3D-Printed Catheter Jacket for Flexibility and Pushability
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Solution Overview
Problem
Existing manufacturing processes for medical catheters and leads face challenges in balancing flexibility and stiffness, particularly in navigating tortuous body paths, and are limited by conventional extrusion methods.
Innovation Solution
Additive manufacturing systems that allow for customization by printing a jacket over a subassembly, including components like electrode rings, with a flexible liner between the printed jacket and the lead, and using a heating cartridge with an inlet die and clamp to guide and secure substrates for precise manufacturing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional extrusion manufacturing is used, then manufacturing simplicity is maintained, but device complexity and customization capability are limited
Solution Approach 1:
The manufacturing process is segmented into distinct stages: substrate preparation, subassembly positioning, liner installation, and selective area printing. This segmentation allows each step to be independently optimized and controlled, enabling complex customizations without overwhelming process complexity
Solution Approach 2:
Components such as the substrate, subassembly, and liner are prepared and positioned in advance before the additive manufacturing process begins. This preliminary preparation enables the main printing process to focus only on adding material in specific areas, rather than manufacturing entire components from scratch
2Ease of operation
If the catheter is made sufficiently flexible to navigate tortuous paths, then navigability is improved, but structural stiffness and pushability deteriorate
Solution Approach 1:
The catheter structure incorporates different material properties in different regions: the liner provides flexibility in certain zones for navigation, while the printed jacket applied in specific areas provides localized stiffness and strength for pushability. This spatial variation of material properties resolves the contradiction between flexibility and stiffness
Solution Approach 2:
The catheter is constructed as a composite structure combining multiple materials with different properties: a flexible liner material and a stiffer printed jacket material. The composite construction allows the device to exhibit both flexible and stiff characteristics depending on the local material composition and layering
3Reliability
If internal components are encapsulated within the printed jacket, then component protection is improved, but manufacturing complexity increases
Solution Approach 1:
Internal components are positioned on the substrate and the liner is installed in advance of the jacket printing process. This preliminary arrangement of components eliminates the need for complex post-processing assembly steps and allows the printing process to simply encapsulate pre-positioned elements
Solution Approach 2:
The manufacturing process merges component positioning, liner installation, and jacket formation into a single integrated workflow. Components are positioned and encapsulated in one continuous process rather than through separate manufacturing and assembly steps, reducing overall manufacturing complexity
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
Enables the production of complex medical devices with enhanced flexibility and structural integrity, allowing for easier navigation through body pathways while maintaining component functionality.
Implementation Method 1
a heating cartridge extending from a proximal side to a distal side... a heating element thermally coupled to the heating cartridge to heat the interior volume
Implementation Method 2
activate the heating element to melt any portion of the first filament in the interior volume
Implementation Method 3
the heating cartridge defining an interior volume and a substrate channel extending through the interior volume
Data Source
AI summary
An additive manufacturing system for producing a medical catheter or lead and a method thereof. The system including a heating cartridge defining an interior volume and at least one filament port. The system also including a heating element thermally coupled to the heating cartridge to heat the interior volume, a filament handling system to feed at least one filament through the at least one filament port, and a substrate handling system. The substrate handling system including a clamp to secure a portion of a substrate to be moved relative to the heating cartridge to apply a jacket to the substrate. In one or more embodiments, a subassembly is positioned on the substrate and has an electrode ring. The jacket printed to cover at least a portion of the subassembly and spaced apart from the electrode ring.