Needle Guidance System Research Articles

Fun with electricity: A novel ballistics gelatin model with LED tracking for ultrasound needle guidance.

Use of ultrasound (US) for procedural needle guidance can improve success rates, safety, and accuracy. Often, training is performed on task trainers, which can be prohibitively expensive. Determining undesired needle placement is difficult when the needle is poorly visualized with US. Currently available simulation phantoms cannot provide real-time feedback on the location of needle placement. The primary objective was to develop and determine feasibility of a low-cost simulation phantom with an internal circuit and LED light system to determine when a needle contacts internal structures. We also aimed to determine whether its use was associated with increased comfort level. Emergency medicine (EM) residents (PGY-1 to PGY-3) performed in-plane and out-of-plane US needle guidance using homemade phantoms. Comfort levels were assessed by pre- and post intervention survey. Outcomes were measured on Likert scale (minimum = 1, maximum = 5). The primary outcome was change in confidence markers before and after the simulation task. Secondary outcomes were survey results of comparisons of these models to prior training experiences on simulators and humans. All EM residents (30) in our program were invited to participate. Twenty participants enrolled and completed the study. In the primary outcome, median comfort with out-of-plane and in-plane guidance increased after using the model but was more pronounced for out-of-plane guidance. On a posttest survey, residents rated the models overall very similar to prior experience on simulators (median 5/5 [IQR 4.0-5.0]) and moderately similar to humans (median 3/5 [IQR 3.0-4.0]). We created a low-cost ballistic gelatin phantom with an internal electric needle guidance system. Use of the phantom for training was associated with increased learner comfort with the procedure. Learners rated the characteristics of the phantom as similar to higher-cost commercial equipment and humans.

Real-time three-dimensional fluoroscopy-navigated percutaneous pelvic screw placement for fragility fractures of the pelvis in the hybrid operating room

BackgroundThe prognosis of conservative treatment for fragility fracture of the pelvis (FFP) in the older patients remains poor. Percutaneous pelvic screw placement (PPSP), which aids in the treatment of FFP, can be challenging to perform using fluoroscopy alone because of the proximity of blood vessels and neuroforamina. Hence, this study aimed to investigate the accuracy and clinical outcomes of PPSP using real-time 3D fluoroscopic navigation for FFP in the hybrid operating room.MethodsThis study included 41 patients with FFP who underwent PPSP in a hybrid operating room between April 2016 and December 2020. Intraoperative C-arm cone-beam CT was performed under general anesthesia. Guidewire trajectory was planned using a needle guidance system. The guidewire was inserted along the overlaid trajectory using 3D fluoroscopic navigation, and a 6.5 mm cannulated cancellous screw (CCS) was placed. The clinical outcomes and accuracy of the screw placement were then investigated.ResultsA total of 121 screws were placed. The mean operative time was 84 ± 38.7 minutes, and the mean blood loss was 7.6 ± 3.8 g. The mean time to wheelchair transfer was 2 days postoperatively. Pain was relieved in 35 patients. Gait ability from preoperative and latest follow-up after surgery was maintained in 30 (73%) patients. All 41 patients achieved bone union. Of the 121 screws, 119 were grade 0 with no misplacement; only 2 patients had grade 1 perforations.ConclusionPPSP using real-time 3D fluoroscopic navigation in a hybrid operating room was accurate and useful for early mobilization and pain relief among older patients with FFP with an already-installed needle biopsy application.

