Fixing this condition requires surgical adjustment of the valve leaflets to improve the amount of leaflet tissue overlap, otherwise known as the coaptation height, to ensure that the valve can form a tight seal upon closure. However, there are currently no quantitative methods to measure coaptation height during surgery.

Solution

Develop a medical device that can provide real-time visualization and measurement of the mitral valve’s coaptation zone.

System Components

Main Body — Internal:

Main Body — External:

Electronics:

How To Use

Impact

This work is a stepping stone to the development of the first fiber optic device intended to quantitatively assess mitral valve function.

The further development of this device could have major positive implications for the lives of millions suffering from heart valve disease worldwide. Because there is currently no comparable technology on the market, this device could contribute heavily to a larger system of improved quantification of valve function across the heart.

System Diagram

Client and End User

Potential Clients:

• Pediatric and adult cardiac surgeons performing mitral valve repairs either via an interventional device (MitraClip, Mitralign, Cardioband, etc.) or open-heart surgery.
• Cardiologists performing valve assessments (if device was employed in catheter-based approach.

End User:

• Patients with mitral valve insufficiency.

Build

Main Body and Electronics Fabrication:

Sensor Fabrication:

Optical Fiber Preparation:

Finished Prototype:

Evaluation

Prototype in Porcine Valve:

Technical Specifications

Design-Dependent

Design-Independent

Future Work

Despite the device’s achievements, there is still much room for improvement.

On the hardware side, in the next iteration of the device:

• The form factor of the main device body should be altered to better suit an operating room environment. This would primarily entail altering the handle to be angled upwards rather than downwards.
• PMMA optical fibers should be replaced with glass optical fibers for better light transmission and decreased probe thickness.
• The device should allow for the sensor to be secured without needing to use set screws.
• Lastly, once the device is able to consistently measure coaptation height of one leaflet, the capability of the sensor should be expanded to allow for simultaneous bidirectional viewing of the coaptation region on both the anterior and posterior leaflet surfaces.

On the software side,

• Next step is to further develop and integrate a MATLAB algorithm that can take in images of the anterior and posterior leaflet surfaces from the device and, through image processing, find upper and lower leaflet boundaries prior to creating a mapping of coaptation heights for the imaged region.
  
  The current state of the software, which has been developed up to this point using mock leaflet images, can be found in Appendix C of the final report.

Full Text

For a full description of the ideation, design, build, and evaluation process, please refer to the full text below.