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Dual Excitation Catheter-delivered Laser Ultrasound Thrombolysis (DECLUT) for Deep Vein Thrombosis (DVT) Treatment

Award Number: R41HL154735
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2020
PERIOD OF PERFORMANCE END DATE: 07/31/2022

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Dual Excitation Catheter-delivered Laser Ultrasound Thrombolysis (DECLUT) for Deep Vein Thrombosis (DVT) Treatment - Dual Excitation Catheter-delivered Laser Ultrasound Thrombolysis (DECLUT) for Deep Vein Thrombosis (DVT) Treatment Deep-vein thrombosis (DVT), or the formation of clots in the deep veins of the legs, affects two million Americans per year. DVT can cause pulmonary embolism (PE), which is fatal in >0.1 million cases annually in the US alone, presents as sudden death in 20-25% of cases. Recent innovative DVT treatment techniques, such as pharmacological dissolution or fibrinolysis, mechanical fragmentation and sonothrombolysis, showed progressive results. However, the low thrombolysis efficiency, vein injury associated severe regional dysfunction, the relatively large size of clot debris, risk of recurrent and distal embolism are key limitations for effective DVT treatments. More recently, research on ultrasound thrombolysis using multifrequency ultrasound excitations, combined continuous wave and laser ultrasound excitations, and excitations using microbubbles (MBs) showed promising lytic rate, but these demonstrated methods used transducers with relatively large aperture and are not applicable to integrated catheter for intravascular thrombolysis. In this project, a dual excitation catheter-delivered laser ultrasound thrombolysis (DECLUT) technology is proposed to address the existing challenges in DVT treatments. In specific, a 7-French catheter integrated with a small aperture dual frequency high intensity ultrasound transducer, a laser ultrasound transducer, and a micro-tube for delivery of MBs and lytic agent (t-PA) will be designed, prototyped and characterized, followed by in-vitro and ex-vivo thrombolysis tests. With the proposed technique, fast clot dissolution can be expected because of the use of MBs and the dual-ultrasound excitation; safe clot-dissolving can be achieved due to the minimal use of lytic agent, the reduced physical contact to the target clot and the minimal acoustic exposure of the surrounding vessel wall. The proposed DECLUT technology provides a new tool enabling physicians in more accurate, fast and safe DVT treatment, and facilitating the development of novel intravascular drugs and device therapies. In addition to DVT treatments and other intravascular thrombolysis, the proposed DECLUT technique will be also be useful in minimal invasive cancer treatment and targeted drug delivery.


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: 2024 ( Subtotal = $0 )
2024	2020	SONOVASCULAR, INC	101 GLEN LENNOX DR UNIT 250	CHAPEL HILL	NC	27517	ORANGE	USA	Blood Diseases and Resources Research	000	1	11/30/2023	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	SONOVASCULAR, LLC	5411 ENVIRON WAY	CHAPEL HILL	NC	27517	ORANGE	USA	Blood Diseases and Resources Research	000	1	10/26/2020	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $150,000 )
2020	2020	SONOVASCULAR, LLC	5411 ENVIRON WAY	CHAPEL HILL	NC	27517	ORANGE	USA	Blood Diseases and Resources Research	000	1	8/11/2020	NEW	$150,000
														Subtotal = $150,000

Grand Total All Awards = $150,000

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Dual Excitation Catheter-delivered Laser Ultrasound Thrombolysis (DECLUT) for Deep Vein Thrombosis (DVT) Treatment

Award Number: R41HL154735

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/15/2020

PERIOD OF PERFORMANCE END DATE: 07/31/2022

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