Bivalirudin Anticoagulant for Stem Cell Viability in Cardiovascular Therapy
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Solution Overview
Problem
Current methods for aspirating, processing, and delivering bone marrow-derived stem cells for cardiovascular diseases are inefficient, often resulting in cell damage due to shear stress and inappropriate viscosity, and existing anticoagulants like heparin can impair stem cell function and cause adverse events.
Innovation Solution
A rapid point-of-care method using bivalirudin as an anticoagulant to minimize clot formation and maintain stem cell viability, combined with a disposable centrifugal cell stratification device for efficient isolation and delivery of bone marrow stem cells at controlled viscosity and flow rates, ensuring safe and effective transcatheter injection.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Object-affected harmful factors
If conventional anticoagulants like heparin are used during bone marrow aspiration and processing, then clot formation is prevented, but stem cell function is impaired and adverse events occur
Solution Approach 1:
The patent uses bivalirudin as an intermediary anticoagulant agent that mediates between the need to prevent clot formation during bone marrow processing and the need to preserve stem cell function. Bivalirudin directly inhibits thrombin without the harmful effects of heparin on stem cells, serving as a safer mediator in the blood coagulation system during the procedure.
Solution Approach 2:
The patent changes the parameter of anticoagulant type from heparin to bivalirudin, and optimizes the concentration of bivalirudin to achieve effective clot prevention while minimizing impact on stem cell viability and function. This parameter change resolves the contradiction by finding an optimal balance point.
2Productivity
If bone marrow is processed and stored for extended periods, then cell isolation and testing can be completed, but cell viability decreases due to prolonged exposure to anticoagulant
Solution Approach 1:
The patent performs rapid cell isolation, concentration, and quality assessment procedures as preliminary actions within a compressed timeframe. By completing critical processing steps quickly using automated systems and point-of-care testing, the exposure time to anticoagulant is minimized while still achieving complete cell isolation and necessary testing.
Solution Approach 2:
The patent accelerates the processing workflow by skipping unnecessary delays and using rapid assessment methods. The streamlined protocol rushes through the critical steps of cell isolation, concentration, and quality verification in a matter of hours rather than days, reducing the time cells are exposed to anticoagulant and preserving viability.
3Stability of the object's composition
If high concentration of anticoagulant is used to prevent clotting, then blood remains fluid during procedure, but stem cell function and viability are negatively affected
Solution Approach 1:
The patent changes the parameter of anticoagulant concentration to an optimized level of bivalirudin that is sufficient to maintain blood fluidity during aspiration and processing but low enough to minimize negative effects on stem cell function. This optimized concentration parameter resolves the contradiction between maintaining fluidity and preserving cell function.
4Manufacturing precision
If extensive laboratory infrastructure and multi-hour procedures are used for stem cell processing, then thorough cell isolation and testing can be achieved, but cost and time requirements increase
Solution Approach 1:
The patent employs automated cell isolation systems and point-of-care testing devices that perform cell separation, concentration, and quality assessment functions autonomously or with minimal human intervention. These self-service systems maintain high isolation quality while dramatically reducing procedure time and eliminating the need for extensive centralized laboratory infrastructure.
Solution Approach 2:
The patent segments the cell processing procedure into modular steps that can be performed sequentially in a streamlined manner. By dividing the process into discrete, automated modules for aspiration, cell isolation, concentration, and quality testing, the system achieves thorough processing while reducing overall time and infrastructure requirements compared to traditional centralized laboratory approaches.
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 enables the safe and efficient delivery of viable stem cells, reducing apoptosis and improving ischemic conditions by maintaining cell viability and function, with a 4-fold improvement in left ventricle ejection fraction and 25% improvement in amputation-free survival rate compared to conventional methods.
Implementation Method 1
a disposable centrifugal cell stratification device for efficient isolation and delivery of bone marrow stem cells
Data Source
AI summary
The present invention relates to a method and composition for the aspiration, processing, testing and infusion of bone marrow derived stem cells, as an adjuvant treatment in cardiovascular disorders. More specifically, the invention provides for the methods and compositions for the aspiration, analysis, processing, infusate preparation and infusion of bone-marrow derived stem cells, particularly in a rapid point-of-care environment, wherein a centrifugal fractionation and optically monitored separation of the bone marrow yield desired cellular product in the desired concentration and viscosity.