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Particle leakage in extracorporeal blood purification systems based on microparticle suspensions
Jens Hartmann1, Claudia Schildboeck, Martin Brandl
1Center for Biomedical Technology, Danube University Krems, Krems, Austria. jens.hartmann@donau-uni.ac.at
Aim:
The newly developed 'Microspheres based Detoxification System' (MDS) designed for any extracorporeal adsorption therapy uses microparticles as adsorbents characterized by a size of 1-20 microm in diameter which are recirculated in the secondary (filtrate) circuit connected to a hollow fiber filter located in the primary (blood) circuit. In the case of a leakage or rupture in the hollow fiber filter, microspheres can enter patients' blood circuits and cause embolic episodes in different organs with varying degrees of clinical relevance. Aim of this study was to determine the amount of particles infused to a patient during a long-term treatment under different failure conditions of the filter.
Methods:
The filters were prepared by cutting single hollow fibers. Fresh-frozen plasma (FFP) and a mixture of glycerol and water were used as a medium together with microparticles potentially used in the MDS. The amounts of particles transferred from the filtrate into the primary circuit were measured.
Results:
The analysis of particle transfer in the case of a single cut hollow fiber inside the membrane results in particle volumes of up to 26 ml calculated for 10 h.
Conclusion:
Particle leakage in microparticle suspension based detoxification systems can lead to considerable particle transfer to the patient. Therefore, a particle detection unit which is able to detect critical amounts of particles (<1 ml particle volume/treatment) in the extracorporeal blood line is necessary for patient safety.
Insights
Microspheres used in detoxification systems can leak into patient bloodlines, potentially causing harm. This study quantizes particle transfer under filter failure, highlighting the need for safety monitoring systems in extracorporeal therapies.
Area of Science:
- Biomedical Engineering
- Materials Science
- Nephrology
Background:
- The Microspheres based Detoxification System (MDS) utilizes microparticles for extracorporeal adsorption therapy.
- Microparticles (1-20 microm) recirculate in a secondary circuit, connected to a primary blood circuit via a hollow fiber filter.
- Filter integrity is crucial, as leakage can lead to embolic episodes in patients.
Purpose of the Study:
- To quantify particle infusion into the blood circuit during long-term treatment under various hollow fiber filter failure conditions.
- To assess the risk of microsphere embolization in patients undergoing MDS therapy.
Main Methods:
- Hollow fiber filters were intentionally compromised by cutting single fibers.
- Microparticles were suspended in a plasma-like medium (FFP and glycerol/water mixture).
- Particle transfer from the filtrate to the primary circuit was measured.
Main Results:
- A single cut hollow fiber resulted in significant particle transfer.
- Calculated particle volumes transferred reached up to 26 ml over a 10-hour period.
- This demonstrates a considerable risk of particle leakage during MDS treatment.
Conclusions:
- Particle leakage poses a significant risk in microparticle suspension-based detoxification systems.
- A particle detection unit is essential for patient safety.
- Detecting critical particle amounts (<1 ml/treatment) in the extracorporeal bloodline is necessary.
