Segmented Mandrel Catheter Construction for Uniform Wall Thickness
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Solution Overview
Problem
Conventional methods for constructing catheters with multiple layers often result in issues like sinkage, air bubbles, and wall thickness irregularities, and fail to accommodate large devices for deployment within the body, which can cause trauma and require high forces, compromising patient safety.
Innovation Solution
A method involving a mandrel with varying diameters for creating tubular devices with large proximal and distal ends, including a liner, reinforcement layer, and outer jacket, where the mandrel is removed to form a tubular body with distinct regions, allowing for a deployable device within the distal region and a handle for deployment.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Manufacturing precision
If conventional methods are used to construct catheters with multiple layers, then the catheter can be manufactured, but it results in sinkage, air bubbles, and wall thickness irregularities
Solution Approach 1:
The mandrel is divided into multiple segments (first mandrel segment, second mandrel segment, third mandrel segment) with different diameters, allowing each segment to be independently formed and then assembled. This segmentation enables precise control of wall thickness in different regions without the defects associated with conventional single-piece construction methods
Solution Approach 2:
Different regions of the catheter are given different local properties through the use of segments with varying diameters and the application of liner material at different stages. The first, second, and third segments allow for optimized wall thickness and structural properties in specific regions, eliminating the uniform construction limitations that cause manufacturing defects
2Adaptability or versatility
If the catheter lumen is enlarged to accommodate large devices for deployment, then large devices can be deployed, but it increases trauma to the patient and requires high forces
Solution Approach 1:
The catheter structure incorporates dynamic elements through its multi-segmented design, allowing the catheter to adapt its configuration during deployment. The segmented mandrel structure enables the catheter to flex and adjust to anatomical variations, reducing trauma while maintaining the capability to deploy large devices
Solution Approach 2:
The multi-segmented mandrel structure creates a nested configuration where smaller diameter segments are positioned within or adjacent to larger diameter segments. This nesting allows the catheter to maintain a compact profile for safe navigation through the body while providing enlarged lumens in specific regions for device deployment
3Adaptability or versatility
If a single large lumen is provided throughout the catheter, then large devices can be deployed, but it compromises patient safety due to increased trauma
Solution Approach 1:
The catheter provides different lumen sizes at different locations along its length. The first, second, and third mandrel segments create regions with varying internal diameters, allowing large devices to be accommodated in specific regions while maintaining smaller, safer dimensions in other regions for patient safety during navigation and deployment
4Strength
If multiple layers are added to achieve desired mechanical properties, then the catheter can perform complex functions, but it leads to manufacturing defects
Solution Approach 1:
The catheter construction process is segmented into multiple stages corresponding to the first, second, and third mandrel segments. Each segment is formed and assembled independently, allowing precise control of layer formation and thickness in each region without the cumulative defects that occur in conventional multi-layer construction
Solution Approach 2:
The liner material is applied in advance to the mandrel segments before final assembly. This preliminary application of the liner to each segment individually ensures proper adhesion and uniform thickness before the segments are combined, preventing manufacturing defects that would occur if layers were added after assembly
Data Source
AI summary
Apparatus and methods are provided for making catheters having relatively larger distal and proximal regions and/or including intermediate layers that minimize or eliminate gaps during manufacturing, and to catheters or other tubular devices made using such apparatus and methods.