Tapered Sleeve for Stent Deployment Control
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Solution Overview
Problem
The endoluminal delivery and deployment of expandable medical devices, such as stents and stent-grafts, face challenges in transitioning from a collapsed configuration to a fully expanded configuration within the body, requiring improved methods for constraining and releasing these devices to achieve effective therapeutic outcomes.
Innovation Solution
The use of conical frustum-shaped sleeves that constrain expandable devices in an intermediate configuration, allowing for staged deployment through eversion and retraction, enabling the device to expand from a collapsed to a fully expanded state by releasing the sleeve in stages, facilitating precise expansion and deployment within the body.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Length of moving object
If an expandable device is constrained by a sleeve for delivery, then the device can be transported to the treatment site in a collapsed configuration, but the deployment process becomes complex and requires removal or eversion of the sleeve
Solution Approach 1:
The expandable device is nested within a delivery catheter, which itself contains a deployment balloon. This nested structure allows the device to be delivered in a compact collapsed state while enabling controlled expansion at the treatment site through balloon inflation, simplifying the overall deployment process compared to traditional sleeve removal methods
Solution Approach 2:
The expandable device is pre-mounted onto the delivery catheter in a collapsed configuration before reaching the treatment site. This preliminary preparation allows for streamlined delivery and enables the operator to simply inflate the balloon to deploy the device, reducing procedural complexity
2Speed
If the expandable device is allowed to expand freely, then the device achieves its functional configuration quickly, but control over the expansion process is lost
Solution Approach 1:
The deployment balloon provides dynamic control over the expansion process. By controlling balloon inflation pressure and timing, the operator can regulate the expansion speed and progression of the stent from collapsed to fully expanded state, achieving both rapid deployment and precise control
Solution Approach 2:
The system provides visual feedback through fluoroscopic imaging that allows the operator to monitor the expansion process in real-time. This feedback enables adjustment of inflation parameters to achieve the desired expansion speed and ensure proper device deployment
3Stability of the object's composition
If a traditional sleeve is used to constrain the expandable device, then the device maintains its collapsed configuration during delivery, but the sleeve must be removed or evverted which complicates the procedure
Solution Approach 1:
The traditional sleeve constraint is replaced by a balloon-expandable mechanism. The balloon is inflated to expand the stent and then deflated and removed, extracting the constraint element after use rather than requiring it to be everted or left in place, thereby simplifying the deployment procedure
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 enhances the deployment process by allowing controlled expansion of expandable devices, ensuring a precise fit within anatomical lumens and improving the therapeutic effectiveness of devices like stents and stent-grafts by maintaining structural integrity and biocompatibility throughout the deployment process.
Implementation Method 1
Expandable devices can have a reduced diameter when in a collapsed configuration, and can be designed to spontaneously dilate (i.e., elastically recover)
Implementation Method 2
or be balloon-expanded, from their collapse configuration, through one or more intermediate configurations, up to a maximum functional configuration
Data Source
AI summary
The present disclosure describes methods of making a sleeve comprising a conical frustum having first and second end profiles and a lumen there through for covering and constraining an expandable device, and apparatuses, systems, and assemblies comprising an expandable device and a sleeve having a frustoconical shape when the expandable device is at least partially expanded. The present disclosure further describes methods for deploying an expandable device in a patient comprising releasing a releasable seam disposed on a sleeve and everting the sleeve while retracting it from the expandable device.