Background and objectives Learning epidural anesthesia traditionally involves bedside teaching. Visualization aids or a simulator can help in acquiring motor skills, increasing patient safety and steepening the learning curve. We evaluated the face and construct validity of the TU-Delft Epidural Simulator and the effect of needle visualization. Methods Sixty-eight anesthesiologists, anesthesia residents, and final-year medical students tested the epidural simulator. Participants performed six epidural simulations with and six without needle visualization. We tested face validity on a Likert scale questionnaire. We collected data with the simulator software (spinal taps, dura contacts, bone contacts, attempts, and time) and tested for correlation with the performer's experience (construct validity). A visualization aid was tested in a randomized crossover design. Results Face validity as rated by the participants was above average, with a mean of 3.7 (2.0-4.8) on a 5-point scale. Construct validity was indicated by significantly more spinal taps (0.4 [0-4) vs 0.07 [0-2], p=0.04) and more dura contacts (0.58 [0-6] vs 0.37 [0-3], p=0.002) by the inexperienced group compared with the expert group. The visualization aid improved performance by reducing the number of bone contacts and the number of attempts, and by decreasing the procedure time. Prior visualization training reduced the total procedure time from 279 s (69-574) to 180 s (53-605) (p=0.01) for the "blind" procedure. Conclusions The TU-Delft Epidural Simulator is a useful tool for teaching motor skills during epidural needle placement. Prior use of a visualization tool improves performance even without visual support during consequent simulations.

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A range of complex percutaneous procedures, such as biopsy or regional anesthesia, rely heavily on accurate needle insertion. Small variations in the mechanical properties of the pierced tissue can however cause deviations from the projected needle path and can thus result in inaccurate placement of the needle. Navigation of a rigid needle towards the target tissue is traditionally based on the surgeons capacity to interpret small variations in the needle insertion force. A more accurate measurement of these small force variations enables improvement in needle targeting, can potentially aid in enhancing force feedback in robotic needle placement and can provide valuable information on tissue-tool interaction. In this study we investigated several concepts for the design of a force sensor based on a fiber-optic Fabry-Pérot interferometer to measure needle-tissue interaction forces on the tip of a 18 G needle, where special attention was given to concepts for a sensor with (1), an intrinsic low cross-sensitivity to temperature and (2), elementary design and fabrication. Three concepts, using either a quartz capillary, an Invar capillary or a thin polyimide film as the force sensitive element were prototyped and subjected to both static and dynamic testing. The force transducer based on a quartz capillary presented the lowest cross-sensitivity to temperature ( 12mN/∘ C) and good accuracy (maximum measurement error of 65 mN /10 N ) in a measurement of static forces. However, limited strength of the sensor is expected to prevent usage of the quartz capillary in small diameter needles. The concepts for a sensor based on an Invar capillary or a thin polyimide film proved a higher cross-sensitivity to temperature ( 50mN/∘ C and 220mN/∘ C, respectively) and higher maximum measurement error (350 mN /10 N , 800 mN /10 N ), comparable to those of FBG-based sensors reported in literature, but are likely to be more suitable for integration in very small biopsy needles.@en

Steering of needles involves the planning and timely modifying of instrument-tissue force interactions to allow for controlled deflections during the insertion in tissue. In this work, the effect of tip shape on these forces was studied using 10 mm diameter needle tips. Six different tips were selected, including beveled and conical versions, with or without pre-bend or pre-curve. A six-degree-of-freedom force/torque sensor measured the loads during indentations in tissue simulants. The increased insertion (axial) and bending (radial) forces with insertion depth-the force-displacement slopes-were analyzed. Results showed that the ratio between radial and axial forces was not always proportional. This means that the tip load does not have a constant orientation, as is often assumed in mechanics-based steering models. For all tip types, the tip-load assumed a more radial orientation with increased axial load. This effect was larger for straight tips than for pre-bent or pre-curved tips. In addition, the force-displacement slopes were consistently higher for (1) increased tip angles, and for (2) beveled tips compared to conical tips. Needles with a bent or curved tip allow for an increased bending force and a decreased variability of the tip load vector orientation.

