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
Engineering Contradiction Analysis
1Reliability
If a traditional ostomy bag is used, then waste evacuation is achieved, but frequent bag changes and skin irritation occur
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.
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.
2Reliability
If a traditional ostomy bag is used, then waste collection is achieved, but skin irritation and leaks occur
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.
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.
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
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.
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.
Data Source
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.


