Spatial sensitivity distribution assessment and Monte Carlo simulations for needle-based bioimpedance imaging during venipuncture using the finite element method.

Despite being among the most common medical procedures, needle insertions suffer from a high error rate. Impedance measurements using electrode-equipped needles offer promise for improved tissue targeting and reduced errors. Impedance visualization usually requires an extensive pre-measured impedance dataset for tissue differentiation and knowledge of the electric fields contributing to the resulting impedances. This work presents two finite element simulation approaches for both problems. The first approach describes the generation of a multitude of impedances with Monte Carlo simulations for both, homogeneous and inhomogeneous tissue to circumvent the need to rely on previously measured data. These datasets could be used for tissue discrimination. The second method describes the simulation of the spatial sensitivity distribution of an electrode layout. Two singularity analysis methods were employed to determine the bulk of the sensitivity within a finite volume, which in turn enables consistent 3D visualization. The modeled electrode layout consists of 12 electrodes radially placed around a hypodermic needle. Electrical excitation was simulated using two neighboring electrodes for current carriage and voltage pickup, which resulted in 12 distinct bipolar excitation states. Both, the impedance simulations and the respective singularity analysis methods were compared with each other. The results show that the statistical spread of impedances is highly dependent on the tissue type and its inhomogeneities. The bounded bulk of sensitivities of both methods are of similar extent and symmetry. Future models should incorporate more detailed tissue properties such as anisotropy or changing material properties due to tissue deformation to gain more accurate predictions.

Novel and inexpensive gamma radiation sensor: initial concept and design.

PURPOSE: Early detection of tumors and their spread, particularly in lymph node illnesses, is critical for a full recovery. However, it is currently difficult due to a lack of imaging or detection devices that provide the necessary spatial depth and location information. Consequently, it would be beneficial to have a simple and cost-effective sensor device to determine the 3D position of, e.g., a lymph node in the patient's coordinate system. METHODS: In this work, we present a concept and design for a novel semiconductor-based 3D detection system that uses inexpensive off-the-shelf components to measure gamma activity. A simple Arduino-type microcontroller calculates the 3D position of the probe based on the number of the measured pulse, the spatial sensitivity characteristics, and the known geometry of the device. RESULTS: The system was set up from four photodiodes (Osram BPW34), a transistor-based pre-amplifier, and a two-stage operational amplifier as the main stage. Doing so, a signal sufficient to be read by the microcontroller could be produced. The performed calculations proved that for a system consisting of at least four photodiodes, it is possible to determine precise location of a gamma radiation source. CONCLUSIONS: After successful first experiments with a single diode, the optimal spatial arrangement of the diodes as well as their orientation will be determined to achieve a compact, cost effective yet fast, and accurate sensor device for every-day clinical application.

Needle-Based Electrical Impedance Imaging Technology for Needle Navigation.

Needle insertion is a common procedure in modern healthcare practices, such as blood sampling, tissue biopsy, and cancer treatment. Various guidance systems have been developed to reduce the risk of incorrect needle positioning. While ultrasound imaging is considered the gold standard, it has limitations such as a lack of spatial resolution and subjective interpretation of 2D images. As an alternative to conventional imaging techniques, we have developed a needle-based electrical impedance imaging system. The system involves the classification of different tissue types using impedance measurements taken with a modified needle and the visualization in a MATLAB Graphical User Interface (GUI) based on the spatial sensitivity distribution of the needle. The needle was equipped with 12 stainless steel wire electrodes, and the sensitive volumes were determined using Finite Element Method (FEM) simulation. A k-Nearest Neighbors (k-NN) algorithm was used to classify different types of tissue phantoms with an average success rate of 70.56% for individual tissue phantoms. The results showed that the classification of the fat tissue phantom was the most successful (60 out of 60 attempts correct), while the success rate decreased for layered tissue structures. The measurement can be controlled in the GUI, and the identified tissues around the needle are displayed in 3D. The average latency between measurement and visualization was 112.1 ms. This work demonstrates the feasibility of using needle-based electrical impedance imaging as an alternative to conventional imaging techniques. Further improvements to the hardware and the algorithm as well as usability testing are required to evaluate the effectiveness of the needle navigation system.

Feasibility of pressurized intra peritoneal aerosol chemotherapy using an ultrasound aerosol generator (usPIPAC).

