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Vasodilation Needle for Trans-Radial Access

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HL149449-01A1
Agency Tracking Number: R43HL149449
Amount: $376,567.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA19-272
Timeline
Solicitation Year: 2019
Award Year: 2020
Award Start Date (Proposal Award Date): 2020-08-26
Award End Date (Contract End Date): 2021-08-25
Small Business Information
11107 ROSELLE ST, STE 213
San Diego, CA 92121-1206
United States
DUNS: 804419740
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 WILLIAM COMBS
 (317) 274-2268
 wicombs@iupui.edu
Business Contact
 GHASSAN KASSAB
Phone: (858) 249-7400
Email: gkassab@3dtholdings.com
Research Institution
N/A
Abstract

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.NARRATIVE
Percutaneous arterial catheterization, used in a wide variety of procedures including angiography and stent
placement, is traditionally done through the femoral artery, but physicians are increasingly opting to use an artery
in the wrist. This is a development for patients, who can quickly recover and walk out of the hospital the same
day; however, radial access spasm is a frequent complication that is painful for patients and challenging for
doctors. Our project is aimed at using safe and effective electrical stimulation through the access needle to relax
the radial artery to enhance patient comfort, improve physician efficiency, and reduce health care costs.

* Information listed above is at the time of submission. *

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