Dual-Balloon Dilation Device for GI Stricture Anchoring
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Solution Overview
Problem
Current balloon dilators for GI stricture sites are limited in diameter range, often require multiple devices for adequate dilation, and tend to over-dilate surrounding tissue due to length discrepancies, leading to migration issues during procedures.
Innovation Solution
A dilation device featuring a catheter with a dual expandable system, including a dilation balloon and an occlusion anchor balloon, which are designed to minimize migration and excess dilation by anchoring the dilation balloon within the stricture site, allowing for a wider range of diameters and reduced procedure complexity.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If current balloon dilators are used for GI stricture dilation, then the stricture site can be dilated, but the dilator tends to migrate or slip during the dilation process, leading to over-dilation of surrounding tissue
Solution Approach 1:
The dilator is divided into multiple functional segments: a first expandable body for dilation, a second expandable body for anchoring, and a catheter body. This segmentation allows each component to perform its specific function independently, with the anchor body preventing migration while the dilation body provides precise control over the dilated area.
Solution Approach 2:
The anchor expandable body is deployed first to secure the dilator in place at the stricture site before the dilation expandable body is inflated. This preliminary anchoring action prevents migration during the subsequent dilation process, ensuring the dilator remains positioned correctly throughout the procedure.
2Manufacturing precision
If multiple balloon catheters are inserted sequentially to achieve desired dilation, then the stricture can be adequately dilated, but the procedure time and complexity increase
Solution Approach 1:
Multiple functional capabilities are merged into a single dilator device: the catheter body, the dilation expandable body for stricture dilation, and the anchor expandable body for securing position. This integration allows the operator to perform anchoring and dilation in a single procedure rather than requiring multiple sequential catheter insertions.
Solution Approach 2:
The dilator is designed as a multi-functional device that can perform anchoring, positioning, and dilation functions all in one device. The expandable bodies can be inflated to different diameters, providing universal applicability for various stricture sizes and locations without requiring multiple specialized catheters.
3Reliability
If the dilator length is increased to accommodate slippage, then migration is compensated for, but over-dilation of areas around the stricture site occurs
Solution Approach 1:
The dilator implements local quality by concentrating the dilation effect precisely at the stricture site through the anchor expandable body. The anchor body creates a localized expansion zone that confines the dilation force to the target area, preventing transmission of dilation force to surrounding healthy tissue while maintaining position 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 device effectively reduces migration and excess dilation, enabling precise stricture dilation with a shorter balloon length and fewer procedures, while providing a dual function for both dilation and potential stone removal in GI and biliary tracts.
Implementation Method 1
In some variations, the fluid or gas used to fill the dilation expandable body or the occlusion anchor expandable body may be pressurized.
Data Source
AI summary
The disclosure provides for a device and method for dilation. The dilation device may include a catheter body having a proximal portion and a distal portion, a dilation expandable body in fluid communication with a first opening on the distal portion of the catheter body, and an occlusion anchor expandable body in fluid communication with a second opening on the distal portion of the catheter body. The method for dilating a stricture site may include inserting the dilation device into a stricture site of a patient, expanding the occlusion anchor expandable body at the stricture site, and expanding the dilation expandable body at the stricture site.