MEM Sensor Alignment for Prosthetic Heart Valves
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Solution Overview
Problem
There is a need for improved monitoring and measurement of prosthetic heart valve functionality before, during, and after implantation to ensure proper functioning and address issues like calcification and paravalvular leakage.
Innovation Solution
The integration of microelectromechanical (MEM) sensors with prosthetic heart valves, which are attached using sutures that allow the sensors to maintain alignment with the valve structure during expansion and collapse, enabling accurate measurement of physiological parameters such as blood pressure and flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If the prosthetic valve is collapsed to a small circumferential size for delivery, then the valve can be delivered less invasively via catheter, but the sensor alignment with the valve structure becomes misaligned
Solution Approach 1:
The sensor attachment system allows the sensor to dynamically change its orientation relative to the valve structure. The suture configuration enables the sensor to rotate and realign automatically as the valve transitions between collapsed and expanded states, maintaining measurement accuracy throughout the dynamic process.
Solution Approach 2:
The system accommodates parameter changes in sensor orientation by using a flexible attachment method. The suture arrangement allows the sensor body angle to change from non-parallel during collapse to parallel during expansion, adapting to the varying geometric parameters of the valve.
2Measurement precision
If the sensor is rigidly attached to maintain alignment, then measurement accuracy is improved, but the valve cannot be collapsed to small size for delivery
Solution Approach 1:
The attachment system transitions from a static rigid connection to a dynamic flexible connection. The suture-based attachment allows movement during delivery while maintaining functional alignment during operation, enabling both collapsibility and measurement accuracy.
3Ease of operation
If the sensor body axis is parallel to the stent longitudinal axis in collapsed condition, then the valve can be delivered via catheter, but the sensor cannot accurately measure physiological parameters during expanded condition
Solution Approach 1:
The sensor attachment system is designed to be dynamic rather than static. The suture configuration allows the sensor to rotate and achieve proper alignment (parallel axes) when the valve is in its expanded operational state, while permitting non-aligned configuration during collapsed delivery state.
Data Source
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Figure 3A~3B
AI summary
Prosthetic heart devices may be implanted into the heart with a sensor (400) coupled to the device, the sensor being configured to measure physiological data, such as blood pressure, in the heart. Devices that may employ such sensors include prosthetic heart valves (100, 2000, 300, 4000) and occlusion devices (5000, 6000), although sensor systems may be deployed in the heart separate from other implantable devices. The sensors may include a body (402) with different configurations for attaching to the implantable device, such as apertures for sutures or fingers for connecting to structures of the implantable device. The sensors may provide data that allow a determination of aortic regurgitation or other information indicative of function of the implantable device and patient health during and after implantation of the device.