Ethanol-Based Embolic Composition with Viscosity Control

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Solution Overview

Problem

Current embolic agents using anhydrous ethanol face challenges such as difficulty in accurate dosage control, visibility issues under imaging, high operational complexity, and potential for recanalization due to their properties and interactions with blood vessels.

Innovation Solution

A pharmaceutical composition containing ethanol with a concentration of at least 50% combined with a liquid thickener like Povidone and an imaging agent, allowing for adjustable viscosity and visibility under imaging, enabling direct injection into blood vessels for precise embolization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If anhydrous ethanol is used as embolic agent, then embolization effect is achieved, but dosage control is difficult and ectopic embolism occurs

Engineering Contradiction:
Improveembolization effectVSAvoiddosage control
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent changes the concentration parameter of ethanol from 100% (anhydrous) to 50-95%, and adjusts viscosity parameters by adding thickeners. This allows for controlled flow rate and improved dosage precision while maintaining embolization effectiveness, directly resolving the contradiction between reliable embolization and precise dosage control

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates a composite embolic agent by combining ethanol with thickeners (such as gelatin, dextran, or carboxymethyl cellulose) and imaging agents. This composite formulation provides viscous control for accurate dosage, imaging capability for monitoring, and maintains the embolization effect, simultaneously addressing multiple contradictions

Inventive Principle:
Principle #40Composite materials

2Reliability

If anhydrous ethanol is injected directly, then embolization is achieved, but flow rate is too large causing pulmonary hypertension

Engineering Contradiction:
Improveembolization effectVSAvoidflow rate
Core Design Contradiction:
ReliabilityVSSpeed

Solution Approach 1:

By adding thickeners to increase the viscosity parameter of the embolic agent, the patent reduces the flow rate of ethanol injection. This allows for controlled, slow injection that maintains embolization effect while preventing pulmonary hypertension caused by rapid injection of large volumes

Inventive Principle:
Principle #35Parameter changes

3Difficulty of detecting and measuring

If imaging agent is added to make ethanol visible, then imaging capability is improved, but ethanol concentration is diluted reducing therapeutic effect

Engineering Contradiction:
Improveimaging capabilityVSAvoidethanol concentration
Core Design Contradiction:
Difficulty of detecting and measuringVSQuantity of substance

Solution Approach 1:

The patent creates a composite formulation where imaging agents (such as iodine-containing compounds or metal particles) are incorporated into the ethanol-thickener system. The imaging agent is used in small quantities that provide sufficient imaging contrast without significantly diluting the ethanol concentration, thus maintaining both imaging capability and therapeutic effect

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The imaging agent provides localized visibility only where needed for imaging purposes, while the bulk composition remains high-concentration ethanol-thickener mixture. This allows the system to have imaging capability in specific regions without compromising the overall ethanol concentration and therapeutic effectiveness

Inventive Principle:
Principle #3Local quality

4Reliability

If Onyx embolic agent is used, then embolization is achieved, but operation is complicated and adhesion to microcatheter occurs

Engineering Contradiction:
Improveembolization effectVSAvoidoperational complexity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The patent uses a simpler, more disposable-friendly formulation based on ethanol and common thickeners that can be easily handled with standard catheters. The formulation does not require special handling procedures, shaking, or pre-filling steps, making it easier to operate and less prone to adhesion issues compared to complex formulations like Onyx

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

5Reliability

If anhydrous ethanol is used, then embolization effect is achieved, but visibility under X-ray or ultrasonic waves is poor

Engineering Contradiction:
Improveembolization effectVSAvoidimaging visibility
Core Design Contradiction:
ReliabilityVSDifficulty of detecting and measuring

Solution Approach 1:

The patent incorporates imaging agents into the ethanol-thickener formulation to create a composite embolic agent that provides both therapeutic and diagnostic functions. The imaging agents (such as iodine-based compounds for X-ray or echogenic particles for ultrasound) enhance visibility without compromising the embolization effect

Inventive Principle:
Principle #40Composite 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 composition achieves high-performance vascular embolization with adjustable viscosity and imaging capabilities, preventing recanalization and reducing side effects, while being cost-effective and suitable for various clinical applications.

Implementation Method 1

ethanol with a concentration of not less than 50% and a liquid ethanol thickener

Methodology Applied
Scientific EffectViscosity modification:

Implementation Method 2

it is invisible in the cavity under X-rays or ultrasonic waves, and an imaging agent needs to be added

Methodology Applied
Scientific EffectX-ray imaging: X-Ray

Implementation Method 3

it is invisible in the cavity under X-rays or ultrasonic waves

Methodology Applied
Scientific EffectUltrasonic imaging: Ultrasound

Implementation Method 4

Anhydrous ethanol, due to its dehydration and erosion effect, denatures the contacted hemoglobin and directly destroys the vascular endothelial cells

Methodology Applied
Scientific EffectDehydration effect:

Implementation Method 5

Anhydrous ethanol, due to its dehydration and erosion effect, denatures the contacted hemoglobin

Methodology Applied
Scientific EffectErosion effect: Erosion

Implementation Method 6

A gas-liquid preparation comprising the pharmaceutical composition containing ethanol is provided, which comprises a plurality of sections of the pharmaceutical composition containing ethanol separated by a gas

Methodology Applied
Scientific EffectGas-liquid separation:

Data Source

PatentUS20240173270A1Pharmaceutical composition containing ethanol and use thereof
Publication Date: 2024.05.30 MEDESSENCE LIFESCIENCES SUZHOU INC
  • US20240173270A1 patent drawing
  • US20240173270A1 patent drawing
  • US20240173270A1 patent drawing

AI summary

Disclosed are a pharmaceutical composition containing ethanol and a use thereof. The pharmaceutical composition can be used in vivo for animals, and is prepared from the following raw material: ethanol having a concentration no lower than 50% and a liquid ethanol thickener. The pharmaceutical composition containing ethanol provided in the present invention has high developability and sufficient fluidity without toxic side effect on normal tissues. The present invention does not solidify in blood and can break endothelial cells or mucous membrane superficial tissues so as to allow for permanent embolization.