Endovascular Valve Leaflet Fixation via Catheter Gripper
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Solution Overview
Problem
Current methods for treating mitral valve regurgitation often require open heart surgery, which is traumatic and has high mortality and morbidity, and minimally invasive procedures face challenges in visualizing and delivering fixation devices to the valve leaflets effectively.
Innovation Solution
The development of a system for endovascular or minimally invasive tissue approximation and repair, using a fixation device with gripper elements and a gripper pusher mechanism that allows for the coaptation of valve leaflets without open chest access, enabling easier delivery and repositioning of fixation devices for optimal placement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open heart surgery is used to repair mitral valve regurgitation, then effective valve repair can be achieved, but the procedure becomes traumatic with high mortality and morbidity
Solution Approach 1:
The patent replaces the mechanical open-heart surgical system with a catheter-based endovascular system. The fixation device is delivered through a catheter inserted into the heart's chambers, allowing valve repair without external incisions or sternotomy. This substitution eliminates the traumatic aspects of open surgery while maintaining repair effectiveness through percutaneous access and internal device deployment.
Solution Approach 2:
The patent introduces a catheter as an intermediary tool to deliver the fixation device to the target valve. The catheter serves as a conduit that navigates through the heart's vasculature to reach the mitral valve, enabling the fixation device to be positioned precisely at the valve leaflets without requiring direct external access to the heart muscle. This intermediary approach minimizes surgical trauma while ensuring accurate device placement.
2Object-affected harmful factors
If minimally invasive catheter-based procedures are used, then surgical trauma is reduced, but visualization and delivery of fixation devices becomes challenging
Solution Approach 1:
The patent incorporates radiopaque materials into the fixation device and catheter components, enabling these structures to be visualized under fluoroscopic imaging. The radiopaque elements appear as distinct contrasts on X-ray images, allowing real-time tracking of the catheter and fixation device positions during the minimally invasive procedure. This visual enhancement resolves the visualization challenge while maintaining the low-trauma benefits of catheter-based access.
3Object-affected harmful factors
If fixation devices are delivered via catheter, then open chest access is avoided, but device delivery and positioning becomes more complex
Solution Approach 1:
The patent employs a nested structure where the fixation device is contained within the catheter during delivery. The fixation device, with its movable arms and gripping elements, is collapsed or folded within the catheter lumen, allowing it to pass through narrow vascular pathways. Upon reaching the target valve, the fixation device is deployed by expanding or unfolding from its compact catheter-confined state. This nesting approach simplifies the delivery process by reducing the profile of the fixation device during transit while enabling complex positioning at the destination.
4Manufacturing precision
If traditional surgical techniques are used, then precise tissue approximation can be achieved, but the procedure requires open heart surgery with high mortality and morbidity
Solution Approach 1:
The patent replaces the external surgical manipulation system with an internal endovascular system. The fixation device, deployed from within the heart chambers, approximates valve leaflet tissue through internal gripping and coaptation mechanisms. This substitution maintains precise tissue approximation capability while dramatically improving patient safety by eliminating the need for open heart surgery, cardiopulmonary bypass, and associated surgical risks.
Data Source
AI summary
The invention provides devices, systems and methods for tissue approximation and repair at treatment sites. The devices, systems and methods of the invention will find use in a variety of therapeutic procedures, including endovascular, minimally-invasive, and open surgical procedures, and can be used in various anatomical regions, including the abdomen, thorax, cardiovascular system, heart, intestinal tract, stomach, urinary tract, bladder, lung, and other organs, vessels, and tissues. The invention is particularly useful in those procedures requiring minimally-invasive or endovascular access to remote tissue locations, where the instruments utilized must negotiate long, narrow, and tortuous pathways to the treatment site. In addition, many of the devices and systems of the invention are adapted to be reversible and removable from the patient at any point without interference with or trauma to internal tissues.