Frameless IUD Anchoring with Echogenic Stainless Steel Tube

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Solution Overview

Problem

Current frameless intrauterine contraceptive devices (IUDs) face challenges in visualizing the anchoring mechanism, leading to potential expulsion and perforation of the uterus, and cause heavy menstrual bleeding due to their size and design.

Innovation Solution

Incorporating a tiny stainless steel tube below the anchoring knot to enhance ultrasound visibility and using a design with alternating copper and gold cylinders to increase copper ion release, while minimizing device size and surface area to reduce menstrual blood loss.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a frameless design is used to eliminate dimensional incompatibility, then adaptability to different uterus sizes and shapes is improved, but the ability to visualize the anchoring mechanism deteriorates

Engineering Contradiction:
Improveadaptability to uterus size and shapeVSAvoidvisibility of anchoring mechanism
Core Design Contradiction:
Adaptability or versatilityVSDifficulty of detecting and measuring

Solution Approach 1:

An echogenic marker (tiny metal tube or coil) is introduced as an intermediary element that does not interfere with the frameless design's adaptability but provides the necessary ultrasound visibility. This marker is threaded onto the anchoring thread and positioned to allow visualization of the anchoring mechanism while maintaining the flexibility and size adaptability of the frameless structure.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Object-affected harmful factors

If the size of copper elements is reduced to minimize device size, then tolerance and menstrual blood loss are improved, but contraceptive effectiveness deteriorates

Engineering Contradiction:
Improvemenstrual blood lossVSAvoidcontraceptive effectiveness
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The surface area and configuration of copper elements are optimized to maximize copper ion release per unit area. By creating a frameless design with distributed copper tubes or wires that have increased surface area-to-volume ratio, the device achieves high contraceptive effectiveness with minimal total copper mass, thereby reducing menstrual blood loss while maintaining reliability.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The device combines copper elements with biocompatible polymer materials to create a composite structure. The copper provides contraceptive effectiveness through ion release, while the polymer matrix allows for flexible, frameless design that minimizes device size and contact area with the endometrium, reducing menstrual blood loss.

Inventive Principle:
Principle #40Composite materials

3Reliability

If copper surface area is increased to enhance contraceptive effectiveness, then reliability is improved, but menstrual blood loss increases

Engineering Contradiction:
Improvecontraceptive effectivenessVSAvoidmenstrual blood loss
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The copper elements are designed with optimized parameters including increased surface area-to-volume ratio through thin-walled tubes or wires, strategic distribution throughout the device, and surface treatments that enhance copper ion release efficiency. This allows achieving high contraceptive effectiveness with minimal total copper mass, thereby reducing menstrual blood loss.

Inventive Principle:
Principle #35Parameter changes

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 solution allows for accurate anchoring visualization, reducing the risk of uterine perforation and heavy menstrual bleeding, while maintaining high contraceptive effectiveness and flexibility.

Implementation Method 1

steel is more echogenic on ultrasound than copper and therefore the stainless steel tube can be kept extremely small

Methodology Applied
Scientific EffectUltrasound reflection: Ultrasound

Implementation Method 2

copper and gold (or silver) enter into an electrochemical reaction... creating these galvanic cells... The copper elements then form the anode and the gold the cathode of the galvanic cell

Methodology Applied
Scientific EffectGalvanic cell: Battery (electricity)

Implementation Method 3

The addition of gold increases the copper ion release in the uterine environment thereby enhancing the contraceptive effectiveness

Methodology Applied
Scientific EffectIon release: Electrolysis

Data Source

PatentEP2515806B1Improvements to frameless intrauterine devices and systems
Publication Date: 2017.10.18 PAT&CO BVBA
  • EP2515806B1 patent drawing

AI summary

A frameless copper- releasing contraceptive IUD or a hormone - releasing contraceptive IUS, comprising a suture thread ( 3 ), supporting the active component (s) and an anchor ( 5 ) to be inserted in the wall of the uterus with a specially designed applicator or inserter in order to secure the IUD/ IUS in the uterine cavity. The anchor consists of a knot made at one end of the thread. A tiny metal tube ( 6 ), preferably of stainless steel, is threaded onto the thread and fixed immediately below or above the anchoring knot to make the anchor visible on ultrasound and/or x-ray. The anchoring knot may be provided with a tightly fitting ogival, bell or cone-shaped cap consisting of a biodegradable polymer. The active element ( 2 ) consists for example of a succession of threaded copper cylinders.