Asymmetric Prosthetic Aortic Valve Frame for TAVI
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Solution Overview
Problem
Transcatheter aortic valve implantation (TAVI) often results in new-onset cardiac conduction disturbances, particularly left bundle branch block (LBBB), due to the asymmetric forces applied to the aortic valve during prosthetic valve deployment, which existing prosthetic aortic valves fail to mitigate effectively.
Innovation Solution
A prosthetic aortic valve system with a frame shaped to define upstream, downstream, and constriction portions, featuring prosthetic leaflets coupled to the constriction portion and a prosthetic-valve coil in non-wireless electrical communication with electrodes, allowing for pacing signals to be applied and cardiac parameters to be sensed, thereby reducing horizontal forces and improving force distribution.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a prosthetic aortic valve is deployed in the aortic valve annulus, then the valve replacement function is achieved, but horizontal forces are applied to the commissures causing cardiac conduction disturbances
Solution Approach 1:
The frame is designed with an asymmetric hourglass shape where the commissures are positioned at different heights relative to the aortic annulus plane. This asymmetric configuration allows the valve to distribute forces more evenly, reducing the horizontal forces applied to the commissures during deployment while maintaining effective valve replacement function.
2Ease of operation
If the prosthetic valve is delivered compressed in a catheter, then percutaneous transluminal delivery is enabled, but the valve structure must be simplified
Solution Approach 1:
The prosthetic valve is designed to be nested within a delivery catheter in a compressed state. The frame comprises interconnected struts that can be crimped together to fit within the catheter lumen, then expand to their functional configuration upon deployment. This nesting approach enables percutaneous transluminal delivery while maintaining the complex asymmetric hourglass structure needed to reduce commissural forces.
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 system effectively reduces the incidence of cardiac conduction disturbances by optimizing force distribution and alignment during deployment, enhancing the stability and functionality of the prosthetic aortic valve.
Implementation Method 1
The non-implantable control circuitry is configured to drive the cathode and the anode to apply a pacing signal to a heart of the patient, detect at least one cardiac parameter using the at least two sensing skin ECG electrodes, and at least partially responsively to the detected at least one cardiac parameter, set parameters of the pacing signal, by wirelessly transferring energy from the energy-transmission coil to the prosthetic-valve coil by inductive coupling
Data Source
AI summary
A prosthetic aortic valve is provided, which is configured to be delivered to a native aortic valve of a patient in a constrained delivery configuration within a delivery sheath. The prosthetic aortic valve includes a frame, which includes interconnected stent struts arranged so as to define interconnected stent cells; a plurality of prosthetic leaflets coupled to the frame; a cathode and an anode, which are mechanically coupled to the frame; and a prosthetic-valve coil, which is in non-wireless electrical communication with the cathode and the anode, and is coupled to a plurality of the stent struts, running along the stent struts so as to surround a plurality of the stent cells when the prosthetic aortic valve is in an expanded fully-deployed configuration upon release from the delivery sheath. Other embodiments are also described.