Objective preclinical measures for bone conduction implants.

The study evaluates the accuracy of predicting intracochlear pressure during bone conduction stimulation using promontory velocity and ear canal pressure, as less invasive alternatives to intracochlear pressure. Stimulating with a percutaneous bone conduction device implanted in six human cadaveric ears, measurements were taken across various intensities, frequencies, and stimulation positions. Results indicate that intracochlear pressure linearly correlates with ear canal pressure (R2 = 0.43, RMSE = 6.85 dB), and promontory velocity (R2 = 0.47, RMSE = 6.60 dB). Normalizing data to mitigate the influence of stimulation position leads to a substantial improvement in these correlations. R2 values increased substantially to 0.93 for both the ear canal pressure and the promontory velocity, with RMSE reduced considerably to 2.02 (for ear canal pressure) and 1.94 dB (for promontory velocity). Conclusively, both ear canal pressure and promontory velocity showed potential in predicting intracochlear pressure and the prediction accuracy notably enhanced when accounting for stimulation position. Ultimately, these findings advocate for the continued use of intracochlear pressure measurements to evaluate future bone conduction devices and illuminate the role of stimulation position in influencing the dynamics of bone conduction pathways.

Automatic breach detection during spine pedicle drilling based on vibroacoustic sensing.

Pedicle drilling is a complex and critical spinal surgery task. Detecting breach or penetration of the surgical tool to the cortical wall during pilot-hole drilling is essential to avoid damage to vital anatomical structures adjacent to the pedicle, such as the spinal cord, blood vessels, and nerves. Currently, the guidance of pedicle drilling is done using image-guided methods that are radiation intensive and limited to the preoperative information. This work proposes a new radiation-free breach detection algorithm leveraging a non-visual sensor setup in combination with deep learning approach. Multiple vibroacoustic sensors, such as a contact microphone, a free-field microphone, a tri-axial accelerometer, a uni-axial accelerometer, and an optical tracking system were integrated into the setup. Data were collected on four cadaveric human spines, ranging from L5 to T10. An experienced spine surgeon drilled the pedicles relying on optical navigation. A new automatic labeling method based on the tracking data was introduced. Labeled data was subsequently fed to the network in mel-spectrograms, classifying the data into breach and non-breach. Different sensor types, sensor positioning, and their combinations were evaluated. The best results in breach recall for individual sensors could be achieved using contact microphones attached to the dorsal skin (85.8%) and uni-axial accelerometers clamped to the spinous process of the drilled vertebra (81.0%). The best-performing data fusion model combined the latter two sensors with a breach recall of 98%. The proposed method shows the great potential of non-visual sensor fusion for avoiding screw misplacement and accidental bone breaches during pedicle drilling and could be extended to further surgical applications.

State-of-the-Art of Non-Radiative, Non-Visual Spine Sensing with a Focus on Sensing Forces, Vibrations and Bioelectrical Properties: A Systematic Review.

In the research field of robotic spine surgery, there is a big upcoming momentum for surgeon-like autonomous behaviour and surgical accuracy in robotics which goes beyond the standard engineering notions such as geometric precision. The objective of this review is to present an overview of the state of the art in non-visual, non-radiative spine sensing for the enhancement of surgical techniques in robotic automation. It provides a vantage point that facilitates experimentation and guides new research projects to what has not been investigated or integrated in surgical robotics. Studies were identified, selected and processed according to the PRISMA guidelines. Relevant study characteristics that were searched for include the sensor type and measured feature, the surgical action, the tested sample, the method for data analysis and the system's accuracy of state identification. The 6DOF f/t sensor, the microphone and the electromyography probe were the most commonly used sensors in each category, respectively. The performance of the electromyography probe is unsatisfactory in terms of preventing nerve damage as it can only signal after the nerve is disturbed. Feature thresholding and artificial neural networks were the most common decision algorithms for state identification. The fusion of different sensor data in the decision algorithm improved the accuracy of state identification.

