Validation of a novel smart drilling system to monitor bone impedance during transpedicular screw placement: a pilot study.

Transpedicular screw placement is a high-risk procedure routinely performed in spine surgery. To decrease the rate of complications, it is necessary to find innovative solutions to assist the surgeon during screw insertion so as to avoid the chance of mispositioning. In this study, we developed a new drilling system able to estimate the mechanical properties of drilled tissues. Several investigations show that cortical bone requires a high level of thrust force and torque during drilling compared to trabecular bone. To implement an algorithm for bony breakthrough detection, a new drilling system has been built together with a mechanical support to drill the pedicle along a pre-planned trajectory. The mechanical support is equipped with a smart rotative drill that embeds force and position sensors. Ten human vertebral segments have been used to test the surgical platform, for percutaneous bone drilling. 10 transpedicular holes from L1 to L5 have been performed bilaterally. The holes were further evaluated by computed tomographic scans to measure bone density in the cortical and in the trabecular layers. To compare bone density with the bony mechanical impedance two new parameters (DHU and DPAI) have been introduced. The results show that in 18 out of 20 cases the D values of bone density and mechanical impedance, related to the same bone transition, differ less than 10%. The proposed system is thus able to evaluate the variation of bone density of the cortical and the trabecular layer using impedance. Therefore, it is possible to use the described system to increase the accuracy of transpedicular screw placement.

A new surgical positioning system for robotic assisted minimally invasive spine surgery and transpedicular approach to the disc.

Minimally Invasive Spine Surgery (MISS) procedures for the treatment of spinal pathologies have experienced exponential growth due to improved techniques and decreased trauma to the patient. Several MISS procedures that require the use of a trans-pedicular cannula as a guiding tool for pedicle screw placement, delivery of biomaterials to the vertebral body or injection of biologics to the disc space have been described. Although these are clear advantages of MISS, the limited dissection and exposure may reduce the accuracy and stability of operation and make spine surgeons rely heavily on intraoperative fluoroscopy, raising concerns over the level of radiation exposure. Robot-assisted minimal invasive surgery has aroused more attention for its high precision and stability, minimizing risks of damage to neurovascular structures and diminishing harmful exposure to ionizing radiation. The aim of this paper is to describe and characterize a new surgical positioning system for for robotic assisted MISS. The system is conceived to be integrated in a surgical platform capable of supporting the surgeon in a new procedure to treat degenerative intervertebral disc disease. For this purpose, it is necessary to orientate a cannula in order to guide the bone drill along a planned route, to access the intervertebral disc through the pedicle and endplate. In particular, we describe a mechanism that percutaneously guides a cannula towards the intervertebral disc based on the acquisition of few fluoroscopic images. The design of the positioning system, with its features and constrains imposed by the presence of instrumentation and medical staff in the operating room, as well as the software for trajectory planning during surgery, are here described.

A theoretical framework for studying the electromagnetic stimulation of nervous tissue.

In this paper we present a model for calculating the electric field, and its spatial derivatives, produced by arbitrarily shaped, oriented and placed coils carrying time-varying currents. The model has been validated by comparing its results with those obtained using FEM simulations. The model provides a simple and fast computation framework to investigate the electromagnetic stimulation of neural tissues. Some example applications are also provided.

A miniaturized electrolytic pump sensorized with a strain gauge based on thermoplastic nanocomposite for drug delivery systems.

In this paper we present a miniature electrolytic pump sensorized with a novel strain sensor to be used as active component of a drug delivery system. It consists of an electrolytic solution reservoir where inert electrodes are immersed. By polarizing the electrodes, the electrolytic reaction is activated and the produced gases (i.e. oxygen and hydrogen) displace an elastic membrane delimiting the electrolytic solution reservoir. In order to measure and monitor the membrane displacement, and therefore the volume of drug ejected, a strain gauge sensor has been prepared using a conductive thermoplastic nanocomposite elastomer (CTPE). The sensor has been fixed on the deformable membrane. The conductive thermoplastic elastomer is a good candidate for this application because of its high sensitivity. Furthermore, the CTPE allows to customize the resistance of the device in order to obtain low power consumption.

A smart pill for drug delivery with sensing capabilities.

In this paper a novel system for local drug delivery is described. The actuation principle of the micropump used for drug delivery relies on the electrolysis of a water-based solution, which is separated from a drug reservoir by an elastic membrane. The electrolytically produced gases pressurize the electrolytic solution reservoir, causing the deflection of the elastic membrane. Such deflection, in turn, forces the drug out of its reservoir through a nozzle. The proposed system is integrated in a swallowable capsule, equipped with an impedance sensor useful to acquire information on the physiological conditions of the tissue. Such information can be used to control pump activation.

Current trends in the design of scaffolds for computer-aided tissue engineering.

