Evaluation of an Experimentally Designed Stereotactic Guidance System for Determining Needle Entry Point during Uniplanar Fluoroscopy-guided Intervention

Abstract BACKGROUND AND IMPORTANCE: Many techniques for accessing the cavernous sinus have been described, from a transfemoral venous approach to a direct surgical exposure and cannulation of the superior ophthalmic vein. The cavernous sinus can be accessed safely through direct transorbital puncture and cannulation of a preceding venous confluence with an 18-gauge angiocatheter. This technique is performed under constant fluoroscopy using bony landmarks. The use of XperGuide software allows the operator to obtain an intraprocedural computed tomography and to identify the optimum needle entry point and trajectory to avoid at-risk structures such as the optic nerve in this case. This trajectory is then superimposed onto the real-time fluoroscopic image, and the guidance trajectory is followed during needle insertion. CLINICAL PRESENTATION: The patient is a 66-year-old woman who spontaneously developed a left-sided cavernous sinus syndrome. She was found to have an indirect carotid cavernous fistula on angiography. Because of tortuosity and occlusion of venous access points to the cavernous sinus, access via transorbital puncture was preferred. The XperGuide system was used to avoid the at-risk structures, and coils were safely deployed within the cavernous sinus after successful cannulation with this guidance system. The patient had complete resolution of her fistula and experienced no complications from the procedure. CONCLUSION: The XperGuide software guidance system is helpful during direct transorbital puncture of the cavernous sinus because it allows better monitoring of real-time needle location along a safe trajectory selected by the operator to avoid damaging local soft tissue structures.

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Improving patient safety during introduction of novel medical devices through cumulative summation analysis

Journal of Neurosurgery ◽

10.3171/2017.8.jns17936 ◽

2018 ◽

Vol 130 (1) ◽

pp. 213-219 ◽

Cited By ~ 4

Author(s):

Vejay N. Vakharia ◽

Roman Rodionov ◽

Andrew W. McEvoy ◽

Anna Miserocchi ◽

Rachel Sparks ◽

...

Keyword(s):

Patient Safety ◽

Early Warning ◽

Entry Point ◽

Guidance System ◽

Target Point ◽

Preclinical Testing ◽

Increased Risk ◽

Cumulative Summation ◽

Cusum Analysis ◽

Trajectory Guidance

OBJECTIVEThe aim of this study was to implement cumulative summation (CUSUM) analysis as an early-warning detection and quality assurance system for preclinical testing of the iSYS1 novel robotic trajectory guidance system.METHODSAnatomically accurate 3D-printed skull phantoms were created for 3 patients who underwent implantation of 21 stereoelectroencephalography electrodes by surgeons using the current standard of care (frameless technique). Implantation schema were recreated using the iSYS1 system, and paired accuracy measures were compared with the previous frameless implantations. Entry point, target point, and implantation angle accuracy were measured on postimplantation CT scans. CUSUM analysis was undertaken prospectively.RESULTSThe iSYS1 trajectory guidance system significantly improved electrode entry point accuracies from 1.90 ± 0.96 mm (mean ± SD) to 0.76 ± 0.57 mm (mean ± SD) without increasing implantation risk. CUSUM analysis was successful as a continuous measure of surgical performance and acted as an early-warning detection system. The surgical learning curve, although minimal, showed improvement after insertion of the eighth electrode.CONCLUSIONSThe iSYS1 trajectory guidance system did not show any increased risk during phantom preclinical testing when used by neurosurgeons who had no experience with its use. CUSUM analysis is a simple technique that can be applied to all stages of the IDEAL (idea, development, exploration, assessment) framework as an extra patient safety mechanism. Further clinical trials are required to prove the efficacy of the device.

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Computed tomography-guided vertebroplasty using a stereotactic guidance system (stereo-guide)

Surgical Neurology International ◽

10.4103/2152-7806.63912 ◽

2010 ◽

Vol 1 (1) ◽

pp. 17 ◽

Cited By ~ 2

Author(s):

Arun-Angelo Patil

Keyword(s):

Computed Tomography ◽

Guidance System ◽

Stereotactic Guidance

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An Analysis of Location of Needle Entry Point and Palpated PSIS in S1 Nerve Root Block

The Korean Journal of Pain ◽

10.3344/kjp.2010.23.4.242 ◽

2010 ◽

Vol 23 (4) ◽

pp. 242 ◽

Cited By ~ 2

Author(s):

Shin Hyung Kim ◽

Kyung Bong Yoon ◽

Duck Mi Yoon ◽

Seong Ah Choi ◽

Eun Mi Kim

Keyword(s):

Nerve Root ◽

Entry Point ◽

Nerve Root Block ◽

Needle Entry

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COMPASS: localization in laparoscopic visceral surgery

Current Directions in Biomedical Engineering ◽

10.1515/cdbme-2020-0013 ◽

2020 ◽

Vol 6 (1) ◽

Author(s):

Regine Hartwig ◽

Daniel Ostler ◽

Hubertus Feußner ◽

Maximilian Berlet ◽

Kevin Yu ◽

...

