longitudinal distance between end portions to be modified after deployment. The actuating shaft can be longitudinally moved relative to the balloon chamber to set different distances, enabling the device to adapt to varying LAA anatomies rather than being fixed at a single predetermined length.
Solution Approach 2:
The device enables parameter changes by allowing adjustment of the longitudinal dimension through the actuating shaft mechanism. This parameter adjustment capability permits optimization of both length and radial expansion to match specific LAA geometries, resolving the contradiction between structural simplicity and anatomical adaptability.
2Ease of operation
If self-expandable occlusion devices are used, then the deployment process is simplified, but the conformability to LAA geometry and sealing performance deteriorate
Solution Approach 1:
The device transitions from a static self-expandable structure to a dynamic adjustable structure. After initial deployment, the actuating shaft can be moved to adjust the longitudinal distance, allowing the device to conform to the specific LAA geometry while maintaining ease of deployment through the balloon expansion mechanism.
Solution Approach 2:
The balloon chamber is first expanded to establish initial anchoring and sealing, then the actuating shaft is adjusted to optimize the longitudinal dimension for perfect conformability. This two-stage approach combines preliminary ease of deployment with subsequent optimization of anatomical match.
3Device complexity
If fixed-length occlusion devices are used, then the device design is simplified, but the ability to adapt to anatomical variations and prevent blood leakage deteriorates
Solution Approach 1:
The device incorporates a dynamic adjustment mechanism where the actuating shaft can be longitudinally moved to set different distances between end portions. This dynamic capability allows optimization of sealing performance for various LAA anatomies without substantially complicating the overall device design, as the adjustment mechanism integrates with the existing balloon structure.
Solution Approach 2:
The device separates the inflation function (balloon chamber) from the length adjustment function (actuating shaft). This segmentation allows independent optimization of both sealing through balloon expansion and length adaptation through shaft movement, achieving reliable sealing across anatomical variations.
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 the LAA by adapting to its anatomical variations, preventing blood leakage and enhancing therapeutic efficacy.
Implementation Method 1
a valve, which can be closed after inflation of the balloon chamber
Implementation Method 2
an actuating shaft, which is (a) disposed at least partially within the balloon chamber, (b) connected to a distal end portion of the balloon, and (c) longitudinally moveable with respect to a proximal end portion of the balloon so as to set a distance between the distal and the proximal end portions of the balloon
Data Source
AI summary
An occlusion device is provided for occluding a left atrial appendage (LAA), including a compliant balloon defining a fluid-tight balloon chamber. An actuating shaft is disposed at least partially within the balloon chamber, and configured to set a distance between distal and proximal end portions of the balloon. A locking mechanism is configured to assume locked and unlocked states, and is configured, when in the locked state, to maintain, between the distal and the proximal end portions of the balloon, the distance set using the actuating shaft. The occlusion device is shaped so as to define a fluid flow path along a portion of the actuating shaft. A valve is configured to selectively allow or block fluid flow between the fluid flow path and the balloon chamber when the valve is in open and closed states, respectively. Other embodiments are also described.