Intravascular Device Delivery With Flexible Sheath Force Control
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Solution Overview
Problem
Intravascular medical procedures face challenges in precisely positioning and recapturing medical devices due to the need for stiff sheaths and high longitudinal forces, which can compromise delivery through tortuous anatomy and complicate repositioning.
Innovation Solution
An intravascular device delivery system with an elongated member comprising an outer sleeve, steerable catheters, and a disc handle, allowing for precise control of the distal end cap and delivery disc to manage sheath movement, along with a loading assembly using an ice/water bath to reduce loading forces and a clamping assembly for secure holding.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Force
If a stiff sheath is used to apply high longitudinal forces for device deployment, then the device can be deployed with sufficient force, but the delivery system cannot navigate through tortuous anatomy
Solution Approach 1:
The delivery system is divided into multiple functional segments: a flexible outer sheath for navigation, an inner delivery catheter for device containment, and a separate mechanism for applying longitudinal force. This segmentation allows each component to optimize its specific function without compromising the others.
Solution Approach 2:
The system transitions from a static stiff sheath to a dynamic configuration where the outer sheath remains flexible for navigation, while controlled longitudinal forces are applied through the disc handle mechanism to deploy the device when needed. The system adapts its stiffness characteristics based on operational requirements.
2Force
If a stiff sheath is used to deploy the device with high force, then the device deployment is effective, but the sheath complicates repositioning and recapture operations
Solution Approach 1:
The disc handle mechanism enables dynamic control of longitudinal forces, allowing the operator to apply force for deployment when needed and release it for recapture operations. This dynamic control makes the system adaptable to different procedural needs including repositioning and recapture.
Solution Approach 2:
The inner delivery catheter acts as an intermediary between the flexible outer sheath and the device. It allows precise control of device positioning and enables recapture by withdrawing the delivery catheter, independent of the outer sheath's stiffness characteristics.
3Force
If high longitudinal forces are applied to move the sheath relative to the device, then the device can be deployed, but the forces complicate precise positioning control
Solution Approach 1:
The system separates the force application function (disc handle) from the positioning control function (delivery catheter). This allows independent optimization: the delivery catheter provides precise positioning while the disc handle provides controlled force application when deployment is required.
Solution Approach 2:
The delivery catheter serves as an intermediary that provides fine positional control during navigation and positioning, while the outer sheath and disc handle mechanism provide force application only when deployment is needed, preventing force-related positioning errors.
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
Enables precise positioning and recapture of intravascular devices with reduced forces, facilitating delivery through complex vasculature and improving procedural control and safety.
Implementation Method 1
a loading assembly using an ice/water bath to reduce loading forces
Data Source
AI summary
An intravascular device delivery system includes an elongated member with a distal end cap and a delivery disc that are longitudinally movable using a disc handle. A main body of the disc handle is configured to move the distal end cap and a movable body of the disc handle is configured to move the delivery disc. The movable body is movable relative to the main body, and the main body and movable body are movable together.