Upcoming Event

Cleveland Clinic
Department of Biomedical Engineering 
BME Guest Speaker
"Cerebrovascular Care in 2019 - Advances and Challenges"
M. Shazam Hussain, MD
Staff, Cerebrovascular Center
Cleveland Clinic
Friday, November 15, 2019
Hosted by: Vinod Labhasetwar, PhD

Transcatheter Mitral Stent/Valve Prosthetic

Client: Dr. Jose L. Navia

Services Provided: Initial design and quick & dirty prototyping of suture-less transcatheter mitral stent / Stent performance test / Stent / Valve deliver system design and prototyping / Pericardium tissue treatment / Stent reposition device design and prototyping / Stent radial strength testing device design and fabrication / Stent/Valve fabrication / Stent/Valve hydrodynamic performance evaluation / Animal studies / IP application

This project was directed by Dr. Navia with Product Development Funds provided by the GCIC. MDS worked closely with physicians, the animal study team, and with external companies. This is one of the many projects in which the Polymer Core has held a key role. The project objective is to design a valve stent that can be delivered via a catheter system into the mitral valve annulus rather than having open heart surgery. The valve stent is place over the diseased native valve.
There are no catheter-based mitral valve replacement devices on the market. We are not aware of any human studies using catheter-based mitral valves. Currently, mitral valve replacement is available only as a surgical procedure. However, a significant percentage of heart failure patients are not candidates for open heart surgery because of the progression of disease but many of them could be candidates for less-invasive, catheter based replacement. To-date, all catheter based valve products have been for the aortic valve.
During the brainstorming session, the Polymer Core devised a “Wing-Open” concept, and made a quick & dirty prototype to further demonstrate the idea. The key feature of the design is that there are struts opening and protruding into the valve annulus simultaneously and automatically while the stent opens, so that it attaches securely to the valve annulus without suturing. The MDS Engineering Core designed the engineering drawings, followed by FEA analysis done by the CoBi Core. After the design was optimized, the prototype was made by laser cutting. Stent performance was evaluated in the Polymer Core. The feedback was discussed in the group meeting, and modification was made accordingly. Meanwhile, the physiological information was collected by surgeons and physicians. The stent delivery system, such as a balloon catheter, was design and fabricated in the Polymer Core. After the stent/valve was fabricated, its hydrodynamic performance was evaluated on the home-made pulsatile mock loop in the Polymer Core. Then, its physiological performance was evaluated using animal model. The studies indicated that the surgeon was able to easily and quickly deploy the stent in the annulus of each sheep. Once implanted, the valve stents showed no mitral regurgitation and no perivalvular leak. The valve stent attached securely and show no migration. All of the IP generated during the process was compiled and Cleveland Clinic Innovations filed a patent application. A spin-off company, Navigate, was established to further develop this state-of-the-art technology.
In short, this project is an excellent example that shows how three of the MDS Cores collaborated and worked together as a single integrated unit to complete the project.