Medical Device Sheath Coating for Controlled Braid Penetration
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Solution Overview
Problem
Conventional sheath manufacturing methods for medical devices result in inconsistent stiffness and variability due to irregular penetration of coatings into braided tubes, leading to undesired variations in device properties.
Innovation Solution
A multi-layered sheath structure with a first layer more susceptible to melting and a second layer less susceptible to melting, where the first layer penetrates into the braided sheath while the second layer controls the penetration depth, ensuring consistent stiffness by applying heat to the tube.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If heat is applied to the tube to enable coating penetration into the braided sheath, then the coating penetration is improved, but the penetration depth becomes inconsistent and variable
Solution Approach 1:
The coating is divided into two distinct layers: a first layer with high penetration capability that penetrates into the braided sheath, and a second layer with low penetration capability that remains on the outer surface. This segmentation allows each layer to perform its specific function independently, ensuring consistent penetration depth and uniform device properties.
Solution Approach 2:
Different regions of the coating have different properties: the first layer is designed to be more susceptible to melting and penetration, while the second layer is designed to be less susceptible and remain on the surface. This local differentiation ensures that the penetration process is controlled and consistent, with each layer contributing to the overall device performance.
2Ease of manufacture
If a single-layer coating is used, then the manufacturing process is simpler, but the stiffness and flexibility consistency varies
Solution Approach 1:
The coating is segmented into two layers with distinct functions. The first layer provides penetration into the braided sheath for flexibility, while the second layer remains on the surface for stiffness control. This segmentation enables consistent device properties while maintaining a relatively simple manufacturing process using co-extrusion technology.
Solution Approach 2:
The coating uses a composite structure with two different polymer materials having different melting points and penetration characteristics. This composite approach allows the coating to provide both penetration capability and surface integrity, ensuring consistent stiffness and flexibility across devices.
3Ease of operation
If the first layer penetrates deeply into the sheath, then the flexibility is improved, but the stiffness becomes inconsistent
Solution Approach 1:
The coating is divided into two layers where the first layer penetrates into the braided sheath to provide flexibility, while the second layer remains on the outer surface to maintain stiffness. This segmentation ensures that flexibility and stiffness are independently controlled, resulting in consistent device performance.
Solution Approach 2:
The first layer is designed with local quality for penetration and flexibility, while the second layer is designed with local quality for surface integrity and stiffness. This local differentiation ensures that the device achieves the desired flexibility without compromising stiffness consistency.
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 method achieves consistent stiffness and flexibility across medical devices by precisely controlling the penetration of the first layer into the braided sheath, reducing variability and enhancing manufacturing consistency.
Implementation Method 1
applying heat to the tube or sheath such that the first layer penetrates into the sheath. The first layer may be more susceptible to melting than the second layer
Implementation Method 2
The second layer may be formed from a material configured to shrink when exposed to a predetermined temperature. As heat is applied to the tube, the second layer may contact the sheath and inhibit the first layer from flowing deeper into the sheath
Implementation Method 3
applying heat to the tube or sheath such that the first layer penetrates into the sheath
Implementation Method 4
The first layer may be chemically bonded to the second layer. The tube may include an adhesives layer between the first layer and the second layer
Data Source
AI summary
Sheaths for medical devices and related methods are described. A method of manufacturing a medical device may include providing a sheath. The method may further include providing a tube. The tube may include an inner first layer and an outer second layer. The first layer may be more susceptible to melting than the second layer. The method may include positioning the tube around the sheath such that the first layer is closer to the sheath than the second layer is. The method may further include applying heat to the tube or the sheath such that the first layer penetrates the sheath.