Published Technical Disclosure Archive

Enhanced Systems and Methods for Manufacturing 3D Printed Medical Devices

Publication ID: 24-11857735_0001_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Systems and Methods for Manufacturing 3D Printed Medical Devices,” Published Technical Disclosure No. 24-11857735_0001_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857735_0001_PTD
This technical disclosure describes improvements that would be readily apparent to a Person Having Ordinary Skill In The Art (PHOSITA) when considered in combination with the foundational architecture disclosed in U.S. Patent No. 11,857,735.

Summary of the Inventive Concept

Improved systems and methods for additive manufacturing of medical devices, enabling production of customized devices with enhanced properties and quality control.

Background and Problem Solved

The original patent disclosed systems and methods for manufacturing 3D printed medical devices, but was limited by the inability to produce devices with customized flex modulus, color properties, and surface finish. The new inventive concept addresses these limitations by introducing multi-material extrusion, hybrid 3D printing, and real-time monitoring to enhance the manufacturing process.

Detailed Description of the Inventive Concept

The enhanced systems and methods for manufacturing 3D printed medical devices comprise a multi-material extrusion mechanism that enables concurrent deposition of varying stiffness filaments at adjustable blend ratios, allowing for the production of medical devices with customized flex modulus and color properties. Additionally, a hybrid 3D printing process combining Fused Deposition Modeling (FDM) and Stereolithography (SLA) techniques is employed to achieve enhanced surface finish and mechanical properties. Furthermore, a real-time monitoring module enables in-process quality control and adaptive adjustment of printing parameters to ensure consistent product quality. The resulting 3D printed medical devices exhibit improved biocompatibility, reduced thrombogenicity, and enhanced resistance to biofouling.

Novelty and Inventive Step

The new claims introduce novel and non-obvious features, including the multi-material extrusion mechanism, hybrid 3D printing process, and real-time monitoring module, which provide significant improvements over the original patent. These features enable the production of customized medical devices with enhanced properties, thereby overcoming the limitations of the original patent.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include the use of different 3D printing techniques, such as Selective Laser Sintering (SLS) or Binder Jetting, or the incorporation of additional materials with varying properties. Variations could also include the use of different monitoring modules or post-processing techniques to enhance the device's properties.

Potential Commercial Applications and Market

The enhanced systems and methods for manufacturing 3D printed medical devices have significant commercial potential in the medical device industry, particularly in the production of customized catheters, implantable stimulation leads, and other medical devices. The target market includes medical device manufacturers, hospitals, and research institutions.

CPC Classifications

SectionClassGroup
A A61 A61M25/0012
B B29 B29C64/118
B B29 B29C64/209
B B29 B29C64/295
B B29 B29C64/336
B B29 B29C64/393
B B33 B33Y10/00
B B33 B33Y30/00
B B33 B33Y40/00
B B33 B33Y50/02
B B33 B33Y80/00
A A61 A61N1/05
B B29 B29K2995/007
B B29 B29L2031/7542

Field of Art

Medical Device Manufacturing, Additive Manufacturing, and 3D Printing Technologies with focus on medical device fabrication techniques, particularly for catheters and implantable leads

Person of Ordinary Skill (PHOSITA) Profile

A skilled practitioner with expertise in biomedical engineering, materials science, and advanced manufacturing techniques, possessing knowledge of 3D printing methodologies, medical device design, and material property optimization

Obviousness Rationale

A PHOSITA would recognize that the PTD's disclosed variations represent predictable extensions of the source patent's fundamental 3D printing methodology for medical devices. The proposed multi-material extrusion, hybrid printing techniques, and real-time monitoring are logical progressions of existing additive manufacturing technologies. These variations demonstrate incremental improvements that would be apparent to a skilled practitioner seeking to optimize medical device manufacturing processes.

Obvious Combinations & Variations

Source Patent Element
Elongate substrate with heating cartridge for 3D printing medical devices
PTD Variation
Multi-material extrusion mechanism enabling concurrent deposition of varying stiffness filaments
Obviousness Reasoning
A PHOSITA would find it obvious to extend single-material printing to multi-material techniques as a predictable enhancement in manufacturing flexibility, using known material blending and extrusion principles
Source Patent Element
Catheter jacket with particulate surface composition
PTD Variation
Composite material combining multiple materials with enhanced biocompatibility and reduced thrombogenicity
Obviousness Reasoning
Material property optimization is a standard design approach in medical device manufacturing, representing a known technique for improving device performance through material selection
Source Patent Element
Rotational and longitudinal movement of substrate during printing
PTD Variation
Hybrid 3D printing process combining FDM and SLA techniques for enhanced surface finish
Obviousness Reasoning
Combining multiple additive manufacturing techniques is a predictable solution for improving surface quality, representing an obvious optimization strategy for a skilled practitioner
Source Patent Element
3D printing system for medical devices
PTD Variation
Real-time monitoring module for in-process quality control and adaptive parameter adjustment
Obviousness Reasoning
Implementing process monitoring and adaptive control is a standard engineering approach for improving manufacturing consistency, representing a known technique in advanced manufacturing
Source Patent Element
Catheter jacket with specific durometer properties
PTD Variation
Laser-based surface treatment technique to enhance surface roughness and biofouling resistance
Obviousness Reasoning
Surface modification techniques are well-known in medical device manufacturing, representing a predictable method for improving device performance through post-processing
35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857735 and the disclosed technical variations, a person having ordinary skill in the art would find the claimed innovations obvious and therefore unpatentable. The proposed enhancements represent predictable extensions of existing 3D printing methodologies for medical devices, utilizing known techniques of material selection, process optimization, and manufacturing control to incrementally improve device fabrication techniques.

Original Patent Information

Patent NumberUS 11,857,735
TitleSystems and methods for manufacturing 3D printed medical devices
Assignee(s)Medtronic, Inc.