TAVI Valve Inflation Programming for Material Variation and Precise Sizing
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Solution Overview
Problem
Conventional prosthetic heart valve deployment methods lack precision and customization for individual patient anatomies, leading to variable oversizing or undersizing, which can result in clinical issues such as paravalvular leakage, annular rupture, and valve migration.
Innovation Solution
A system and method that includes a prosthetic heart valve with a collapsible and expandable stent, a delivery device with an inflatable balloon, and a memory for storing data on part-to-part noise and process variation factors, allowing for the calculation of adjusted inflation parameters to achieve precise and customized valve sizing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If conventional manual deployment methods are used with nominal valve sizes, then the deployment process is simple and quick, but precision and customization for individual patient anatomies are lacking, leading to variable oversizing or undersizing
Solution Approach 1:
The system performs preliminary measurements and calculations of inflation parameters during the manufacturing process, storing these values in memory within the delivery device. This preliminary action allows the actual deployment to use pre-calculated precise parameters rather than requiring complex real-time calculations during the procedure.
Solution Approach 2:
The delivery device contains its own memory with stored inflation parameters and can autonomously deploy the valve using these pre-programmed values. The system serves itself by having the implantable device contain the information needed for its own precise deployment without requiring external calculation or adjustment during the procedure.
2Adaptability or versatility
If nominal valve sizes are used to cover a range of patient anatomies, then device versatility is maintained, but the amount of oversizing or stretching of native tissue varies, causing clinical issues
Solution Approach 1:
The system provides customized inflation parameters tailored to each specific valve device's characteristics and the specific patient anatomy. Instead of using a single nominal size for all patients, each valve receives locally optimized inflation values stored in its memory, ensuring precise fit for that particular implantation scenario.
Solution Approach 2:
The system changes the inflation parameters based on specific device characteristics (part-to-part noise factors) and patient anatomy variations. By adjusting these parameters rather than changing the physical valve size, the system maintains versatility while achieving reliable, customized deployment for each patient.
3Productivity
If material and processing variations are not accounted for, then manufacturing is simpler and faster, but part-to-part noise and process variation cause inconsistent deployment results
Solution Approach 1:
The system performs preliminary characterization of material and processing variations during manufacturing, storing compensation factors in the device memory. This preliminary measurement and storage of variation data allows the deployment phase to use pre-determined adjusted parameters rather than requiring complex real-time adjustments.
Solution Approach 2:
The system incorporates feedback from manufacturing process data and material characterization into the inflation parameter calculations. By measuring actual device properties during or after manufacturing and using this feedback to adjust the stored inflation parameters, the system compensates for variations without slowing down the overall manufacturing process.
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
Enables precise and customized valve sizing, reducing clinical complications like paravalvular leakage and annular rupture by accounting for material and processing variations, thereby improving clinical outcomes.
Implementation Method 1
the balloon is inflated to force the balloon-expandable valve to transition from the collapsed or crimped condition into an expanded or deployed condition
Implementation Method 2
the prosthetic heart valve tending to remain in the shape into which it is expanded by the balloon
Data Source
AI summary
In some embodiments, a method includes providing a prosthetic heart valve including a collapsible and expandable stent having struts and a valve assembly coupled to the stent, the valve assembly having a plurality of leaflets and a cuff, providing a delivery device including a catheter extending between a proximal end and a distal end, an inflatable balloon, a handle coupled to the catheter, and a memory for storing data disposed within the handle, recording at least one of part-to-part noise factors and process variation factors and storing it in the memory, calculating an adjusted inflation parameter based on the at least one of part-to-part noise factor and process variation factor, advancing the delivery device to a native aortic valve of a patient while the prosthetic heart valve is disposed about the inflatable balloon, and inflating the balloon according to the adjusted inflation parameter.