Ethyl Cellulose Ethanol Ablation for Localized Lesion Treatment

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Solution Overview

Problem

Access to effective treatment for malignant, premalignant, and benign lesions is limited by physiological constraints and resource shortages, particularly in regions lacking specialized medical personnel and infrastructure, as seen in the case of head and neck squamous cell carcinoma and cervical cancer, where current treatments like cryotherapy and loop electrosurgical excision are costly and require specialized equipment.

Innovation Solution

A novel ethanol ablation method using ethyl cellulose to enhance ethanol localization and efficacy, combined with a fluorescent dye for visualization, which is administered at controlled rates to treat lesions effectively without specialized equipment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If pure ethanol is used for ablation, then the treatment can be administered without specialized equipment, but the ethanol leaks into nearby tissue and is rapidly cleared by vascular clearance, reducing efficacy

Engineering Contradiction:
Improveadministration simplicityVSAvoidtreatment efficacy
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent combines ethanol with ethyl cellulose to create a composite ablation solution. The ethyl cellulose component provides viscosity control and localized gel formation upon contact with tissue water, while ethanol provides the cytotoxic ablation effect. This composite approach maintains the simplicity of administration without specialized equipment while preventing leakage and rapid vascular clearance, thereby resolving the contradiction between ease of manufacture and treatment reliability

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The patent modifies the physical parameters of ethanol by adjusting viscosity through ethyl cellulose concentration (0.1-10% w/v) and controlling gel formation kinetics. By changing the viscosity parameter and the gelation time parameter, the solution remains injectable without specialized equipment but forms a stable gel in situ that prevents leakage and extends retention time, thus resolving the contradiction between administration simplicity and treatment efficacy

Inventive Principle:
Principle #35Parameter changes

2Reliability

If gel ethanol is used to control localization, then treatment efficacy is enhanced, but the formulation complexity increases

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

Solution Approach 1:

The gel ethanol formulation utilizes the natural water content of tissue to trigger gel formation. Upon injection, the ethyl cellulose-ethanol solution automatically gels as it contacts the aqueous environment of the tumor tissue, eliminating the need for external gelation agents or complex delivery systems. This self-gelling property enhances localization and efficacy while keeping the formulation relatively simple, resolving the contradiction between treatment efficacy and formulation complexity

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The patent uses ethyl cellulose as an intermediary substance that bridges the gap between liquid ethanol (easy to administer) and gel state (localized retention). The ethyl cellulose acts as a mediator that transforms the physical state of ethanol in situ without requiring complex formulation ingredients or specialized delivery equipment, thus enhancing efficacy while limiting formulation complexity

Inventive Principle:
Principle #24Intermediary (Mediator)

3Measurement precision

If fluorescent dye is added for visualization, then real-time monitoring of gel ethanol distribution is enabled, but the formulation becomes more complex

Engineering Contradiction:
Improvedistribution visualizationVSAvoidformulation complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent incorporates fluorescent dyes (such as fluorescein or indocyanine green) into the gel ethanol formulation to enable optical visualization. The fluorescent component allows real-time monitoring of solution distribution and gel formation through fluorescence imaging. This color/fluorescence change property provides precise measurement of distribution while adding minimal complexity to the formulation, as the dye is simply mixed into the existing ethyl cellulose-ethanol system

Inventive Principle:
Principle #32Color changes

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 method achieves significant lesion reduction and treatment with reduced side effects, suitable for resource-limited settings, and can be applied to various cancer types and benign lesions, including cervical and head and neck cancers, with real-time visualization ensuring effective delivery.

Implementation Method 1

Ethyl cellulose is soluble in ethanol, but forms a stiff gel when it encounters an aqueous environment (tissue), which is referred to here as gel ethanol.

Methodology Applied
Scientific EffectGel formation: Gel

Implementation Method 2

Using a hand-held Pocket Scope, a product that we have previously developed, we can visualize gel ethanol distribution in vivo in real time.

Methodology Applied
Scientific EffectFluorescence: Fluorescence

Data Source

PatentUS12350341B2Methods for the treatment of cancer and benign lesions by ablation
Publication Date: 2025.07.08 DUKE UNIV
  • US12350341B2 patent drawing
  • US12350341B2 patent drawing
  • US12350341B2 patent drawing

AI summary

The present disclosure provides methods for the treatment of a lesion, such as a cancerous lesion, a precancerous lesion, or a benign lesion (e.g. a benign lesion on the skin) in a subject comprising administering to the subject a therapeutically effective amount of a therapy solution comprising a viscous carrier and an alcohol or hydrophobic anti-cancer agent, such that the lesion is treated. In some embodiments, the therapy solution includes an ethyl cellulose-ethanol mixture. In some embodiments, the therapy solution is administered to the lesion at a rate of from about 1 mL/hr to about 15 mL/hr.