Electrospun Biodegradable Sheath for Intraluminal Endoprosthesis Sealing
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Solution Overview
Problem
Current vascular implants with permanent polymer sheaths slow endothelialization, increase thrombosis risk, and hinder normal vascular peristalsis due to their slow and incomplete sealing properties, posing serious complications in treating vessel perforations or ruptures.
Innovation Solution
A method for producing an intraluminal endoprosthesis with a biodegradable sheath formed from polymer fibers using electrospinning, incorporating biodegradable poly-L-lactide and 1,3-dioxan-2-one, which seals vascular injuries and supports tissue healing without long-term presence.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a permanent polymer sheath is used to seal vascular perforations, then immediate haemostasis is achieved, but endothelialization is slow and incomplete, increasing thrombosis risk
Solution Approach 1:
The patent changes the material parameter from permanent polymer to biodegradable polymer (poly-L-lactide), which fundamentally alters the interaction with vascular tissue. The biodegradable nature allows the sheath to maintain sealing function initially while progressively degrading to allow complete endothelialization, thereby reducing thrombosis risk without compromising immediate sealing effectiveness
Solution Approach 2:
The patent employs a biodegradable polymer sheath that is designed to be temporary rather than permanent. The sheath provides immediate sealing function and then degrades over time to allow complete vascular healing, eliminating the long-term thrombosis risk associated with permanent polymer sheaths. This approach treats the sheath as a temporary protective barrier rather than a permanent implant
2Reliability
If a permanent polymer sheath is used for sealing, then vascular perforation is sealed effectively, but normal vascular peristalsis is prevented
Solution Approach 1:
The patent changes the mechanical properties parameter by using biodegradable polymer instead of permanent polymer. The sheath maintains sufficient sealing strength during the critical healing period but gradually loses mechanical integrity over time, allowing normal vascular peristalsis to resume without compromising the initial sealing effectiveness
Solution Approach 2:
The patent introduces temporal dynamics to the sheath properties through biodegradation. The sheath transitions from a rigid, peristalsis-restricting permanent structure to a progressively softer, more compliant biodegradable material that maintains sealing function initially but allows natural vascular motion to resume as it degrades, eliminating the static restriction of permanent polymer sheaths
3Duration of action of stationary object
If a permanent polymer sheath is used, then sealing function is maintained indefinitely, but the sheath no longer performs any function after 2-3 days
Solution Approach 1:
The patent embraces the temporary nature of the sheath by using biodegradable polymer that is designed to degrade after serving its protective function. This eliminates the functional redundancy problem of permanent sheaths that continue to exist after healing is complete, allowing the sheath to naturally disappear after providing the necessary 2-3 day sealing function
Solution Approach 2:
The patent allows the sheath to be discarded through controlled biodegradation after it has served its protective function. The biodegradable polymer naturally breaks down and is absorbed by the body after 2-3 days, eliminating the need for permanent sheath removal and avoiding the functional redundancy associated with permanent implants that outlive their necessary function
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 biodegradable sheath provides effective sealing for at least 48 hours, enhances endothelialization, reduces thrombosis risk, and allows normal vascular function by degrading when no longer needed, thus minimizing long-term complications.
Implementation Method 1
forming the sheath (3) from polymer fibres (30) on the support structure (2), wherein a polymer solution (10) is dispensed from a nozzle (101) by means of electrospinning
Data Source
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AI summary
The invention relates to a method for producing an intraluminal endoprosthesis (1), in particular in the form of a stent, wherein the endoprosthesis (1) comprises a support structure (10) and a sheath (3) arranged on the support structure (2), and wherein the method comprises the steps of: providing the support structure (2), and forming the sheath (3) from polymer fibres on the support structure, wherein a polymer solution is dispensed from a nozzle by means of electrospinning, and wherein the polymer solution (10) comprises at least one biodegradable polymer.