Simulated Heart Valve Root with Calcification and Tears
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Solution Overview
Problem
Conventional methods for testing and training in prosthetic heart valve implantation lack realism, particularly in simulating the calcified or diseased state of the aortic annulus, which is critical for accurate placement and sealing of expandable valves, and existing animal models do not accurately replicate the conditions of human patients.
Innovation Solution
A simulated heart valve root system that mimics the anatomy of a diseased patient, featuring a flexible tubular body with simulated calcification and tears, and a reinforcing sleeve for increased hoop strength, allowing for realistic training and testing of prosthetic valve placement and leak detection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If animal models with healthy heart valves are used for training and testing, then the procedure is simple and cost-effective, but the realism and accuracy of simulating diseased human valve conditions deteriorates
Solution Approach 1:
The patent creates a simulated heart valve root that copies the pathological features of diseased human valves (calcification, tears, distortion) in an artificial model. This allows training and testing to be performed on a realistic representation of diseased valve anatomy without using actual patient specimens or complex animal models, thus maintaining simplicity while improving realism.
Solution Approach 2:
The patent modifies the physical parameters of the simulated valve root by incorporating varying degrees of calcification, tears, and anatomical distortion that match diseased human valve conditions. This allows the model to accurately represent pathological states while remaining a controllable artificial system rather than requiring living animal subjects.
2Productivity
If conventional testing methods are used, then the testing process is simple and quick, but the accuracy of evaluating valve placement and sealing performance deteriorates
Solution Approach 1:
The simulated heart valve root provides a realistic copy of diseased valve anatomy that enables accurate evaluation of valve placement and sealing performance. The model includes pathological features such as calcification and tears that allow for meaningful assessment of paravalvular leakage, maintaining testing speed while improving measurement accuracy.
3Loss of time
If expandable valves are implanted remotely without open-heart surgery, then patient recovery time is reduced, but the ability to precisely position and secure the valve to the annulus deteriorates
Solution Approach 1:
The simulated heart valve root serves as an intermediary training tool that allows physicians to practice remote valve implantation techniques with precise positioning control before performing actual procedures on patients. The model enables repeated practice of catheter-based valve deployment and positioning without the risks associated with actual patient procedures.
Data Source
AI summary
A simulated heart valve root used for training physicians in techniques of implantation of prosthetic heart valves as well as for more realistically testing the efficacy of prosthetic heart valves. The simulated heart valve root is made of the flexible, tubular body having an inner wall defining an annular ledge within which the prosthetic heart valve is implanted. Discrete nodes or areas of simulated calcification may be provided on the annular ledge. A simulated aortic root includes alternating cusps and commissures with calcification simulated at least at one of the commissures. A tear in the annular ledge may also be provided which simulates a tear that might occur from a valvuloplasty procedure. A reinforcing sleeve may surround the flexible tubular body to provide rigidity or hoop strength thereto. A method of testing includes mounting the simulated heart valve root in a flow conduit, implanting a prosthetic heart valve in the root, applying pulsatile flow to the assembly, and monitoring for leaks. The simulated heart valve root may also be incorporated within a larger simulated heart for use in training physicians to remotely implant prosthetic heart valves.