This study proposes an optically sensorized force-sensing tendon for minimally invasive surgical instruments. The tendon is composed of a high strength, polarization maintaining (PM) optical fiber with Bragg sensors (FBGs) that negate the cross-sensitivity of conventional FBGs. The PM-FBG fiber is locally reinforced with high stiffness Kevlar that enhances its load carrying capacity while enabling higher curvatures in tendon routing. The composite tendon has a mean diameter of ∼268 μ m which preserves the form-factor of instruments within this scope. Importantly, the tendons can improve the functionality of such tools by enabling local force and tissue-resistance estimation. This paper explores the performance of these sensorized tendons in terms of strength, stability, response under dynamic load, friction, and sensitivity as a force measuring tool within an 18 Ga articulate Nitinol (NiTi) cannula (a proxy for potential applications). Results reaffirm the potential of a bi-modal sensing and actuation component within instruments for robotic surgery.

Cardiovascular, orthopedic, and interventional radiology procedures using fluoroscopy require healthcare professionals to wear heavy lead garments for radiation protection, which can lead to musculoskeletal injuries, discomfort, and fatigue. A mobile lead garment frame, MobiLead, was designed to mitigate these issues by moving the lower garment load off body to a structural frame and redistributing the load of the upper garment from the shoulders to the hips through a torso frame. The frame was designed to be compact with a minimal footprint for maneuverability in operating rooms with limited space, while still giving the surgeon adequate mobility for various emergency procedures. Preliminary analysis of device efficacy was conducted using electromyography (EMG) of load-bearing muscles during use and qualitative surgeon user feedback surveys. Nonparametric permutation tests showed that the MobiLead device mean activation was significantly lower than the standard lead garment ( p < 0.001 ). Surgeon feedback and use testing showed that the device fits under a sterile gown and is maneuverable in an operating room (OR).

This paper describes the development and testing of a low-cost three-dimensional (3D) printed wearable hand exoskeleton to assist people with limited finger mobility and grip strength. The function of the presented orthosis is to support and enable light intensity activities of daily living and improve the ability to grasp and hold objects. The Sparthan Exoskeleton prototype utilizes a cable-driven design applied to individual digits with motors. The initial prototype is presented in this paper along with a preliminary evaluation of durability and performance efficacy.

In medical jet injection, a narrow fluid drug stream is propelled at high velocity into skin without a needle. Previous studies have shown that the volume delivered is highly dependent on a number of factors. This paper details the development of an electronic force sensor for medical jet injection and shows that the normal contact force exerted on the tissue by the nozzle is an additional factor affecting volume delivered. Using this sensor, we measure the forces at the nozzle tip in the normal direction with a sensitivity of 18 μ N, calibrated over a range from 1 N to 8 N with a mean absolute error of 8 mN, and a maximum overload of 300 N. We further measure forces at the nozzle tip in the lateral direction with a sensitivity of 8 μ N, calibrated over a range from 0.1 N to 7 N, with a mean absolute error of 101 mN for lateral contact force magnitude and 1.60 deg for lateral contact force direction. Experimental validation confirms that the force sensor does not adversely affect the accuracy and precision of ejected volume from the jet injector. We use this setup to examine the effect of normal contact force on volume delivered into postmortem porcine tissue. Experimental results demonstrate that volume delivered with normal contact force between 4 N and 8 N is significantly more accurate and precise compared to volume delivered with normal contact force between 0 N and 3.9 N.

Pectus carinatum (PC) presents itself as a protrusion on the chest wall of adolescent individuals. Current treatment for PC is performed with a Pectus carinatum orthosis (PCO) that applies a compressive force to the protrusion. While this treatment is accepted, the magnitude of compressive forces applied remains unknown leading to excessive or deficient compression. Although the need for this quantitative data is recognized, no studies reporting the data or methods are available. The purpose of this study was to design an accurate force measurement system (FMS) that could be incorporated into a PCO with minimal bulk. Components of the FMS were three-dimensional (3D)-printed and incorporated into an existing PCO design. The FMS was calibrated using a custom indenter that applied forces to the FMS in a controlled manner. Evaluation of the FMS on five human participants was also performed. A reliability measure of the FMS was calculated for analysis. The FMS was implemented into the PCO and able to withstand the applied forces. The calibration revealed an increase in load cell error with increased magnitude of applied force (mean error [SD] = 5.59 N [6.48 N]). Participants recruited to evaluate the FMS demonstrated reliable forces (R = 96%) with smaller standard deviations than those during the calibration. The FMS was shown capable of measuring PCO forces but requires further testing and improvement. This system is the foundational component in a wireless, minimalistic sensor system to provide real time force feedback to both the clinician and patient.

