Multi-Lumen Catheter Shaft Extrusion for Faster Wire Integration
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Solution Overview
Problem
The existing manufacturing process for catheters with multiple wires is inefficient due to the time-consuming gluing of small polymeric jackets along the main jacket, which affects the steerable properties and increases production time, especially for devices with more wires.
Innovation Solution
The method involves extruding or co-extruding a main lumen with integrally-formed or multi-lumen layers, where the side lumens are sized to accommodate elongate members like steering and electrical wires, and an outer layer is formed around these lumens, optionally with a braided layer, to create a bonded structure that eliminates the need for separate gluing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If small polymeric jackets are glued along the main jacket to enclose wires, then the wires are enclosed and the catheter structure is formed, but the manufacturing process becomes time-consuming and inefficient
Solution Approach 1:
The patent combines multiple separate polymeric jackets into a single integrated multi-lumen layer that is co-extruded with the main lumen. This merging eliminates the need for separate gluing operations, directly resolving the contradiction by maintaining wire enclosure functionality while dramatically improving manufacturing efficiency through a single continuous extrusion process
Solution Approach 2:
The multi-lumen layer serves multiple functions simultaneously: it encloses multiple wires, provides structural support, and integrates with the main lumen in a single component. This multi-functionality allows the structure to maintain reliability for wire enclosure while eliminating the need for separate assembly steps, thereby improving productivity
2Quantity of substance
If multiple small jackets are glued along the main jacket, then more wires can be enclosed, but the manufacturing process becomes even more time-consuming
Solution Approach 1:
The patent merges multiple small jackets into a single co-extruded multi-lumen layer containing multiple lumens. This allows multiple wires to be enclosed simultaneously in one extrusion process rather than requiring separate gluing operations for each jacket, directly reducing manufacturing time while increasing the number of wires that can be enclosed
Solution Approach 2:
The multi-lumen layer is segmented into multiple internal lumens, each capable of enclosing a wire. This segmentation within a single integrated structure allows multiple wires to be enclosed without requiring multiple separate assembly operations, thereby reducing manufacturing time while increasing wire capacity
3Reliability
If small jackets are glued along the main jacket, then the catheter structure is formed, but the steerable properties are compromised due to improper alignment
Solution Approach 1:
The patent merges the main lumen and side lumens into a single co-extruded structure where the relative positions are determined by the extrusion process itself. This ensures perfect alignment and spacing between lumens, maintaining structural reliability while enabling proper steerable properties since the side lumens can be precisely positioned relative to the main lumen without manual alignment
Solution Approach 2:
The patent changes the manufacturing parameter from manual gluing (which allows misalignment) to co-extrusion (which provides precise geometric control). This parameter change in the manufacturing process ensures that the side lumens are formed with exact spacing and orientation, maintaining both structural integrity and steerable functionality
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 approach reduces manufacturing time, enhances efficiency, and minimizes product defects by integrating the side lumens directly with the main lumen, allowing for more flexible and efficient production of catheters with multiple wires.
Implementation Method 1
extruding an inner polymeric layer, the inner polymeric layer defining a main lumen having an inner surface and an outer surface and further defining two or more side lumens spaced about the outer surface of the main lumen
Implementation Method 2
The inner polymeric layer, the braided layer and the outer polymeric layer may be heated to bond the inner polymeric layer, the braided layer and the outer polymeric layers together
Data Source
AI summary
A method of manufacturing a catheter shaft includes extruding an inner polymeric layer having a main lumen and two or more side lumens spaced about the main lumen; forming an outer polymeric layer about the inner polymeric layer; and inserting at least one elongate member, such as a wire, through each side lumen of the inner polymeric layer. The side lumens are less than about ⅕ the size of the main lumen. The method may further include the step of forming a braided layer between the inner polymeric layer and the outer polymeric layer. In an alternate embodiment, the method includes co-extruding an inner polymeric layer and a multi-lumen layer, the multi-lumen layer having two or more side lumens; forming an outer polymeric layer about the multi-lumen layer; and inserting at least one elongate member through each side lumen. Catheter assemblies made according to the described methods are also disclosed.