Lumped element models of sound conduction in the human ear: A systematic review.

Lumped element models facilitate investigating the fundamental mechanisms of human ear sound conduction. This systematic review aims to guide researchers to the optimal model for the investigated parameters. For this purpose, the literature was reviewed up to 12 July 2023, according to the PRISMA guidelines. Seven models are included via database searching, and another 19 via cross-referencing. The quality of the models is assessed by comparing the predicted middle ear transfer function, the tympanic membrane impedance, the energy reflectance, and the intracochlear pressures (ICPs) (scala vestibuli, scala tympani, and differential) with experimental data. Regarding air conduction (AC), the models characterize the pathway from the outer to the inner ear and accurately predict all six aforementioned parameters. This contrasts with the few existing bone conduction (BC) models that simulate only a part of the ear. In addition, these models excel at predicting one observable parameter, namely, ICP. Thus, a model that simulates BC from the coupling site to the inner ear is still lacking and would increase insights into the human ear sound conduction. Last, this review provides insights and recommendations to determine the appropriate model for AC and BC implants, which is highly relevant for future clinical applications.

Intraoperative tissue classification methods in orthopedic and neurological surgeries: A systematic review.

Accurate tissue differentiation during orthopedic and neurological surgeries is critical, given that such surgeries involve operations on or in the vicinity of vital neurovascular structures and erroneous surgical maneuvers can lead to surgical complications. By now, the number of emerging technologies tackling the problem of intraoperative tissue classification methods is increasing. Therefore, this systematic review paper intends to give a general overview of existing technologies. The review was done based on the PRISMA principle and two databases: PubMed and IEEE Xplore. The screening process resulted in 60 full-text papers. The general characteristics of the methodology from extracted papers included data processing pipeline, machine learning methods if applicable, types of tissues that can be identified with them, phantom used to conduct the experiment, and evaluation results. This paper can be useful in identifying the problems in the current status of the state-of-the-art intraoperative tissue classification methods and designing new enhanced techniques.

The wettability of electron spun membranes by synovial fluid.

Aseptic loosening due to periprosthetic osteolysis has been accepted as one of the leading causes of revision procedures in patients with previous joint arthroplasty. Recently, several strategies for suppression of osteolysis were proposed, mostly based on biological treatment such as mitigation of chronic inflammatory reactions. However, these biological treatments do not stop the debris migration but only reduce the inflammatory reaction. To address this shortcoming, we propose the concept of ultrahigh molecular weighted polyethylene particles filtration storage by electrospun membranes. Firstly, the surface tension of synovial fluid (SF) is obtained by use of a pendant droplet. Secondly, the contact angle of the electrospun membranes wetted by two different liquids is measured to obtain the free surface energy using of the Owens-Wendt model. Additionally, the wettability of electrospun membranes by SF as a function of technology parameters is studied.

A Method Based on 3D Shape Analysis Towards the Design of Flexible Instruments for Endoscopic Maxillary Sinus Surgery.

The emergence of steerable flexible instruments has widened the uptake of minimally invasive surgical techniques. In sinus surgery, such flexible instruments could enable the access to difficult-to-reach anatomical areas. However, design-oriented metrics, essential for the development of steerable flexible instruments for maxillary sinus surgery, are still lacking. This paper proposes a method to process measurements and provides the instrument designer with essential information to develop adapted flexible instruments for limited access surgery. This method was applied to maxillary sinus surgery and showed that an instrument with a diameter smaller than 2.4 mm can be used on more than 72.5% of the subjects' set. Based on the statistical analysis and provided that this flexible instrument can bend up to [Formula: see text] it is estimated that all areas within the maxillary sinus could be reached through a regular antrostomy without resorting to extra incision or tissue removal in 94.9% of the population set. The presented method was partially validated by conducting cadaver experiments.

Development of an Instrument to Assess the Stability of Cementless Femoral Implants Using Vibration Analysis During Total Hip Arthroplasty.

