Development of a Novel in-Plane Intravascular Ultrasound (IVUS)/Fiber Optical Imaging-Integrated Micro Puncture Balloon Catheter System for TIPS Creation

Transjugular intrahepatic portosystemic shunt (TIPS), a highly effective and life-saving procedure for patients with portal hypertension-related complications, remains one of the most challenging and radiation-intensive procedures. We are developing a novel in-plane intravascular ultrasound(IVUS)/fiber optical imaging-integrated micropuncture needle/balloon catheter system for TIPS creation.

Materials and Methods: This new technique and novel device development include three phases, (i) design and production of a 10-French three-channel 21 or 22G needle-integrated balloon catheter system equipped with a handle at the end, in which a gear and gear track system is contained to drive the needle. ∅ 0.4 mm fiber optical borescope and 8-Fr. Siemens ACUSON ultrasound catheter was integrated into the needle and catheter channel respectively to guide the intrahepatic puncture; (ii) optimization of  the key components and parameters of the needle/balloon catheter systems in livers of 6 live adult pigs, including the length of the gear track, needle outer diameter, and angle of the curved needle tip; (iii) testing the entire system in the livers of 3 live pigs for creating the intrahepatic portosystemic shunt and compare the puncture times, procedure time and radiation dose with the traditional TIPS procedure.

Results: We successfully built a 21G-needle integrated balloon catheter system that can accommodate the 8-Fr. ACUSON ultrasound catheter and fiber optical borescope to guide the needle puncture from the hepatic vein to the portal vein for TIPS creation. In-plane intravascular ultrasound is useful for demonstrating the portal vein system and real-time monitoring of the trajectory of the needle and fiber optical imaging is helpful for the instant confirmation of the needle in the portal vein. The optimal key parameters for the 100% success of puncture into the portal vein in 3 testing pigs  include the 7cm-long curved needle tip and 120-135° angle of the needle tip curve. Compared with the traditional TIPS using Rösch-Uchida system, our system can decrease the needle puncture times（3±1 vs 7±2), procedure time (32±5 vs 47±9 minutes), and radiation dose((180mGy vs 891 mGy).

Conclusion: We developed and tested an innovative in-plane IVUS/fiber optical imaging-integrated micro puncture balloon catheter system for TIPS creation in live pigs. This advancement lays the groundwork for further validation of the device and technique, aiming to simplify and ensure the safety of the TIPS procedure.