Enhanced Customized Sleeve Manufacturing for Prostheses

Publication ID: 24-11857439_0006_PTD
Published: October 28, 2025
Category:Direct Improvements & Enhancements

Legal Citation

pr1or.art Inc., “Enhanced Customized Sleeve Manufacturing for Prostheses,” Published Technical Disclosure No. 24-11857439_0006_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857439_0006_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 innovative system and method for manufacturing customized sleeves for prostheses, offering improved durability, comfort, and hygiene, while reducing production time and waste.

Background and Problem Solved

The original patent disclosed a method for manufacturing customized sleeves for prostheses, but it had limitations in terms of material durability, manufacturing efficiency, and infection risk. The new inventive concept addresses these limitations by introducing advanced materials, 3D printing technology, and antimicrobial coatings, enabling the production of high-quality customized sleeves with enhanced comfort, grip, and stability.

Detailed Description of the Inventive Concept

The enhanced system comprises a mold holder, a preform injector, and a temperature control system, designed for high-volume production and minimal waste generation. The preform is manufactured using 3D printing technology to achieve a precise fit and optimal comfort for the individual. The preform is made of a hybrid elastomer material with improved durability and resistance to wear, and an outer layer of a bi-component silicone with enhanced grip and stability. Additionally, the preform can be treated with an antimicrobial coating to reduce the risk of infection and promote healthy skin conditions.

Novelty and Inventive Step

The new claims introduce the use of 3D printing technology, hybrid elastomer materials, and antimicrobial coatings, which are not present in the original patent. These innovations provide a significant improvement in terms of comfort, durability, and hygiene, making the new inventive concept non-obvious and novel compared to the original patent.

Alternative Embodiments and Variations

Alternative embodiments of the inventive concept could include the use of different materials, such as advanced polymers or nanomaterials, or the integration of sensors and monitoring systems to track the performance and health of the customized sleeve. Variations of the system could also be designed for specific types of prostheses or individuals with unique needs.

Potential Commercial Applications and Market

The enhanced customized sleeve manufacturing system has significant commercial potential in the prosthetics industry, with potential applications in hospitals, clinics, and rehabilitation centers. The target market includes individuals with limb loss or impairment, as well as healthcare providers and manufacturers of prosthetic devices.

CPC Classifications

SectionClassGroup
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

Field of Art

Medical Prosthetics Manufacturing, with expertise in elastomeric materials, molding techniques, and custom fabrication processes for prosthetic sleeves and interfaces

Person of Ordinary Skill (PHOSITA) Profile

A biomedical engineer or materials scientist with advanced training in polymer engineering, 3D printing technologies, and prosthetic device manufacturing, possessing knowledge of medical-grade materials and customization techniques

Obviousness Rationale

A person having ordinary skill would recognize that the PTD's variations represent predictable extensions of the source patent's fundamental manufacturing approach, utilizing known techniques in materials science and additive manufacturing to incrementally improve prosthetic sleeve production. The core manufacturing methodology remains substantially consistent, with the PTD introducing refinements that would be apparent to a skilled practitioner seeking to optimize prosthetic sleeve design and fabrication.

Obvious Combinations & Variations

Source Patent Element
Elastomer material preform with open proximal end for prosthetic sleeve manufacturing
PTD Variation
3D printing the preform to achieve precise fit and using hybrid elastomer materials
Obviousness Reasoning
3D printing is a known technique for creating customized medical devices, and material optimization would be an expected design improvement for a PHOSITA seeking enhanced prosthetic performance
Source Patent Element
Silicone gel preform with bi-component silicone injection
PTD Variation
Adding antimicrobial coating and developing enhanced grip outer layer
Obviousness Reasoning
Surface modification and antimicrobial treatments are standard techniques in medical device manufacturing to improve patient safety and device functionality
Source Patent Element
Temperature-controlled manufacturing process between 20-25°C
PTD Variation
Implementing advanced temperature control system for high-volume production
Obviousness Reasoning
Process optimization and scaling are predictable engineering challenges that a skilled practitioner would address through systematic improvements in manufacturing infrastructure
Source Patent Element
Customized sleeve manufacturing method using limb end mold
PTD Variation
Integrating sensor and monitoring systems to track sleeve performance
Obviousness Reasoning
Incorporating diagnostic capabilities is a logical progression in medical device design, representing an obvious enhancement to existing customization techniques
Source Patent Element
Elastomer preform with variable thickness
PTD Variation
Using advanced polymers and nanomaterials for improved material properties
Obviousness Reasoning
Material science progression and exploration of alternative substrate compositions represent standard research and development practices in prosthetic manufacturing
35 U.S.C. § 103 Summary: Pursuant to 35 U.S.C. § 103, the variations disclosed in the Published Technical Disclosure render obvious any subsequent patent claims covering customized prosthetic sleeve manufacturing techniques substantially similar to those described in US Patent 11857439, as the claimed innovations represent predictable technological extensions employing known methods in materials science, additive manufacturing, and medical device engineering.

Original Patent Information

Patent NumberUS 11,857,439
TitleMethod for manufacturing a customized sleeve for a prosthesis