Catheter Jacket Printing Around Electrode Subassemblies
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Solution Overview
Problem
Existing manufacturing processes for medical devices like catheters and leads face challenges in balancing flexibility and stiffness, particularly when navigating tortuous paths in the human body, and conventional methods limit design customization and manufacturing options.
Innovation Solution
Additive manufacturing systems that allow for the customization of medical devices by printing a jacket over a subassembly, which may include components like electrode rings, and using a substrate or mandrel with a liner to maintain flexibility, along with components like inlet dies and clamps to guide and hold substrates in position during printing.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Adaptability or versatility
If conventional extrusion manufacturing is used for catheters, then manufacturing simplicity is maintained, but design customization and manufacturing options are limited
Solution Approach 1:
The catheter is divided into multiple segments or layers that can be manufactured separately and then assembled. This allows each segment to be optimized independently for specific functions (flexibility, stiffness, radiopacity) while maintaining overall manufacturing efficiency through modular production processes
Solution Approach 2:
Multiple functional layers and components are nested within each other during the manufacturing process, with inner layers containing specific functional elements (such as radiopaque markers, flexible segments, or stiffening elements) that are encapsulated by outer layers, enabling complex functionality within a unified structure
2Strength
If catheter stiffness is increased to enable pushing through vasculature, then pushability is improved, but flexibility to navigate tortuous paths deteriorates
Solution Approach 1:
Different sections of the catheter are assigned different mechanical properties: proximal sections may be stiffer to provide pushability during advancement, while distal sections are made more flexible to navigate tortuous vasculature. Material composition, wall thickness, and structural features are locally optimized for specific functional requirements along the catheter length
Solution Approach 2:
The catheter incorporates composite construction with multiple materials having different mechanical properties. This may include combinations of flexible polymers, stiffening elements, radiopaque materials, and lubricious coatings in specific configurations to achieve both pushability and flexibility simultaneously within different regions of the device
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 customization, allowing for easier integration of internal components and improved manufacturing processes without increasing complexity.
Implementation Method 1
a heating element thermally coupled to the heating cartridge to heat the interior volume
Implementation Method 2
moving the heating cartridge relative to the substrate at least in a longitudinal direction to form a printed jacket around the substrate
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.