Inflatable Balloon Fetal Head Elevation Device

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Solution Overview

Problem

Existing fetus delivery assisting devices, such as the Fetal Pillow device, can be used incorrectly, leading to failure in achieving desired elevation of the fetal head during caesarean sections, and may be difficult to insert and position accurately in the pelvic cavity.

Innovation Solution

A fetus delivery assisting device with an inflatable balloon attached to a rigid base and a curved shaft, designed for easy insertion and removal, featuring indicators for accurate placement and a two-way tap for controlled inflation, to ensure correct positioning and effective elevation of the fetal head.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the Fetal Pillow device is inserted manually through the vaginal opening, then the device can be introduced into the maternal pelvic cavity, but it is difficult to place it in the correct position underneath the fetal head

Engineering Contradiction:
Improveease of insertionVSAvoidpositioning accuracy
Core Design Contradiction:
Ease of operationVSMeasurement precision

Solution Approach 1:

A flexible catheter with a balloon is used as an intermediary tool to deliver the support structure to the correct position. The catheter can be easily inserted through the vaginal opening and its flexibility allows it to navigate the anatomical structures to place the support element precisely underneath the fetal head, solving both the ease of insertion and positioning accuracy requirements

Inventive Principle:
Principle #24Intermediary (Mediator)

2Strength

If the device is made with a rigid base plate for structural support, then the device can effectively elevate the fetal head, but it becomes difficult to insert and position accurately

Engineering Contradiction:
Improvesupport capabilityVSAvoidease of insertion
Core Design Contradiction:
StrengthVSEase of operation

Solution Approach 1:

The device is segmented into distinct functional components: a flexible catheter for easy insertion and positioning, a balloon for structural support and elevation, and a support element. This segmentation allows each component to be optimized for its specific function - the catheter for accessibility and the balloon for strength - thereby resolving the contradiction between insertability and support capability

Inventive Principle:
Principle #1Segmentation

3Productivity

If pushing the fetal head through the vaginal route is used during caesarean section, then delivery can be attempted, but direct trauma to the fetus and maternal trauma with infections occur

Engineering Contradiction:
Improvedelivery speedVSAvoidtrauma and infection
Core Design Contradiction:
ProductivityVSObject-affected harmful factors

Solution Approach 1:

The device provides beforehand cushioning by positioning a supportive element underneath the fetal head before delivery attempts are made. This pre-positioned support prevents direct trauma during manipulation and reduces the risk of maternal tissue injury and subsequent infection, allowing for safer and more efficient delivery

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

4Productivity

If reverse breech extraction technique is used, then fetal delivery can be achieved, but the technique is difficult and traumatic unless the operator is familiar with it

Engineering Contradiction:
Improvedelivery effectivenessVSAvoidoperator difficulty
Core Design Contradiction:
ProductivityVSEase of operation

Solution Approach 1:

The device acts as an intermediary tool that simplifies the extraction process. Instead of requiring the operator to perform complex manual maneuvers like reverse breech extraction, the device provides mechanical assistance through its balloon and support elements, making the procedure easier to perform while maintaining effectiveness and reducing trauma

Inventive Principle:
Principle #24Intermediary (Mediator)

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 allows for accurate and easy placement under the fetal head, preventing expulsion and ensuring effective elevation, thereby reducing maternal and fetal complications associated with difficult deliveries.

Implementation Method 1

The balloon of the device is then inflated when filled with fluid, which elevates the fetal head and helps disengage it from the maternal pelvic cavity

Methodology Applied
Scientific EffectFluid pressure: Pressure Increase

Data Source

PatentUS12213702B2Fetus delivery assisting device
Publication Date: 2025.02.04 COOPERSURGICAL INC
  • US12213702B2 patent drawing
  • US12213702B2 patent drawing
  • US12213702B2 patent drawing

AI summary

A fetus delivery assisting device (10) for assisting with the birth of a fetus. The device (10) comprises a shaft (16). At one end of the shaft (16) is a rigid base (18) to which an inflatable balloon (12) is mounted. The rigid base (18) and the inflatable balloon (12) are configured to accept a fetal head. The inflatable balloon (12) is configured to displace the fetal head from a pelvic cavity when inflated. The shaft (16) is configured for manipulating the inflatable balloon (12) to displace the fetal head from the pelvic cavity.