OBJECTIVE: The level of primary implant fixation in cementless total hip arthroplasty is a key factor for the longevity of the implant. Vibration-based methods show promise for providing quantitative information to help surgeons monitor implant fixation intraoperatively. A thorough understanding of what is driving these changes in vibrational behavior is important for further development and improvement of these methods. Additionally, an instrument must be designed to enable surgeons to leverage these methods. This study addresses both of these issues. METHOD: An augmented system approach was used to develop an instrument that improves the sensitivity of the vibrational method and enables the implementation of the necessary excitation and measurement equipment. The augmented system approach took into account the dynamics of the existing bone-implant system and its interaction with the added instrument. RESULTS: Two instrument designs are proposed, accompanied by a convergence-based method to determine the insertion endpoint. The modal strain energy density distribution was shown to affect the vibrational sensitivity to contact changes in certain areas. CONCLUSION: The augmented system approach led to an instrument design that improved the sensitivity to changes in the proximal region of the combined bone-implant-instrument system. This fact was confirmed both in silico and in vitro. Clinical Impact: The presented method and instruments address practical intraoperative challenges and provide perspective to objectively support the surgeon's decision-making process, which will ensure optimal patient treatment.

Acoustic analysis to monitor implant seating and early detect fractures in cementless THA: An in vivo study.

The initial stability of cementless total hip arthroplasty (THA) implants is obtained by an interference fit that allows osseointegration for a long term secondary stability of the implant. Yet, finding the insertion endpoint that corresponds to an appropriate initial stability is currently often based on a number of subjective experiences of the orthopedic surgeon, which can be challenging. In order to assist the orthopedic surgeons in their pursuit to find this optimal initial stability, this study aims to determine whether the analysis of sound that results from the implant insertion hammer blows can be used to objectively monitor the insertion process of cementless THA implants. An in vivo study was conducted. The experimental results revealed vibro-acoustic behavior sensitive to implant seating, related to the low frequency content of the response spectra. This sensitive low-frequency behavior was quantified by a set of specific vibro-acoustic features and metrics that reflected the power and similarity of the low-frequency response. These features and metrics allowed monitoring the implant seating and their convergence agreed well with the endpoint of insertion as determined by the orthopedic surgeon. Intraoperative fractures caused an abrupt and opposite change of the vibro-acoustic behavior prior to the notification of the fracture by the orthopedic surgeon. The observation of such an abrupt change in the vibro-acoustic behavior can be an important early warning for loss of implant stability. The presented vibro-acoustic measurement method shows potential to serve as a decision supporting source of information as it showed to reflect the implant seating.

The Use of a Vibro-Acoustic Based Method to Determine the Composite Material Properties of a Replicate Clavicle Bone Model.

Replicate bones are widely used as an alternative for cadaveric bones for in vitro testing. These composite bone models are more easily available and show low inter-specimen variability compared to cadaveric bone models. The combination of in vitro testing with in silico models can provide further insights in the evaluation of the mechanical behavior of orthopedic implants. An accurate numerical representation of the experimental model is important to draw meaningful conclusions from the numerical predictions. This study aims to determine the elastic material constants of a commonly used composite clavicle model by combining acoustic experimental and numerical modal analysis. The difference between the experimental and finite element (FE) predicted natural frequencies was minimized by updating the elastic material constants of the transversely isotropic cortical bone analogue that are provided by the manufacturer. The longitudinal Young's modulus was reduced from 16.00 GPa to 12.88 GPa and the shear modulus was increased from 3.30 GPa to 4.53 GPa. These updated material properties resulted in an average natural frequency difference of 0.49% and a maximum difference of 1.73% between the FE predictions and the experimental results. The presented updated model aims to improve future research that focuses on mechanical simulations with clavicle composite bone models.

Two Different Methods to Measure the Stability of Acetabular Implants: A Comparison Using Artificial Acetabular Models.