Development of a Head-Mounted Holographic Needle Guidance System for Enhanced Ultrasound-Guided Neuraxial Anesthesia: System Development and Observational Evaluation

BackgroundNeuraxial anesthesia is conventionally performed using a landmark-based technique. Preprocedural ultrasound is often used in challenging clinical scenarios to identify an ideal needle path. The procedure is then carried out by the operator recreating the ultrasound needle path from memory. We suggest that a needle guidance system using the Microsoft HoloLens mixed reality headset, which projects a hologram of the ideal needle path, can assist operators in replicating the correct needle angulation and result in fewer needle passes.ObjectiveThe objective of the study was to develop software for the mixed reality HoloLens headset, which could be used to augment the performance of neuraxial anesthesia, and establish its face validity in lumbar spine phantom models.MethodsWe developed an ultrasound transducer marker and software for the HoloLens, which registers the position and angulation of the ultrasound transducer during preprocedural scans. Once an image of a clear path from skin to the intrathecal space is acquired, a hologram of the ideal needle path is projected onto the user’s visual field. The ultrasound probe is removed while the hologram remains in the correct spatial position to visualize the needle trajectory during the procedure as if conducting real-time ultrasound. User testing was performed using a lumbar spine phantom.ResultsPreliminary work demonstrates that novice (2 anesthesia residents) and experienced operators (5 attending anesthesiologists) can rapidly learn to use mixed reality holograms to perform neuraxial anesthesia on lumbar spine phantoms.ConclusionsOur study shows promising results for performing neuraxial anesthesia in phantoms using the HoloLens. Although this may have wide-ranging implications for image-guided therapies, further study is required to quantify the accuracy and safety benefit of using holographic guidance.Trial RegistrationClinicalTrials.gov NCT04028284; https://clinicaltrials.gov/ct2/show/NCT04028284

Multimodal Characterization of a PSMA-Positive Thyroid Nodule Using 68Ga-PSMA and 124Iodine PET/US Fusion Imaging.

A 54-year-old male diagnosed with prostate cancer was referred for 68Gallium-PSMA-11 PET/CT. The scan revealed a solitary PSMA-positive thyroid lesion. On PET/ultrasound fusion imaging, a nodule with moderate risk of malignancy (TIRADS 4B) could be unambiguously correlated. Additional 124Iodine PET/ultrasound fusion imaging revealed normal iodine uptake within the PSMA-positive thyroid nodule. Fine-needle aspiration cytology was performed using an ultrasound needle-guidance system. The cytopathological investigation confirmed a benign thyroid nodule and excluded a thyroid carcinoma as well as a prostate cancer metastasis. Immunohistochemistry was positive for thyroglobulin staining.

Technical feasibility and efficacy of a standard needle magnetization system for ultrasound needle guidance in thyroid nodule-targeting punctures: a phantom study.

PurposeThe aim of this study was to assess the feasibility and efficacy of an ultrasound needle guidance system (NGS) based on standard needle magnetization in a phantom study of thyroid nodule (TN)-targeting punctures.MethodsSix trainees and a staff radiologist performed TN-targeting punctures with or without the NGS in phantom models (group 1, experience <50 cases; group 2, experience ≥50 cases and <100 cases; group 3, experience ≥100 cases of TN-targeting punctures). The feasibility, technical success rate, number of punctures, and procedure time were recorded.ResultsThe feasibility of NGS was 98.6% (138/140). In group 1, the technical success rate increased from 60.0%±8.2% to 80.0%±8.2% when the NGS was used (P=0.046), with a reduction in the number of punctures from 2.2 to 1.2 (P=0.005). In group 2, the rate changed from 95.0%±5.8% to 100.0%±0.0% with the NGS (P=0.157), with a minimal decrease in the number of punctures from 1.1 to 1.0 (P=0.157). The procedure time significantly decreased in both groups (P=0.041 and P=0.010, respectively) when the NGS was used. In group 3, there were no significant differences in the technical success rate and the number of punctures according to whether the NGS was used (P=0.317 and P=0.317, respectively).ConclusionNGS using standard needle magnetization is technically feasible and has potential to improve the efficacy of TN-targeting punctures for less-experienced operators, especially beginners, according to the findings of this phantom study.

