Development of four different devices to turn over introducer sheaths

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Abstract

Introduction

We developed four prototype sheath-turning auxiliary devices (STADs) and evaluated them in an in vitro study setup designed to enable the change of catheter direction in endovascular interventions.

Methods

Four different prototypes, A through D, of STADs were designed and created by modifying commercially available dilators and catheters. All STADs work with different anchor-like tips to ensure fixation inside the vessel at the puncture site. The STAD is loaded into the introducer sheath, retracted with the introducer sheath, and turned at the puncture site. The STADs were tested in an in vitro vascular study setup using bovine veins. Success rates and procedure times were calculated, and the handling, reliability, and overall performance were evaluated. The maximum soft tissue thickness (STTmax) applicable was tested using bovine vessels with 7-mm thickness surrounded by a soft tissue phantom consisting of chicken breast. A retrospective cross-sectional observation in 108 patients from our center was performed to provide mean STTmax at the common femoral artery in patients for comparison.

Results

The success rate ranged between 75% for prototype D and 90% for prototypes A and C. The procedure time averaged 60 seconds (range, 25–165 seconds). The mean handling was rated 2.4 (good) for prototype A, 2.0 (good) for prototype B, 2.6 (satisfactory) for prototype C, and 3.5 (poor) for prototype D. Mean reliability was rated 3.4 (satisfactory) for prototype A, 2.0 (good) for prototype B, 1.6 (good) for prototype C, and 2.4 (good) for prototype D. Mean overall performance was rated 2.0 (good) for prototype C, 2.6 (satisfactory) for prototype B, 3.3 (poor) for prototype D, and 3.4 (poor) for prototype A. In the cross-sectional patient observation, the mean STTmax was 3.3 cm (range, 0,5–13 cm) with a 95% confidence interval of the distribution including an STTmax of up to 8 cm. The STTmax was ≤5 cm in 100 of 108 patients (93%). The applicable STTmax for prototype A was 1 cm (8 of 10 successful cases), 3 cm for prototype B (9 of 10 successful cases), 5 cm for prototype C (8 of 10 successful cases), and 3 cm for prototype D (7 of 10 successful cases).

Conclusions

All four STAD prototypes offered the ability of turning the sheaths at the puncture site in an in vitro vascular study setup. In the future, this concept may allow routine clinical performance of turning maneuvers at the groin vascular access site.

Clinical Relevance

We developed and tested four different turning devices that are loaded into an introducer sheath in interventions and that enable the introducer sheath to be turned in a blood vessel. There is no standard procedure or dedicated device on the market that allows such a function in interventional procedures, such as at the groin vascular access site or on venous shunts. The idea is to offer a safe method to perform such procedures to facilitate angiographic diagnostics and to improve the safety of interventions by means of reducing the number of punctures that are being performed as well as the time of the intervention.

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