The total number of total hip arthroplasties is increasing every year, and approximately 10% of these surgeries are revisions. New implant design and surgical techniques are evolving quickly and demand accurate preclinical evaluation. The initial stability of cementless implants is one of the main concerns of these preclinical evaluations. A broad range of initial stability test methods is currently used, which can be categorized into two main groups: Load-to-failure tests and relative micromotion measurements. Measuring relative micromotion between implant and bone is recognized as the golden standard for implant stability testing as this micromotion is directly linked to the long-term fixation of cementless implants. However, specific custom-made set-ups are required to measure this micromotion, with the result that numerous studies opt to perform more straightforward load-to-failure tests. A custom-made micromotion test set-up for artificial acetabular bone models was developed and used to compare load-to-failure (implant push-out test) with micromotion and to assess the influence of bone material properties and press-fit on the implant stability. The results showed a high degree of correlation between micromotion and load-to-failure stability metrics, which indicates that load-to-failure stability tests can be an appropriate estimator of the primary stability of acetabular implants. Nevertheless, micromotions still apply as the golden standard and are preferred when high accuracy is necessary. Higher bone density resulted in an increase in implant stability. An increase of press-fit from 0.7 mm to 1.2 mm did not significantly increase implant stability.

Handheld Active Add-On Control Unit for a Cable-Driven Flexible Endoscope.

The instruments currently used by surgeons for in utero treatment of the twin-to-twin transfusion syndrome (TTTS) are rigid or semi-rigid. Their poor dexterity makes this surgical intervention risky and the surgeon's work very complex. This paper proposes the design, assembly and quantitative evaluation of an add-on system intended to be placed on a commercialized cable-driven flexible endoscope. The add-on system is lightweight and easily exchangeable thanks to the McKibben muscle actuators embedded in its system. The combination of the flexible endoscope and the new add-on unit results in an easy controllable flexible instrument with great potential use in TTTS treatment, and especially for regions that are hard to reach with conventional instruments. The fetoscope has a precision of 7.4% over its entire bending range and allows to decrease the maximum planar force on the body wall of 6.15% compared to the original endoscope. The add-on control system also allows a more stable and precise actuation of the endoscope flexible tip.

Modal frequency and shape curvature as a measure of implant fixation: A computer study on the acetabular cup.

Modal parameters are often investigated in order to assess the initial fixation of an implant. Most of studies are focused on the natural frequencies and frequency response function. Usually the femoral stem is tested although the acetabular cup fixation is important as well. The results of implant stability assessment are inconsistent and seem to suggest that frequency as a stability indicator is not sufficiently sensitive. In this study the sensitivity of the modal properties to changes in the bone-implant interface was investigated with the help of the finite element method (FEM). A novel fixation index based on modal shape curvature was investigated as a potential measure of the implant fixation. Modal frequencies are sensitive to interface changes in some manner, but suffer from insensitivity to local changes at bone-implant interface. The sensitivity up to 44% of natural frequencies to stiffness change due insertion steps was observed. The tested damage indicators are able to detect localized small changes in peripheral stiffness (5% stiffness reduction) with 95% confidence under the noise up to 1%. The modal shapes and their curvatures have a great potential to be a robust fixation indicator.

A mixed-reality surgical trainer with comprehensive sensing for fetal laser minimally invasive surgery.

PURPOSE: Smaller incisions and reduced surgical trauma made minimally invasive surgery (MIS) grow in popularity even though long training is required to master the instrument manipulation constraints. While numerous training systems have been developed in the past, very few of them tackled fetal surgery and more specifically the treatment of twin-twin transfusion syndrome (TTTS). To address this lack of training resources, this paper presents a novel mixed-reality surgical trainer equipped with comprehensive sensing for TTTS procedures. The proposed trainer combines the benefits of box trainer technology and virtual reality systems. Face and content validation studies are presented and a use-case highlights the benefits of having embedded sensors. METHODS: Face and content validity of the developed setup was assessed by asking surgeons from the field of fetal MIS to accomplish specific tasks on the trainer. A small use-case investigates whether the trainer sensors are able to distinguish between an easy and difficult scenario. RESULTS: The trainer was deemed sufficiently realistic and its proposed tasks relevant for practicing the required motor skills. The use-case demonstrated that the motion and force sensing capabilities of the trainer were able to analyze surgical skill. CONCLUSION: The developed trainer for fetal laser surgery was validated by surgeons from a specialized center in fetal medicine. Further similar investigations in other centers are of interest, as well as quality improvements which will allow to increase the difficulty of the trainer. The comprehensive sensing appeared to be capable of objectively assessing skill.

