Hyaluronidase-Enhanced Botulinum Toxin Diffusion

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Solution Overview

Problem

Current methods for treating cholinergically-influenced disorders, such as overactive bladder and hyperhidrosis, require multiple injections of botulinum toxin, which can be painful and inefficient due to the large size of the toxin molecule limiting its diffusion.

Innovation Solution

The use of extracellular matrix digesting enzymes, like hyaluronidase, to enhance the diffusion of botulinum toxin by breaking down the extracellular matrix, allowing for reduced or eliminated injections by administering the enzyme followed by the toxin, either through instillation or topical application, to achieve therapeutic effects.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple injections of botulinum toxin are administered to treat cholinergically-influenced disorders, then therapeutic effectiveness is achieved, but patient comfort deteriorates due to pain and inconvenience from multiple needle penetrations

Engineering Contradiction:
Improvetherapeutic effectivenessVSAvoidpatient comfort
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent introduces an extracellular matrix digesting enzyme as an intermediary substance that facilitates the diffusion and distribution of botulinum toxin throughout the target tissue. This enzyme acts as a mediator between the toxin and the extracellular matrix, breaking down the matrix structure to enable more effective and uniform toxin penetration, thereby reducing the number of injections needed while maintaining therapeutic effectiveness and improving patient comfort

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If multiple injections of botulinum toxin are administered to ensure adequate diffusion and coverage, then treatment efficacy is improved, but the complexity and time required for treatment increases

Engineering Contradiction:
Improvetreatment efficacyVSAvoidtreatment complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent applies preliminary action by administering the extracellular matrix digesting enzyme before the botulinum toxin to prepare the tissue structure. This preliminary enzymatic breakdown of the extracellular matrix creates favorable conditions for subsequent toxin diffusion, ensuring adequate coverage and efficacy with fewer injections and reduced treatment complexity

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The extracellular matrix digesting enzyme serves as a facilitator that enhances toxin distribution throughout the target area. By degrading the extracellular matrix structure, the enzyme creates pathways that allow the botulinum toxin to diffuse more effectively, thereby achieving treatment efficacy with reduced injection numbers and simplified treatment protocols

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

This approach significantly reduces the number of injections needed, enhances the toxin's diffusion, and provides sustained therapeutic benefits for disorders like overactive bladder and hyperhidrosis, improving patient comfort and treatment efficacy.

Implementation Method 1

The use of extracellular matrix digesting enzymes, like hyaluronidase, to enhance the diffusion of botulinum toxin by breaking down the extracellular matrix

Methodology Applied
Scientific EffectExtracellular matrix digestion: Enzyme

Implementation Method 2

enhances the diffusion of botulinum toxin by breaking down the extracellular matrix

Methodology Applied
Scientific EffectDiffusion: Diffusion

Data Source

PatentUS8697066B2Botulinum toxin compositions and methods
Publication Date: 2014.04.15 ALLERGAN INC

AI summary

Disclosed herein are methods of using extracellular matrix digesting enzymes and neurotoxins, such as a Clostridial neurotoxins, to treat various medical conditions, such as overactive bladder, benign prostatic hyperplasia, hyperhidrosis, for example.