# Vasodilation Needle for Trans-Radial Access

> **NIH NIH R43** · 3DT HOLDINGS, LLC · 2020 · $376,567

## 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.

## Key facts

- **NIH application ID:** 10005827
- **Project number:** 1R43HL149449-01A1
- **Recipient organization:** 3DT HOLDINGS, LLC
- **Principal Investigator:** William Combs
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $376,567
- **Award type:** 1
- **Project period:** 2020-08-26 → 2023-08-25

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10005827

## Citation

> US National Institutes of Health, RePORTER application 10005827, Vasodilation Needle for Trans-Radial Access (1R43HL149449-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10005827. Licensed CC0.

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