Universal Cardioplegic Solution for Myocardial Protection

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Solution Overview

Problem

Current cardioplegic solutions for cardiac surgery face challenges such as high risks of myocardial injury, ischemia, and logistical complexities, particularly in maintaining asystole and managing potassium levels, which can lead to surgical complications and increased mortality.

Innovation Solution

A general-purpose cardioplegic solution is developed that uses a single formulation for both achieving and maintaining asystole, with adjustable potassium chloride content and pH buffering, allowing for flexible infusion ratios and rates to optimize myocardial protection, reducing the need for multiple solutions and minimizing surgical complications.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If multiple separate cardioplegic solutions are used (high-potassium for arrest, low-potassium for maintenance), then cardiac arrest and asystole maintenance can be achieved, but solution preparation complexity and labor input increase

Engineering Contradiction:
Improvecardiac arrest and asystole maintenanceVSAvoidsolution preparation complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the functions of high-potassium solution (for cardiac arrest) and low-potassium solution (for asystole maintenance) into a single universal cardioplegic solution. This eliminates the need for separate solution preparations and reduces labor input while maintaining reliable cardiac arrest and asystole maintenance through continuous infusion at controlled rates

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The universal cardioplegic solution is designed to perform multiple functions: inducing cardiac arrest, maintaining asystole, and protecting myocardium throughout surgery. A single solution formulation with potassium chloride (4-8 g/L) can replace multiple specialized solutions, simplifying the overall system while achieving comprehensive cardiac protection

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

2Reliability

If potassium chloride concentration is increased to ensure cardiac arrest, then cardiac arrest is achieved more reliably, but risk of hyperkalemia and failure to restore heart function increases

Engineering Contradiction:
Improvecardiac arrest achievementVSAvoidhyperkalemia risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent employs dynamic adjustment of potassium chloride concentration within the range of 4-8 g/L based on surgical phase requirements. During cardiac induction, higher concentrations (closer to 8 g/L) are used to ensure reliable arrest, while during maintenance phase, lower concentrations (closer to 4 g/L) are used to prevent hyperkalemia. This dynamic approach allows the solution to adapt to changing physiological conditions

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The solution formulation allows flexible adjustment of potassium chloride concentration as a key parameter. By maintaining potassium levels within the optimized range of 4-8 g/L and controlling infusion rates, the system achieves reliable cardiac arrest while preventing dangerous hyperkalemia through parameter optimization rather than fixed high concentrations

Inventive Principle:
Principle #35Parameter changes

3Reliability

If cold crystalloid cardioplegia is used for myocardial protection, then cardiac arrest is achieved, but surgical complications increase due to cooling requirements and blood substitute use

Engineering Contradiction:
Improvecardiac arrestVSAvoidsurgical complications
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent fundamentally changes the temperature parameter from cold (4°C) to warm (37°C), eliminating hypothermia-related complications. The solution maintains physiological temperature, avoiding the need for systemic cooling and preventing cold-induced surgical complications while still achieving reliable cardiac arrest through optimized potassium chloride concentration and continuous infusion

Inventive Principle:
Principle #35Parameter changes

4Object-affected harmful factors

If warm blood cardioplegia is used without cooling, then hypothermia complications are avoided, but myocardial protection efficiency decreases

Engineering Contradiction:
Improvehyperthermia avoidanceVSAvoidmyocardial protection
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The patent creates a composite cardioplegic solution combining warm blood (maintaining physiological temperature) with optimized crystalloid components including potassium chloride (4-8 g/L), magnesium sulfate, and buffering agents. This composite formulation achieves both warm temperature (avoiding hypothermia) and effective myocardial protection (through optimized electrolyte composition and continuous infusion), resolving the contradiction between temperature management and protection efficacy

Inventive Principle:
Principle #40Composite materials

Data Source

PatentUS10987378B2Universal cardioplegic solution (variants)
Publication Date: 2021.04.27 OBSHCHESTVO S OGRANICHENNOJ OTVETSTVENNOSTJU KARDIOSISTEMFARMA OOO KSF
  • US10987378B2 patent drawing
  • US10987378B2 patent drawing

AI summary

This invention relates to medicine, more specifically, to cardiac surgery, and may be used for protecting the heart from ischemia when administering cardioplegia in normothermia or hypothermia. The general-purpose cardioplegic solution contains pharmaceutically acceptable potassium ions; magnesium ions; a base and an acid providing a pH buffer in a range of 7.1-8.9; a diuretic providing osmolality in a range of 275-460 mOsmol/kg. Said solution is used for cardiac protection in cardiopulmonary bypass, as well as for achieving asystole and maintaining the achieved asystole. The procedure for administering the general-purpose cardioplegic solution involves maintaining the achieved asystole by decreasing the flow rate of starting components of said solution relative to the flow rate of autoblood thus decreasing the solution to autoblood ratio.