Multi-Segment Balloon Inflation for Prosthetic Heart Valve
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Solution Overview
Problem
Existing prosthetic heart valve delivery systems face challenges in achieving uniform expansion and precise placement during transcatheter aortic valve replacement (TAVR) due to asymmetric forces required to expand the valve, leading to potential uneven expansion and embolization risks.
Innovation Solution
The proposed solution involves a prosthetic heart valve delivery system with a multi-balloon configuration, where the balloon is segmented into proximal, center, and distal segments, each with independent inflation lumens and sensors to monitor pressure. This allows for real-time feedback and adjustment of inflation rates to ensure uniform expansion of the prosthetic heart valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If a single balloon is used for valve expansion, then the device complexity is reduced, but uniform expansion cannot be achieved due to asymmetric forces
Solution Approach 1:
The single balloon is divided into multiple segments (proximal, central, distal) that can be inflated independently. Each segment has its own inflation lumen and pressure sensor, allowing separate control of inflation forces to compensate for asymmetric valve geometry and achieve uniform expansion throughout the valve structure.
2Ease of operation
If manual inflation control is used, then the device complexity is reduced, but real-time adjustment of inflation rates is difficult
Solution Approach 1:
Pressure sensors are integrated into each balloon segment to provide real-time feedback on inflation pressure. This feedback is transmitted to a control system that automatically adjusts the inflation rate of each segment, ensuring uniform expansion while reducing the need for complex manual control mechanisms.
3Reliability
If independent inflation segments are used, then uniform expansion is improved, but the device complexity increases
Solution Approach 1:
Multiple inflation lumens are nested within the balloon structure, with each lumen supplying inflation fluid to a specific segment. This nested arrangement allows independent control of multiple segments while maintaining a compact overall structure and minimizing the increase in device complexity.
4Measurement precision
If pressure sensors are added to each segment, then real-time feedback is improved, but the device complexity increases
Solution Approach 1:
The pressure sensors serve multiple functions: they monitor inflation pressure, detect expansion status, and provide feedback for control adjustments. This multi-functionality reduces the need for additional separate systems, thereby limiting the increase in device complexity while achieving precise real-time pressure measurement.
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 multi-balloon configuration enables precise control over the expansion of the prosthetic heart valve, reducing the risk of uneven expansion and embolization, while ensuring accurate placement and uniform expansion, thereby improving the safety and efficacy of TAVR procedures.
Implementation Method 1
A first sensor may be operably coupled to the proximal balloon segment and a second sensor may be operably coupled to the distal balloon segment, the first sensor configured to relay data to the balloon inflation system indicative of a state of expansion of the proximal balloon segment, and the second sensor configured to relay data to the balloon inflation system indicative of a state of expansion of the distal balloon segment. The first sensor may be a first pressure sensor positioned in fluid communication with the interior volume of the proximal balloon segment and the second sensor may be a second pressure sensor positioned in fluid communication with the interior volume of the distal balloon segment.
Data Source
AI summary
A prosthetic heart valve delivery system may include a handle, an outer catheter extending distally from the handle, and a balloon mounted to a distal end portion of the outer catheter. A prosthetic heart valve may be configured to be received over the balloon, and a balloon inflation system may be configured to inflate and deflate the balloon. The balloon may include a proximal balloon segment and a distal balloon segment positioned distal to the proximal balloon segment. An interior volume of the proximal balloon segment may be fluidly isolated from an interior volume of the distal balloon segment so that the proximal balloon segment and the distal balloon segment may be inflated independently of each other.