Resuscitative Fluid Composition for Hypovolemia Treatment

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Solution Overview

Problem

Current treatments for hypovolemia and hypotension, such as Hextend and hypertonic saline solutions, have limitations including renal impairment, high sodium loads, and limited effectiveness in low extracellular volume conditions, as well as storage and logistical challenges.

Innovation Solution

A composition comprising specific salts, natural or synthetic sugars, and a high molecular weight, non-ionic, hydrophilic polymer, which can be in solid or liquid form, is administered to increase intravascular volume and pressure, providing resuscitative effects without the drawbacks of existing solutions, and can be easily stored and transported.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Volume of moving object

If Hextend (6% hetastarch) is used for plasma volume expansion, then intravascular volume is increased, but renal injury and mortality increase

Engineering Contradiction:
Improveintravascular volumeVSAvoidrenal injury
Core Design Contradiction:
Volume of moving objectVSObject-affected harmful factors

Solution Approach 1:

The patent changes the chemical composition parameters by replacing HES with a combination of hydroxypropyl starch and gelatin, creating a new resuscitative fluid formulation that maintains volume expansion efficacy while eliminating renal toxicity

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent uses a composite material approach by combining hydroxypropyl starch and gelatin in specific ratios (0.5:1 to 2:1 weight ratio) to create a synergistic formulation that provides both volume expansion and renal safety

Inventive Principle:
Principle #40Composite materials

2Weight of moving object

If hypertonic saline (7.5% NaCl) is used for volume replacement, then intravascular volume is expanded with reduced carrying weight, but high sodium loads cause adverse effects

Engineering Contradiction:
Improvecarrying weightVSAvoidsodium overload
Core Design Contradiction:
Weight of moving objectVSObject-affected harmful factors

Solution Approach 1:

The patent changes the osmotic composition by using a balanced electrolyte formulation with multiple ions (Na+, K+, Ca2+, Mg2+, Cl-, HCO3-, Lactate-) instead of high concentration single salt, achieving volume expansion without sodium overload

Inventive Principle:
Principle #35Parameter changes

3Volume of moving object

If human albumin solutions are used for treating hypovolemic shock, then plasma volume is expanded, but cost and storage limitations increase

Engineering Contradiction:
Improveplasma volumeVSAvoidstorage requirements
Core Design Contradiction:
Volume of moving objectVSEase of manufacture

Solution Approach 1:

The patent replaces expensive human albumin with a cost-effective synthetic formulation using hydroxypropyl starch and gelatin that can be manufactured and stored without cold chain requirements

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

Solution Approach 2:

The patent changes the physical state parameter by formulating the resuscitative fluid to be stable at room temperature and during freezing, eliminating cold chain storage requirements

Inventive Principle:
Principle #35Parameter changes

4Volume of moving object

If Hextend or HTS are used when extracellular volume is low, then volume replacement is attempted, but effectiveness is reduced

Engineering Contradiction:
Improveextracellular volumeVSAvoidtreatment effectiveness
Core Design Contradiction:
Volume of moving objectVSReliability

Solution Approach 1:

The patent optimizes the osmolarity parameter of the resuscitative fluid to match physiological conditions, ensuring effective volume expansion even when extracellular volume is low

Inventive Principle:
Principle #35Parameter 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 composition effectively restores blood volume and pressure, reduces organ distress, and has a long shelf-life, making it suitable for emergency situations without causing renal impairment or sodium overload, and is more effective than existing solutions in maintaining blood pressure for extended periods.

Implementation Method 1

The composition contains certain pre-selected quantities of salts, natural or synthetic sugars, and at least one high molecular weight, non-ionic, hydrophilic polymer... The composition has the capability to increase intravascular volume and pressure of the treated subject

Methodology Applied
Scientific EffectOsmotic pressure: Osmotic Pressure

Data Source

PatentEP3307283B1Composition and methods for treatment of loss of fluids leading to hypotension and/or hypovolemia
Publication Date: 2020.09.02 CELLPHIRE INC
  • EP3307283B1 patent drawingFigure 1
  • EP3307283B1 patent drawingFigure 2
  • EP3307283B1 patent drawingFigure 3

AI summary

The present invention is directed to a composition containing at least one salt, at least one natural or synthetic saccharide, and at least one natural or synthetic high molecular weight, non-ionic, hydrophilic polymer. When in a liquid form, the composition is ready for infusion or injection to patients that suffer from loss of fluids that causes reduced volume and/or pressure in the systemic circulation. The composition is also suitable for treatment of organ conditions where blood flow is impaired or insufficient, resulting in organ distress, including tissue loss. The invention also relates to use as a prophylaxis to prevent medical consequences of anticipated conditions where depleted circulatory fluids, low blood pressure, or impaired organ perfusion require correction.