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1.

Purpose

Facet joint insertion is a common treatment of chronic pain in the back and spine. This procedure is often performed under fluoroscopic guidance, where the staff’s repetitive radiation exposure remains an unsolved problem. Robotic ultrasound (rUS) has the potential to reduce or even eliminate the use of radiation by using ultrasound with a robotic-guided needle insertion. This work presents first clinical data of rUS-based needle insertions extending previous work of our group.

Methods

Our system implements an automatic US acquisition protocol combined with a calibrated needle targeting system. This approach assists the physician by positioning the needle holder on a trajectory selected in a 3D US volume of the spine.

Results

By the time of submission, nine facets were treated with our approach as first data from an ongoing clinical study. The insertion success rate was shown to be comparable to current clinical practice. Furthermore, US imaging offers additional anatomical context for needle trajectory planning.

Conclusion

This work shows first clinical data for robotic ultrasound-assisted facet joint insertion as a promising solution that can easily be incorporated into the clinical workflow. Presented results show the clinical value of such a system.
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2.

Purpose

To develop and evaluate an approach to estimate the respiratory-induced motion of lesions in the chest and abdomen.

Materials and methods

The proposed approach uses the motion of an initial reference needle inserted into a moving organ to estimate the lesion (target) displacement that is caused by respiration. The needles position is measured using an inertial measurement unit (IMU) sensor externally attached to the hub of an initially placed reference needle. Data obtained from the IMU sensor and the target motion are used to train a learning-based approach to estimate the position of the moving target. An experimental platform was designed to mimic respiratory motion of the liver. Liver motion profiles of human subjects provided inputs to the experimental platform. Variables including the insertion angle, target depth, target motion velocity and target proximity to the reference needle were evaluated by measuring the error of the estimated target position and processing time.

Results

The mean error of estimation of the target position ranged between 0.86 and 1.29 mm. The processing maximum training and testing time was 5 ms which is suitable for real-time target motion estimation using the needle position sensor.

Conclusion

The external motion of an initially placed reference needle inserted into a moving organ can be used as a surrogate, measurable and accessible signal to estimate in real-time the position of a moving target caused by respiration; this technique could then be used to guide the placement of subsequently inserted needles directly into the target.
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3.

Purpose

During needle interventions, successful automated detection of the needle immediately after insertion is necessary to allow the physician identify and correct any misalignment of the needle and the target at early stages, which reduces needle passes and improves health outcomes.

Methods

We present a novel approach to localize partially inserted needles in 3D ultrasound volume with high precision using convolutional neural networks. We propose two methods based on patch classification and semantic segmentation of the needle from orthogonal 2D cross-sections extracted from the volume. For patch classification, each voxel is classified from locally extracted raw data of three orthogonal planes centered on it. We propose a bootstrap resampling approach to enhance the training in our highly imbalanced data. For semantic segmentation, parts of a needle are detected in cross-sections perpendicular to the lateral and elevational axes. We propose to exploit the structural information in the data with a novel thick-slice processing approach for efficient modeling of the context.

Results

Our introduced methods successfully detect 17 and 22 G needles with a single trained network, showing a robust generalized approach. Extensive ex-vivo evaluations on datasets of chicken breast and porcine leg show 80 and 84% F1-scores, respectively. Furthermore, very short needles are detected with tip localization errors of less than 0.7 mm for lengths of only 5 and 10 mm at 0.2 and 0.36 mm voxel sizes, respectively.

Conclusion

Our method is able to accurately detect even very short needles, ensuring that the needle and its tip are maximally visible in the visualized plane during the entire intervention, thereby eliminating the need for advanced bi-manual coordination of the needle and transducer.
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4.

Purpose

To test the effectiveness of a central venous catheter (CVC) insertion strategy and a hand hygiene (HH) improvement strategy to prevent central venous catheter-related bloodstream infections (CRBSI) in European intensive care units (ICUs), measuring both process and outcome indicators.

