Introducer Sheath Pre-Formed Bends Embolic Coil Delivery
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Solution Overview
Problem
There is a need for alternative introducer sheaths and methods for manufacturing, packaging, and using introducer sheaths for embolic coil devices, as existing solutions have advantages and disadvantages that are not fully addressed.
Innovation Solution
The introduction of introducer sheaths with pre-formed bends and a flared proximal end, packaged with an embolic coil device, using a mandrel to shape and soften the sheath, and packaging in a dispenser coil to facilitate convenient storage and delivery.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Stability of the object's composition
If the introducer sheath is made with pre-formed bends, then the coil position is maintained stably during delivery, but the device complexity increases
Solution Approach 1:
The introducer sheath is pre-formed with bends during manufacturing to maintain the embolic coil in a compressed, positioned state during delivery. The bends are created beforehand using a mandrel or form, allowing the sheath to naturally hold the coil configuration without requiring additional active control mechanisms during the procedure.
2Ease of manufacture
If the proximal end of the sheath is flared, then the loading and deployment of the coil is facilitated, but the ease of operation is reduced
Solution Approach 1:
The flared proximal end is applied locally to the sheath structure, creating a widened opening only at the proximal end while maintaining a narrower distal end. This localized geometric modification facilitates coil insertion and deployment at the proximal end without affecting the overall flexibility or操控性 of the sheath body during navigation.
3Manufacturing precision
If the sheath is softened during manufacturing, then the bends can be formed accurately, but the manufacturing process complexity increases
Solution Approach 1:
The sheath material undergoes a temporary change in its physical parameters during manufacturing - specifically, it is softened by heating to a temperature where it becomes pliable enough to be formed into bends around a mandrel. After forming, the sheath is cooled to restore its original mechanical properties, creating the desired geometric configuration without requiring complex assembly steps.
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 solution provides a stable and efficient method for delivering embolic coils to aneurysms, ensuring the coil remains in a reduced profile during transport and deployment, with pre-formed bends maintaining coil position and a flared end facilitating easy loading and deployment.
Implementation Method 1
softening the introducer sheath
Data Source
AI summary
Introducer sheaths for use with embolic coil devices and methods for making and using the same. An example introducer sheath assembly may include an introducer sheath having a proximal end, a distal end, and a body portion defined therebetween. The body portion may include two or more bends formed therein. An embolic coil device may be disposed within the introducer sheath.