Valve Leaflet Fixation With Sensor-Based Grasp Assessment
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Solution Overview
Problem
Existing methods for treating cardiac valve regurgitation, particularly mitral and tricuspid valve regurgitation, face challenges in stabilizing and grasping valve leaflets effectively, especially via minimally invasive approaches, due to leaflet movement out of phase, poor imaging, and variable anatomy, leading to less desirable coaptation and potential slippage.
Innovation Solution
Devices and systems for stabilizing, grasping, and assessing valve leaflets using fixation devices with proximal and distal elements, equipped with sensors to ensure proper grasping and fixation, allowing for adjustment and assessment before and after fixation, and optionally incorporating magnetic or frictional elements for secure tissue engagement.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If minimally invasive approaches are used for valve repair, then patient trauma and recovery time are reduced, but the ability to stabilize and grasp valve leaflets effectively deteriorates
Solution Approach 1:
The fixation device is nested within a delivery catheter that provides a stable platform for deployment. The proximal and distal elements are contained within the catheter until ready for use, allowing minimally invasive access while maintaining structural integrity and operational control during the procedure
Solution Approach 2:
The delivery catheter acts as an intermediary between the operator and the fixation device, providing mechanical leverage and stability for deploying the distal and proximal elements. This mediator enables effective tissue engagement despite the constraints of minimally invasive access
2Reliability
If fixation devices are deployed to grasp valve leaflets, then coaptation is achieved, but device complexity increases
Solution Approach 1:
The fixation device is divided into separate functional components: distal elements for initial tissue engagement, proximal elements for securing the grasp, and a delivery mechanism. This segmentation allows each component to be optimized for its specific function while simplifying the overall deployment sequence
Solution Approach 2:
The distal and proximal elements are designed to be movable relative to each other, transitioning from a compressed delivery state to an expanded fixation state. This dynamic configuration enables the device to adapt to varying tissue geometries while maintaining a compact profile during minimally invasive delivery
3Measurement precision
If sensors are added to assess grasping quality, then measurement precision improves, but device complexity increases
Solution Approach 1:
Sensors are integrated into the fixation device to provide real-time feedback on tissue engagement quality. This feedback mechanism allows the operator to assess whether proper grasping has been achieved and make adjustments before final deployment, improving procedural success rates
Solution Approach 2:
The sensor assembly serves multiple functions: detecting tissue presence, measuring grasping force, and providing positional information. This multi-functionality reduces the need for separate assessment devices while maintaining comprehensive monitoring capability
Data Source
AI summary
Devices, systems and methods are provided for stabilizing and grasping tissues such as valve leaflets, assessing the grasp of these tissues, approximating and fixating the tissues, and assessing the fixation of the tissues to treat cardiac valve regurgitation, particularly mitral valve regurgitation.