Methods

Adult ICUs from 14 hospitals in 11 European countries participated in this stepped-wedge cluster randomised controlled multicentre intervention study. After a 6 month baseline, three hospitals were randomised to one of three interventions every quarter: (1) CVC insertion strategy (CVCi); (2) HH promotion strategy (HHi); and (3) both interventions combined (COMBi). Primary outcome was prospective CRBSI incidence density. Secondary outcomes were a CVC insertion score and HH compliance.

Results

Overall 25,348 patients with 35,831 CVCs were included. CRBSI incidence density decreased from 2.4/1000 CVC-days at baseline to 0.9/1000 (p < 0.0001). When adjusted for patient and CVC characteristics all three interventions significantly reduced CRBSI incidence density. When additionally adjusted for the baseline decreasing trend, the HHi and COMBi arms were still effective. CVC insertion scores and HH compliance increased significantly with all three interventions.

Conclusions

This study demonstrates that multimodal prevention strategies aiming at improving CVC insertion practice and HH reduce CRBSI in diverse European ICUs. Compliance explained CRBSI reduction and future quality improvement studies should encourage measuring process indicators.
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5.

Purpose

This study aimed to evaluate the diagnostic properties of transabdominal sonography with the post-void technique for cervical length measurement.

Methods

This study was a prospective cohort study. The inclusion criteria were pregnant women aged 18–40 years with gestational age of 18–23 completed weeks. Transabdominal sonography with vertical bladder depth of less than 5 cm and transvaginal cervical length measurements were carried out by a single experienced sonographer.

Results

There were 307 eligible pregnant women. The mean age of all subjects was 29.0 years. The mean cervical length obtained through transabdominal and transvaginal measurement was 3.33 and 3.47 cm, respectively. Ten patients (3.3 %) were identified as having a short cervix using transvaginal sonography, and 12 patients (3.9 %) were identified using transabdominal sonography.

Conclusion

Transabdominal sonography with vertical bladder depth of less than 5 cm performed better compared with transvaginal sonography. It may not be necessary to perform transvaginal sonography if transabdominal sonography reveals the cervical length to be more than 2.5 cm.
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6.

Purpose

Intraoperative optical coherence tomography (iOCT) is an increasingly available imaging technique for ophthalmic microsurgery that provides high-resolution cross-sectional information of the surgical scene. We propose to build on its desirable qualities and present a method for tracking the orientation and location of a surgical needle. Thereby, we enable the direct analysis of instrument–tissue interaction directly in OCT space without complex multimodal calibration that would be required with traditional instrument tracking methods.

Method

The intersection of the needle with the iOCT scan is detected by a peculiar multistep ellipse fitting that takes advantage of the directionality of the modality. The geometric modeling allows us to use the ellipse parameters and provide them into a latency-aware estimator to infer the 5DOF pose during needle movement.

Results

Experiments on phantom data and ex vivo porcine eyes indicate that the algorithm retains angular precision especially during lateral needle movement and provides a more robust and consistent estimation than baseline methods.

Conclusion

Using solely cross-sectional iOCT information, we are able to successfully and robustly estimate a 5DOF pose of the instrument in less than 5.4 ms on a CPU.
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7.

Background

The success of radiofrequency ablation (RF) of the medial branch of the dorsal ramus in patients with facet joint pain depends on the effective coagulation distance. To date, computed tomography(CT)-guided techniques do not reach the nerve in parallel but rather than punctually. We report a new CT-guided technique to enhance parallelism and proximity of the RF needle to the nerve.

Materials and methods

Two examiners with different experience with CT-guided procedures in corpses performed all punctures at the lumbar spine on 10 corpses. A RF needle was inserted 1?cm lateral to the spinous process of the vertebra located caudal to the target nerve. The needle was advanced under CT guidance at a flat angle between the superior articular process and the base of the costal or transverse process of the cranial vertebra. The position was verified by dissection. Needle position was judged successful provided the needle could be positioned in the first attempt with no more than one angle correction.

Results

In 86 out of 100 possible cases (50 per side) at the 5 lumbar segments, the RF needle could be depicted by CT in the target area with no more than one correction of the needle position. Anatomical dissections revealed that 47 out of 86 needles (54.6%) fulfilled the requirements of parallelism and proximity to the nerve. The dorsal ramus was never reached by the RF needle. Higher success rates were obtained in the middle segments compared to the border segments of L1–L2 and L5–S1.

