Helical Coil Polymeric Stent for Stricture Drainage Patency
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Solution Overview
Problem
Existing implantable stents face challenges in providing effective drainage pathways and maintaining patency in body lumens, particularly in the presence of strictures, with limitations in design and manufacturing methods.
Innovation Solution
A polymeric stent with a polymeric tubular body featuring tightly arranged helical coil windings and optional shape memory properties, along with anti-migration features and drainage ports, adapts to form primary and secondary drainage pathways upon deployment, enhancing patency and drainage efficiency.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional stent designs are used, then the device structure is simple and easy to manufacture, but the drainage pathway is insufficient and patency is compromised in the presence of strictures
Solution Approach 1:
The stent is segmented into multiple functional regions including a proximal flared section, a distal flared section, and an intermediate section with helical coils. Each segment serves a specific function: the flared sections provide anchoring and radial expansion, while the helical coils create the primary drainage pathway. This segmentation allows the complex drainage function to be achieved through modular structural elements that can be manufactured using standard techniques.
Solution Approach 2:
The invention transitions from a traditional two-dimensional planar stent structure to a three-dimensional helical coil configuration. The helical coils wind around the stent body to form a tubular primary drainage pathway, adding a dimensional element that creates volume and internal space for fluid flow. This dimensional change enables the stent to provide both structural support and an enlarged drainage pathway simultaneously.
2Productivity
If the stent is designed with tightly arranged helical coil windings to create a primary drainage pathway, then drainage efficiency is improved, but the manufacturing process becomes more difficult
Solution Approach 1:
The stent utilizes changes in physical parameters of the polymeric material, particularly its shape memory properties and phase transition characteristics. The material is processed in a temporary configuration (compressed or flat state) that is easy to manufacture and deliver, then undergoes a parameter change (phase transition or shape recovery) upon deployment to form the complex helical coil structure with optimized drainage pathways. This allows complex geometry to be achieved through material property changes rather than complex manufacturing processes.
3Reliability
If the stent expands to create larger primary drainage pathways, then stricture impact is reduced, but the delivery and deployment process becomes more complex
Solution Approach 1:
The stent is designed with dynamic shape transformation capabilities, transitioning from a compressed delivery configuration to an expanded deployed configuration. The polymeric material's elastic recovery and shape memory properties enable this dynamic transformation. During delivery, the stent is constrained in a compact form; upon release, it dynamically expands to its final shape with large primary drainage pathways, automatically adapting to the body lumen and stricture without requiring complex delivery mechanisms.
Solution Approach 2:
The stent is pre-formed in its final functional configuration (with helical coils and drainage pathways) during manufacturing, but temporarily constrained in a compressed state for delivery. The preliminary action of forming the complex geometry is performed during manufacturing when the material is pliable, then the structure is maintained in a constrained state until deployment. This allows the complex drainage structure to be ready beforehand without requiring complex delivery systems to create it during implantation.
4Stability of the object's composition
If anti-migration features are added to maintain stent position, then stent stability is improved, but the device complexity increases
Solution Approach 1:
The anti-migration features (flared sections) are merged with the primary structural components of the stent rather than being added as separate elements. The flared sections are integrated into the stent body at the proximal and distal ends, combining the anchoring function with the structural support function. This merging approach provides stable positioning without significantly increasing overall device complexity, as the same polymeric material and basic structural principles are used throughout.
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 stent effectively expands to create larger primary drainage pathways, reduces stricture impact, and maintains position with anti-migration features, ensuring improved drainage and patency in body lumens.
Implementation Method 1
a shape memory polymeric tubular body having a delivery configuration when constrained by a delivery device and a deployed configuration when not constrained by a delivery device. When in the deployed configuration, the shape memory polymeric tubular body forms a plurality of tightly arranged helical coil windings that together define a drainage pathway
Data Source
AI summary
A polymeric stent is adapted for placement within a body cavity to provide a primary drainage passageway and a secondary drainage passageway for the body cavity. The polymeric stent includes a polymeric tubular body including a first end region, a second end region and an intervening intermediate region. The polymeric tubular body has a remembered configuration in which the intervening intermediate region of the polymeric tubular body forms a plurality of tightly arranged helical coil windings that define the primary drainage passageway and a delivery configuration different from the remembered configuration when constrained by a delivery device.