Keyword(s):

Real Time ◽

Visceral Surgery ◽

Entry Point ◽

Surgical Instruments ◽

Guidance System ◽

Measurement Unit ◽

Line Of Sight ◽

Test Scenario ◽

Penetration Length ◽

Surgical Workflow

AbstractTracking of surgical instruments is an essential step towards the modernization of the surgical workflow by a comprehensive surgical landscape guidance system (COMPASS). Real-time tracking of a laparoscopic camera used in minimally-invasive surgery is required for applications in surgical workflow documentation, machine learning, image-localization, and intra-operative visualization. In our approach, an inertial measurement unit (IMU) assists the tool tracking in situations when no line-of-sight is available for infrared (IR) based tracking of the laparoscopic camera. The novelty of this approach lies in the localization method adjusted for the laparoscopic visceral surgery, particularly when the line-of-sight is lost. It is based on IMU tracking and the positioning of the trocar entry point. The trocar entry point is the remote center of motion (RCM), reducing degrees of freedom. We developed a method to tackle localization and a real-time tool for position and orientation estimation. The main error sources are given and evaluated in a test scenario. It reveals that for small changes in penetration length (e.g., pivoting), the IMU’s accuracy determines the error.

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Development of a miniaturized robotic guidance device for stereotactic neurosurgery

Journal of Neurosurgery ◽

10.3171/2021.9.jns21794 ◽

2021 ◽

pp. 1-10

Keyword(s):

Robotic System ◽

Guidance System ◽

Small Scale ◽

Application Development ◽

Seamless Integration ◽

Clinical Series ◽

Technical Specifications ◽

Stereotactic Guidance ◽

Guidance Systems ◽

Guidance Device

OBJECTIVE Consistently high accuracy and a straightforward use of stereotactic guidance systems are crucial for precise stereotactic targeting and a short procedural duration. Although robotic guidance systems are widely used, currently available systems do not fully meet the requirements for a stereotactic guidance system that combines the advantages of frameless surgery and robotic technology. The authors developed and optimized a small-scale yet highly accurate guidance system that can be seamlessly integrated into an existing operating room (OR) setup due to its design. The aim of this clinical study is to outline the development of this miniature robotic guidance system and present the authors’ clinical experience. METHODS After extensive preclinical testing of the robotic stereotactic guidance system, adaptations were implemented for robot fixation, software usability, navigation integration, and end-effector application. Development of the robotic system was then advanced in a clinical series of 150 patients between 2013 and 2019, including 111 needle biopsies, 13 catheter placements, and 26 stereoelectroencephalography (SEEG) electrode placements. During the clinical trial, constant modifications were implemented to meet the setup requirements, technical specifications, and workflow for each indication. For each application, specific setup, workflow, and median procedural accuracy were evaluated. RESULTS Application of the miniature robotic system was feasible in 149 of 150 cases. The setup in each procedure was successfully implemented without adding significant OR time. The workflow was seamlessly integrated into the preexisting procedure. In the course of the study, procedural accuracy was improved. For the biopsy procedure, the real target error (RTE) was reduced from a mean of 1.8 ± 1.03 mm to 1.6 ± 0.82 mm at entry (p = 0.05), and from 1.7 ± 1.12 mm to 1.6 ± 0.72 mm at target (p = 0.04). For the SEEG procedures, the RTE was reduced from a mean of 1.43 ± 0.78 mm in the first half of the procedures to 1.12 ± 0.52 mm (p = 0.002) at entry in the second half, and from 1.82 ± 1.13 mm to 1.57 ± 0.98 mm (p = 0.069) at target, respectively. No healing complications or infections were observed in any case. CONCLUSIONS The miniature robotic guidance device was able to prove its versatility and seamless integration into preexisting workflow by successful application in 149 stereotactic procedures. According to these data, the robot could significantly improve accuracy without adding time expenditure.

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