Conclusions

We could demonstrate that the principle of parallelism and proximity of the needle to the nerve could be fulfilled with this new technique; however, needle positioning requires practice due to the oblique puncture direction.
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8.
M. Tröger 《Arthroskopie》2016,29(3):179-185

Background

Knees with a limited range of motion caused by intraarticular scars benefit from arthroscopic arthrolysis. Usually these scars result from previous surgery, severe trauma with damage of intraarticular structures.

Objectives

The aim of this procedure is to improve the patients’ range of motion which is necessary for activities of work and daily life. Scar tissue is debrided and resected arthroscopically with a radiofrequency device, a shaver or a punch.

Indications

Indications are a flexion deficit of max. 40°, an extension deficit of max. 20°, reduced mobility of patella, intraarticular reason for limited range of motion, cyclops after anterior cruciate liagment reconstruction, fibrotic Hoffa fat pad.

Contraindications

Contraindications are an extraarticular origin of limited range of motion (e.?g. fibrotic quadriceps muscle), local and general infection, major osteoarthritis, noncompliance, complex regional pain syndrome type I.

Postoperative management

A continuous physical therapy to maintain range of motion is essential. If necessary, continuous passive motion is implemented. Pain adapted weight-bearing should be used for mobilization. A sufficient oral and (when indicated) regional pain management is important to guarantee the benefit of the surgery.

Results

Patients with a lack of mobility of the knee gain a significantly increased range of motion by this arthroscopic procedure. Because of the minimal invasiveness, trauma of surgery and risk of infection are reduced. In many cases the function of the knee joint can be completely restored or at least improved considerably. Complications such as early osteoarthritis can be avoided.
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9.

Purpose

An artificial site for cell or pancreatic islet transplantation can be created using a polymeric scaffold, even though it suffers subcutaneously from improper vascularisation. A sufficient blood supply is crucial for graft survival and function and can be enhanced by transplantation of mesenchymal stem cells (MSCs). The purpose of this study was to assess the effect of syngeneic MSCs on neoangiogenesis and cell engraftment in an artificial site by multimodal imaging.

Procedures

MSCs expressing a gene for luciferase were injected into the artificial subcutaneous site 7 days after scaffold implantation. MRI experiments (anatomical and dynamic contrast-enhanced images) were performed on a 4.7-T scanner using gradient echo sequences. Bioluminescent images were acquired on an IVIS Lumina optical imager. Longitudinal examination was performed for 2 months, and one animal was monitored for 16 months.

Results

We confirmed the long-term presence (lasting more than 16 months) of viable donor cells inside the scaffolds using bioluminescence imaging with an optical signal peak appearing on day 3 after MSC implantation. When compared to controls, the tissue perfusion and vessel permeability in the scaffolds were significantly improved at the site with MSCs with a maximal peak on day 9 after MSC transplantation.

Conclusions

Our data suggest that the maximal signal obtained by bioluminescence and magnetic resonance imaging from an artificially created site between 3 and 9 days after MSC transplantation can predict the optimal time range for subsequent cellular or tissue transplantation, including pancreatic islets.
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10.

Purpose

We present a fully image-based visual servoing framework for neurosurgical navigation and needle guidance. The proposed servo-control scheme allows for compensation of target anatomy movements, maintaining high navigational accuracy over time, and automatic needle guide alignment for accurate manual insertions.

Method

Our system comprises a motorized 3D ultrasound (US) transducer mounted on a robotic arm and equipped with a needle guide. It continuously registers US sweeps in real time with a pre-interventional plan based on CT or MR images and annotations. While a visual control law maintains anatomy visibility and alignment of the needle guide, a force controller is employed for acoustic coupling and tissue pressure. We validate the servoing capabilities of our method on a geometric gel phantom and real human anatomy, and the needle targeting accuracy using CT images on a lumbar spine gel phantom under neurosurgery conditions.

