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Development of Optical Imaging/IVUS-Guided Micropuncture System for TIPS Creation

Award Number: R01EB034369
ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/07/2023
PERIOD OF PERFORMANCE END DATE: 11/30/2027

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Development of Optical Imaging/IVUS-Guided Micropuncture System for TIPS Creation - In 2017, decompensated cirrhosis caused more than 1.32 million deaths globally and 62,943 deaths in the USA. A transjugular intrahepatic portosystemic shunt (TIPS), an intraparenchymal artificial shunt created between the hepatic vein (HV) and the portal vein (PV), is the most effective life-saving procedure to stop acute variceal bleeding (AVB) that cannot be controlled endoscopically. TIPS is also effective to decrease the risk of recurrence of tense ascites and improve renal dysfunction in patients with chronic liver disease. However, Intrahepatic puncture for TIPS creation remains one of the most challenging and radiation-intensive procedure, carrying high risks of various complications in up to 20% of cases even in the hands of experienced Interventional Radiologists. Intraperitoneal hemorrhage caused by liver and extrahepatic portal vein rupture is the most catastrophic major complication of TIPS creation. In children, TIPS has been employed to alleviate symptoms of refractory ascites and variceal bleeding, but only adult TIPS puncture sets are available for kids with portal hypertension. The intrahepatic puncture devices, complications and technical failure rate have not changed since TIPS was invented by interventional radiologists (IR). To address the critical issues described above, we are developing a novel in-plane IVUS/fiber optic imaging-integrated micro puncture balloon catheter system for TIPS creation. Tests of the fine needle/balloon catheter system in pig cadavers for TIPS creation resulted in 100% success of placing a 5Fr. catheter in the portal vein from the right hepatic vein. This novel fine needle(22G)/balloon catheter system is expected to eliminate the risk and significantly lower the difficulties of TIPS techniques, which will ultimately increase the availability of TIPS treatment. The in-plane IVUS and/or fiber optic imaging guidance will further facilitate TIPS creation. Therefore, we need to implement a series of experiments to bridge the gap between our laboratory innovation of a novel system for TIPS creation and clinical translation for treating patients with portal hypertension. At first, we will optimize the key components and parameters of the needle/balloon catheter systems using human excised cirrhotic liver specimens. Secondly, we will develop the technique of using fiber optic imaging and/or in-plane IVUS- integrated needle/balloon catheter system for TIPS creation in normal adult pigs, optimize the technical parameters, and further validate the technique of using the system for TIPS in pigs with liver cirrhosis and portal hypertension. At last, we will develop the technique of using this novel system for TIPS creation in baby and young pigs, optimize the technical parameters, and further validate the technique of using the system for TIPS in young pigs with portal hypertension. We are confident that the success of this project will lead to significant breakthroughs in the procedure of TIPS creation and benefit millions of patients with decompensated cirrhosis.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $332,132 )
2026	2026	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	3	12/8/2025	NON-COMPETING CONTINUATION	$332,132
														Subtotal = $332,132

Issue Date FY: 2025 ( Subtotal = $415,165 )
2025	2025	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	2	11/27/2024	NON-COMPETING CONTINUATION	$373,650
2025	2025	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	001	2	5/19/2025	NON-COMPETING CONTINUATION	$41,515
														Subtotal = $415,165

Issue Date FY: 2024 ( Subtotal = $423,708 )
2024	2024	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	001	1	4/22/2024	NEW	$33,451
2024	2024	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	1	12/7/2023	NEW	$390,257
														Subtotal = $423,708

Grand Total All Awards = $1,171,005

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Development of Optical Imaging/IVUS-Guided Micropuncture System for TIPS Creation

Award Number: R01EB034369

ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 12/07/2023

PERIOD OF PERFORMANCE END DATE: 11/30/2027

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