Vibration-based fixation assessment of tibial knee implants: A combined in vitro and in silico feasibility study.

The preoperative diagnosis of loosening of cemented tibial knee implants is challenging. This feasibility study explored the basic potential of a vibration-based method as an alternative diagnostic technique to assess the fixation state of a cemented tibia implant and establish the method's sensitivity limits. A combined in vitro and in silico approach was pursued. Several loosening cases were simulated. The largest changes in the vibrational behavior were obtained in the frequency range above 1500 Hz. The vibrational behavior was described with two features; the frequency response function and the power spectral density band power. Using both features, all experimentally simulated loosening cases could clearly be distinguished from the fully cemented cases. By complementing the experimental work with an in silico study, it was shown that loosening of approximately 14% of the implant surface on the lateral and medial side was detectable with a vibration-based method. Proximal lateral and medial locations on the tibia or locations toward the edge of the implant surface measured in the longitudinal direction were the most sensitive measurement and excitation locations to assess implant fixation. These results contribute to the development of vibration-based methods as an alternative follow-up method to detect loosened tibia implants.

Development of an acoustic measurement protocol to monitor acetabular implant fixation in cementless total hip Arthroplasty: A preliminary study.

In cementless total hip arthroplasty (THA), the initial stability is obtained by press-fitting the implant in the bone to allow osseointegration for a long term secondary stability. However, finding the insertion endpoint that corresponds to a proper initial stability is currently based on the tactile and auditory experiences of the orthopedic surgeon, which can be challenging. This study presents a novel real-time method based on acoustic signals to monitor the acetabular implant fixation in cementless total hip arthroplasty. Twelve acoustic in vitro experiments were performed on three types of bone models; a simple bone block model, an artificial pelvic model and a cadaveric model. A custom made beam was screwed onto the implant which functioned as a sound enhancer and insertor. At each insertion step an acoustic measurement was performed. A significant acoustic resonance frequency shift was observed during the insertion process for the different bone models; 250 Hz (35%, second bending mode) to 180 Hz (13%, fourth bending mode) for the artificial bone block models and 120 Hz (11%, eighth bending mode) for the artificial pelvis model. No significant frequency shift was observed during the cadaveric experiment due to a lack of implant fixation in this model. This novel diagnostic method shows the potential of using acoustic signals to monitor the implant seating during insertion.

A biomechanical testing system to determine micromotion between hip implant and femur accounting for deformation of the hip implant: Assessment of the influence of rigid body assumptions on micromotions measurements.

BACKGROUND: Accurate pre-clinical evaluation of the initial stability of new cementless hip stems using in vitro micromotion measurements is an important step in the design process to assess the new stem's potential. Several measuring systems, linear variable displacement transducer-based and other, require assuming bone or implant to be rigid to obtain micromotion values or to calculate derived quantities such as relative implant tilting. METHODS: An alternative linear variable displacement transducer-based measuring system not requiring a rigid body assumption was developed in this study. The system combined advantages of local unidirectional and frame-and-bracket micromotion measuring concepts. The influence and possible errors that would be made by adopting a rigid body assumption were quantified. Furthermore, as the system allowed emulating local unidirectional and frame-and-bracket systems, the influence of adopting rigid body assumptions were also analyzed for both concepts. Synthetic and embalmed bone models were tested in combination with primary and revision implants. Single-legged stance phase loading was applied to the implant - bone constructs. FINDINGS: Adopting a rigid body assumption resulted in an overestimation of mediolateral micromotion of up to 49.7µm at more distal measuring locations. Maximal average relative rotational motion was overestimated by 0.12° around the anteroposterior axis. Frontal and sagittal tilting calculations based on a unidirectional measuring concept underestimated the true tilting by an order of magnitude. INTERPRETATION: Non-rigid behavior is a factor that should not be dismissed in micromotion stability evaluations of primary and revision femoral implants.

