Coaptation Mapping Technology for Heart Valve Assessment
A device that can be used to assess the valve operation intra-operatively while the heart is open
Background
Approximately 60,000 heart valve repair operations are performed annually in the US. Typically, the surgeon determines the valve defect and the required repair using preoperative echocardiography. Before starting the repair, the valve is inspected using so-called passive testing, which involves injecting saline into the ventricle and assessing the amount and site of saline regurgitation through the valve. After a repair, the efficacy of the repair is also assessed using passive testing. If the repair seems adequate, the heart is closed and the repair is further assessed using echocardiography. If post-operative echocardiography indicates significant leakage, the patient is put back on the heart-lung machine and additional repairs are carried out. These re-surgeries increase patient morbidity and cost. Additionally, considerable experience is needed to accurately assess a valve repair with passive testing and there is no correlation between the results of passive testing and surgical outcomes. Therefore, there is an urgent need for methods that can quantitatively assess the adequacy of a valve repair while the heart is open.
Technology Overview
This invention is a device that can be used to assess the valve operation intra-operatively while the heart is open. The new device is based on accurate measurement of the valve coaptation height, i.e., the length of the opposing leaflets that overlap to close the valve. It is known that larger coaptation heights and more equal heights of opposing leaflets are predictors of better surgical outcomes and better valve function. The new device can use a range of sensor technologies such as electronic sensors, optical methods, ultrasound sensors, or thermistors for coaptation height measurement. By allowing the surgeon to accurately measure the coaptation height intra-operatively, the new device will enable the surgeon to assess the efficacy of a repair and, if needed, to adjust the repair in real time.
Stage of Development
The inventors built a prototype of the device and carried out initial tests in a water bath. These tests determined that capacitance was the right measurement for assessing tissue contact. Using the capacitance as the measurement, the inventors performed a series of follow-up experiments on the mitral valve of an explanted porcine heart. These experiments showed that the new device could provide accurate and consistent measurements of coaptation height with a high signal-to-noise ratio.
Further Details:
Hoganson, D. and Hammer, P.E., Childrens Medical Center Corp, 2020. Valve coaptation measurement devices. U.S. Patent Application 16/755,015.
Benefits
- Reduces the frequency of re-surgeries, hence reducing the duration and cost of the surgery and patient morbidity
- Measures coaptation height for either one or both leaflets simultaneously
- Can be used before, during, and after surgery
- Can be manufactured to work for adult valves as well as delicate infant valves
Applications
- Heart valve repair
- Heart valve assessment
IP Status
