Valve Leaflet Fixation With Sensor Feedback for Minimally Invasive Repair
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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 and variable anatomy, leading to poor imaging and unpredictable procedures.
Innovation Solution
Devices and systems for stabilizing, grasping, and fixating valve leaflets using fixation devices with proximal and distal elements, equipped with sensors for grasping assessment and fixation evaluation, allowing for atraumatic engagement and secure tissue approximation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If minimally invasive approaches are used for valve repair, then patient trauma is reduced, but grasping and stabilizing valve leaflets becomes more difficult
Solution Approach 1:
The patent employs a delivery catheter as an intermediary device that navigates through the patient's vasculature to reach the heart valve. The catheter delivers the fixation device to the target location, enabling minimally invasive access without requiring open chest surgery. The catheter acts as a mediator between the operator and the difficult-to-reach valve leaflets, providing a stable platform for deployment while maintaining patient safety.
Solution Approach 2:
The patent replaces traditional mechanical grasping systems with a delivery catheter-based deployment system. Instead of using complex mechanical arms or robotic manipulators to grasp valve leaflets, the invention uses a catheter-delivered fixation device that can be precisely positioned and deployed. This substitution simplifies the mechanical complexity while maintaining effective tissue engagement through the catheter pathway.
2Stability of the object's composition
If fixation devices are deployed to grasp valve leaflets, then tissue approximation is achieved, but accurate assessment of grasping quality becomes difficult
Solution Approach 1:
The patent incorporates sensors within the fixation device that provide real-time feedback on tissue engagement characteristics. These sensors detect parameters such as tissue impedance, force distribution, or positional information, which are transmitted to the operator to assess whether the valve leaflets are properly grasped and approximated. This feedback mechanism enables precise evaluation of grasping quality without requiring additional imaging or invasive measurement techniques.
3Measurement precision
If sensors are added to fixation devices for real-time assessment, then measurement precision is improved, but device complexity increases
Solution Approach 1:
The patent integrates multiple functions into the fixation device, including tissue grasping, stabilization, and sensing capabilities within a single unified structure. The fixation device serves as both the mechanical element for tissue approximation and the platform for sensor deployment. This multi-functionality reduces the need for separate dedicated sensing devices, thereby limiting the increase in overall system complexity while maintaining accurate measurement capabilities.
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.