Self-Centralizing Balloon for Medical Device Orientation
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Solution Overview
Problem
Medical devices inserted into body cavities face challenges in maintaining a stable orientation and field of view within varying diameter and shape lumens, leading to reduced inspection accuracy and increased patient discomfort due to the inflatable balloon's tendency to settle in a volume-maximizing shape, causing the carrier to tilt and the imaging device's field of view to veer off-axis.
Innovation Solution
A self-deformable inflatable balloon with a low compliance material, coupled with a sleeve mechanism that allows for longitudinal deformation, maintains the carrier's orientation by folding or sliding along the carrier, ensuring the balloon assumes a shape that keeps the carrier parallel to the lumen axis, and a stabilizing element maintains the imaging unit's centralization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the inflatable balloon is made with low compliance material to maintain volume, then the balloon can provide stable pressure seal, but the balloon tends to settle in volume-maximizing shape causing carrier tilt and field of view deviation
Solution Approach 1:
The balloon assembly is segmented into an inflatable balloon portion and a non-inflatable stabilizing element portion. The stabilizing element is rigidly coupled to the carrier and extends along the longitudinal axis, physically separating the volume-maximizing function from the orientation-stabilizing function. This segmentation allows the balloon to maintain pressure seal while the stabilizing element prevents carrier tilt and keeps the imaging device centralized.
Solution Approach 2:
The stabilizing element acts as an intermediary component between the inflatable balloon and the carrier/imaging device. It transfers the force from the inflated balloon while maintaining the carrier's alignment with the lumen axis. The stabilizing element mediates the conflict between volume maximization and orientation stability, ensuring the imaging device remains centralized regardless of balloon volume changes.
2Reliability
If the balloon diameter is made larger than the lumen diameter to ensure sealing contact, then the pressure seal is improved, but the balloon cannot navigate through varying diameter lumens
Solution Approach 1:
The inflatable balloon is designed to be dynamically deformable, transitioning between an inflated state (for sealing) and a deflated state (for navigation). The low compliance material maintains volume when inflated but allows the balloon to be compressed during insertion. This dynamic capability enables the same balloon to navigate varying diameter lumens while providing stable sealing contact when deployed.
Solution Approach 2:
The balloon's physical parameters (volume, diameter, shape) are changed by controlling the inflation/deflation process. When deflated, the balloon has small cross-sectional dimensions allowing navigation through narrow lumens. When inflated, the balloon achieves the required sealing diameter. This parameter change enables adaptation to both navigation and sealing requirements.
3Stability of the object's composition
If the balloon material is made non-extendable to prevent material extension, then the balloon maintains its shape, but the balloon cannot adapt to varying lumen diameters
Solution Approach 1:
The balloon transitions from a static, non-extendable state during navigation to a dynamic, deformable state during sealing. The low compliance material provides shape stability when volume is maintained but allows controlled deformation during insertion and adaptation to varying lumens. This dynamic behavior resolves the contradiction between shape stability and adaptability.
Solution Approach 2:
The balloon is deflated and inserted into the lumen in a compressed state, allowing it to navigate through narrow passages. Once positioned, the balloon is inflated to its full volume, at which point the non-extendable material maintains its shape to provide stable sealing contact. This preliminary action (insertion in compressed state) followed by inflation resolves the contradiction between adaptability and shape stability.
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 solution allows for precise navigation and inspection within varying lumen diameters and shapes, maintaining the imaging device's field of view centralized, reducing patient discomfort and inspection time by ensuring the carrier remains aligned with the lumen axis, even through bends and varying diameters.
Implementation Method 1
the balloon material and thickness are appropriately selected such that the balloon is practically not extendable but expandable. More specifically, when a stress force (tension) is applied to the balloon material, an extension of the material is very small, e.g. not exceeding 10% for 4-6 mPa. Accordingly, if the circular-shaped balloon enters a smaller diameter region of the lumen, a force is applied to the balloon from the walls of the lumen deforming the balloon towards its elongated, elliptical-like, shape while practically not causing extension of the material itself.
Data Source
AI summary
An apparatus is presented for use with a biologically-compatible-fluid pressure source. The apparatus comprises an elongated carrier defining a fluid passageway and adapted to be inserted through a proximal opening of a body lumen having a main axis and certain diameter; an inflatable balloon assembly having an inflatable part self-deformable between its substantially circular geometric state and multiple elongated geometry states in which cross sectional dimensions of the inflatable balloon part are different in accordance with the diameter of the lumen, and being in fluid communication with said fluid passageway, the cross sectional dimension of the substantially circular geometric state being equal to or greater than said diameter of said body lumen; and at least one sleeve extending from at least one end respectively of said inflatable part of the balloon assembly along a central axis of said inflatable balloon part, said at least one sleeve being by its one end is rigidly coupled to the respective end of the balloon part and having one of the following configurations: (a) being by its other end fixed to the carrier at a certain location and being foldable and extendable in accordance with longitudinal deformation of the inflatable balloon part, and (b) having a fixed length and being by its other end slidable along the carrier in accordance with longitudinal deformation of the inflatable balloon part. Deformation of the inflatable part of the balloon maintains the balloon assembly orientation such that the carrier passing through the balloon assembly substantially coincides with said main axis of said lumen.