Intelligent Ostomy Appliance Systems

Publication ID: 24-11857453_0008_PTD
Published: October 28, 2025
Category:Synergistic Combinations

Legal Citation

pr1or.art Inc., “Intelligent Ostomy Appliance Systems,” Published Technical Disclosure No. 24-11857453_0008_PTD, Published October 28, 2025, available at https://archive.pr1or.art/24-11857453_0008_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. 11,857,453.

Summary of the Inventive Concept

This inventive concept integrates ostomy appliances with emerging technologies like IoT, AI, blockchain, and advanced materials to create a more efficient, personalized, and connected ostomy care system.

Background and Problem Solved

The original patent for an ostomy appliance addressed the need for a non-circular flange for mechanical attachment of a bag or pouch. However, it did not account for the complexities of modern ostomy care, such as tracking appliance performance, optimizing design, and ensuring supply chain integrity. This new inventive concept solves these problems by combining the original patent's innovative flange design with cutting-edge technologies.

Detailed Description of the Inventive Concept

The Intelligent Ostomy Appliance Systems comprise several synergistic components. Firstly, an IoT-enabled sensor is integrated into the ostomy appliance to track and transmit data on its interaction with a drape material, enabling real-time monitoring of appliance performance. Secondly, AI-driven simulations analyze the interaction between the ostomy appliance and the drape material, generating design recommendations for improved performance. Thirdly, a blockchain-based tracking system records and verifies the ostomy appliance's usage history, ensuring supply chain integrity and facilitating recall management. Additionally, novel ostomy appliance materials with enhanced durability and biocompatibility are developed through the integration of vapor permeable, antimicrobial materials with nanomaterial-based coatings. Finally, a smart ostomy appliance system incorporates an integrated sensor to detect changes in stoma size or shape, alerting users or healthcare providers of potential issues.

Novelty and Inventive Step

The new claims introduce the innovative combination of IoT, AI, blockchain, and advanced materials with the original ostomy appliance design, providing a novel and non-obvious solution for modern ostomy care. The integration of these technologies enables real-time monitoring, data-driven design optimization, and secure tracking, which are not anticipated by the original patent.

Alternative Embodiments and Variations

Alternative embodiments of the Intelligent Ostomy Appliance Systems could include variations in sensor design, AI algorithms, blockchain protocols, and material compositions. For example, the IoT sensor could be replaced with a Bluetooth Low Energy (BLE) module, or the AI-driven simulations could be augmented with machine learning algorithms. These variations would ensure broad conceptual coverage and adaptability to diverse user needs.

Potential Commercial Applications and Market

The Intelligent Ostomy Appliance Systems have significant commercial potential in the global ostomy care market, projected to reach $3.5 billion by 2025. Target industries include healthcare providers, medical device manufacturers, and pharmaceutical companies. The system's ability to improve patient outcomes, reduce healthcare costs, and enhance supply chain efficiency will drive adoption and revenue growth.

CPC Classifications

SectionClassGroup
A A61 A61F5/4404
A A61 A61F5/448
A A61 A61B46/00
A A61 A61B2090/037
A A61 A61F2013/00978
A A61 A61M1/90

Field of Art

Medical Device Technology, specifically Ostomy Appliance Systems, involving biomedical engineering, sensor technologies, materials science, and healthcare informatics

Person of Ordinary Skill (PHOSITA) Profile

A skilled practitioner with expertise in medical device design, biomedical engineering, with knowledge of IoT technologies, materials engineering, and healthcare monitoring systems, typically holding a Master's or PhD in biomedical engineering or related field

Obviousness Rationale

A PHOSITA would recognize that integrating emerging technologies like IoT sensors, AI analytics, and blockchain tracking into existing ostomy appliance designs represents a predictable evolution of medical device technology. The source patent's foundational ostomy appliance design provides a clear technical framework for implementing advanced monitoring and optimization technologies. These technological extensions represent incremental improvements using standard engineering techniques and readily available technological components.

Obvious Combinations & Variations

Source Patent Element
Non-circular ostomy appliance with mechanical attachment flange
PTD Variation
Adding IoT-enabled sensor to track appliance performance and interaction with drape material
Obviousness Reasoning
Integrating sensors into medical devices is a known technique, and a PHOSITA would find it obvious to enhance monitoring capabilities using standard IoT technologies
Source Patent Element
Vapor permeable ostomy appliance material
PTD Variation
Incorporating nanomaterial-based coatings and antimicrobial properties
Obviousness Reasoning
Material enhancement through nanotechnology is a predictable approach in medical device design, representing an obvious optimization of existing material properties
Source Patent Element
Ostomy appliance with aperture for stoma
PTD Variation
Integrated sensor for detecting changes in stoma size or shape with automated notification system
Obviousness Reasoning
Implementing real-time monitoring of medical device performance is a standard engineering approach, particularly for devices interacting directly with human physiology
Source Patent Element
Non-circular flange design for mechanical attachment
PTD Variation
Blockchain-based tracking system with unique device identifier
Obviousness Reasoning
Implementing supply chain and usage tracking through blockchain represents an obvious technological extension using standard identification and verification techniques
Source Patent Element
Basic ostomy appliance design
PTD Variation
AI-driven simulation for design optimization and performance analysis
Obviousness Reasoning
Applying computational design optimization techniques is a predictable approach in engineering, representing a standard method for iterative product improvement
35 U.S.C. § 103 Summary: Pursuant to 35 U.S.C. ยง 103, the variations disclosed in this Published Technical Disclosure would be considered obvious to a Person Having Ordinary Skill In The Art based on the teachings of US Patent 11857453, as the technological extensions represent predictable combinations of known medical device design techniques with emerging IoT, AI, and materials technologies, thereby rendering potential patent claims obvious and unpatentable.

Original Patent Information

Patent NumberUS 11,857,453
TitleOstomy appliance
Assignee(s)Sanguine Technology, LLC