Flexible Ostomy Implant with Inverted Flared Portion
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Solution Overview
Problem
Current ostomy management technologies face challenges such as skin irritation, stoma leaks, bleeding, and the need for frequent bag changes due to unpredictable stoma size changes over time.
Innovation Solution
An ostomy device featuring a flexible implant that can transition between two shapes, with a tubular body and a flared portion that can be inverted to attach to the patient anatomy, allowing for controlled stoma size and reduced adhesion needs for ostomy bags.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional ostomy bags are used with adhesives to attach to the skin, then the bag can be secured to collect waste, but skin irritation occurs due to adhesive contact with the skin
Solution Approach 1:
The implant acts as an intermediary device between the stoma and the ostomy bag. It provides a stable attachment point for the bag while its flared portion integrates with the abdominal wall tissue, eliminating the need for adhesives to contact the skin directly. The implant's porous exterior surface allows tissue integration, creating a secure mechanical anchor point.
Solution Approach 2:
The invention replaces the adhesive-based mechanical attachment system with a tissue-integrated mechanical anchor system. The flared portion of the implant is designed to be inverted and sutured to the abdominal wall, creating a permanent mechanical attachment point that eliminates adhesive contact with the skin.
2Adaptability or versatility
If the stoma size is allowed to vary naturally over time, then the body adapts to healing and functional changes, but stoma leaks occur due to unpredictable size changes
Solution Approach 1:
The implant provides a dynamic solution by creating a stable external framework that accommodates internal stoma size changes. The flared portion's geometric shape maintains a consistent opening size at the skin level, while the internal structure can adapt to healing and functional changes in the stoma, preventing leaks despite size variations.
Solution Approach 2:
The implant changes the geometric parameters of the stoma opening by providing a fixed external diameter through its flared portion. This creates a consistent opening size at the skin level, independent of internal stoma diameter changes, ensuring reliable seal integrity for ostomy bag attachment.
3Reliability
If the stoma opening size is reduced to minimize bag attachment issues, then bag sealing becomes easier, but the patient experiences difficulty with bowel movements through the stoma
Solution Approach 1:
The implant solves the contradiction by operating in a different dimensional space - it provides structural support and defines the opening geometry at the external skin level, while leaving the internal stoma lumen dimensions unaffected. This allows the internal opening to remain large enough for comfortable bowel movements while the external flared portion creates a precise, sealable opening for the ostomy bag.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The device provides a consistent stoma size, reduces skin irritation by minimizing adhesives, and allows for easier bag attachment, improving patient comfort and reducing complications.
Implementation Method 1
the implant comprises a porous or microporous exterior surface to enable tissue integration
Data Source
AI summary
An ostomy device includes an implant formed of a flexible material and shaped so that the implant is capable of transitioning between a first shape and a second shape. The implant includes a tubular body sized and shaped for insertion within a lumen extending through a hole in an abdominal wall, a flared portion extending radially outward and away from the body when the implant is in the first shape, and a transition region between the body and the flared portion. The transition region and the flared portion are bendable so that transitioning the implant from the first shape into the second shape comprises inverting the flared portion so that a surface of the flared portion can be brought into contact with an outer surface of patient anatomy, whereupon the implant can be attached to the patient anatomy in the second shape.