Stent Shaping Balloon and Mandrel for Varying Diameter Profiles
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Solution Overview
Problem
Current stent crimping devices are limited in forming complex shapes, as they are primarily mechanized and designed for simple geometric forms like constant-diameter cylinders and cones, failing to accommodate stents with varying diameters along their length.
Innovation Solution
A pressure vessel and mandrel apparatus that uses a shaping balloon to compress stents onto a mandrel with a varying diameter profile, allowing for the formation of complex shapes by inflating and deflating the balloon to conform the stent to the desired shape, with optional heating and cooling capabilities for shape-memory materials.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If purely mechanized crimping devices are used, then basic geometric shapes can be formed, but complex shapes with varying diameters cannot be achieved
Solution Approach 1:
The patent employs a balloon-expandable stent mechanism where a balloon is inflated within the stent to expand it from a compressed delivery configuration to a deployed configuration. This pneumatic approach enables complex shape formation without requiring complex mechanized crimping devices, as the balloon expansion naturally conforms to the desired geometric profile defined during manufacturing.
2Ease of operation
If self-expanding resilient materials are used, then automatic expansion occurs, but precise control over complex shapes is limited
Solution Approach 1:
The patent utilizes shape memory materials that can be programmed to expand to specific geometries by changing temperature parameters. The stent is manufactured in a compressed configuration, then when deployed (either self-expanding or balloon-expanded), the material's shape memory properties enable it to transition to a pre-defined complex geometry with high precision, combining automation with shape accuracy.
3Manufacturing precision
If balloon expansion is used, then plastically deformable materials can be shaped, but the process requires precise pressure control
Solution Approach 1:
The patent uses a balloon as an intermediary element between the pressure control system and the stent. The balloon distributes pressure uniformly across the stent structure during expansion, enabling precise shape formation without requiring complex direct pressure control mechanisms. The balloon acts as a mediator that translates pressure control into controlled stent deformation.
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 the formation of stents with complex shapes, including varying diameters, facilitating the creation of stents for specific anatomical applications, such as prosthetic heart valves, with improved precision and versatility compared to existing devices.
Implementation Method 1
a shaping balloon defining a balloon interior chamber... When the plates are thus stacked, the lower plate opening, upper plate opening, and balloon central opening form a continuous mandrel-receiving lumen
Data Source
AI summary
An apparatus for crimping a radially expandable stent includes a pressure vessel, shaping balloon, and mandrel. The mandrel is configured to slidingly receive a stent thereon, and to be slidingly advanced into the pressure vessel. The shaping balloon is inflated to radially compress the stent onto the form of the mandrel; such compression need not be uniform. Pressurization of the shaping balloon facilitates the expansion of the balloon to achieve compression of the stent, with depressurization of the shaping balloon causing the balloon to return to an unexpanded state.