Results

Despite the varying resolution of the acquired 3D sweeps, we achieved direction-independent positioning errors of \(0.35\pm 0.19\) mm and \(0.61^\circ \pm 0.45^\circ \), respectively. Our method is capable of compensating movements of around 25 mm/s and works reliably on human anatomy with errors of \(1.45\pm 0.78\) mm. In all four manual insertions by an expert surgeon, a needle could be successfully inserted into the facet joint, with an estimated targeting accuracy of \(1.33\pm 0.33\) mm, superior to the gold standard.

Conclusion

The experiments demonstrated the feasibility of robotic ultrasound-based navigation and needle guidance for neurosurgical applications such as lumbar spine injections.
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11.

Objective

To compare the safety and estimate the response profile of olanzapine, a second-generation antipsychotic, to haloperidol in the treatment of delirium in the critical care setting.

Design

Prospective randomized trial

Setting

Tertiary care university affiliated critical care unit.

Patients

All admissions to a medical and surgical intensive care unit with a diagnosis of delirium.

Interventions

Patients were randomized to receive either enteral olanzapine or haloperidol.

Measurements

Patient’s delirium severity and benzodiazepine use were monitored over 5 days after the diagnosis of delirium.

Main results

Delirium Index decreased over time in both groups, as did the administered dose of benzodiazepines. Clinical improvement was similar in both treatment arms. No side effects were noted in the olanzapine group, whereas the use of haloperidol was associated with extrapyramidal side effects.

Conclusions

Olanzapine is a safe alternative to haloperidol in delirious critical care patients, and may be of particular interest in patients in whom haloperidol is contraindicated.
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12.

Purpose

To evaluate and compare the needle placement accuracy, patient dose, procedural time, complication rate and ablation success of microwave thermoablation using a novel robotic guidance approach and a manual approach.

Methods

We performed a retrospective single-center evaluation of 64 microwave thermoablations of liver tumors in 46 patients (10 female, 36 male, mean age 66 years) between June 2014 and February 2015. Thirty ablations were carried out with manual guidance, while 34 ablations were performed using robotic guidance. A 6-week follow-up (ultrasound, computed tomography and MRI) was performed on all patients.

Results

The total procedure time and dose-length product were significantly reduced under robotic guidance (18.3 vs. 21.7 min, \(p<0.001\); 2216 vs. 2881 mGy\(\times \)cm, \(p = 0.04\)). The position of the percutaneous needle was more accurate using robotic guidance (needle deviation 1.6 vs. 3.3 mm, \(p< 0.001\)). There was no significant difference between both groups regarding the complication rate and the ablation success.

Conclusion

Robotic assistance for liver tumor ablation reduces patient dose and allows for fast positioning of the microwave applicator with high accuracy. The complication rate and ablation success of percutaneous microwave thermoablation of malignant liver tumors using either CT fluoroscopy or robotic guidance for needle positioning showed no significant differences in the 6-week follow-up.
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13.

Purpose

Volar percutaneous scaphoid fracture fixation is conventionally performed under fluoroscopy-based guidance, where surgeons need to mentally determine a trajectory for the insertion of the screw and its depth based on a series of 2D projection images. In addition to challenges associated with mapping 2D information to a 3D space, the process involves exposure to ionizing radiation. Three-dimensional ultrasound has been suggested as an alternative imaging tool for this procedure; however, it has not yet been integrated into clinical routine since ultrasound only provides a limited view of the scaphoid and its surrounding anatomy.

Methods

We propose a registration of a statistical wrist shape + scale + pose model to a preoperative CT and intraoperative ultrasound to derive a patient-specific 3D model for guiding scaphoid fracture fixation. The registered model is then used to determine clinically important intervention parameters, including the screw length and the trajectory of screw insertion in the scaphoid bone.

Results

Feasibility experiments are performed using 13 cadaver wrists. In 10 out of 13 cases, the trajectory of screw suggested by the registered model meets all clinically important intervention parameters. Overall, an average 94 % of maximum allowable screw length is obtained based on the measurements from gold standard CT. Also, we obtained an average 92 % successful volar accessibility, which indicates that the trajectory is not obstructed by the surrounding trapezium bone.

