A pilot clinical study of developing an External Assist Targeting Device for rapid and precise renal calyx access during percutaneous nephrolithotomy

doi:10.1016/j.ajur.2022.01.001

Asian Journal of Urology, 2023, 10 (3): 364-371 doi: 10.1016/j.ajur.2022.01.001

Original Article

A pilot clinical study of developing an External Assist Targeting Device for rapid and precise renal calyx access during percutaneous nephrolithotomy

Qinghui Wu^a,Kesavan Esuvaranathan^a,b,Teck Kheng Lee^c,Soo Leong Foo^c,Jian Ping Chai^d,*(

),Edmund Chiong^a,b

^a Department of Urology, National University Hospital, Singapore
^b Department of Surgery, National University of Singapore, Singapore
^c Institute of Technical Education, Technology Development Centre, Singapore
^d Invivo Medical Pte. Ltd., Singapore

Abstract
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Abstract

Objective To design a device to increase the accuracy of the targeting process and reduce the radiation exposure to both the patients and the medical staff.
Methods We analyzed the inherent problem and designed the External Assist Targeting Device (EATD) to assist in the alignment of needle targeting on the desired renal calyx under fluoroscopic guidance. The EATD was designed to allow rapid and precise access to calyces at all angles, with a simple two-step puncture protocol developed for puncturing a target renal calyx. We then tested the device in a pilot human trial with four patients.
Results In experiments with phantom models, the time for successful targeting was reduced by 31% using the device. The mean fluoroscopic time was reduced by 40%. In initial human trial, the puncture time was shortened by 66% and the radiation dose was decreased by 65% compared to free-hand technique. No complication was observed during the trial.
Conclusion The EATD was found to be cost effective, portable, simple to set up, and safe to operate for assisting in the percutaneous nephrolithotomy procedures. Our preliminary tests showed high degree of accuracy in gaining precise access to a targeted renal calyx with much shorter time and lesser radiation dose. The EATD also has the potential to be used to access other organs with precision under fluoroscopic guidance.

Key words： Percutaneous nephrolithotomy Kidney puncture Renal calculi Targeting device Fluoroscopy guidance

Received: 28 May 2021 Available online:

Corresponding Authors: Jian Ping Chai E-mail: joseph.chai@invivo-medical.com

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	Qinghui Wu
	Kesavan Esuvaranathan
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	Soo Leong Foo
	Jian Ping Chai
	Edmund Chiong

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Cite this article:

Qinghui Wu,Kesavan Esuvaranathan,Teck Kheng Lee, et al. A pilot clinical study of developing an External Assist Targeting Device for rapid and precise renal calyx access during percutaneous nephrolithotomy[J]. Asian Journal of Urology, 2023, 10(3): 364-371.

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http://www.ajurology.com/EN/10.1016/j.ajur.2022.01.001 OR http://www.ajurology.com/EN/Y2023/V10/I3/364

Triangulation using biplanar alignment. (A) Set up X-ray at 0°; (B) Establish vertical plane; (C) Align vertical plane with target and entry point; (D) Set X-ray to between 20° to 30°; (E) Align needle to target within vertical plane; (F) Push needle towards target.

Urologist controlling the External Assist Targeting Device to fine tune and aim the needle under fluoroscopy guidance during percutaneous nephrolithotomy; note that his hands were working outside direct radiation exposure most of the time.

Fluoroscopy screens and schematic drawings. (A) The fluoroscope being set at 0°; (B) The needle aligned to establish the vertical plane on the target point; (C) The fluoroscope being turned and set between 15° and 45°; (D) “Depth” view of the needle aligned to the target. Adj 1, adjustment for lateral rotation; Adj 2, adjustment for lateral translation; Adj 3, adjustment for needle rotation in the plane.

Urologist pushing the needle in after achieving all the alignments. Successful puncture was confirmed by fingertip tactile feedback from the metal bead. The gelatin was later cut to examine the needle tract.

X-ray images of a gelatin model. (A) Obtained at 0° showing alignment of the first plane; (B) Obtained at 30° offset showing the alignment of the depth.

Comparison of mean puncture time and fluoroscope screening time between free-hand and device-assisted procedure.

Comparison of number of attempts by urologists needed to achieve successful puncture between free-hand and device-assisted procedure (p<0.01).

Demographic and clinical characteristic of the percutaneous nephrolithotomy patients.

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