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Vasodilation Needle for Trans-Radial Access

Award Number: R43HL149449
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/26/2020
PERIOD OF PERFORMANCE END DATE: 08/25/2023

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Vasodilation Needle for Trans-Radial Access - SUMMARY The number of percutaneous arterial access procedures using the transradial access (TRA) approach is growing rapidly in the US. Interventionalists are adopting the TRA technique due to lower risks associated with bleeding and no need for active vascular closure devices. TRA catheterization also satisfies patients because of increased comfort and mobility. Same-day discharge is generally possible, which lowers costs for patients and health insurance companies. Radial artery spasm (RAS) is the most common complication encountered with the TRA technique, however, making access difficult and/or causing sheath entrapment. RAS can be painful for patients and is difficult for interventionalists to manage. Various pharmacological agents are used, but there are two problems with that strategy. First, there is no generally accepted drug regimen with proven efficacy in treating RAS. Second, pharmacological treatment is initiated only after a problem has arisen. Since the clinically important problem of RAS persists, we propose a completely different approach to mitigating this complication; i.e., electrical-induced relaxation of radial artery smooth muscle cells by use of electrified needle (e-needle). Our preliminary data show that the radial artery dilates in response to electrical stimulation with extracellular electrodes. This observation leads us to hypothesize that TRA devices can be transformed into vasodilating extracellular electrodes (with the return path provided by a skin patch electrode). Our aim is to assemble a prototype device and demonstrate its safety and efficacy in vivo in swine. The novel access e-needle will be used under ultrasound guidance to simultaneously measure radial artery diameter and assess prototype efficacy. Further, safety will be determined by measuring the electrocardiogram and arterial blood pressure during prototype use as well as histopathology after explanting the swine radial artery. Our novel approach to RAS promises to shift the current clinical paradigm from one of ad hoc attempts at pharmacological management (in which there is no consistency, but undesired side effects like hypotension) to one based on well-understood biophysical and biomedical engineering principles. Our project offers to improve patient care and save time for physicians with a novel TRA e-needle that dilates the artery it contacts the vessel for access. This will spare patients the pain of experiencing vasospasm, eliminate risks from unnecessary pharmacological agents, lower medical costs, and improve physician efficiency.


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	3DT HOLDINGS, LLC	11107 ROSELLE ST STE 213	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cardiovascular Diseases Research	000	1	4/9/2024	NEW	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2020	3DT HOLDINGS, LLC	11107 ROSELLE ST STE 213	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cardiovascular Diseases Research	000	1	8/12/2022	NEW	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $376,567 )
2020	2020	3DT HOLDINGS, LLC	11107 ROSELLE ST, STE 213	SAN DIEGO	CA	92121	SAN DIEGO	USA	Cardiovascular Diseases Research	000	1	8/26/2020	NEW	$376,567
														Subtotal = $376,567

Grand Total All Awards = $376,567

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Vasodilation Needle for Trans-Radial Access

Award Number: R43HL149449

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/26/2020

PERIOD OF PERFORMANCE END DATE: 08/25/2023

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