In vitro biocompatibility evaluation of the dynamic bubble trap

Area of Science:

• Biomedical Engineering
• Materials Science
• Hematology

Background:

• Biocompatibility assessment is crucial before clinical application of medical devices.
• The dynamic bubble trap (DBT) is a novel device requiring safety evaluation.
• In vitro models simulating physiological conditions are valuable for preliminary testing.

Purpose of the Study:

• To evaluate the hemocompatibility of the dynamic bubble trap (DBT).
• To determine if the DBT adversely affects blood parameters under simulated physiological conditions.
• To provide safety data for the DBT prior to its use in clinical trials.

Main Methods:

• An in vitro model was established to simulate physiological conditions.
• Twenty experimental runs were conducted: ten with the DBT and ten as a control.
• Fifteen blood parameters, including hemogram, hemostasis, complement system, and cytokines, were measured at five intervals during 180-minute trials at a 3 L/min blood flow rate.

Main Results:

• No statistically significant differences were observed in any of the fifteen tested blood parameters between the DBT and control groups.
• Hemocompatibility was maintained throughout the experimental duration.
• The DBT demonstrated no adverse impact on the measured hematological, hemostatic, complement, or cytokine profiles.

Conclusions:

• The dynamic bubble trap (DBT) exhibits excellent hemocompatibility in this in vitro study.
• The DBT is a safe tool for in vivo application, as evidenced by the lack of adverse effects on blood parameters.
• These findings support the progression of the DBT to clinical trials.