Ostomy Implant with Living Hinge for Secure Stoma Sealing

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Solution Overview

Problem

Existing ostomy management technologies, such as ostomy bags, can lead to complications like skin irritation, stoma leaks, and psychosocial issues for patients with permanent stomas, and they require frequent emptying and replacement.

Innovation Solution

An ostomy device with an implant that includes a body with a channel and a flange for attachment to the skin, featuring a living hinge that flares to contact intestinal walls and a stoma plug with a membrane for gas passage, allowing for selective opening and closing of the waste evacuation channel.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a traditional ostomy bag is used, then waste evacuation is achieved, but frequent bag changes and skin irritation occur

Engineering Contradiction:
Improveostomy management reliabilityVSAvoidtime for bag changes
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The implant incorporates a living hinge that enables dynamic transformation from a compressed insertion state to an expanded functional state. The hinge allows the distal portion to flare outward and contact intestinal walls, securing the implant in place and eliminating the need for frequent bag changes while maintaining reliable waste evacuation.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The implant is pre-configured with a compressed body and living hinge mechanism that enables automatic expansion and securing upon insertion. The sheath is removed after insertion to allow the living hinge to bend and the second portion to flare, pre-establishing contact with intestinal walls before the device begins its primary function.

Inventive Principle:
Principle #10Preliminary action

2Reliability

If a traditional ostomy bag is used, then waste collection is achieved, but skin irritation and leaks occur

Engineering Contradiction:
Improveleak preventionVSAvoidskin irritation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The implant utilizes a flexible living hinge mechanism that allows the body to transition from a rigid insertion state to a flared functional state. This flexible transformation enables the distal portion to conform to and contact the intestinal walls, creating a secure seal that prevents leaks and reduces skin irritation without requiring adhesive bags.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The implant automatically secures itself to the intestinal walls through the living hinge mechanism upon insertion. The hinge bends and the second portion flares to contact the intestinal walls, self-establishing a leak-proof connection without requiring external adhesive systems that cause skin irritation.

Inventive Principle:
Principle #25Self-service

3Reliability

If the living hinge is allowed to bend immediately, then the second portion flares to contact intestinal walls, but the implant cannot be inserted properly

Engineering Contradiction:
Improveimplant securingVSAvoidinsertion ease
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The implant is designed with the living hinge in a pre-compressed state during manufacturing and storage. A sheath is provided that maintains the compressed configuration during insertion, allowing the implant to be passed through the stoma easily. After insertion, the sheath is removed to allow the hinge to bend and the second portion to flare, automatically securing the implant to the intestinal walls.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The sheath acts as an intermediary element that constrains the living hinge during insertion, preventing premature bending. This intermediary maintains the implant in a manageable, compressed state for easy passage through the stoma, then is removed to allow the hinge to transition to its functional flared state for securing against the intestinal walls.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentUS20250152404A1Ostomy implant device and method
Publication Date: 2025.05.15 BOSTON SCI MEDICAL DEVICE LTD
  • US20250152404A1 patent drawing
  • US20250152404A1 patent drawing
  • US20250152404A1 patent drawing

AI summary

An ostomy device includes an implant including a body sized and shaped for implantation in a stoma. The body includes a first portion defining a channel extending from a first end to a second end. The first end is configured to interface with a lumen interior to an abdomen. The second end is configured to provide a path from the lumen through the channel to an exterior of the abdomen. The implant further includes a flange attached to an exterior of the body. The flange includes a collar extending from a first rim attached to an exterior of the body to a second rim attachable to a skin adjacent to the stoma.