3D Printed Catheter with Embedded Internal Structures
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Solution Overview
Problem
Existing manufacturing processes for medical catheters and leads face challenges in balancing flexibility and stiffness, as well as incorporating complex internal structures and non-circular lumens, which complicates design and production, especially when navigating tortuous body paths.
Innovation Solution
Additive manufacturing techniques allow for the customization of medical devices by printing multiple layers with internal components and non-circular lumen shapes, using a combination of elongate substrates and spacers to define the lumen shape, and varying filament materials to achieve desired mechanical properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional extrusion manufacturing is used for catheters, then manufacturing process is simple, but design flexibility and ability to incorporate complex internal structures is limited
Solution Approach 1:
The catheter is divided into multiple segments or layers that are manufactured separately and then assembled. This allows each segment to be optimized independently for specific functions (flexibility, stiffness, internal structures) while maintaining overall device performance, resolving the contradiction between design flexibility and manufacturing complexity.
Solution Approach 2:
Complex internal structures such as lumens, grooves, and channels are embedded within the catheter wall during the manufacturing process. Multiple functional elements are nested within each other (e.g., internal grooves containing pull wires, lumens within the catheter body), enabling complex functionality without proportionally increasing manufacturing complexity.
2Strength
If catheter stiffness is increased to push through vasculature, then pushability improves, but flexibility to navigate tortuous paths deteriorates
Solution Approach 1:
Different sections of the catheter are assigned different mechanical properties. The proximal section may be stiffer to provide pushability, while distal sections are made more flexible to navigate tortuous vasculature. This local differentiation allows the catheter to simultaneously exhibit both pushability and flexibility where needed.
Solution Approach 2:
The catheter incorporates composite material structures combining materials with different mechanical properties. For example, a stiff outer layer provides structural support and pushability, while an inner flexible layer or embedded flexible elements maintain the ability to bend and navigate curves, resolving the contradiction between pushability and flexibility.
3Adaptability or versatility
If non-circular lumen shapes are created using traditional manufacturing, then fluid flow characteristics improve, but manufacturing complexity and tooling requirements increase
Solution Approach 1:
Traditional mechanical molding or extrusion tooling for creating non-circular lumens is replaced with additive manufacturing techniques. The additive process allows complex non-circular cross-sections to be created directly from digital models without requiring complex physical molds or tooling, significantly reducing manufacturing complexity while maintaining lumen shape customization.
Solution Approach 2:
The manufacturing approach transitions from fixed geometric parameters defined by physical tooling to programmable digital parameters. This allows easy modification of lumen shape parameters (cross-sectional geometry, internal features) by changing digital models rather than replacing physical tooling, improving manufacturing ease while maintaining design versatility.
Data Source
AI summary
Systems and methods for manufacturing elongate medical devices including internal components embedded between multiple jacket layers. The system including a heating cartridge, a heating element, a filament handling system, a substrate handling system, and a controller to feed and melt each of the filaments for forming the multiple jacket layers. The system may include a single heating cartridge adapted to make multiple passes to form a first and second jacket or multiple heating cartridges that sequentially form a first and second jacket.