Delivery Catheter Deformable Tip for Edge-Free Resheathing
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Solution Overview
Problem
Minimally invasive delivery catheters face challenges in avoiding injury to vessel walls and natural aortic valves during the resheathing process of implants, particularly due to the formation of sharp edges at the distal catheter end, which can lead to complex reaction forces and increased stress during the recapture of partially released implants.
Innovation Solution
A delivery catheter design featuring an atraumatic distal catheter tip with a deformable region that expands radially upon axial compression, using a plunger to apply compressive force and create a temporary buffer zone, preventing edge formation and reducing the risk of injury by ensuring a larger diameter than the expanded implant capsule.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If the catheter tip is made from soft/atraumatic material to protect vessel walls, then protection of vessel inner wall and natural aortic valve is improved, but edge formation at the distal catheter end becomes more pronounced during resheathing
Solution Approach 1:
The catheter tip is designed with a deformable region that can dynamically change its shape during the resheathing process. When the outer shaft is moved relative to the inner shaft, the deformable region expands radially to maintain a smooth contour and prevent edge formation, while remaining fixed to the inner shaft in its initial state.
Solution Approach 2:
The catheter tip transitions from a fixed state to a deformable state through parameter changes. The deformable region changes its radial dimension in response to relative displacement between the inner and outer shafts, transforming the catheter tip's geometry to prevent edge exposure during resheathing operations.
2Adaptability or versatility
If the catheter components are heavily loaded to enable recapture of partially released implant, then recapture capability is improved, but edge formation and potential injury risk increase
Solution Approach 1:
The catheter tip's deformable region dynamically adapts its shape during the recapture process. As the outer shaft moves relative to the inner shaft during implant recapture, the deformable region expands to maintain a smooth outer contour, preventing edge formation even under the heavy loads associated with recapture operations.
3Stability of the object's composition
If the catheter tip is fixed to the inner shaft for structural stability, then structural stability is improved, but ability to prevent edge formation during resheathing is reduced
Solution Approach 1:
The catheter tip is segmented into a fixed region and a deformable region. The fixed region maintains structural stability by being attached to the inner shaft, while the deformable region can expand radially to prevent edge formation during resheathing, combining both requirements in a single integrated structure.
Solution Approach 2:
Different regions of the catheter tip have different properties: the fixed region provides structural stability through attachment to the inner shaft, while the deformable region provides edge prevention capability through radial expansion. This local differentiation of properties resolves the contradiction between stability and shape maintenance.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The solution effectively reduces the risk of injury to vessel walls and natural aortic valves by eliminating edge exposure and preventing detachment of deposits, simplifying the recapture process and reducing the likelihood of embolism during aortic valve implantation.
Implementation Method 1
A plunger is axially displaceable with respect to the catheter tip in response to movement of the outer shaft to apply axial compressive force to the catheter tip and deform the region that is deformable and expand that region radially.
Implementation Method 2
apply axial compressive force to the catheter tip and deform the region that is deformable and expand that region radially
Data Source
AI summary
A delivery catheter includes an inner shaft having an atraumatic distal catheter tip. The inner shaft is configured to carry the implant thereon. The catheter tip includes a region that is fixed to the inner shaft and a region that is deformable and not fixed to the inner shaft. An outer shaft surrounds the inner shaft and is displaceable relative thereto. An implant capsule at a distal end of the outer shaft is configured to encase the implant and to release the implant at the target site via relative displacement of the inner and outer shafts. A plunger is axially displaceable with respect to the catheter tip in response to movement of the outer shaft to apply axial compressive force to the catheter tip and deform the region that is deformable and expand that region radially.