Stent Preparation Arrangement Using Defined Medium Flow
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Solution Overview
Problem
Conventional methods for preparing and packaging stents for implantation often result in contamination, leading to complications such as inflammatory reactions and thrombosis, due to the presence of microparticles and other contaminants that are not adequately removed during the cleanroom process.
Innovation Solution
A method and arrangement that involves a processing unit with a cover and a flow unit to generate a defined medium flow around the stent, ensuring continuous cleanliness by flushing out contaminants and maintaining a sterile environment throughout handling, storage, and insertion, using a flexible casing that allows for compression and protection of the stent while preventing exposure to contaminating atmospheres.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If stent is compressed and handled in conventional cleanroom conditions, then manufacturing process is simple and cost-effective, but contamination by microparticles and other contaminants occurs leading to inflammatory reactions and thrombosis
Solution Approach 1:
The patent employs multiple nested protective layers: an inner protective cover that directly contacts the stent, an outer protective cover that encloses the inner cover, and a sealing element that creates a sealed chamber. This nested structure protects the stent from contamination while maintaining a manageable processing system.
Solution Approach 2:
The patent introduces a defined medium (such as sterile liquid or gas) as an intermediary between the stent and the external environment. This medium flushes contaminants away from the stent surface and maintains a controlled atmosphere within the sealed chamber, preventing contamination without requiring complex cleanroom infrastructure.
2Measurement precision
If visual inspection is performed manually after stent mounting, then particle detection is attempted, but particles between stent and catheter/balloon remain undetectable and contamination occurs
Solution Approach 1:
The patent performs contamination prevention actions before the contamination problem arises. The sealed chamber with defined medium is established prior to stent mounting and crimping operations, continuously flushing away particles that might otherwise accumulate in hard-to-reach areas. This eliminates the need for subsequent manual inspection and re-cleaning.
Solution Approach 2:
The patent extracts the inspection and cleaning functions from the manual process by implementing a continuous automated flushing system. The defined medium continuously removes particles from all surfaces, including those between the stent and catheter/balloon, making manual inspection unnecessary.
3Ease of manufacture
If cooling is applied to stent for compression, then stent becomes easier to compress, but water vapor and other gaseous substances condense and freeze on stent surface hindering compression and damaging surface
Solution Approach 1:
The patent creates an inert or controlled atmosphere within the sealed chamber using a defined medium. This medium prevents water vapor and other gaseous substances from condensing and freezing on the cooled stent surface, while still allowing the stent to be compressed effectively. The defined medium may be heated or circulated to prevent condensation.
4Strength
If protective layer is inserted between stent and crimping device, then stent surface is protected during compression, but protective layer must be removed and stent exposed to atmosphere again causing recontamination
Solution Approach 1:
The patent maintains continuous protection of the stent surface throughout the entire processing sequence. The sealed chamber with defined medium provides uninterrupted protection during cooling, compression, and handling operations, eliminating the need to remove any protective layer and preventing recontamination.
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 approach significantly reduces restenosis and maintains a high degree of cleanliness on the stent surface, preventing germ cell deposition and irregular growth, thereby improving the ingrowth behavior and reducing complications post-implantation.
Implementation Method 1
a flow unit (5) for generating a flow of a defined medium through the sheath (2)... a flow of a defined medium is passed through the sheath (2)... the flow surrounds the implant within the sheath
Implementation Method 2
ensuring continuous cleanliness by flushing out contaminants... The flow surrounds the implant within the sheath from all sides
Data Source
Figure 1a~1b
Figure 1c~1d
Figure 2a~2c
AI summary
In a method and an arrangement for preparing an implant for implantation in a lumen in a body, at least one processing unit (1) for processing the implant (7; 103), a cover (2) that has a front opening (3) and a rear opening (4) which is arranged at least in part on or in the processing unit (1), and at least one flow unit (5) are used. The implant (7; 103) can be stored inside the cover (2), between the openings (3, 4) therein. The flow unit (5) is used to generate a flow (P) of a defined medium through the cover (2) and is connected to at least one opening (3; 4) in the cover (2), the flow (P) flowing around the implant (7; 103) within the cover (2).