A novel, needle array dry electrode consisting of 10 × 10 array of stainless steel (SS) Microtips was developed for electroencephalography (EEG) monitoring. The developed dry electrode uses commercially available, inexpensive, SS acupuncture needles certified for invasive use, to collect the EEG signal. The microtips of the acupuncture needles project out of a flat Teflon base by approximately 150 μ m. Mechanical failure analysis was carried out, with theoretical calculations for individual needles and experimental measurements with a universal testing machine (UTM). The theoretically calculated critical load for failure for individual needle was 0.88 N, while the UTM measurements show the failure occurring at 0.95 N; this difference is probably due to the simplified assumptions used in calculations. The UTM measurements of the individual needle applied against a Silicone elastomer reveal that the force required for the penetration of the needle of the electrode into skin maybe as low as 0.01 N. Needle array insertion into silicone elastomer sheet and its optical inspection was carried out to assess the ability of the microneedles to penetrate the skin. The impedance of the electrode, measured in three electrode configuration in 0.9% NaCl solution, was approximately 6.8KΩ at 20 Hz, which is sufficiently low to fulfill the requirements of biopotential measurement. The construction and characteristics of the developed needle array dry electrode show that they are suitable for penetrating the stratum corneum of the skin and acquire the EEG signal directly from the interstitial fluidic layer underneath. The construction of the electrode and its mechanical and electrical characteristics show that it is a promising dry electrode for long duration EEG Monitoring.

Wide mesh or tape sutures are used to close high-tension wounds such as in hernia or tendon repair. However, wide sutures produce large knots that are susceptible to increased palpability, infection, and foreign body response. To prevent such adverse events, we developed a small suture anchor to replace wide suture knots. The suture anchor was iteratively developed using three-dimensional (3D) design software and produced via 3D printing. Anchor prototypes underwent monotonic, cyclic fatigue, and stress-life testing in a benchtop soft tissue suture model. Results were compared to a standard of care knot and alternative suture fixation devices. The final anchor design was selected based on minimal size and mechanical performance. The size of the final anchor (200 mm 3 ) was 33% smaller than a tape suture knot and 68% smaller than a mesh suture knot. Monotonic testing of mesh and tape sutures revealed a significantly greater anchor failure load compared to knot and alternative fixations (p < 0.05). Additionally, all anchors successfully completed cyclic fatigue testing without failure while other fixations, including knot, failed to complete cyclic fatigue testing multiple times. Stress-life testing demonstrated durable anchor fixation under varying tensile stresses. Failure mode analysis revealed anchor fracture and tissue failure as modes of anchor failure, each of which occurred at supraphysiologic forces. We created a small suture anchor that significantly outperforms knot and alternative suture fixations in benchtop testing and addresses concerns of increased palpability, infection, and foreign body response from large suture knots.

Manufacturers are constantly seeking to design new, better performing transvenous cardiac leads to prevent perforation of the heart by the lead tip. Currently, there is no standardized test method to measure the buckling load of leads, a major factor in the propensity of the lead to perforate the heart. This study further investigates the effect of boundary conditions on buckling loads at the lead tip of different transvenous cardiac leads achieved using different variations of our initial physiologically relevant test method. The goals of the test are to create the maximum buckling load with high repeatability and the simplest possible design. A buckling test was performed to capture maximum buckling load using three leads of each model (five currently available cardiac lead models) and were tested in each of six test setups. The buckling test methodology had a substantial effect on the load-displacement profiles, regardless of whether the lead was a pacemaker or defibrillator lead. By adding the right ventricular (RV) constraint, the buckling load more than doubled for most leads. The use of a lubricant reduced friction between the lead body and the RV surface, and thereby subsequently lowered the buckling load in those setups that used the RV constraint. In addition, the use of the lubricant reduced the variability in the results. The addition of both the RV constraint and the lubricant substantially influences the mechanical behavior of transvenous cardiac leads and is recommended for buckling testing of transvenous cardiac leads.

