Stent Valve Delivery Catheter With Radiopaque Alignment Markers
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Solution Overview
Problem
Conventional cardiac valve replacement procedures require large incisions and cardiopulmonary bypass, and less invasive transcatheter approaches face challenges in ease of use and ensuring proper positioning and stability of replacement valves.
Innovation Solution
A catheter delivery system with radio-opaque indicators and intuitive handle design for precise stent alignment and deployment, featuring a stent holder with crimp connections and adjustable gear ratios for controlled stent release.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a delivery catheter is designed with a stent holder that provides secure retention, then stent stability is improved, but the device complexity increases due to additional retention mechanisms
Solution Approach 1:
The stent holder is designed with a nested structure where the stent is received within a holder body that includes an expansion cavity. The holder is itself contained within the delivery catheter, creating a nested arrangement that provides secure retention while maintaining a compact overall structure and avoiding excessive complexity.
Solution Approach 2:
The delivery catheter is divided into distinct functional segments: a proximal handle portion, a mid-section with the stent holder, and a distal tip. The stent holder itself is segmented with a proximal end, distal end, and expansion cavity. This segmentation allows each component to be optimized independently for its specific function while simplifying the overall design.
2Reliability
If the delivery catheter includes a sheath for covering the stent during delivery, then stent protection is improved, but the device complexity increases due to additional components
Solution Approach 1:
A sheath is provided as a flexible covering that can be advanced over the stent during delivery. The sheath is designed to be flexible enough to conform to the stent's shape while providing adequate protection. This thin-film approach provides effective protection without adding significant structural complexity to the device.
Solution Approach 2:
The sheath is nested within the delivery catheter structure, with the proximal end of the sheath received within the holder body. This nested arrangement allows the sheath to be integrated into the existing catheter architecture rather than adding a separate complex subsystem, thereby providing protection while minimizing increased device complexity.
3Object-affected harmful factors
If the delivery catheter is designed for percutaneous approach, then invasiveness is reduced, but positioning precision becomes more difficult to achieve
Solution Approach 1:
Radio-opaque markers are incorporated into the delivery catheter to replace complex mechanical positioning indicators. These markers enable visualization of the catheter's position and orientation in real-time during the percutaneous procedure, allowing precise positioning to be achieved through imaging guidance rather than complex mechanical measurement systems.
Solution Approach 2:
The delivery catheter includes feedback mechanisms through radio-opaque markers that provide real-time information about the catheter's position and orientation. This feedback allows the operator to adjust the catheter positioning accordingly, ensuring accurate placement of the stent valve while maintaining the reduced invasiveness of the percutaneous approach.
Data Source
AI summary
A delivery catheter for a stent. The delivery catheter may have a distal end and a proximal end. The distal end includes a stent attachment region adapted to receive a stent. The stent may be of the self-expanding type. The catheter further includes a handle at its proximal end and at least one sheath which may at least partially circumferentially cover the stent such as to retain it in a collapsed configuration. The sheath is coupled at its proximal end to an actuator located on the handle portion. The catheter further includes at least one radio-opaque indicator for indicating a rotational orientation of the delivery catheter and/or the stent when observed using medical imaging during implantation of the stent.