Enhanced Method for Manufacturing Customized Sleeves for Prostheses

Publication ID: 24-11857439_0001_PTD

Published: October 28, 2025

Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Method for Manufacturing Customized Sleeves for Prostheses,” Published Technical Disclosure No. 24-11857439_0001_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857439_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. 11,857,439.

Summary of the Inventive Concept

An improved method for manufacturing customized sleeves for prostheses, featuring advanced injection techniques and materials to enhance comfort, durability, and customization.

Background and Problem Solved

The original patent disclosed a method for manufacturing customized sleeves for prostheses, but it had limitations in terms of material selection, injection techniques, and customization options. The new inventive concept addresses these limitations by introducing advanced materials, robotic arm-based injection, and 3D printing techniques to create complex geometries and patterns, resulting in improved comfort, durability, and customization for users.

Detailed Description of the Inventive Concept

The new inventive concept involves the use of advanced materials, such as polymer cross-linkable at low temperature, and innovative injection techniques, including spiral pattern injection and multi-layer injection with varying hardness. The method also incorporates the use of robotic arms and 3D printing techniques to enable the creation of complex geometries and patterns. This results in customized sleeves with improved comfort, durability, and customization options. The system comprises a mold of an end of a limb of an individual, a preform made of an elastomer material, and an injection device for injecting the polymer around the preform. The preform has a variable thickness, and the injection device is configured to inject the polymer in a spiral pattern or in multiple layers with varying hardness.

Novelty and Inventive Step

The new claims introduce novel elements, such as the use of polymer cross-linkable at low temperature, robotic arm-based injection, and 3D printing techniques, which are not present in the original patent. These elements provide an inventive step by enabling the creation of customized sleeves with improved comfort, durability, and customization options.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include the use of different materials, such as bi-component silicone, or varying the injection patterns and techniques. Additionally, the system could be adapted for use with different types of prostheses or for manufacturing customized sleeves for other medical devices.

Potential Commercial Applications and Market

The enhanced method for manufacturing customized sleeves for prostheses has significant commercial potential in the medical device industry, particularly in the prosthetics and orthotics market. The improved comfort, durability, and customization options provided by the new inventive concept could lead to increased adoption and market share.

CPC Classifications

Section	Class	Group
A	A61	A61F2/5046
B	B29	B29C45/0053
B	B29	B29C45/14065
B	B29	B29C45/14336
B	B29	B29C65/48
B	B29	B29C66/729
A	A61	A61F2002/5053
A	A61	A61F2002/5056
A	A61	A61F2002/7837
B	B29	B29C2045/0079
B	B29	B29C2045/14155
B	B29	B29K2083/00
B	B29	B29K2105/0061
B	B29	B29L2031/7532

Section 103 Obviousness Analysis (PHOSITA)

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Field of Art

Medical prosthetics manufacturing, specifically custom prosthetic sleeve fabrication involving elastomeric materials and injection molding techniques, requiring expertise in materials science, biomedical engineering, and precision manufacturing processes

Person of Ordinary Skill (PHOSITA) Profile

A skilled practitioner with advanced degrees in biomedical engineering or materials science, familiar with silicone-based medical device manufacturing, injection molding techniques, and prosthetic interface design, possessing knowledge of polymer processing and medical device fabrication standards

Obviousness Rationale

A person having ordinary skill would recognize that the PTD's variations represent predictable extensions of the source patent's core manufacturing methodology, utilizing known techniques in polymer processing, injection molding, and prosthetic sleeve customization to achieve incremental improvements in manufacturing precision and material performance

Obvious Combinations & Variations

Source Patent Element

Silicone gel preform with variable thickness for prosthetic sleeve

PTD Variation

Introducing polymer cross-linkable at low temperature with spiral pattern injection

Obviousness Reasoning

A PHOSITA would find it obvious to modify injection techniques and material chemistry to enhance manufacturing precision, as both approaches aim to improve prosthetic sleeve conformity and comfort through controlled material deposition

Source Patent Element

Injection molding of elastomer material around a preform

PTD Variation

Using robotic arm with programmed injection patterns

Obviousness Reasoning

Implementing robotic precision in manufacturing is a predictable design optimization for achieving more consistent and uniform material distribution, representing an obvious technological progression in medical device fabrication

Source Patent Element

Manufacturing method for customized prosthetic sleeves

PTD Variation

3D printing techniques for creating complex geometries and patterns

Obviousness Reasoning

Integrating 3D printing into existing manufacturing processes is a known technique for enhancing design flexibility and customization, which a PHOSITA would recognize as an obvious technological improvement

Source Patent Element

Single-material injection process

PTD Variation

Multi-layer injection with varying material hardness

Obviousness Reasoning

Creating gradient material properties through layered injection is a predictable engineering solution for enhancing prosthetic interface performance, representing a finite and obvious design approach

Source Patent Element

Temperature-controlled manufacturing process

PTD Variation

Low-temperature cross-linkable polymers with precise injection techniques

Obviousness Reasoning

Exploring alternative polymer chemistries and processing conditions is an obvious investigative approach for a skilled practitioner seeking to optimize material performance and manufacturing efficiency

35 U.S.C. § 103 Summary: Based on the teachings of US Patent 11857439 and the disclosed variations, a person having ordinary skill in the art would find the claimed innovations obvious, as they represent predictable technological extensions utilizing known manufacturing techniques, material science principles, and design optimization strategies in prosthetic sleeve fabrication. The published technical disclosure demonstrates that the claimed variations would have been obvious to a skilled practitioner at the time of invention, thereby establishing robust prior art under 35 U.S.C. § 103.

Original Patent Information

Patent Number	US 11,857,439
Title	Method for manufacturing a customized sleeve for a prosthesis