Conclusions

These promising results indicate that determining clinically important screw insertion parameters for scaphoid fracture fixation is feasible using 3D ultrasound imaging. This suggests the potential of this technology in replacing fluoroscopic guidance for this procedure in future applications.
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14.

Purpose

Contrast-enhanced ultrasound (CEUS) can distinguish between central lung cancer and atelectatic lung tissue. The aim of this study was to explore the clinical value of CEUS for biopsy in patients with central lung cancer with obstructive atelectasis.

Methods

One hundred and twelve patients were selected and CEUS was performed to display central lung cancer and atelectatic lung tissue. The front edge of central lung cancer was punctured with a needle, avoiding the necrotic area, under the guidance of CEUS.

Results

All of the 112 lesions were diagnosed with a clear central lung cancer mass and atelectatic lung tissue. In 104 cases, the central lung cancer mass presented with a “slow-in and fast-out” pattern compared to atelectatic lung tissue. In eight cases, the central lung cancer mass presented with a “fast-in and fast-out” pattern compared to atelectatic lung tissue. The mean number of punctures was 2.6, and the success rate of puncture biopsy was 98%. Of the 112 patients, six cases had hemoptysis during the procedure and 10 patients had bloody sputum in the postoperative period. No complications were found in the other cases.

Conclusion

CEUS has important clinical value for needle biopsy of central lung cancer with atelectasis.
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15.

Introduction

To present short-term safety and efficacy data of men with lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) treated with Aquablation.

Methods

Men with LUTs secondary to BPH (60–150 cc) underwent Aquablation treatment from February 2016 to December 2017 across 17 investigational sites in the USA from two contemporary investigational device exemption (IDE) studies called WATER (NCT02505919) and WATER II (NCT03123250).

Results

One hundred seven males with mean age of 67.3?±?6.5 years were treated with Aquablation; mean prostate volume was 99.4?±?24.1 cc. The pooled results show that large prostates have an average procedure time of less than 36 min and discharge on average 1.6?±?1 days. The IPSS decreased by 16.7?±?8.1 points at 3 months and Qmax increased by 11.2?±?12.4 ml/s. The Clavien-Dindo (CD) grade 2 or higher event rate at 3 months was 29%. A non-hierarchical breakdown for CD events yielded 18% grade 2 and 19% grade 3 or higher.

Conclusion

Men with LUTS secondary to BPH (60–150 cc) in a pooled analysis were treated safely and effectively with Aquablation up to 3 months postoperatively.

Trial Registration

ClinicalTrials.gov identifiers, NCT02505919 and NCT03123250.

Funding

PROCEPT BioRobotics.
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16.

Purpose

The conventional medical ultrasound imaging has a low lateral spatial resolution, and the image quality depends on the depth of the imaging location. To overcome these problems, this study presents a synthetic aperture (SA) ultrasound imaging method using a ring transducer array.

Methods

An experimental ring transducer array imaging system was constructed. The array was composed of 2048 transducer elements, and had a diameter of 200 mm and an inter-element pitch of 0.325 mm. The imaging object was placed in the center of the ring transducer array, which was immersed in water. SA ultrasound imaging was then employed to scan the object and reconstruct the reflection image.

Results

Both wire phantom and ex vivo experiments were conducted. The proposed method was found to be capable of producing isotropic high-resolution images of the wire phantom. In addition, preliminary ex vivo experiments using porcine organs demonstrated the ability of the method to reconstruct high-quality images without any depth dependence.

Conclusion

The proposed ring transducer array and SA ultrasound imaging method were shown to be capable of producing isotropic high-resolution images whose quality was independent of depth.
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17.

Purpose

Endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) is the most reliable method for the histological diagnosis of pancreatic tumors. Rapid on-site fluorescence-guided histological diagnosis was evaluated by topically applying an enzymatically activatable probe onto the EUS-FNA samples; the probe fluoresces in the presence of γ-glutamyltranspeptidase (GGT).