Ultrasound Needle Guidance System for Precision Vaccinations and Drug Deliver

Image-guided needles are currently used for drug delivery in bodies, but the additional time associated with aligning and maintaining the needle’s position results in increased patient discomfort or risk of invasion of the human body. In this paper, a needle guidance system using piezoelectric materials is designed and analyzed for precise drug delivery without damaging parts of the body and improving processing time. A piezoelectric generates an ultrasound wave that can propagate through different mediums, and a second piezoelectric crystal can receive that energy and convert it into voltage. A 1D real-time image represents the changes of the voltage induced in the double piezoelectric crystal. Extensive data analysis and visualization are done using different obstacles and location of the needle verified for other mediums. The presence of obstacles in between those crystals can be identified in the real-time grayscale image. The needle can reach its destination using this image information as directional guidance. This guided drug delivery improves patient recovery time and eliminates extra injuries that can be caused due to wrong needle injections, such as lumbar puncture-related nerve damage.

Standard Needle Magnetization for Ultrasound Needle Guidance: First Clinical Experiences in Fine‐Needle Aspiration Cytology of Thyroid Nodules

Fine-needle aspiration cytology using a novel ultrasound needle guidance system on the basis of standard needle magnetization was consecutively performed in 30 (15 in-plane and 15 out-of-plane) suspicious thyroid nodules. Nondedicated, commercially available needles were used. The technical effectiveness and safety of the system were satisfying; system failures were observed in 2 cases. The needle tip could be (at least occasionally) visualized inside the thyroid nodule in 96%, and the subjective procedure ratings were excellent in 57%. The out-of-plane technique was significantly superior in both respects (P = .021 and .027, respectively). Standard needle magnetization ultrasound needle guidance was easy to apply and cost-effective and has the potential to improve fine-needle aspiration cytology performance.

Optical fiber technology enables smart needles for epidurals: an in-vivo swine study.

Nowadays, epidural space identification is made by using subjective and manual techniques characterized by failure rates up to 7%. In this work, we propose a fiber optic sensor technology based needle guidance system, that is directly inspired by the most common technique currently used for epidurals; through real-time strain measurements, the fiber Bragg grating integrated inside the needle lumen is able to effectively perceive the typical force drop occurring when the needle enters the epidural space. An in vivo swine study demonstrates the validity of our approach, paving the way for the development of lab-in-a-needle systems.

Technical Note: Error metrics for estimating the accuracy of needle/instrument placement during transperineal magnetic resonance/ultrasound-guided prostate interventions.

Image-guided systems that fuse magnetic resonance imaging (MRI) with three-dimensional (3D) ultrasound (US) images for performing targeted prostate needle biopsy and minimally invasive treatments for prostate cancer are of increasing clinical interest. To date, a wide range of different accuracy estimation procedures and error metrics have been reported, which makes comparing the performance of different systems difficult. A set of nine measures are presented to assess the accuracy of MRI-US image registration, needle positioning, needle guidance, and overall system error, with the aim of providing a methodology for estimating the accuracy of instrument placement using a MR/US-guided transperineal approach. Using the SmartTarget fusion system, an MRI-US image alignment error was determined to be 2.0±1.0mm (mean±SD), and an overall system instrument targeting error of 3.0±1.2mm. Three needle deployments for each target phantom lesion was found to result in a 100% lesion hit rate and a median predicted cancer core length of 5.2mm. The application of a comprehensive, unbiased validation assessment for MR/US guided systems can provide useful information on system performance for quality assurance and system comparison. Furthermore, such an analysis can be helpful in identifying relationships between these errors, providing insight into the technical behavior of these systems.

Conventional vs Computer-Assisted Stereoscopic Ultrasound Needle Guidance for Renal Access: A Randomized Crossover Bench-Top Trial.

