Esophageal Deflection Device with Variable Stiffness and Temperature Sensors
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Solution Overview
Problem
Current esophageal deflection methods during surgical procedures, such as catheter ablation for atrial fibrillation, are inadequate in ensuring consistent and safe displacement of the esophagus, leading to potential damage and complications due to the sensitivity of esophageal tissue to RF energy and heat, and existing devices are complex to manufacture and use, with potential for perforation and inconsistent deflection.
Innovation Solution
A biocompatible esophageal deflection device with an elongate outer tube that can be flexed to create a curved deflection, combined with a retractable insertion tube to maintain the deflection, allowing for precise and consistent esophageal displacement, featuring variable stiffness sections and temperature sensors for real-time monitoring.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If an endoscope is used for mechanical deflection of the esophagus, then the esophagus can be displaced, but the deflection is inconsistent and may be lost after removal due to elastic rebound
Solution Approach 1:
The deflection device is pre-formed with a curved shape that matches the desired deflection geometry. The curve is created during manufacturing using a mandrel or by forming the memory alloy in a curved configuration, so that when deployed, it automatically provides the correct deflection shape without requiring complex manipulation during the procedure.
Solution Approach 2:
The patent utilizes temperature-dependent shape memory properties of the alloy. The deflection device is heated to a transition temperature above which it maintains a straight configuration during insertion, then cools to below the transition temperature where it transforms to the curved deflected shape, providing automatic shape transformation based on temperature parameters.
2Ease of operation
If a small diameter deflection device is used, then insertion is easier, but the contact area with the esophagus wall is reduced, concentrating force and increasing perforation risk
Solution Approach 1:
The deflection device is nested within a delivery catheter during insertion. The curved deflection device is contained inside a straight outer catheter, allowing the entire assembly to be inserted through the esophagus in a straight configuration. Once positioned, the deflection device is deployed from the catheter, where it then transforms to its curved shape to provide deflection with distributed contact force.
Solution Approach 2:
The deflection device is constructed with a flexible yet sufficiently rigid structure that can conform to the esophageal wall while maintaining its curved shape. The material and structural design allow the device to distribute mechanical force across a larger surface area of the esophageal wall, reducing stress concentration and minimizing perforation risk despite the relatively small device diameter.
3Reliability
If the esophagus is deflected during ablation, then safety is improved, but RF energy may be shunted to the deflection device causing thermal injury
Solution Approach 1:
The deflection device serves as a physical intermediary that spatially separates the esophagus from the ablation site. By creating a curved deflection, the device increases the distance between the ablation catheter and the esophageal wall, reducing the risk of RF energy-induced thermal injury to the esophagus during the ablation procedure.
Solution Approach 2:
The patent employs temperature-dependent shape memory properties to transform the device configuration in response to temperature changes. The alloy transitions from a straight state at higher temperatures to a curved state at lower temperatures, enabling automatic shape transformation based on thermal parameters without requiring external control mechanisms.
4Reliability
If a complex deflection device with multiple components is used, then deflection control is improved, but manufacturing complexity and ease of use are reduced
Solution Approach 1:
The deflection function and the structural support function are merged into a single integrated component. The shape memory alloy structure simultaneously provides the curved deflection geometry and the mechanical rigidity needed to maintain that deflection, eliminating the need for separate control wires, adjustment mechanisms, or multiple structural components that would increase manufacturing complexity.
Solution Approach 2:
The deflection device is designed to automatically transform to its curved configuration through passive mechanisms, such as temperature-dependent shape memory effects or elastic recovery, without requiring active control systems, motors, or complex manipulation by the operator. The device serves its own deflection function through its inherent material properties and structural design.
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 ensures reliable and consistent esophageal deflection, reducing the risk of damage during procedures, is easy to use, and provides real-time temperature monitoring for safer ablation, thereby enhancing procedural safety and reducing surgeon fatigue.
Implementation Method 1
The deflection device includes a shape memory alloy and the deflection device is formed into a curved shape by heating the shape memory alloy to a temperature above an austenite finish temperature and then cooling the shape memory alloy to a temperature below the austenite finish temperature
Implementation Method 2
heating the shape memory alloy to a temperature above an austenite finish temperature and then cooling the shape memory alloy to a temperature below the austenite finish temperature
Implementation Method 3
The elongate outer tube is capable of being flexed if a threshold amount of force is applied and has a curved deflection between the distal end and the central portion
Data Source
AI summary
An esophageal deflection device includes an elongate outer tube that has a natural curved deflection at a position that corresponds to a targeted esophagus region for deflection. The curved deflection includes variable stiffness sections disposed longitudinally in the curved deflection to provide variation in stiffnesses in the longitudinal direction. The variable stiffness sections can be formed via variable material properties, variable wall thicknesses, and/or variable material omissions. An insertion rod or tube includes a portion that is stiffer than the curved deflection, and slides into the elongate outer tube to straighten the tube to guide the deflection device into an esophagus. Subsequent withdrawal of the insertion tube or rod will allow the curved deflection to return to its natural shape and deflect the targeted region of the esophagus. A three-dimensional array of temperature sensors can be disposed near an outer surface of the elongate outer tube.