BACKGROUND: We tested the feasibility of ultrasound technology for generating pressurized intraperitoneal aerosol chemotherapy (usPIPAC) and compared its performance vs. comparator (PIPAC). MATERIAL AND METHODS: A piezoelectric ultrasound aerosolizer (NextGen, Sinaptec) was compared with the available technology (Capnopen, Capnomed). Granulometry was measured for water, Glc 5%, and silicone oil using laser diffraction spectrometry. Two- and three-dimensional (2D and 3D) spraying patterns were determined with methylene blue. Tissue penetration of doxorubicin (DOX) was measured by fluorescence microscopy in the enhanced inverted Bovine Urinary Bladder model (eIBUB). Tissue DOX concentration was measured by high-performance liquid chromatography (HPLC). RESULTS: The droplets median aerodynamic diameter was (usPIPAC vs. PIPAC): H20: 40.4 (CI 10-90%: 19.0-102.3) vs. 34.8 (22.8-52.7) µm; Glc 5%: 52.8 (22.2-132.1) vs. 39.0 (23.7-65.2) µm; Silicone oil: 178.7 (55.7-501.8) vs. 43.0 (20.2-78.5) µm. 2D and 3D blue ink distribution pattern of usPIPAC was largely equivalent with PIPAC, as was DOX tissue concentration (usPIPAC: 0.65 (CI 5-95%: 0.44-0.86) vs. PIPAC: 0.88 (0.59-1.17) ng/ml, p = 0.29). DOX tissue penetration with usPIPAC was inferior to PIPAC: usPIPAC: 60.1 (CI 5.95%: 58.8-61.5) µm vs. PIPAC: 1172 (1157-1198) µm, p < 0.001). The homogeneity of spatial distribution (top, middle and bottom of the eIBUB) was comparable between modalities. DISCUSSION: usPIPAC is feasible, but its performance as a drug delivery system remains currently inferior to PIPAC, in particular for lipophilic solutions.

Miniature low-cost γ-radiation sensor for localization of radioactively marked lymph nodes.

Detection of metastasis spread at an early stage of disease in lymph nodes can be achieved by imaging techniques, such as PET and fluoride-marked tumor cells. Intraoperative detection of small metastasis can be problematic especially in minimally invasive surgical settings. A γ-radiation sensor can be inserted in the situs to facilitate intraoperative localization of the lymph nodes. In the minimally invasive setting, the sensor must fit through the trocar and for robot-aided interventions, a small, capsule-like device is favorable. Size reduction could be achieved by using only a few simple electronic parts packed in a single-use sensor-head also leading to a low-cost device. This paper first describes the selection of an appropriate low-cost diode, which is placed in a sensor head (Ø 12 mm) and characterized in a validation experiment. Finally, the sensor and its performance during a detection experiment with nine subjects is evaluated. The subjects had to locate a 137Cs source (138 kBq activity, 612 keV) below a wooden plate seven times. Time to accomplish this task and error rate were recorded and evaluated. The time needed by the subjects to complete each run was 95 ± 68.1 s for the first trial down to 40 ± 23.9 s for the last. All subjects managed to locate the 137Cs source precisely. Further reduction in size and a sterilizable housing are prerequisites for in vitro tests on explanted human lymph nodes and finally in vivo testing.

Design and Applicability of a Mechanical Impedance Sensor for Vein Penetration Detection.

Intravenous needle insertion is typically conducted manually, with needles guided into vessels by feel while looking for a brief flash of blood. This process is imprecise and leads to mispositioned needles, multiple reinsertion attempts, increased procedure time and higher costs for the hospital. We present a method for indicating that the needle has reached the vein by measuring the change in mechanical impedance of the needle as it passes through different tissue layers. Testing in a phantom indicated that this has the potential to identify transitions through tissue boundaries.

Knee-ankle-foot orthosis with powered knee for support in the elderly.

A prototype of a powered knee orthotic device was developed to determine whether fractional external torque and power support to the knee relieves the biomechanical loads and reduces the muscular demand for a subject performing sit-to-stand movements. With this demonstrator, consisting of the subsystems actuation, kinematics, sensors, and control, all relevant sensor data can be acquired and full control is maintained over actuator parameters. A series-elastic actuator based on a direct current motor provides up to 30 Nm torque to the knee via a hinge joint with an additional sliding degree of freedom. For reasons of feasibility under everyday conditions, user intention is monitored by employing a noninvasive, nonsticking muscle activity sensor to replace electromyographic sensors, which require skin preparation. Furthermore, foot plates with force sensors have been developed and included to derive ground reaction forces. The actual knee torque needed to provide the desired support is based on an inverse dynamics model using ground reaction forces signals and leg kinematics. A control algorithm including disturbance feed forward has been implemented. A demonstration experiment with two subjects showed that 23 % of moment support in fact leads to a similar reduction in activation of the main knee extensor muscle.

Development of a low-cost polymethylmethacrylate stand-alone cervical cage: technical note.

