Sizing Device for Prosthetic Heart Valve Positioning
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Solution Overview
Problem
Conventional delivery devices for collapsible prosthetic heart valves face challenges in accurate sizing and positioning, leading to risks such as valve migration and improper anchoring due to anatomical variations and calcification levels, which can result in severe complications.
Innovation Solution
A collapsible and expandable stent with a sensor system that measures native valve annulus dimensions and calcification levels, using microelectromechanical sensors and deployment devices to ensure proper fitment and anchoring of the prosthetic valve.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If conventional delivery devices are used for collapsible prosthetic heart valves, then the valve can be delivered less invasively via catheter, but accurate sizing and positioning becomes difficult leading to valve migration and improper anchoring
Solution Approach 1:
The patent applies preliminary action by measuring the native annulus dimensions and calcification levels before valve deployment. The sensor system is integrated into the delivery device to perform measurements during the delivery process, allowing the operator to select the appropriate valve size beforehand and adjust the deployment timing to achieve proper positioning and anchoring.
Solution Approach 2:
The patent replaces conventional mechanical sizing methods with a sensor-based measurement system. Microelectromechanical sensors are integrated into the delivery device to electronically measure annulus dimensions and calcification levels, substituting traditional mechanical calipers or estimation methods with precise electronic sensing and data processing.
2Volume of moving object
If valve size is reduced to fit smaller delivery catheters, then delivery invasiveness is reduced, but valve anchoring capability deteriorates due to mismatch with native annulus
Solution Approach 1:
The sensor system performs preliminary measurement of the native annulus dimensions and calcification levels before valve selection. This allows the operator to determine the optimal valve size that will provide adequate anchoring while still being deliverable through the catheter system, resolving the conflict between small collapsed size and anchoring capability.
Solution Approach 2:
The patent changes the approach from selecting fixed valve sizes to using sensor-measured parameters (annulus diameter, calcification level) to guide valve selection and deployment. The sensor data provides quantitative parameters that allow optimization of the valve-to-annulus size ratio for proper anchoring despite the constraints of catheter-deliverable dimensions.
3Measurement precision
If more sensors are added to the sizing device, then measurement accuracy improves, but device complexity increases
Solution Approach 1:
The sensor system is designed to perform multiple functions: measuring annulus dimensions, assessing calcification levels, and potentially guiding deployment. By making the sensor system multi-functional, the patent reduces the need for separate measurement devices and minimizes overall system complexity while maintaining high measurement precision.
Solution Approach 2:
The patent merges the sizing device, sensor system, and delivery device into an integrated platform. The sensor is coupled directly to the stent and delivery apparatus, combining multiple functions into a single unified system rather than requiring separate devices for measurement and delivery, thereby reducing overall complexity.
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 solution reduces the risk of valve migration and improper positioning by providing accurate measurements for selecting the appropriate prosthetic valve size and shape, enhancing clinical success and safety by minimizing complications related to anatomical variations and calcification.
Implementation Method 1
a sensor coupled to the annulus section of the stent, the sensor being capable of collecting information related to the native valve annulus
Data Source
AI summary
A sizing device for a collapsible prosthetic heart valve includes a collapsible and expandable stent. A microelectromechanical sensor is coupled to the stent, the sensor being capable of collecting information related to the size and stiffness of tissue.