A system was developed for computed tomography (CT)-guided needle placement in the thorax and abdomen, providing precise aiming of a needle guide (NG) to reach a user-specified target in a single manual insertion. The objective of this work is to present its technical design and analyze its performance in terms of placement error in air. The individual contributions to the placement error of a fiducial marker based system-to-CT registration system, a two degrees-of-freedom (2DOFs) drive system to aim the NG, and a structural link between NG and CT table were experimentally determined, in addition to the placement error of the overall system. An error contribution of 0.81 ± 0.34 mm was determined for the registration system, <1.2 mm and <3.3 mm for the drive system, and 0.35 mm and 0.43 mm for two load cases of the structural link. The overall unloaded system achieved 1.0 ± 0.25 mm and 2.6 ± 0.7 mm at 100 mm and 250 mm depth, respectively. The overall placement errors in air do not exceed the ≤ 5 mm error specified as a clinical user requirement for needle placement in tissue.

This study evaluated the biomechanical efficacy of single-tunnel double-bundle anterior cruciate ligament (ACL) reconstruction technique. The graft construct is achieved using a novel fixation device that splits an ACL (SPACL) graft into two bundles, recreating the anteromedial (AM) and posterolateral (PL) bundles for ACL reconstruction. A pullout strength test of the SPACL was performed using a 7-mm bovine digital extensor tendon graft. The capability in restoration of knee kinematics after SPACL reconstruction was investigated using cadaveric human knees on a robotic testing system under an anterior tibial load of 134 N and a simulated quadriceps load of 400 N. The data indicated that the SPACL graft has a pullout strength of 823.7±172.3 N. Under the 134 N anterior tibial load, the anteroposterior joint laxity had increased constraint using the SPACL reconstruction but not significantly (p > 0.05) at all selected flexion angles. Under the 400 N quadriceps load, no significant differences were observed between the anterior tibial translation of intact knee and SPACL conditions at all selected flexion angles, but the SPACL graft induced a significant increase in external tibial rotation compared to the intact knee condition at all selected flexion angles with a maximal external rotation of −3.20 deg ±3.6 deg at 90 deg flexion. These data showed that the SPACL technique is equivalent or superior to existing ACL reconstruction techniques in restoration of knee laxity and kinematics. The new SPACL reconstruction technique could provide a valuable alternation to contemporary ACL reconstruction surgery by more closely recreating native ACL kinematics.

Instrument-assisted soft tissue manipulation (IASTM) is a form of mechanotherapy, e.g., massage, that uses rigid devices which may be machined or cast. The delivered force, which is a critical parameter during IASTM, is not measured and not standardized in current clinical IASTM practice. In addition to the force, the angle of treatment and stroke frequency play an important role during IASTM. For accurate IASTM treatment, there is a strong need to scientifically characterize the IASTM delivered force, angle of treatment, and stroke frequency. This paper presents a novel, mechatronic design of an IASTM device that can measure the localized pressure on the soft tissue in a clinical treatment. The proposed design uses a three-dimensional (3D) load cell, which can measure all three-dimensional force components simultaneously. The device design was implemented using an IMUduino microcontroller board which provides tool orientation angles. These orientation angles were used for coordinate transformation of the measured forces to the tool–skin interface. Additionally, the measured force value was used to compute the stroke frequency. This mechatronic IASTM tool was validated for force measurements in the direction of tool longitudinal axis using an electronic plate scale that provided the baseline force values to compare with the applied force values measured by the tool. The load cell measurements and the scale readings were found to agree within the expected degree of accuracy.