Determination of replicate composite bone material properties using modal analysis.

Replicate composite bones are used extensively for in vitro testing of new orthopedic devices. Contrary to tests with cadaveric bone material, which inherently exhibits large variability, they offer a standardized alternative with limited variability. Accurate knowledge of the composite's material properties is important when interpreting in vitro test results and when using them in FE models of biomechanical constructs. The cortical bone analogue material properties of three different fourth-generation composite bone models were determined by updating FE bone models using experimental and numerical modal analyses results. The influence of the cortical bone analogue material model (isotropic or transversely isotropic) and the inter- and intra-specimen variability were assessed. Isotropic cortical bone analogue material models failed to represent the experimental behavior in a satisfactory way even after updating the elastic material constants. When transversely isotropic material models were used, the updating procedure resulted in a reduction of the longitudinal Young's modulus from 16.00GPa before updating to an average of 13.96 GPa after updating. The shear modulus was increased from 3.30GPa to an average value of 3.92GPa. The transverse Young's modulus was lowered from an initial value of 10.00GPa to 9.89GPa. Low inter- and intra-specimen variability was found.

A nondestructive method to verify the glenosphere-baseplate assembly in reverse shoulder arthroplasty.

BACKGROUND: Glenoid dissociation is a rare postoperative complication in reverse shoulder arthroplasty that has severe consequences for the patient and requires revision in most cases. A mechanically compromised Morse taper is hypothesized to be the main cause of this complication, with bony impingements and soft tissue interpositioning being cited as the most important problems. Intraoperative assessment of the taper assembly is challenging. Current methods require applying considerable torque to the glenosphere or relying on radiographs. MATERIALS AND METHODS: This in vitro study demonstrates how the assembly quality can be accurately determined in a nondestructive way by exploiting the implant-specific relation between screw and Morse taper characteristics by measuring the angular rotation-torque curve. RESULTS: The feasibility of the method is demonstrated on 2 reverse implant models. Several data features that can statistically discriminate between optimal and suboptimal assemblies are proposed. CONCLUSION: Suboptimal assemblies can be detected using the method presented, which could easily be integrated in the current surgical workflow. Clinical recommendations based on the method's rationale are also presented, allowing detection of the most severe defect cases with surgical instruments currently in use.

Consequences of reaming with flat and convex reamers for bone volume and surface area of the glenoid; a basic science study.

BACKGROUND: The effect of reaming on bone volume and surface area of the glenoid is not precisely known. We hypothesize that (1) convex reamers create a larger surface area than flat reamers, (2) flat reamers cause less bone loss than convex reamers, and (3) the amount of bone loss increases with the amount of version correction. METHODS: Reaming procedures with different types of reamers are performed on similar-sized uniconcave and biconcave glenoids created from Sawbones foam blocks. The loss of bone volume, the size of the remaining surface area, and the reaming depth are measured and evaluated. RESULTS: Reaming with convex reamers results in a significantly larger surface area than with flat reamers for both uniconcave and biconcave glenoids (p = 0.013 and p = 0.001). Convex reamers cause more bone loss than flat reamers, but the difference is only significant for uniconcave glenoids (p = 0.007). CONCLUSIONS: In biconcave glenoids, convex reamers remove a similar amount of bone as flat reamers, but offer a larger surface area while maximizing the correction of the retroversion. In pathological uniconcave glenoids, convex reamers are preferred because of the conforming shape.