Engineers in the Polymer Core work closely with physicians, surgeons, and researchers throughout Cleveland Clinic to provide extensive services on medical device design, prototype and evaluation. We help our inventors to “prove the concept” of their novel inventions, which will ultimately benefit our patients. We also help research groups at Lerner Research Institute to fabricate or repair research instruments, which are not commercially available, such as cell culture fixture, test instruments, etc.
The Polymer Core covers all areas of medical device development starting with the initial brainstorming session, device design, prototyping, and device testing including in vitro and in vivo. Our lab has been intimately involved in the fabrication of the artificial heart and the ventricle assist device at Cleveland Clinic for the past 25 years. We also work on a wide variety of balloon, valve, catheter, cannula, stent and prosthetic-related devices.
We have participated in projects to improve surface biocompatibility as diverse as components for artificial heart programs.
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 / Research model development / IP application
This project was directed by Dr. Navia with Product Development Funds provided by the Global Cardiovascular Innovation Center. Medical Device Solutions worked closely with physicians, the research subject 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.
The Polymer Core devised a “wing-open” concept and created a prototype to demonstrate the idea. The key feature of the design 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 Medical Device Solutions 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 research model. The studies indicated that the surgeon was able to easily and quickly deploy the stent in the annulus of each study subject. 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.
This project is an excellent example that shows how three Medical Device Solutions cores collaborated and worked together as a single integrated unit to complete the project.