Ultrasound (US) guidance during renal access and mass biopsy reduces radiation exposure, but can be technically challenging. A needle guidance system might simplify these procedures. The purpose of this randomized crossover trial was to compare conventional and computer-assisted US needle guidance systems for renal access and mass biopsy. Seventy-one subjects were randomized to perform renal access or mass biopsy on a phantom using conventional and computer-assisted US guidance in a crossover study design. The primary outcome was success rate including subgroup analysis by experience level. Secondary outcomes included total procedure time, time to hit target, number of course corrections, and total punctures. In addition, subjective preferences of participants were also collected. Procedure success rate was higher with the computer-assisted US than with conventional US for both novice (98.0% (48/49) vs 81.6% (40/49); p < 0.001) and experienced US users (100% (22/22) vs 81.8% (18/22); p < 0.001). Computer-assisted US significantly shortened the total procedure time (94.0 seconds vs 192.9 seconds; p ≤ 0.001), time required to hit the target (62.5 seconds vs 121.6 seconds; p ≤ 0.001), and the number of course corrections (0.56 vs 2.89; p < 0.001) compared with conventional US. Computer-assisted US did not significantly reduce the number of needle punctures (1.75 vs 2.39; p = 0.132). Seventy-three percent of subjects preferred the computer-assisted US system. A computer-assisted needle guidance system increases effective US targeting for renal access and mass biopsy for novice and experienced users.

Quick and stable parallel puncture of hepatic tumors using a double-barreled needle direction system for ultrasound-guided bipolar radiofrequency ablation.

In bipolar radiofrequency ablation (RFA) therapy, insertion of multiple needles at appropriate points on a target is difficult. The aim of our study was to evaluate a simplified method for multi-electrode insertion using a newly developed double-barreled needle guidance system for percutaneous RFA of hepatic tumors. RFA using two bipolar electrodes was performed in 15 consecutive patients (nine men, six women; mean age, 72.0 ± 8.2years) with a solitary small (≤3cm) hepatic tumor. The first five nodules were treated using the conventional puncture method with the standard attachment, then 10 nodules were ablated using the parallel puncture method with the double-barreled attachment. The times required for double-needle placement and the shapes of the ablated areas were compared between the two puncture methods. The parallel puncture method required a shorter time for double-needle placement than the conventional method (12s [range, 8-24] vs 96s [range, 50-240]; P = 0.0003), and allowed continuous observation of the tip of all needles and the size of the ablated area as it increased until completion of the ablation. The method also provided a stable ellipsoidal ablated area. The median height, width and thickness were 30mm (range, 22-34), 30mm (range, 21-33) and 20mm (range, 7-25), respectively, using 20-mm electrodes, and 34mm (range, 32-41), 36mm (range, 35-38) and 24mm (range, 23-24), respectively, using 30-mm electrodes. The parallel puncture method may be a feasible procedure for multi-needle RFA therapy.

The Infiniti Plus ultrasound needle guidance system improves needle visualization during the placement of spinal anesthesia.

The Infiniti Plus ultrasound needle guidance system improves needle visualization during the placement of spinal anesthesia.

Enhancing needle visualization during parasagittal approach in paravertebral block for patients undergoing simple mastectomy using in-plane, multiangle ultrasound needle guidance system

Background:Ultrasound-guided paravertebral blocks during breast surgeries with in-plane needle approaches can be challenging due to difficult needle visualization. The purpose of this study was to assess the usefulness of using a needle guide while performing in-plane parasagittal approach paravertebral block for breast surgery.Patients and Methods:Eighty patients, American Society of Anesthesiologists physical status I-III, aged 20-40 years with breast mass scheduled for simple mastectomy surgery, were involved in prospective, controlled, randomized study, and were randomly divided by closed envelope method into two groups: Group I (n = 40): Scheduled for ultrasound-guided paravertebral block or group II (n = 40): Scheduled for ultrasound-guided paravertebral block using the needle guide. Both techniques compared as regards: (i) Needle visibility and block performance time; (ii) number of needle passes; (iii) duration of the block; (iv) doctor and patient satisfaction; and (v) incidence of complications.Results:Needle visibility score was better in group II (2.92 ± 0.26 vs. 1.9 ± 0.44, P < 0.0001). Block performance time was shorter in group II (90.92 ± 15 vs. 128.25 ± 16s, P < 0.0001). A number of needle passes were less in group II (1.27 ± 0.45 vs. 2.2 ± 0.68, P < 0.0001). Doctor and patient satisfaction were better in group II (P = 0.015). No differences were found regarding the duration of the block and incidence of complications between groups.Conclusion:A needle guide can help reduce the time needed to perform a parasagittal in-plane thoracic paravertebral block, with a significant reduction in the block performance time, the number of needle passes, better needle visibility and better doctor and patient's satisfaction. However, there was no significant difference regarding the duration of the block or incidence of complications.

