Independent Proximal Element Actuation for Mitral Valve Clip Delivery
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Solution Overview
Problem
Existing minimally invasive and percutaneous techniques for treating mitral valve regurgitation face challenges in delivering and deploying fixation devices, such as clips, due to difficulties in visualization and require open chest access, leading to high mortality and morbidity. There is a need for improved methods and systems that allow for endovascular or minimally invasive repair of cardiac valves without open chest access, with easier delivery, repositioning, and optional removal of fixation devices.
Innovation Solution
A system for fixation of heart valve leaflets using a fixation device with proximal and distal elements that can be aligned in parallel or coaxially, featuring a sliding or rotating lock mechanism, echogenic markers for visualization, and a catheter with flow conduits for fluid flushing, allowing for atraumatic grasping, repositioning, and removal of the device.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If open chest access and cardiopulmonary bypass are used for mitral valve repair, then effective valve repair can be achieved, but patient trauma and mortality/morbidity increase significantly
Solution Approach 1:
The patent replaces the mechanical open-chest surgical system with a catheter-based endovascular system. The fixation device is delivered through a catheter inserted via peripheral vascular access, eliminating the need for sternotomy and cardiopulmonary bypass. The device uses a delivery catheter with proximal and distal elements that can be deployed within the heart through the vasculature, substituting traditional mechanical open-heart surgery with a minimally invasive endovascular approach.
Solution Approach 2:
The patent introduces a delivery catheter as an intermediary tool to deliver the fixation device to the target site. The catheter serves as a conduit that allows the fixation device to be transported through the vascular system to the mitral valve location without requiring direct surgical access to the heart. This intermediary approach enables minimally invasive delivery while maintaining the ability to perform effective valve repair.
2Reliability
If clips are used to fasten valve leaflets together, then regurgitation can be reduced, but delivery and deployment becomes challenging due to visualization difficulties
Solution Approach 1:
The patent incorporates radiopaque markers on the fixation device and echogenic markers that enhance visualization. The radiopaque markers allow the device to be seen clearly under fluoroscopic guidance during delivery and deployment, while echogenic markers provide enhanced visualization under echocardiographic guidance. This enables operators to track the device position and deployment in real-time, overcoming the visualization challenges associated with clip-based repairs.
Solution Approach 2:
The patent employs real-time imaging feedback through fluoroscopy and echocardiography to guide device delivery and deployment. The radiopaque and echogenic markers provide continuous visual feedback about device position, orientation, and engagement with the valve leaflets, allowing operators to make adjustments during the procedure to ensure proper placement and reduce regurgitation effectively.
3Reliability
If fixation devices are deployed to repair valves, then tissue approximation is achieved, but repositioning and removal becomes difficult
Solution Approach 1:
The patent designs the fixation device with dynamic, reversible engagement mechanisms. The proximal and distal elements can be deployed to approximate tissue, but the device allows for repositioning and optional removal through controlled manipulation of the delivery catheter and fixation elements. This dynamic design enables the device to transition between deployed and retrieved states, providing flexibility for repositioning if optimal placement is not initially achieved.
Solution Approach 2:
The patent allows the fixation device to be deployed in a preliminary, non-permanent manner before final fixation. The device can be positioned and tested for proper tissue approximation and regurgitation reduction, with the option to adjust or remove it before committing to permanent fixation. This preliminary action approach ensures optimal placement while maintaining the ability to correct suboptimal deployments.
Data Source
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AI summary
Fixation system for fixation of leaflets of a heart valve including an implantable fixation device having a first arm and a second arm, a first proximal element moveable relative to the first arm between a first position and a second position, and a second proximal element moveable relative to the second arm between a first position and a second position. The fixation system includes a delivery device having a catheter, a first proximal element line and a second proximal element line, and a handle having a first and second proximal element line handles coupled to the first proximal element line and the second proximal element line, respectively. The handle can include an interlock moveable between an unlocked position and a locked position.