Dosage Tool for Botulinum Neurotoxin in Pediatric Spasticity

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Solution Overview

Problem

Current methods lack an effective tool for determining the precise dosage of botulinum neurotoxin for treating lower limb spasticity in subjects under 18 years old, particularly for administering to the gastrocnemius and soleus muscles, which are crucial for managing muscle tone and spasms in conditions like cerebral palsy and spinal cord injuries.

Innovation Solution

A tool comprising planar surfaces or a cursor that allows users to determine the appropriate dosage of botulinum neurotoxin based on the subject's weight, with specific guidelines for unilateral or bilateral administration to the gastrocnemius and soleus muscles, ensuring doses between 5 to 15 units per kilogram for effective treatment sessions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a tool is designed to provide precise dosage amounts for botulinum neurotoxin based on subject weight, then measurement precision is improved, but device complexity increases

Engineering Contradiction:
Improvedosage amount determinationVSAvoidtool structure
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The tool is divided into two separate members: a first member containing dosage information and a second member representing the subject's weight. This segmentation allows each component to have a simple, focused function while collectively providing precise dosage determination through their relationship.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The tool acts as an intermediary device between the subject's weight and the required dosage amount. By introducing this intermediate tool with aligned numerical scales, the complex calculation of dosage based on weight is simplified into a direct visual alignment process.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Adaptability or versatility

If the tool provides comprehensive dosage information for different muscles and administration types, then adaptability is improved, but device complexity increases

Engineering Contradiction:
Improvedosage calculation coverageVSAvoidinformation structure
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The first member is designed to provide universal dosage information that covers multiple muscles (gastrocnemius, soleus), different administration types (unilateral, bilateral), and various subject weights. This multi-functional design allows a single tool to address diverse dosing scenarios without requiring separate devices for each case.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Solution Approach 2:

The tool provides specific dosage recommendations tailored to different local conditions: different muscles (gastrocnemius vs. soleus), different administration approaches (unilateral vs. bilateral). Each section of the first member contains locally optimized dosage information appropriate for specific treatment scenarios.

Inventive Principle:
Principle #3Local quality

3Device complexity

If manual dosage calculation methods are used, then device complexity is reduced, but loss of time increases

Engineering Contradiction:
Improvecalculation methodVSAvoiddosage determination time
Core Design Contradiction:
Device complexityVSLoss of time

Solution Approach 1:

The first member contains pre-calculated dosage information that has been prepared in advance for various weight values. This preliminary action of pre-computing dosage amounts for different weights eliminates the need for complex calculations during the actual dosing process, significantly reducing the time required to determine the correct dosage.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentEP3658177B1Tool for dosing botulinum neurotoxin
Publication Date: 2024.03.20 IPSEN BIOPHARM LTD
  • EP3658177B1 patent drawingFigure 1
  • EP3658177B1 patent drawingFigure 2
  • EP3658177B1 patent drawingFigure 3

AI summary

A method of treating lower limb spasticity in a subject, particularly one which is 18 years of age or under, comprising administering to the subject an effective amount of botulinum neurotoxin. A composition for use in treating lower limb spasticity in a patient comprising botulinum neurotoxin. A tool for use in determining the dosage amount of an active agent to be administered to a subject.