Vaginal Microbiota Inoculum Device for C-Section Infants

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Solution Overview

Problem

Pre-term and C-section born infants often experience abnormal microbiota development, leading to increased risks of immune, inflammatory, and metabolic disorders due to the lack of natural vaginal microbiota seeding, which is crucial for healthy immunological and metabolic programming.

Innovation Solution

Administering an effective amount of maternal vaginal microbiota inoculum or a probiotic composition to pre-term or C-section born infants at birth or shortly thereafter, which stimulates the growth of under-represented bacteria and inhibits over-represented bacteria in their microbiota, mimicking the natural vaginal delivery process.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If Cesarean section delivery is performed, then delivery time is reduced and maternal safety is improved, but natural vaginal microbiota seeding is prevented and infant microbiota development is abnormal

Engineering Contradiction:
Improvematernal safetyVSAvoidmicrobiota composition
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent applies preliminary action by collecting maternal vaginal microbiota samples during the third trimester of pregnancy and storing them for later administration. This allows the microbiota to be prepared in advance and administered to the infant after Cesarean section delivery, compensating for the missed natural seeding opportunity during birth.

Inventive Principle:
Principle #10Preliminary action

2Stability of the object's composition

If vaginal microbiota inoculum is administered to restore normal microbiota, then microbiota composition is improved, but additional medical intervention is required

Engineering Contradiction:
Improvemicrobiota compositionVSAvoidmedical intervention complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The patent uses an intermediary approach by employing a probiotic composition as a mediator between the maternal vaginal microbiota and the infant's gut microbiota. The probiotic composition contains specific bacterial strains that serve as a bridge to restore healthy microbiota development in C-section infants without requiring complex medical procedures.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Stability of the object's composition

If probiotic composition is used to stimulate growth of under-represented bacteria, then microbiota balance is restored, but cost of treatment increases

Engineering Contradiction:
Improvemicrobiota balanceVSAvoidprobiotic composition quantity
Core Design Contradiction:
Stability of the object's compositionVSQuantity of substance

Solution Approach 1:

The patent applies parameter changes by optimizing the concentration and composition of bacterial strains in the probiotic formulation. By carefully selecting specific strains and their concentrations, the patent achieves effective microbiota restoration while minimizing the quantity of probiotic material required, thereby reducing treatment costs.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentUS11564667B2Device and method of restoring microbiota of newborns
Publication Date: 2023.01.31 NEW YORK UNIV
  • US11564667B2 patent drawing
  • US11564667B2 patent drawing
  • US11564667B2 patent drawing

AI summary

The invention relates to methods and compositions for restoring normal microbiota in pre-term newborns or newborns delivered by Cesarean section and methods for preventing or ameliorating diseases associated with delivery by Cesarean section or pre-term birth comprising administering to said newborns at the time of birth or shortly thereafter an effective amount of a vaginal microbiota inoculum obtained from the newborn's mother or a donor or an effective amount of a probiotic composition. The invention also relates to a device for collecting maternal vaginal microbiota from the vaginal canal of a patient. The device can have a housing forming a cavity, an absorbent material removable disposed within the cavity, and a deployment element disposed in the housing and movable along a length of the housing. The movement of the deployment element can displace the absorbent material out of the cavity and in to the vaginal canal.