Advances introduced by additive manufacturing have significantly improved the ability to tailor scaffold architecture, enhancing the control over microstructural features. This has led to a growing interest in the development of innovative scaffold designs, as testified by the increasing amount of research activities devoted to the understanding of the correlation between topological features of scaffolds and their resulting properties, in order to find architectures capable of optimal trade-off between often conflicting requirements (such as biological and mechanical ones). The main aim of this paper is to provide a review and propose a classification of existing methodologies for scaffold design and optimization in order to address key issues and help in deciphering the complex link between design criteria and resulting scaffold properties.

Muscular activity when walking in a non-anthropomorphic wearable robot.

Wearable robots should be designed not to alter human physiological motion. Perturbations introduced by a robot can be quantified by measuring EMG activity. This paper presents tests on the LENAR, an intrinsically back-drivable non-anthropomorphic lower limb wearable robot designed to provide hip and knee flexion/extension assistance. In previous works the robot was demonstrated to exhibit low mechanical impedance and to introduce minor alterations to human kinematic patterns during walking. In this paper muscular activity is assessed, demonstrating small alterations in the EMG patterns during the interaction with the robot, in both unpowered and assistive mode.

An MR-compatible force sensor based on FBG technology for biomedical application.

Fiber Bragg Grating (FBG) technology is very attractive to develop sensors for the measurement of thermal and mechanical parameters in biological applications, particularly in presence of electromagnetic interferences. This work presents the design, working principle and experimental characterization of a force sensor based on two FBGs, with the feature of being compatible with Magnetic Resonance. Two prototypes based on different designs are considered and characterized: 1) the fiber with the FBGs is encapsulated in a polydimethylsiloxane (PDMS) sheet; 2) the fiber with the FBGs is free without the employment of any polymeric layer. Results show that the prototype which adopts the polymeric sheet has a wider range of measurement (4200 mN vs 250 mN) and good linearity; although it has lower sensitivity (≈0.1 nm-N(1) vs 7 nm-N(1)). The sensor without polymeric layer is also characterized by employing a differential configuration which allows neglecting the influence of temperature. This solution improves the linearity of the sensor, on the other hand the sensitivity decreases. The resulting good metrological properties of the prototypes here tested make them attractive for the intended application and in general for force measurement during biomedical applications in presence of electromagnetic interferences.

A micro opto-mechanical displacement sensor based on micro-diffraction gratings: design and characterization.

A micro opto-mechanical displacement sensor is here presented. It is constituted by a sensing element based on two overlapped micro-diffraction gratings (MDGs). They present a platinum layer (45 nm of thick) on a glass substrate, a period of 525 µm constituted by a width of 150 µm of platinum separated (71.4% duty cycle). The working principle is based on the modulation of light intensity induced by the relative displacement between the MDGs: when a laser light perpendicularly hits the MDGs, the intensity of the transmitted light is a periodic function of the relative displacement between the two MDGs. A fiber optic is used to transport the transmitted light to a photodetector in order to avoid concerns related to the alignment between the optical components. The sensor's output is the ratio between the light intensity measured by the photodetector during the displacement of the MDGs and largest light intensity values measured in the whole range of measurement, therefore, it is lower than 1. The proposed sensor allows to discriminate displacement lower than 10 µm, using a cost effective micro-fabrication process implemented by the technique of Lift-Off. It shows a good linear behaviour in two ranges covering about one half of the MDGs period. Within the linear ranges it shows high sensitivity (about 0.5%/µm) and good accuracy (lower than 4% in the whole range of calibration); furthermore, the results show that a design with a duty cycle of 50% overcomes the marked decrease of sensitivity in a range of measurement corresponding to a grating period.

An implantable neural interface with electromagnetic stimulation capabilities.

Invasive interfaces with the Peripheral Nervous System (PNS), which currently rely on electric means for both nerves stimulation and signals recording, are needed in a number of applications, including prosthetics and assistive technologies. Recent studies showed that the quality of the signal-to-noise ratio of the afferent channel might be negatively affected by physiological reactions, including fibrosis. In this paper we propose a novel approach to the development of implantable neural interfaces, where the PNS is excited electromagnetically and in situ, while electrical means are used only for neural signals recording. Electromagnetic (EM) waves, capable of overcoming fibrotic capsules, are generated by microfabricated coils. Stimulation coils and registration electrodes are deposited on the same flexible substrate, also provided with a bio-absorbable coating, which releases anti-fibrotic drugs and neurons-specific functionalized magnetic nanoparticles (NPs). The NPs are intended to improve the capability of local EM waves to elicit membranes depolarization, thus enhancing selectivity. This paper details the concept of the proposed technology and provides a preliminary in silico feasibility study.

A micromachined intensity-modulated fiber optic sensor for strain measurements: working principle and static calibration.