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Background and Objectives Neuraxial blockade using a midline approach can be challenging. Part of this challenge lies in finding the optimal approach of the needle to its target. The present study aimed at finding (1) the optimal point of insertion of the needle between the tips of 2 adjacent spinous processes and (2) the optimal angle relative to the skin at which the needle should approach the epidural or subarachnoid space. Methods A computer algorithm systematically analyzed computed tomography scans of vertebral columns of a cohort of 52 patients. On midsagittal sections, the possible points of insertion of a virtual needle and the corresponding angles through which the epidural or subarachnoid space can be reached were calculated. Results The point chosen to introduce the needle between 2 adjacent spinous processes determines the range of angles through which the epidural or subarachnoid space can be reached. At the thoracic interspaces 1-2 through 3-4, thoracic interspaces 5-6 through 9-10, and at the lumbar vertebral interspaces 2-3 through 4-5, the optimal point of insertion is slightly inferior to the point halfway between the tips of the spinous processes. For thoracic interspace 4-5, the optimal point of insertion is slightly superior to the point halfway between the tips of the spinous processes. For the other interspaces, the optimal point of insertion is approximately halfway between the tips of the spinous processes. The optimal angle to direct the needle varies from 9 degrees at the thoracolumbar junction and at the lumbar interspaces 3-4 and 4-5, to 53 degrees at the thoracic interspace 7-8. Conclusions Our study has resulted in practical suggestions-based on accurate, reproducible measurements in patients-As to where to insert the needle and how to angulate the needle when performing neuraxial anesthesia using a midline approach.

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Medical phantoms can be used to study needle-tissue interaction and to train medical residents. The purpose of this research is to study the suitability of polyvinyl alcohol (PVA) as a liver tissue mimicking material in terms of needle-tissue interaction. Insertions into ex-vivo human livers were used for reference. Six PVA samples were created by varying the mass percentage of PVA to water (4 m% and 7 m%) and the number of freeze-thaw cycles (1, 2 and 3 cycles, 16 hours of freezing at −19 °C, 8 hours of thawing). The inner needle of an 18 Gauge trocar needle with triangular tip was inserted 13 times into each of the samples, using an insertion velocity of 5 mm/s. In addition, 39 insertions were performed in two ex-vivo human livers. Axial forces on the needle were captured during insertion and retraction and characterized by friction along the needle shaft, peak forces, and number of peak forces per unit length. The concentration of PVA and the number of freeze-thaw cycles both influenced the mechanical interaction between needle and specimen. Insertions into 4 m% PVA phantoms with 2 freeze-thaw cycles were comparable to human liver in terms of estimated friction along the needle shaft and the number of peak forces. Therefore, these phantoms are considered to be suitable liver mimicking materials for image-guided needle interventions. The mechanical properties of PVA hydrogels can be influenced in a controlled manner by varying the concentration of PVA and the number of freeze-thaw cycles, to mimic liver tissue characteristics.

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Performance of neuraxial blockade using a midline approach can be technically difficult. It is therefore important to optimize factors that are under the influence of the clinician performing the procedure. One of these factors might be the chosen point of insertion of the needle. Surprisingly few data exist on where between the tips of two adjacent spinous processes the needle should be introduced. A geometrical model was adopted to gain more insight into this issue. Spinous processes were represented by parallelograms. The length, the steepness relative to the skin, and the distance between the parallelograms were varied. The influence of the chosen point of insertion of the needle on the range of angles at which the epidural and subarachnoid space could be reached was studied. The optimal point of insertion was defined as the point where this range is the widest. The geometrical model clearly demonstrated, that the range of angles at which the epidural or subarachnoid space can be reached, is dependent on the point of insertion between the tips of the adjacent spinous processes. The steeper the spinous processes run, the more cranial the point of insertion should be. Assuming that the model is representative for patients, the performance of neuraxial blockade using a midline approach might be improved by choosing the optimal point of insertion.

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Epidural needle insertion is a complex procedure that requires training of residents' psychomotor skills using simulators, alternative to training on cadavers and real patients. Haptic feedback is a key feature in the development of such simulators. Its three important aspects are: i) to provide a realistic simulation, ii) to objectively measure the performance of users, and iii) to classify the users. A high-fidelity simulator is often considered to be the best choice to produce a realistic simulation. However, the trade-off between fidelity of the simulator to its cost is still a key issue and it depends on the objective of simulation. One way to address this issue is to simulate only the important (clinically) haptic cues. In this paper a low-fidelity custom built two degree-of-freedom (1DOF for needle insertion and 1DOF for needle orientation along the midline) haptic interface has been developed and clinically validated by expert/resident anaesthesiologists. The proposed haptic interface provides high translational force by means of a motor and rotational torque by means of a brake. The simulator simulates needle-tissue and needle-bone interaction forces. It has a graphical user interface that displays a cross-sectional image (midline) of the patient's lumbar anatomy. It also incorporates simulation of different virtual patients. The initial face and construct validity tests show promising results for further investigation.

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