Researchers at UCI have developed a novel medical device for use in transcatheter heart valve replacement surgeries. The device provides physicians with more careful control of the catheter insertion, minimizing complications and adverse effects.
·For insertion of catheters in transcatheter heart valve replacement/insertion procedures.
· ·Accurate control: the invention’s gimbal handle provides more robust and fine-tuned control of positioning, orientating, and expanding and contracting the prosthetic valve.
· ·Safer alternative: the higher accuracy afforded by this device, in turn, reduces the chance of errors and makes the overall replacement surgery safer.
Every year, over 5 million Americans are diagnosed with heart valve disease. As a result, people affected by a heart valve disease may need to undergo a transcatheter valve implantation procedure. These procedures can usually be a minimally invasive surgery in which a catheter is wedged into a narrowed valve. Correct valve positioning is crucial for treatment success and optimal outcomes of such transcatheter valve implantation. Most of the current technologies are limited by instant deployment of the transcatheter valve, and once the valve is deployed, repositioning and/or percutaneous retrieval is not possible, or at least difficult or potentially problematic. And if the transcatheter valve is wrongfully positioned, this creates possibly dire complications for the patient.
The researchers at UCI have developed a novel valve insertion device that provides robust control and procedural accuracy in the delivery, deployment and implantation of transcatheter heart valves. The invention may enable repositioning and retrieval of the percutaneously implanted heart valves. A key aspect of the invention relates to a gimbal handle that may be used to remotely and precisely control the expansion/contraction, position, and orientation of an expandable transcatheter valve during a surgical procedure. The gimbal handle is connected to multiple draw lines that are releasably coupled to the circumference of a valve frame of the transcatheter valve via a multi-lumen catheter. The gimbal handle may be used to evenly release or retract all draw lines that pass through the multi-lumen catheter to expand or contract an expandable valve from a collapsed state to an expanded state. The gimbal handle may also be used to generate and control differential tension in the multiple draw lines to precisely tilt the transcatheter valve with regard to pitch and yaw movements or to laterally displace the transcatheter valve relative to the multi-lumen catheter, so that optimal placement of the transcatheter valve is readily achieved.
In vivo studies are currently underway.
|United States Of America||Published Application||2020-035271||11/12/2020||2019-202|
Additional Patent Pending