Micro-Cladded Stent Connectors for Selective Removal and Radiopacity
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Solution Overview
Problem
Current methods for manufacturing medical devices like stents using additive manufacturing are laborious, expensive, and time-consuming, particularly when creating shapes that require partial disconnection of components, and they lack efficient means to enhance radiopacity without additional processing steps.
Innovation Solution
A micro-cladding manufacturing process that forms stents with functionally graded materials, where first connectors remain and second connectors are made embrittle to be easily removable, and radiopaque materials are integrated to enhance visibility during imaging procedures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If additive manufacturing is used to build stents vertically with connectors between bands, then the stent structure can be formed, but the connectors must be built between most or all crowns to provide support for the following layer of material, which increases device complexity and requires additional removal steps
Solution Approach 1:
The patent applies local quality by making different connectors have different material properties. Specifically, connectors are made with varying amounts of radiopaque material (e.g., tungsten) incorporated into the base metal (e.g., cobalt-chromium). Some connectors contain higher concentrations of radiopaque material making them more brittle and suitable for removal, while others have lower concentrations and remain intact. This localized variation in material composition allows selective removal of specific connectors after the stent structure is formed, reducing device complexity without compromising the manufacturing process.
2Difficulty of detecting and measuring
If radiopaque material is welded to the stent after manufacturing, then radiopacity is increased for imaging visibility, but additional processing steps are required which increases manufacturing complexity and time
Solution Approach 1:
The patent merges the radiopacity enhancement function with the stent manufacturing process itself. Instead of welding radiopaque material separately after stent formation, the radiopaque material (such as tungsten powder) is incorporated directly into the base metal powder mixture before additive manufacturing. The micro-cladding process deposits layers of this composite powder, creating a functionally graded material where radiopaque material is distributed throughout the stent structure. This integration eliminates the need for separate welding operations, reducing manufacturing complexity and time while maintaining imaging visibility.
3Adaptability or versatility
If functionally graded materials with micro-cladding are used, then radiopacity and selective connector removal are achieved, but the manufacturing process becomes more complex
Solution Approach 1:
The patent utilizes parameter changes by systematically varying the concentration of radiopaque material in the powder mixture during the micro-cladding process. The composition parameters are changed layer by layer or region by region to create functionally graded connectors with different mechanical properties. By controlling the ratio of radiopaque material to base metal in each deposited layer, the patent achieves both radiopacity enhancement and selective brittleness for connector removal, all within a single integrated manufacturing process rather than requiring multiple separate operations.
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
This method enables efficient production of stents with improved radiopacity and reduced manufacturing complexity, allowing for easier removal of connectors without affecting the stent structure, while also enhancing imaging visibility during medical procedures.
Implementation Method 1
it is desirable for a significant portion of a perimeter of a first portion of the device to not be connected to a second portion of the device... when building such a stent vertically by additive manufacturing
Implementation Method 2
The plurality of second connectors are made by functionally grading the first material with a second material to create embrittlement in the plurality of second connectors
Data Source
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AI summary
A method of making a method of making a stent includes forming a precursor stent using micro-cladding. The precursor stent includes a plurality of bands made of a first material disposed adjacent to each other and a plurality of connectors connecting each band to an adjacent band. The precursor stent includes a plurality of first connectors configured to remain and a plurality of second connectors made by functionally grading the first material with a second material to create embrittlement. The plurality of second connectors are configured to be removed. The precursor stent is processed to remove the plurality of second connectors without adversely affecting the bands and the plurality of first connectors. The second material may be a radiopaque material.