Medical Balloon Sensing Assembly for Valve Implantation
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Solution Overview
Problem
Current medical balloon technologies face challenges in accurately expanding prosthetic heart valves to prevent paravalvular leakage and annular rupture, while avoiding excessive force on calcifications, during minimally invasive procedures.
Innovation Solution
A medical balloon sensing assembly with integrated sensors, including force sensors and a sensor data unit, that maps forces applied to the balloon to determine optimal expansion size and orientation, ensuring safe implantation of prosthetic valves by monitoring the balloon's expansion and surrounding tissue conditions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the balloon is expanded to maximum size to prevent paravalvular leakage, then the sealing performance is improved, but the risk of annular rupture increases
Solution Approach 1:
The patent employs force sensors integrated into the balloon assembly that provide real-time feedback on the forces applied to the annulus during expansion. This feedback mechanism allows the operator to monitor the expansion process and adjust the inflation pressure to prevent exceeding the annular strength, thereby resolving the contradiction between achieving maximum sealing and avoiding annular rupture
Solution Approach 2:
The system performs preliminary mapping of the annular geometry and force distribution before full expansion. This preliminary action allows determination of the optimal expansion size tailored to the specific patient anatomy, enabling maximum sealing performance without exceeding the structural limits of the annulus
2Reliability
If the balloon is expanded to maximum size to prevent paravalvular leakage, then the sealing performance is improved, but the force applied to calcifications increases
Solution Approach 1:
Force sensors distributed around the balloon provide real-time feedback on localized forces applied to calcified regions. This allows the operator to identify areas with excessive force concentration and adjust expansion accordingly, preventing damage to calcifications while maintaining adequate sealing at other regions
Solution Approach 2:
The patent implements non-uniform force distribution through strategically positioned sensors and controlled expansion patterns. Different regions of the balloon can apply different forces, allowing adequate sealing pressure in non-calcified areas while reducing force on calcified regions, thus resolving the contradiction between sealing performance and calcification protection
3Measurement precision
If sensors are integrated into the balloon assembly, then the measurement precision of force distribution is improved, but the device complexity increases
Solution Approach 1:
The patent combines multiple functions into the balloon assembly: the balloon serves both as the expansion device and as the mounting platform for force sensors. This merging eliminates the need for separate sensor positioning devices and simplifies the overall system architecture while achieving precise force distribution mapping
Solution Approach 2:
The balloon assembly is designed with multi-functionality: it provides valve implantation, force application, and simultaneous force measurement through integrated sensors. This universal design reduces the need for additional specialized devices, thereby managing complexity while enhancing measurement precision
Data Source
AI summary
A medical balloon sensing assembly constituted of: a handle; a first catheter extending distally from the handle; an inflatable medical balloon, the inflatable medical balloon secured by the first catheter; at least one sensor position member; and at least one sensor secured to the at least one sensor position member, wherein the at least one sensor position member is arranged to contact an outer face of the inflatable medical balloon.