Procedures

We evaluated GGT expression in pancreatic cancer cell lines in vitro. EUS-FNA was performed in 10 pancreatic tumors. After topical application of the probe, signal intensity was measured using a fluorescence imaging system for 13 min.

Results

GGT was expressed in Panc-1, AsPC-1, and AR42J, but not in KP4 cells. In samples from six cases, several regions of the specimens fluoresced and contained adequate tissue for pathological diagnosis. The remaining four non-fluorescent samples contained very small amounts of carcinoma, normal epithelial cells, or no epithelial cells. The signal intensity at 5 min was 25.5?±?7.7 and 7.7?±?0.5 in fluorescent and non-fluorescent regions, respectively (p?<?0.05).

Conclusions

Application of enzymatically activatable probe onto EUS-FNA samples would be feasible for the rapid evaluation of tissues suitable for histological diagnosis.
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18.

Purpose

To evaluate feasibility of automatic software-based path proposals for CT-guided percutaneous biopsies.

Methods

Thirty-three patients (60 \(\pm \) 12 years) referred for CT-guided biopsy of focal liver lesions were consecutively included. Pre-interventional CT and dedicated software (FraunhoferMeVis Pathfinder) were used for (semi)automatic segmentation of relevant structures. The software subsequently generated three path proposals in downward quality for CT-guided biopsy. Proposed needle paths were compared with consensus proposal of two experts (comparable, less suitable, not feasible). In case of comparable results, equivalent approach to software-based path proposal was used. Quality of segmentation process was evaluated (Likert scale, 1 \(=\) best, 6 \(=\) worst), and time for processing was registered.

Results

All biopsies were performed successfully without complications. In 91 % one of the three automatic path proposals was rated comparable to experts’ proposal. None of the first proposals was rated not feasible, and 76 % were rated comparable to the experts’ proposal. 7 % automatic path proposals were rated not feasible, all being second choice (\(n=1\)) or third choice (\(n=6\)). In 79 %, segmentation at least was good. Average total time for establishing automatic path proposal was 42 \(\pm \) 9 s.

Conclusion

Automatic software-based path proposal for CT-guided liver biopsies in the majority provides path proposals that are easy to establish and comparable to experts’ insertion trajectories.
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19.

Purpose

Flexible needle has the potential to accurately navigate to a treatment region in the least invasive manner. We propose a new planning method using Markov decision processes (MDPs) for flexible needle navigation that can perform robust path planning and steering under the circumstance of complex tissue–needle interactions.

Methods

This method enhances the robustness of flexible needle steering from three different perspectives. First, the method considers the problem caused by soft tissue deformation. The method then resolves the common needle penetration failure caused by patterns of targets, while the last solution addresses the uncertainty issues in flexible needle motion due to complex and unpredictable tissue–needle interaction.

Results

Computer simulation and phantom experimental results show that the proposed method can perform robust planning and generate a secure control policy for flexible needle steering. Compared with a traditional method using MDPs, the proposed method achieves higher accuracy and probability of success in avoiding obstacles under complicated and uncertain tissue–needle interactions. Future work will involve experiment with biological tissue in vivo.

Conclusion

The proposed robust path planning method can securely steer flexible needle within soft phantom tissues and achieve high adaptability in computer simulation.
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20.

Purpose

The experimental investigation of an optical fiber Bragg grating (FBG) sensor for biomedical application is described. The FBG sensor can be used to measure sound pressure and temperature rise simultaneously in biological tissues exposed to ultrasound. The theoretical maximum values that can be measured with the FBG sensor are 73.0 MPa and 30 °C.

Methods

In this study, measurement of sound pressure up to 5 MPa was performed at an ultrasound frequency of 2 MHz. A maximum temperature change of 6 °C was measured in a tissue-mimicking material.

Results

Values yielded by the FBG sensor agreed with those measured using a thermocouple and a hydrophone.

Conclusion

Since this sensor is used to monitor the sound pressure and temperature simultaneously, it can also be used for industrial applications, such as ultrasonic cleaning of semiconductors under controlled temperatures.
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