Instrument for Beating-heart Mitral Valve Chordal Replacement to Treat Prolapse
A novel optically-guided device that significantly enhances the convenience and accuracy of neochordae placement
Background
Mitral valve prolapse (MVP) affects 2-3% of the population. In MVP, one or more of the chordae tendineae, which support the leaflets during systole, fail. As a result, part of the leaflet flutters into the left atrium, preventing the leaflets from sealing properly. MVP can be treated with a surgical repair, whereby the artificial chordae (a.k.a. neochordae) are implanted to restore leaflet support. Even though this procedure is commonly performed in an open-heart surgery, minimally-invasive beating-heart neochordae placement with the help of a catheter is a promising alternative. There are currently a few existing devices that offer this capability, but they all have important limitations. For example, most existing devices rely on ultrasound and fluoroscopic imaging guidance, which are not as efficient as endoscopic imaging. Moreover, some of the existing methods can only implant the chordae in the leaflet belly, which is not the optimal site in terms of valve function and surgical outcome.
Technology Overview
This invention is a novel optically-guided device that significantly enhances the convenience and accuracy of neochordae placement compared with the existing methods. By providing the surgeon with a direct visualization of the leaflet during the surgery, the new device enables the surgeon to accurately estimate the distance of chordae placement site from the leaflet edge. The visualization also allows the surgeon to verify that the anchor placement through the leaflet is performed properly. The new device also gives the surgeon higher flexibility by allowing for different ways of deploying the chordae by either grasping or harpooning the leaflet. Additionally, the new device can work with different types of anchors.
The inventors built a prototype device with an optically-clear silicone grasping surface and with neochordae comprising T-shaped anchors. They evaluated the prototype via ex vivo and in vivo experiments. Ex vivo porcine experiments involved placing neochordae in mitral leaflets of fresh porcine hearts and measuring the force needed to tear them out of the leaflets. The average force required to tear the anchors was 4.2N. During the in vivo swine experiments, a total of 14 neochordae were placed in five pigs. The placement was carried out transapically using only optical guidance. All attempts were successful, and the average delivery time was 169s.
Further Details:
Machaidze, Zurab, et al. "Optically-guided instrument for transapical beating-heart delivery of artificial mitral chordae tendineae." The Journal of thoracic and cardiovascular surgery 158.5 (2019): 1332-1340.
Benefits
- More accurate than open heart surgery because the chordae length can be adjusted while the heart is beating
- Allows the surgeon to assess the quality or thickness of the grasped tissue and the accuracy of placement
- Enhances the success rate, accuracy, and ease of neochordae placement
- Minimally-invasive
Applications
Implantation of artificial chordae tendineae for treatment of mitral valve prolapse.
IP Status