The aim of this study is to develop an intramedullary telescopic nail that—in contrast to the current standard—is rotationally stable and firmly anchored in the bone proximally and distally, without containing any extraosseous components that may alter the surrounding soft tissue. Three prototypes for a positive-locking adapted telescopic intramedullary nail (PLATIN) were developed. In a series of biomechanical tests, the prototypes were compared with two Fassier–Duval telescopic nails, which represent the clinical standard. Axial pressure, torsion, and four-point bending measurements were carried out in a materials testing machine, with the telescopic nails implanted into composite bone. Tests were conducted without failure and up to failure. Specifically, the force required for telescoping, as well as torsional stiffness and bending stiffness, was investigated. Taking into account differences that were inherent in the materials, the prototypes showed similar results in the four-point bending tests. In the pressure tests, the prototypes required greater forces than the Fassier–Duval nails. The torsional stiffness was between 0.020 N·m/deg and 0.135 N·m/deg, depending on the diameter of the nail. Positive-locking effect was achieved by a hexagonal shape of an inner rod part and a hexagonal form-fitting outer tube part. Proximal and distal locking of the telescopic nail in the bone was performed by usage of K-Wires in specific arranged drill holes at the end of both parts. Based on these satisfactory results, the future clinical application of positive-locking irrotational telescopic nails can be expected. Furthermore, redesign or development of new designs for existing telescopic nails is recommended.

This work exploits the advantages of compliant mechanisms (devices that achieve their motion through the deflection of flexible members) to enable the creation of small instruments for minimally invasive surgery (MIS). Using flexures to achieve motion presents challenges, three of which are considered in this work. First, compliant mechanisms generally perform inadequately in compression. Second, for a ± 90 deg range of motion desired for each jaw, the bending stresses in the flexures are prohibitive considering materials used in current instruments. Third, for cables attached at fixed points on the mechanism, the mechanical advantage will vary considerably during actuation. Research results are presented that address these challenges using compliant mechanism principles as demonstrated in a two-degree-of-freedom (2DoF) L-Arm gripper.

This research was directed toward quantitatively characterizing the effects of arterial mechanical treatment procedures on the stress and strain energy states of the artery wall. Finite element simulations of percutaneous transluminal angioplasty (PTA) and orbital atherectomy (OA) were performed on arterial lesion models with various extents and types of plaque. Stress fields in the artery were calculated and strain energy density was used as an explicit description of potential damage to the artery. The research also included numerical simulations of changes in arterial compliance due to orbital atherectomy. The angioplasty simulations show that the damage energy fields in the media and adventitia are predominant in regions of the lesion that are not protected by a layer of calcification. In addition, it was observed that softening the plaque components leads to a lower peak stress and therefore lesser damage energy in the media and adventitia under the action of a semicompliant balloon. Orbital atherectomy simulations revealed that the major portion of strain energy dissipated is concentrated in the plaque components in contact with the spinning tool. The damage and peak stress fields in the media and adventitia components of the vessel were significantly less. This observation suggests less mechanically induced trauma during a localized procedure like orbital atherectomy. Artery compliance was calculated pre- and post-treatment and an increase was observed after the orbital atherectomy procedure. The localized plaque disruption produced in atherectomy suggests that the undesirable stress states in angioplasty can be mitigated by a combination of procedures such as atherectomy followed by angioplasty.

A numerical analysis of a semi-enclosed tubular mechanical embolus retrieval device (MERD) for the treatment of acute ischemic stroke (AIS) is presented. In this research, the finite element analysis (FEA) methodology is used to evaluate mechanical performance and provide suggestions for optimizing the geometric design. A MERD fabricated from nickel–titanium alloy (Nitinol) tubing is simulated and analyzed under complex in vivo loading conditions involving shape-setting, crimping, deployment, and embolus retrieval. As a result, the peak strain of the shape-setting procedure is proved to be safe for the device pattern. However, the MERD shows poor mechanical behavior after crimping into a catheter, because the peak crimping strain obtains a value of 12.1%. The delivery and deployment step demonstrates that the artery wall has little risk of serious injuries or rupture. In addition, the process of simulation of embolus retrieval and device system migration inside the cerebral artery lumen provides useful information during the design process.

Objective pulmonary function (PF) evaluation is essential for the diagnosis, monitoring, and management of many pediatric respiratory diseases as seen in the emergency room, intensive care, and outpatient settings. In this paper, the development and testing of a new noninvasive PF instrument, pneuRIP TM , which utilizes respiratory inductance plethysmography (RIP) are discussed. The pneuRIP TM hardware includes a small circuit board that connects to the RIP bands and measures and wirelessly transmits the band inductance data to any designated wirelessly connected tablet. The software provides indices of respiratory work presented instantaneously in a user-friendly graphical user interface on the tablet. The system was tested with ten normal children and compared with an existing system, Respitrace (Sensormedics, Yorba Linda, CA), under normal and loaded breathing conditions. Under normal breathing, the percentage differences between the two systems were 2.9% for labored breathing index (LBI), 31.8% for phase angle (Φ), 4.8% for percentage rib cage (RC%), and 26.7% for respiratory rate (BPM). Under loaded breathing, the percentage differences between the two systems were 1.6% for LBI, 4.1% for Φ, 8.5% for RC%, and 52.7% for BPM. For LBI, Φ, and RC%, the two systems were in general agreement. For BPM the pneuRIP TM is shown to be more accurate than the respitrace when compared to manually counting the breaths: 13.2% versus 36.4% accuracy for normal breathing and 16.9% versus 60.7% accuracy for breathing under load, respectively.

