Kidney-Shaped Balloon Dilator for Upper Esophageal Sphincter
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Solution Overview
Problem
Current esophageal dilators are cylindrical and do not accurately approximate the biomechanical dimensions of the upper esophageal sphincter, which is kidney bean shaped, leading to ineffective dilation and potential scarring from radiation-induced fibrosis.
Innovation Solution
A balloon dilator designed to resemble a kidney shape or two cylindrical dilators in apposition, made from non-compliant or semi-compliant materials, which can be differentially inflated and may include a drug delivery system, to anatomically complement the upper esophageal sphincter, potentially using a single or dual catheter system for inflation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Shape
If cylindrical dilators with round circumference are used, then the device structure is simple and easy to manufacture, but the dilator does not accurately approximate the kidney bean shape of the upper esophageal sphincter, leading to ineffective dilation
Solution Approach 1:
The dilator is divided into multiple segments or lobes that can be independently shaped to match the kidney bean geometry of the UES. This segmentation allows the dilator to conform to the complex anatomical shape while maintaining manufacturing feasibility through modular construction techniques.
Solution Approach 2:
The dilator design transitions from a symmetric cylindrical shape to an asymmetric kidney bean shape that accurately reflects the anatomical geometry of the upper esophageal sphincter. This asymmetric design enables better approximation of the target tissue shape, improving dilation effectiveness.
2Stability of the object's composition
If non-compliant or semi-compliant materials are used for the balloon dilator, then the dilator maintains its shaped configuration for effective UES approximation, but the device requires more complex inflation control mechanisms
Solution Approach 1:
The balloon dilator incorporates dynamic inflation control that allows transition between different inflation states. The system can be inflated to different pressures and volumes depending on the specific anatomical requirements, providing adaptability while maintaining shape stability through controlled material properties.
Solution Approach 2:
The dilator utilizes changes in inflation parameters (pressure, volume, rate) to achieve the desired shape approximation and dilation effect. By carefully controlling these parameters, the system maintains shape stability while avoiding the need for overly complex mechanical control mechanisms.
3Device complexity
If a single catheter system is used to deliver the balloon dilator, then the device delivery is simpler, but the ability to differentially inflate different portions of the dilator is limited
Solution Approach 1:
The catheter system employs a nested structure where multiple inflation lumens are contained within a single outer catheter sheath. This nesting arrangement allows for differential inflation of different balloon segments through a unified delivery system, maintaining simplicity while enabling versatile inflation patterns.
Solution Approach 2:
The single catheter system is designed with multiple functions integrated into one structure, including separate inflation lumens for differential balloon inflation, drug delivery capabilities, and positioning control. This multi-functionality achieves adaptability without requiring multiple separate catheters.
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 balloon dilator effectively expands the upper esophageal sphincter, reducing scarring and allowing for therapeutic substance delivery, thereby improving tissue remodeling and treatment outcomes.
Implementation Method 1
The balloons are configured to be differentially inflated
Implementation Method 2
made from non-compliant or semi-compliant materials
Data Source
Figure 1A
Figure 1B
Figure 1C
AI summary
An apparatus for dilating an upper esophageal sphincter. The apparatus includes an elongated expandable member having a cross-section shaped to support a natural shape of an upper esophageal sphincter. A catheter extends from the elongated inflatable member.