BACKGROUND AND STUDY AIMS: Stand-alone cervical cages aim to provide primary stability, yield solid fusion in the long-term course, and maintain physiologic alignment. However, many implants designed for these purposes fail in achieving these goals. Following implantation, relatively high rates of cage subsidence and failure of disc height maintenance may lead to cervical kyphosis and poor alignment of the cervical spine. At the same time, costs for cage implantation are relatively high compared with their unfavorable radiologic performance. Thus the aim of the study was to develop and test mechanically a low-cost polymethylmethacrylate (PMMA) cage with similar mechanical and procedural properties compared with a commercial polyetheretherketone (PEEK) cage. MATERIAL AND METHODS: Following determination of the cage design, a casting mold was developed for the production of PMMA cages. Nine cages were produced and compared with nine PEEK cages using static compression tests for 0 and 45 degrees according to the recommendations of the American Society for Testing and Materials. Mean compressive yield strength, mean yield displacement, mean tensile strength, and mean stiffness were determined. RESULTS: At 0 degrees axial compression, the mean compressive yield strength, mean displacement, and mean tensile strength of the PMMA cage was significantly higher compared with the PEEK cage (p < 0.001). Stiffness of both implants did not differ significantly (p = 0.903). At 45 degrees axial compression, PEEK cages could not be investigated because slipping of the holding fixture occurred. Under these conditions, PMMA cages showed a mean compressive yield strength of 804.9 ± 60.5 N, a mean displacement of 0.66 mm ± 0.05 mm, a mean tensile strength of 7.92 ± 0.6 N/mm(2), and a mean stiffness of 1,228 ± 79.4 N/mm. CONCLUSIONS: The newly developed PMMA cage seems to show similar to superior mechanical properties compared with the commercial PEEK cage. Considering a preparation time of only 10 minutes and the low price for the PMMA material, the cost-benefit ratio clearly points to the use of the PMMA cage. However, clinical effectiveness has to be proven in a separate study.

Ultrasonic resonant piezoelectric actuator with intrinsic torque measurement.

Piezoelectric ultrasonic actuators are widely used in small-scale actuation systems, in which a closed-loop position control is usually utilized. To save an additional torque sensor, the intrinsic measurement capabilities of the piezoelectric material can be employed. To prove feasibility, a motor setup with clearly separated actuation for the friction and driving forces is chosen. The motor concept is based on resonant ultrasonic vibrations. To assess the effects of the direct piezoelectric effect, a capacitance bridge-type circuit has been selected. Signal processing is done by a measurement card with an integrated field-programmable gate array. The motor is used to drive a winch, and different torques are applied by means of weights to be lifted. Assessing the bridge voltage, a good proportionality to the applied torque of 1.47 mV/mN·m is shown. A hysteresis of 1% has been determined. The chosen motor concept is useful for intrinsic torque measurement. However, it provides drawbacks in terms of limited mechanical performance, wear, and thermal losses because of the soft piezoelectric material. Future work will comprise the application of the method to commercially available piezoelectric actuators as well as the implementation of the measurement circuit in an embedded system.

Mechanical properties of mesh materials used for hernia repair and soft tissue augmentation.

BACKGROUND: Hernia repair is the most common surgical procedure in the world. Augmentation with synthetic meshes has gained importance in recent decades. Most of the published work about hernia meshes focuses on the surgical technique, outcome in terms of mortality and morbidity and the recurrence rate. Appropriate biomechanical and engineering terminology is frequently absent. Meshes are under continuous development but there is little knowledge in the public domain about their mechanical properties. In the presented experimental study we investigated the mechanical properties of several widely available meshes according to German Industrial Standards (DIN ISO). METHODOLOGY/PRINCIPAL FINDINGS: Six different meshes were assessed considering longitudinal and transverse direction in a uni-axial tensile test. Based on the force/displacement curve, the maximum force, breaking strain, and stiffness were computed. According to the maximum force the values were assigned to the groups weak and strong to determine a base for comparison. We discovered differences in the maximum force (11.1±6.4 to 100.9±9.4 N/cm), stiffness (0.3±0.1 to 4.6±0.5 N/mm), and breaking strain (150±6% to 340±20%) considering the direction of tension. CONCLUSIONS/SIGNIFICANCE: The measured stiffness and breaking strength vary widely among available mesh materials for hernia repair, and most of the materials show significant anisotropy in their mechanical behavior. Considering the forces present in the abdominal wall, our results suggest that some meshes should be implanted in an appropriate orientation, and that information regarding the directionality of their mechanical properties should be provided by the manufacturers.

Acellular dermal matrix seeded with autologous fibroblasts improves wound breaking strength in a rodent soft tissue damage model in neoadjuvant settings.