A Randomized Crossover Study Comparing a Novel Needle Guidance Technology for Simulated Internal Jugular Vein Cannulation

Despite ultrasound guidance for central line placement, complications persist, as exact needle location is often difficult to confirm with standard two-dimension ultrasound. A novel real-time needle guidance technology has recently become available (eZono, Germany) that tracks the needle during insertion. This randomized, blinded, crossover study examined whether this needle guidance technology improved cannulation of a simulated internal jugular (IJ) vein in an ultrasound phantom. One hundred physicians were randomized to place a standard needle in an ultrasound neck phantom with or without the needle guidance system. Video cameras were placed externally and within the lumens of the vessels to record needle location in real time. The primary outcome measured was the rate of posterior wall puncture. Secondary outcomes included number of carotid artery punctures, number of needle passes, final needle position, time to cannulation, and comfort level with this new technology. The incidence of posterior vessel wall puncture without and with needle guidance was 49 and 13%, respectively (P < 0.001, odds ratio [OR] = 7.33 [3.44 to 15.61]). The rate of carotid artery puncture was higher without needle navigation technology than with needle navigation 21 versus 2%, respectively (P = 0.001, OR = 12.97 [2.89 to 58.18]). Final needle tip position being located within the lumen of the IJ was 97% accurate with the navigation technology and 76% accurate with standard ultrasound (P < 0.001, OR = 10.42 [2.76 to 40.0]). Average time for successful vessel cannulation was 1.37 times longer without guidance technology. This real-time needle guidance technology (eZono) shows significant improvement in needle accuracy and cannulation time during simulated IJ vein puncture.

Novice performance of ultrasound-guided needling skills: effect of a needle guidance system.

Ultrasound-guided needle placement is a widely used technical skill that can be challenging to learn. The SonixGPS is a novel ultrasound needle-tracking system that has the potential to improve performance over traditional ultrasound systems. The objective of our study was to determine if the use of the SonixGPS ultrasound system improves performance of novice practitioners in ultrasound-guided needle placement compared with conventional ultrasound in the out-of-plane approach on a simulation model. Twenty-six medical students without previous ultrasound experience were randomized into 2 groups. Each group performed 30 simulated ultrasound nerve blocks on a porcine meat tissue simulation (phantom) model. Both groups used the SonixGPS ultrasound; however, the study group had the needle-tracking system activated, whereas the control group did not. The participants were assessed for success rate, technical aspects of block performance, and certain behaviors that could compromise the quality of the block. Learning curves were developed to assess competence. The needle guidance group reached competence more often. This group had fewer attempts and quality-compromising behaviors than did those using conventional ultrasound. Use of the SonixGPS ultrasound needle guidance system improves the performance of technical needling skills of novice trainees in an ex vivo model. The place of this technology in the wider education of ultrasound-guided regional anesthesia remains to be established.

Clinical applications of the C-arm cone-beam CT-based 3D needle guidance system in performing percutaneous transthoracic needle biopsy of pulmonary lesions.