A novel monobloc design of a two degree-of-freedom (DOF) compliant tool tip for a handheld powered surgical tool is presented in this paper. The monobloc tool tip can pitch and yaw using corner-filleted flexure hinge-based compliant joints and has an integrated compliant grasper. The 2DOF of the tool tip is realized by six compliant joints placed in an alternating fashion, orthogonal to each other. The tool is externally powered and consists of a drive box, a stainless steel tube, and a compliant tool tip at the distal end. The drive box houses a thumb joystick for command input, three servo actuators, and a microcontroller. The microcontroller maps surgeon's command input to the tool tip orientation and grasper actuation. By design, the graspers of the tool tip are actuated by tensile forces conveyed by the tethers, which exert a compressive load on the 2DOF compliant joints. Since the compressive load-carrying capacity of slender flexure-based compliant joints is limited, a design to enhance the compressive load-carrying capacity of the compliant joints with a circular guide is presented. A finite-element simulation was done to verify the design of the compliant joints. Experiments were carried out to assess the relationship between the force input by the servo actuators and joint deflection. Additional experiments were carried out to determine the maximum pinching force that can be exerted by the compliant graspers. A prototype of the complete surgical tool was built to demonstrate the utility of the proposed compliant tool tip as an alternative to traditional tool tip for a handheld powered surgical tool.

To improve arthroscopic skills, the preferred means of training is cadaveric tissue, because this gives the most realistic scenario. A drawback of cadaveric training is that objective performance tracking and accompanied feedback cannot be provided due to the absence of a suitable system. The main criteria were that the system should be compatible with any cadaveric joint, be used with any type of instrument, easy to set up, and measure two critical parameters that reflect the task efficiency (task time) and safety (forces due to instrument–tissue interaction). This resulted in the development of a force measurement system which consists of a custom-made universal vice, a custom-designed six degree-of-freedom (DOF) force measurement table (FMT) coupled to a computer equipped with customized software to record the time and forces in all directions. The FMT was calibrated and able to measure forces in the range of 0–750 N, with an accuracy of 0.1 N. During two cadaveric training courses, measurements were performed with the FMT. It was observed that the acquired force data could discriminate between novices and experts or reflect a certain phase of a navigation task performed in a cadaveric cow and human knee. A distinct phase highlighted from the force measurements is the insufficient joint stressing of novices during navigation. This results in too small a joint space for inspection and forces the novices to readjust the stressing. As forces cannot be seen, the FMT can contribute to more efficient training by providing explicit cues on the exerted loads during training. This enables a more precise supervision of the trainees.

Biomechanical energy harvesters (BMEHs) have shown that useable amounts of electricity can be generated from daily movement. Where access to an electrical power grid is limited, BMEHs are a viable alternative to accommodate energy requirements for portable electronics. In this paper, we present the detailed design and dynamic model of a lower limb-driven energy harvester that predicts the device output and the load on the user. Comparing with existing harvester models, the novelty of the proposed model is that it incorporates the energy required for useful electricity generation, stored inertial energy, and both mechanical and electrical losses within the device. The model is validated with the lower limb-driven energy harvester in 12 unique configurations with a combination of four different motor and three different electrical resistance combinations (3.5 Ω, 7 Ω, and 12 Ω). A case study shows that the device can generate between 3.6 and 15.5 W with an efficiency between 39.8% and 72.5%. The model was able to predict the harvester output peak voltage within 5.6 ± 3.2% error and the peak force it exerts on the user within 9.9 ± 3.4% error over a range of parameter values. The model will help to identify configurations to achieve a high harvester efficiency and provide a better understanding of how parameters affect both the timing and magnitude of the load felt by the user.