Dataset Information

A Radial Clutch Needle for Facile and Safe Tissue Compartment Access.

ABSTRACT: Efficient and safe access to targeted therapeutic sites is a universal challenge in minimally invasive medical intervention. Percutaneous and transluminal needle insertion is often performed blindly and requires significant user skill and experience to avoid complications associated with the damage of underlying tissues or organs. Here, we report on the advancement of a safer needle with a radial mechanical clutch, which is designed to prevent overshoot injuries through the automatic stopping of the needle once a target cavity is reached. The stylet-mounted clutch system is inexpensive to manufacture and compatible with standard hypodermic or endoscopic needles, and therefore can be adapted to achieve safe access in a myriad of minimally invasive procedures, including targeted drug delivery, at-home and in-hospital intravenous access, laparoscopic and endo- and trans-luminal interventions. Here, we demonstrate the clutch needle design optimization and illustrate its potential for rapid and safe minimally invasive cannulation.

SUBMITTER: O'Cearbhaill ED

PROVIDER: S-EPMC7546408 | biostudies-literature | 2019 Oct-Dec

REPOSITORIES: biostudies-literature

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A Radial Clutch Needle for Facile and Safe Tissue Compartment Access.

O'Cearbhaill Eoin D ED Laulicht Bryan B Mitchell Niamh N Yu Lawrence L Valic Michael M Masiakos Peter P Karp Jeffrey M JM

Medical devices & sensors 20191009 5-6

Efficient and safe access to targeted therapeutic sites is a universal challenge in minimally invasive medical intervention. Percutaneous and transluminal needle insertion is often performed blindly and requires significant user skill and experience to avoid complications associated with the damage of underlying tissues or organs. Here, we report on the advancement of a safer needle with a radial mechanical clutch, which is designed to prevent overshoot injuries through the automatic stopping of ...[more]

PMID: 33043277

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Project description:ObjectivesVascular access thrombosis (VAT) is a common complication in patients with end-stage renal disease (ESRD), significantly impacting hemodialysis efficacy and patient survival. Currently, temporary dialysis access is typically established via deep vein catheterization (VC), however, this method is highly invasive and associated with risks of infection and other complications. This study aims to explore the feasibility of using direct anastomosis indwelling needle puncture (DAINP) for temporary dialysis access.MethodsBetween March 2023 and March 2024, patients VAT were recruited at Sir Run Run Shaw Hospital of Zhejiang University School of Medicine to undergo DAINP. Clinical data, including age, gender, dry and wet body weight, and blood biochemical parameters, were collected. Patient VA types, locations, and insertion vessels were documented. Detailed assessments and records of VAT were performed for all patients, including the distance of thrombus from the anastomosis, residual blood flow at the VA anastomosis, and corresponding selection of the DAINP insertion site. Ultrasound was utilized to measure and record the puncture depth. Concurrently, clinical data of patients undergoing venous catheterization (VC) for temporary dialysis access were collected. The operative time for both groups, defined as the interval from ultrasound assessment initiation to completion of the procedure, was recorded and compared.ResultsA total of 74 patients successfully underwent DAINP, with a 100% puncture success rate. Among them, 20 patients had residual blood flow at the VA stump, and the distance between the anastomosis and arterial flow was ≥ 1 cm. Patients with VA located at the elbow demonstrated the greatest puncture depth. Moreover, the operative time for the DAINP group was significantly shorter compared to the 17 patients who underwent VC for VAT during the same period. However, patients with VA located in the groin required a longer operative time for DAINP.ConclusionsThis study demonstrates that DAINP provides a rapid and safe method for establishing temporary hemodialysis access in VAT patients, effectively reducing the invasiveness and risks associated with traditional VC.

Project description:BackgroundThe radial approach is now recommended as the default strategy in diagnostic coronary angiography and percutaneous coronary intervention. Radial artery occlusion (RAO) is the most common complication that limits subsequent angiographic procedures through this access. Recently, distal radial access (DRA) has been recommended as an alternative access site. Despite lower RAO rates in DRA in some recent clinical trials, concerns remain regarding possible complications and limitations due to the small size of the distal radial artery.ObjectiveThe present study aimed to compare traditional radial access (TRA) and DRA concerning RAO in percutaneous coronary procedures.MethodsIn the present prospective cohort study, percutaneous coronary procedures were performed via DRA or TRA in 2 study groups. All consecutive participants underwent DRA from September 2021 to March 2022 and TRA from April 2022 to June 2022. Ultrasonography was performed preprocedurally in the DRA group, and patients with small distal artery diameters (<2 mm) were excluded. The same 6-Fr sheaths and standard air-filled compression devices were used in both groups. The primary endpoint was RAO in ultrasound sonography on the first postprocedural day, and the secondary endpoints were the success rate, access time, angiography time, radial artery spasms, and vascular access complications.ResultsA total of 298 patients were assigned to the DRA group and 278 to the TRA group. The RAO rate was significantly higher in the TRA group than in the DRA group (10.1 % vs 0.9 %; P = 0.0001; OR, 0.08, 95 % CI, 0.01-0.27). The success rate was significantly higher in the TRA group (96 % vs 90.2 %; P = 0.009). Access crossovers were done on 12 patients (4.0 %) in the TRA group and 24 patients (9.8 %) in the DRA group (P < 0.001). The mean access time was significantly lower in the TRA group than in the DRA group (1.9 min vs 2.9 min; P < 0.001). The mean angiography time did not significantly differ between the groups (10.2 min in the TRA group vs 9.9 min in the DRA group). The rate of radial artery spasms was not significantly different between the 2 groups (13.8 % in the TRA group vs 14.5 % in the DRA group). The rates of access site hematoma (12.4 % vs 2.3 %; P < 0.001) and bleeding (10.7 % vs 4.1; P = 0.005) were significantly higher in the TRA group.ConclusionsDRA was safe and feasible with lower rates of RAO and access site complications than TRA. Thus, it could be used as an alternative approach in percutaneous coronary procedures. However, the trade-off for these advantages of DRA is an increase in cross-over rate, and a decrease in puncture success rate.

Dataset Information

A Radial Clutch Needle for Facile and Safe Tissue Compartment Access.

Publications

A Radial Clutch Needle for Facile and Safe Tissue Compartment Access.

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