This study explored the value of flat detector C-arm CT-guidance system in performing percutaneous transthoracic needle biopsy (PTNB) for lung lesions in clinical practice. A total of 110 patients with solid lung lesions were enrolled to undergo PTNB procedures. The mean diameter of lesions was 4.63 cm (range, 0.6-15cm). The needle path was carefully planned and calculated on the C-arm CT system, which acquired three-dimensional CT-like cross-sectional images. The PTNB procedures were performed under needle guidance with fluoroscopic feedbacks. Histopathologic tissue was successfully obtained from 108 patients with a puncture success rate of 98.2% (108/110). The diagnostic accuracy rate was found to be 96.3% (104/108). There was only one case of pneumothorax (0.9%) requiring therapy. The rates of mild pneumothorax and hemoptysis were low (12.0% and 6.5%, respectively). In addition, procedural time could be limited with this technique, which helped to reduce X-ray exposure. Our study shows that C-arm CT-based needle guidance enables reliable and efficient needle positioning and progression by providing real-time intraoperative guidance.

Information Processing in Computer-Assisted Interventions: 4th International Conference, 2013.

Information Processing in Computer-Assisted Interventions: 4th International Conference, 2013.

Treatment of supratentorial spontaneous intracerebral hemorrhage using image-guided minimally invasive surgery: Initial experiences of a flat detector CT-based puncture planning and navigation system in the angiographic suite.

The intracerebral hemorrhage drainage through minimally invasive approach is emerging as an alternative for traditional craniotomy, due to its improved survival rate and reduced complication rate. In this study, we investigated the feasibility and safety of a flat detector CT-based puncture planning and navigation system for minimally invasive hematoma drainage on patients with intracerebral hemorrhage. The minimally invasive hematoma drainage was performed on 21 hypertensive patients with intracerebral hemorrhage in the angiographic suite with the guidance of a flat detector CT-based puncture planning and navigation system. This system is integrated in the angiographic machine, and was used for 1) planning the needle path based on a preprocedural flat detector CT scan, 2) advancing the catheter with real-time fluoroscopic guidance, and 3) confirming the procedure outcome based on an immediate postprocedural flat detector CT. The surgery efficiency, accuracy, and the treatment outcome were measured and compared with the published data. All procedures were successfully completed with the catheter placed 4 ± 1 mm from the planned position. The average surgery time was 40 ± 7 minutes. The volume of the hematoma was reduced to 28 ± 4% of the original volume. The Glasgow Coma Scale score was significantly improved from 10 ± 1 at the admission to 14 ± 1 at the discharge. The Extended Glasgow Coma Scale score also improved from 5 ± 1 at the discharge to 6 ± 1 at the 6-month follow-up. No major complication, rebleeding, and mortality were observed in this study. This flat detector CT-based needle guidance system provided a feasible, convenient, and safe way to perform the puncture and drainage of brain hematoma in the angiographic suite.

MITK-US: real-time ultrasound support within MITK

Intra-procedural acquisition of the patient anatomy is a key technique in the context of computer-assisted interventions (CAI). Ultrasound (US) offers major advantages as an interventional imaging modality because it is real time and low cost and does not expose the patient or physician to harmful radiation. To advance US-related research, the purpose of this paper was to develop and evaluate an open-source framework for US-based CAI applications. We developed the open-source software module MITK-US for acquiring and processing US data as part of the well-known medical imaging interaction toolkit (MITK). To demonstrate its utility, we applied the module to implement a new concept for US-guided needle insertion. Performance of the US module was assessed by determining frame rate and latency for both a simple sample application and a more complex needle guidance system. MITK-US has successfully been used to implement both sample applications. Modern laptops achieve frame rates above 24 frames per second. Latency is measured to be approximately 250 ms or less. MITK-US can be considered a viable rapid prototyping environment for US-based CAI applications.

Robotic ultrasound systems in medicine

Robots ultrasound (RUS) can be defined as the combination of ultrasound imaging with a robotic system in medical interventions. With their potential for high precision, dexterity, and repeatability, robots are often uniquely suited for ultrasound integration. Although the field is relatively young, it has already generated a multitude of robotic systems for application in dozens of medical procedures. This paper reviews the robotic ultrasound systems that have been developed over the past two decades and describes their potential impact on modern medicine. The RUS projects reviewed include extracorporeal devices, needle guidance systems, and intraoperative systems.