Episiotomy Guide Device for Precise Lateral Incision Angles

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Solution Overview

Problem

Current episiotomy procedures lack a device to accurately guide medical practitioners in making lateral incisions, leading to increased risks of third-degree tears and anal incontinence due to imprecise angle measurements, especially during vaginal dilation.

Innovation Solution

A guide device that aligns between the vaginal opening and anus, featuring a guide surface extending laterally to indicate the correct angle for a lateral episiotomy incision, allowing for precise marking or cutting, and can be securely attached to the perineum without causing damage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a midline incision is made during episiotomy, then the incision is easy to make by eye alignment, but the risk of third-degree tear and damage to anal sphincter muscle increases

Engineering Contradiction:
Improveease of incision makingVSAvoidrisk of third-degree tear
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a guide device as an intermediary tool between the practitioner and the tissue. The guide device includes a guide member with a guide surface that extends at a predetermined angle from the perineal midline, providing a physical reference to ensure the incision is made at the correct lateral angle, thereby preventing third-degree tears while maintaining ease of operation

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The guide device establishes a specific angular parameter for the incision by extending the guide surface at a predetermined angle (typically 45-60 degrees) from the perineal midline. This parameter change from a vertical midline approach to a controlled lateral angle is achieved through the geometric design of the guide member, transforming the incision trajectory to reduce anal sphincter damage

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If a lateral incision is made to reduce third-degree tear risk, then the risk of anal incontinence decreases, but the measurement precision of incision angle becomes difficult to achieve accurately

Engineering Contradiction:
Improverisk of anal incontinenceVSAvoidincision angle accuracy
Core Design Contradiction:
Object-affected harmful factorsVSMeasurement precision

Solution Approach 1:

The guide device serves as a physical intermediary that translates the abstract requirement for a precise lateral angle into a concrete geometric reference. The guide member's guide surface is pre-formed at the correct angle, allowing the practitioner to follow the physical edge rather than relying on visual estimation, thereby achieving measurement precision

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The guide member is positioned and secured to the perineal tissue before making the incision. The guide surface is pre-aligned with the perineal midline at the correct angle, establishing the reference frame in advance. This preliminary positioning ensures that when the incision is made along the guide surface, the correct lateral angle is automatically achieved

Inventive Principle:
Principle #10Preliminary action

3Object-affected harmful factors

If the incision angle is adjusted laterally to protect the anal sphincter, then tissue damage is reduced, but the accuracy of the incision position deteriorates due to vaginal dilation during birth

Engineering Contradiction:
Improvetissue damage to anal sphincterVSAvoidincision position accuracy
Core Design Contradiction:
Object-affected harmful factorsVSManufacturing precision

Solution Approach 1:

The guide member is positioned and secured to the perineal tissue before the vaginal dilation process begins. By establishing the correct lateral angle reference in advance, the guide maintains its accuracy throughout the birthing process even as the vaginal opening dilates, ensuring the incision remains at the correct position and angle

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The guide device acts as a stable intermediary reference that does not move with the vaginal dilation. The guide member is anchored to the perineal tissue, providing a fixed angular reference that compensates for the changing geometry of the vaginal opening during birth, thereby maintaining incision position accuracy

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP2185085B1Apparatus for conducting an episiotomy
Publication Date: 2015.10.28 PLYMOUTH HOSPITALS NHS TRUST
  • EP2185085B1 patent drawingFigure 1
  • EP2185085B1 patent drawingFigure 2

AI summary

An episiotomy guide (2) for use in conducting an epiεiotomy on a subject is provided, the guide comprising a guide means for indicating alignment of the guide relative to a line between the vaginal opening and the anus of the subject; and a guide surface rigidly disposed relative to the guide means so as to extend laterally at an angle from the vaginal opening when the guide means is so aligned, the guide surface extending relative to the guide means appropriate for indicating the angle (0) of the line of a lateral episiotomy incision. The guide preferably comprises first (4) and second (10) guide members extending at an appropriate angle in a V-shape. A method of carrying out an episiotomy is also provided, the method comprising placing a guide means extending between the vaginal opening and the anus of the subject, the guide means having a guide surface rigidly disposed with respect thereto, the guide surface extending laterally at an angle from the vaginal opening; and using the guide surface as a guide for making an incision extending from the vaginal opening at the said angle. The guide surface may be used directly in the making of the episiotomy incision or for making a mark on the skin of the subject, for a later incision if required.