Soft tissue defects following resectional surgery or trauma often result in deadspaces and require free or pedicled flaps. A programmed formation of filling tissue with enhanced biomechanical properties could be helpful. This study examined the effects on wound healing of acellular dermal matrix (ADM) seeded with autologous fibroblasts in a standardized rodent model. As pre- or postoperative radiotherapy is standard in many treatments of malignancies, we also investigated the effects of additional radiotherapy. Fischer rats were randomised and received a standardized unilateral soft tissue defect at the buttock. The defect was filled with ADM+fibroblasts or ADM alone. Controls received no filling. Either no radiation, adjuvant (postoperative) or neoadjuvant (preoperative) radiation was applied to the defect site. Six weeks later the defect volume was measured by MR-tomography. Wound breaking strength was examined by tensiometry according to German Industrial Standards. Filling of the defect side was significantly larger in ADM and ADM+fibroblast treated groups compared to the control group in all settings. Wound breaking strength in the unimodal setting was significantly improved in the ADM+fibroblasts group compared to the ADM group. In the neoadjuvant setting there was no significant difference between control and ADM group. However, the ADM+fibroblasts groups showed a significantly increased wound breaking strength compared to the control and the ADM-alone group. Seeded or unseeded ADM is able to fill deadspace in this rodent model in all settings. Implanting non-irradiated, vital, proliferating autologous fibroblasts on ADM results in significantly increased wound breaking strength.

An MR-compatible device for automated and safe application of laser stimuli in experiments employing nociceptive stimulation.

In this paper the establishment of an automatic laser application device that reproducibly delivers laser stimuli in a safe, controlled, and reliable manner is presented. Nociceptive stimulation is widely used in functional magnetic resonance imaging (fMRI) experiments and a number of different methods are employed. One major advantage of laser stimulation as a method to administer painful stimuli is that it selectively activates nociceptors. To avoid damage to the subject's skin, which might occur if the same skin area were stimulated too often, the laser focal spot needs to be repositioned after each stimulus. Here, we describe the design of the mechanical set-up, the functionality, the computation of laser stimulus intensity, the materials used, the monitoring system, and the interface to the control software. Additionally, MR-compatibility and functionality of the device were evaluated and assessed in a 3T MR scanner. Finally, the reliability and validity of the device were tested and demonstrated. It permits easy and investigator-independent use of laser stimulation in the MR scanner.

[The relation of workspace and installation space of epicyclic kinematics with six degrees of freedom]. / Das Verhältnis von Arbeitsraum zu Bauraum epizyklischer Kinematiken mit sechs Freiheitsgraden.

INTRODUCTION: The kinematics of a robotic device significantly determines its installation space when it comes to technical realisation. With regard to the deployment of robotic manipulators in surgery, manipulators with a preferably small installation space are needed. MATERIALS AND METHODS: This study describes six versions of novel epicyclic kinematics with six degrees of freedom (DOF). At first, the kinematics functionality was analysed using Gruebler's formula. Subsequently, the quantitative determination of the relation of workspace and installation space was performed using Matlab algorithms. To qualitatively describe the shape of the workspace, the Matlab visualisation features were utilised. For comparison, the well-known Hexapod was used. RESULTS: The assessed kinematics had 6-DOF-functionality. It became apparent that one version of the epicyclic kinematics having two 3-DOF disk systems mounted in a parallel way featured a particularly good relation of workspace and installation space. Compared to the Hexapod, this is approximately four times better. The shape of the workspaces of all epicyclic kinematics assessed was convex and compact. CONCLUSION: It could be shown that a novel epicyclic kinematics has a notably advantageous relation of workspace and installation space. Apparently, it seems to be well suited for the deployment in robotic machines for surgical procedures.

Today's state of the art in surgical robotics*.

OBJECTIVE: This paper describes the current level of development of robots for surgery. MATERIAL AND METHODS: This paper is based on a literature search in Pubmed, IEEExplore, CiteSeer and the abstract volumes of the MICCAI 2002, 2003 and 2004, CARS 2003 and 2004, CAOS 2003 and 2004, CURAC 2003 and 2004 and MRNV 2004 meetings. RESULTS: Divided into different disciplines (imaging, abdominal and thoracic surgery, ENT, OMS, neurosurgery, orthopaedic surgery, radiosurgery, trauma surgery, urology), 159 robot systems are introduced. Their functionality, deployment, origin and mechanical set-up are described. Additional contacts and internet links are listed. CONCLUSIONS: The systems perform diverse tasks such as milling cavities in bone, harvesting skin, screwing pedicles or irradiating tumors. From a technical perspective the strong specialization of the systems stands out. Most of the systems are being developed in Germany, the United States, Japan or France.