This paper describes an intensity-modulated fiber optic sensor for strain measurements. The sensing element is a polydimetilsiloxane (PDMS) micro-diffraction grating, 15 mm long, 2 mm thick, with channels 150 µm wide, spaced apart 200 µm. The working principle of the sensor can be summarized as follows: when the sensing element is strained perpendicularly to the grating plane, light passing through the grating undergoes a modulation caused by the phenomenon of diffraction. Since the grating is interposed between a laser source and a fiber optic, the coupled radiation intensity between these two optical elements can be considered as an indirect measure of strain. A static calibration of the measuring system has been performed, showing that the device, with measuring range of about 0.04, is capable to discriminate strain of 0.005 and it presents a sensitivity increase with strain in the whole range of measurements.

Optimization of kinetic energy harvesters design for fully implantable Cochlear Implants.

Fully implantable Cochlear Implants (CIs) would represent a tremendous advancement in terms of quality of life, comfort and cosmetics, for patients with profound sensorineural deafness. One of the main challenges involved in the development of such implants consists of finding a power supply means which does not require recharging. To this aim an inertial Energy Harvester (EH), exploiting the kinetic energy produced by vertical movements of the head during walking, has been investigated. Compared to existing devices, the EH needs to exploit very low frequency vibrations (<2.5 Hz) with small amplitude (<9 m/s(2)). In order to maximize the power transduced, an optimization method has been developed, which is the objective of this paper. The method consists in calculating the dynamical behavior of the EH using discrete transforms of experimentally measured acceleration profiles. It is shown that the quick integration of the second order dynamical equation allows the use of computationally intensive optimization techniques, such as Genetic Algorithms (GAs). The robustness of the solution is also evaluated.

ODEs model of foreign body reaction around peripheral nerve implanted electrode.

The foreign body reaction that the neural tissue develops around an implanted electrode contributes to insulate the probe and enhances the electrical and mechanical mismatch. It is a complex interaction among cells and soluble mediators and the knowledge of this phenomenon can benefits of formal and analytical methods that characterize the mathematical models. This work offers a lumped component model, described by ordinary differential equations, that taking into account the main geometrical (size, shape, insertion angle) and chemical (coating surface) properties of the implant predict the thickness of the fibrotic capsule in a time frame when the reaction stabilizes. This tool allows to evaluate different hypothetical solutions for accounting the tissue-electrode mismatch.

Energetic analysis for self-powered cochlear implants.

Cochlear implants (CIs) are used for compensating the so-called deep sensorineural deafness. CIs are usually powered by rechargeable or long-lasting batteries. In this paper, the feasibility of a fully implanted stand-alone device able to provide the electric power required for stimulating the auditory nerve, without external recharging, is investigated. At first, we demonstrate that the sound wave entering the ear is not a sufficient power source. Then, we propose a solution exploiting the mechanical energy associated to head vibration during walking. The energetic feasibility of this approach is demonstrated based on experimental measurements of head motions. Preliminary considerations on the technical feasibility of a fully implanted energy harvester are finally presented.

A novel microstructural approach in tendon viscoelastic modelling at the fibrillar level.

Novel applications in rehabilitation, surgery and tissue engineering require the knowledge of the mechanical behaviour of the tissues at microstructural level. The aim of this work is to investigate the viscoelastic properties of the tendon from the interaction of its biological constituents in the fibrillar network. Traction, relaxation and creep in-vitro tests have been performed on porcine flexor digital tendons. A viscoelastic constitutive equation at finite deformation is presented. The fibrillar deformation modes are described through a network of adaptive links between collagen type I and decorin. The theoretical predictions fit accurately the experimental data. The results of the model demonstrate the mechanical importance of glycosaminoglycan chains of decorin for the differential recruitment and the activation of fibrillar collagen.

Design and development of a miniaturized 2-axis force sensor for tremor analysis during locomotion in small-sized animal models.

This work represents a first step towards the development of a sensorised environment for behavioral phenotyping of animal models. In particular, this paper focuses on tremor analysis in reeler mice, an emerging potential animal model for anatomical and behavioral traits observed in autism. Ground Reaction Force (GRF) sensing is indeed the most direct means of measuring tremor. Although force platforms have extensively been used for large size animals, only few attempts have been made to measure GRF at a single paw for animals as small as mice or rats. Under the hypothesis that in-plane GRF components are directly connected to tremor, a small size, low-cost, 2-axis force sensor for measuring the in-plane components of GRF was designed and developed. Special care was paid to allow self-aligned assembly for repeatability and modularity for combining multiple platforms for a sensorised floor. Preliminarily testing was performed with both reeler and wildtype mice. Fourier analysis was deployed to extract information due to tremor, validating the hypothesis of a direct connection between tremor and in-plane GRFs.