Flexible Polyurethane Intrauterine Frame for Uterine Adaptation

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Solution Overview

Problem

Existing intrauterine devices (IUDs) are often bulky and rigid, leading to side effects such as pain, infection, irregular bleeding, and increased risk of expulsion due to their inability to adapt to cyclic uterine changes and irregular geometry, causing irritation and discomfort.

Innovation Solution

A flexible intrauterine system with a thermoplastic polyurethane elastomer frame of polygonal shape, connected to a reservoir containing a therapeutically active substance, designed to fit the endometrial cavity, providing sufficient stiffness for insertion and resilience to maintain position without causing irritation or expulsion.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If a rigid intrauterine device is used, then structural stability is improved, but adaptability to uterine geometry deteriorates

Engineering Contradiction:
Improvestructural stabilityVSAvoidadaptability to uterine geometry
Core Design Contradiction:
Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The frame is designed with elastic material properties that allow it to dynamically adapt its shape to the uterine cavity while maintaining structural integrity. The elasticity enables the device to flex and conform to individual uterine geometries during insertion and while in place, resolving the contradiction between rigidity and adaptability.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The material parameters of the frame are specifically selected to achieve optimal balance between stiffness and flexibility. By controlling the elastic modulus and mechanical properties of the frame material, the device maintains sufficient structural stability while being able to adapt to varying uterine shapes and sizes.

Inventive Principle:
Principle #35Parameter changes

2Adaptability or versatility

If a flexible intrauterine device is used, then adaptability to uterine geometry is improved, but insertion difficulty deteriorates

Engineering Contradiction:
Improveadaptability to uterine geometryVSAvoidinsertion ease
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The frame's elastic properties enable it to be compressed and deformed during insertion, then automatically return to its original shape once positioned in the uterus. This dynamic behavior facilitates easy insertion through the cervix while maintaining the ability to adapt to the uterine cavity geometry.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The frame is constructed as a flexible elastic structure that can be bent and shaped during insertion procedures. This flexibility allows the device to pass through narrow passages and be positioned accurately, while the elastic memory effect ensures it maintains its functional shape once deployed.

Inventive Principle:
Principle #30Flexible shells and thin films

3Reliability

If a large intrauterine device is used, then contraceptive effectiveness is improved, but expulsion risk deteriorates

Engineering Contradiction:
Improvecontraceptive effectivenessVSAvoidresistance to expulsion
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The frame features variable cross-sectional dimensions with thicker sections providing structural support and thinner sections allowing flexibility. This local variation in geometry enables the device to maintain adequate size for contraceptive effectiveness while having regions that can adapt to uterine contours, reducing expulsion risk.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The frame is designed with curved and rounded features rather than sharp angles, allowing it to conform smoothly to the uterine cavity. This curved geometry distributes pressure evenly and reduces the likelihood of the device being expelled, while maintaining sufficient size for effectiveness.

Inventive Principle:
Principle #14Spheroidality (Curvature)

4Manufacturing precision

If a rigid intrauterine device is used, then manufacturing precision is improved, but tissue irritation deteriorates

Engineering Contradiction:
Improvegeometric precisionVSAvoidtissue irritation
Core Design Contradiction:
Manufacturing precisionVSObject-affected harmful factors

Solution Approach 1:

The frame is constructed as a flexible elastic structure with smooth surfaces and rounded edges, eliminating sharp features that could irritate tissue. The flexibility allows the device to conform to the uterine cavity without creating pressure points, while manufacturing processes maintain precise geometric control.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

All corners and edges of the frame are rounded or curved rather than sharp, and the surface is designed to be smooth. This geometric design reduces mechanical irritation to the endometrium while maintaining manufacturing precision through controlled forming processes.

Inventive Principle:
Principle #14Spheroidality (Curvature)

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 system allows for easy insertion and removal, reduces the risk of perforation, and minimizes side effects by adapting to uterine geometry, ensuring comfortable long-term use and effective delivery of therapeutic agents.

Implementation Method 1

a flexible, elastic frame (1) comprising a thermoplastic polyurethane elastomer

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

The polymer materials are hydrophilic and absorb water in aqueous media. This causes swelling and softening of the material

Methodology Applied
Scientific EffectHydrophilic absorption: Absorption (physical)

Data Source

PatentEP2482768B1An intrauterine system
Publication Date: 2019.09.18 BAYER OY
  • EP2482768B1 patent drawing
  • EP2482768B1 patent drawing
  • EP2482768B1 patent drawing

AI summary

The present invention relates to novel intrauterine systems and to methods for manufacturing these systems. An intrauterine system according to the invention comprises a reservoir and a continuous, closed and flexible frame. The frame comprises a thermoplastic polyurethane elastomer made of a polycarbonate diol, 1,6-hexamethylenediisocyanate, and a chain extender.