Biodegradable Vaginal Plug with Anchor for Prolapse Support

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Solution Overview

Problem

Pelvic organ prolapse, caused by decreased support due to childbirth, hysterectomy, or aging, requires effective surgical interventions that provide internal support to the prolapsed organs while allowing for tissue growth and natural conformation to prevent further prolapse.

Innovation Solution

A system comprising a biodegradable plug, a porous skirt, and an anchor that is inserted into the vagina to promote tissue growth and provide internal support, with the anchor extending to the sacrum for additional support, allowing the vagina to maintain its natural conformation and distribute forces effectively.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Duration of action of stationary object

If a non-biodegradable support structure is used to provide long-term support to the vagina, then the support durability is improved, but the tissue growth and natural conformation are restricted

Engineering Contradiction:
Improvesupport durabilityVSAvoidtissue growth capability
Core Design Contradiction:
Duration of action of stationary objectVSAdaptability or versatility

Solution Approach 1:

The patent applies parameter changes by transitioning the support structure from non-biodegradable to biodegradable material, changing the temporal characteristics of the support. The biodegradable plug provides temporary support during the critical healing period, then degrades to allow long-term tissue growth and natural conformation, resolving the contradiction between immediate support durability and long-term tissue adaptability

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The biodegradable plug acts as an intermediary temporary support structure that mediates between the need for immediate mechanical support and the requirement for long-term tissue growth. It provides structural support during healing, then gradually degrades to be replaced by native tissue, serving as a transient mediator that satisfies both contradictory requirements at different time points

Inventive Principle:
Principle #24Intermediary (Mediator)

2Strength

If a rigid support structure is used to elevate the vagina, then the support strength is improved, but the natural conformation and force distribution are compromised

Engineering Contradiction:
Improvesupport strengthVSAvoidnatural conformation
Core Design Contradiction:
StrengthVSStability of the object's composition

Solution Approach 1:

The patent employs a shell-like biodegradable plug structure that conforms to the vaginal anatomy. This shell provides structural support strength while maintaining flexibility to adapt to the natural vaginal conformation, avoiding the rigidity problem of traditional rigid support structures and enabling proper force distribution across vaginal tissues

Inventive Principle:
Principle #30Flexible shells and thin films

3Adaptability or versatility

If a porous material is used to allow tissue growth, then the tissue integration is improved, but the initial structural support is reduced

Engineering Contradiction:
Improvetissue integrationVSAvoidinitial structural support
Core Design Contradiction:
Adaptability or versatilityVSStrength

Solution Approach 1:

The patent utilizes a biodegradable plug with controlled porosity that balances initial structural support with tissue ingrowth capability. The porous structure provides mechanical support in the early post-operative period while simultaneously allowing tissue penetration and integration, resolving the contradiction between initial strength and tissue integration by providing both functions concurrently rather than sequentially

Inventive Principle:
Principle #31Porous materials

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 provides resilient and durable support to the vagina by encouraging tissue growth through the skirt, allowing the anchor to support the vagina after the plug biodegrades, effectively addressing pelvic organ prolapse by promoting natural conformation and force distribution.

Implementation Method 1

The plug is made of biodegradable material and is insertable into the vagina

Methodology Applied
Scientific EffectBiodegradation: Decomposition (biological)

Data Source

PatentEP3106126B1System for treating pelvic organ prolapse including a shell and an anchor
Publication Date: 2019.07.17 COLOPLAST AS
  • EP3106126B1 patent drawingFigure 1
  • EP3106126B1 patent drawingFigure 2
  • EP3106126B1 patent drawingFigure 3A~3B

AI summary

A system for treating pelvic organ prolapse includes a shell and an anchor. The shell is made of biodegradable material that is insertable into a vagina. The shell has a convex exterior apex that is sized to contact an interior apical portion of the vagina. The anchor has a proximal portion that is attachable to the apex of the shell and a distal portion that is provided with a tissue fixation device that is attachable to tissue exterior the vagina such that the anchor and the shell combine to support and elevate the interior apical portion of a vagina.