Inflatable Introducer Sheath for Lower Push Force Delivery
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Solution Overview
Problem
Existing introducer sheaths require high push forces for advancing delivery devices due to resistance during vessel dilation, leading to potential damage and increased procedural time.
Innovation Solution
An inflatable sheath with a fluid chamber that expands from an unexpanded to an expanded configuration, allowing for reduced push forces and controlled expansion, minimizing vessel trauma and procedural time.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If an expandable introducer sheath formed of highly elastomeric materials is used to dilate the vessel, then the vessel can be dilated by the passing prosthetic device, but portions of the sheath resist expansion requiring higher push forces for advancement of the delivery device and implant to the treatment location
Solution Approach 1:
The sheath is divided into multiple segments with different expansion characteristics. The distal portion is configured to expand to a first diameter while the proximal portion maintains a smaller second diameter, allowing selective dilation of only the treatment site rather than the entire vessel path. This segmentation reduces the push force required while still achieving vessel dilation where needed.
Solution Approach 2:
Different portions of the sheath are given different mechanical properties. The distal portion is made more elastomeric and expandable to accommodate the prosthetic device at the treatment location, while the proximal portion remains less expandable to reduce friction and push force requirements during advancement through the vessel.
2Strength
If a sheath with constant stiffness along its length is used, then the sheath provides consistent support, but the strain relief portion cannot be diluted or expanded without risking damage to the sheath or prosthetic device
Solution Approach 1:
The sheath is segmented into a proximal portion with constant stiffness for structural support and a distal portion with variable stiffness that can expand. This allows the sheath to maintain overall strength while enabling localized expansion at the treatment site without damaging the sheath or prosthetic device.
Solution Approach 2:
The sheath transitions from a uniform structure to one with locally differentiated properties. The distal portion is designed with different material composition or structural characteristics that allow it to expand while the proximal portion maintains constant stiffness, enabling both strength and adaptability in the same sheath structure.
3Object-affected harmful factors
If multiple different sizes of sheaths are used during the procedure, then the vessel can be dilated to the required size, but the procedural time increases and the risk of longitudinal or radial vessel tear or plaque dislodgement increases
Solution Approach 1:
A single sheath design performs multiple functions that previously required multiple different sheaths. The sheath can maintain a compressed state for insertion, then expand to the required diameter at the treatment site, eliminating the need to exchange sheaths during the procedure and reducing both time and vessel trauma risk.
Solution Approach 2:
The sheath transitions from a static, fixed-diameter structure to a dynamic structure that can change diameter. This allows the sheath to be inserted in a low-profile state and then expanded in-situ to the required size, avoiding the need for multiple sheath exchanges and reducing procedural time and vessel trauma.
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 inflatable sheath reduces the required push force, minimizes vessel trauma, and shortens procedure time by allowing for controlled expansion and contraction, while maintaining a snug fit during device delivery.
Implementation Method 1
a fluid chamber that when inflated expands the sheath from an unexpanded configuration in which the central lumen has a first diameter to an expanded configuration in which the central lumen has a second, larger, diameter
Data Source
AI summary
Various implementations include an inflatable sheath for delivering a medical device, the sheath includes a fluid chamber that when inflated expands the sheath from an unexpanded configuration in which the central lumen has a first diameter to an expanded configuration in which the central lumen has a second, larger, diameter.