Burgeoning transendoscopic procedures, such as endoscopic submucosal dissection (ESD), provide a promising means of treating early-stage gastric neoplasia in a minimally-invasive way. However, the remote locations of these lesions, coupled with their origination in the submucosal layers of the gastrointestinal tract, often lead to extreme technical, cognitive and ergonomic challenges which combat the widespread applicability and adoption of these techniques. Among these challenges is achieving the in vivo dexterity required to retract and dissect tissue. By leveraging workspace and force data obtained through clinical studies, we developed a modular, disposable, distally-mounted actuator (an 'active endcap') that can augment an endoscopist's distal dexterity in ways that are not achievable with the endoscope's built-in degrees-of-freedom. The device consists of a flexible articulating 'exoskeleton' manufactured via printed-circuit MEMS (PCMEMS) which engages and deflects electrosurgical tools that are passed through the endoscopic working channel. Embedded proprioceptive sensing is implemented on-board using distributed LED/phototransistor pairs and the principle of light intensity modulation (LIM). The distal degree-of-freedom is actuated using shape memory alloy (SMA) technology, and the actuation transmission system is fully contained within a 1-inch-long end cap that can be mounted on the distal end of the endoscope, thereby obviating the need for a mechanical connection to a proximal source. Proof-of-concept tests demonstrate that the actuator adds over 50 degrees of distal articulation to existing tools and can generate 450 mN of lateral force which has been clinically determined to be sufficient for performing circumferential incisions in ESD.
This paper introduces a manufacturing technique which enables the integration of soft materials and soft fluidic micro-actuators in the Pop-up book MEMS paradigm. Such a technique represents a promising approach to the design and fabrication of low cost and scalable articulated mechanisms provided with sensing capabilities and on-board actuation with potential applications in the field of minimally invasive surgery. Design and integration of soft components in the rigid-flex laminates is described along with the resulting soft pop-up mechanisms realized at different scales. Prototype characterization is presented, demonstrating forces and dexterity in a range suitable for surgical applications, as well as the possibility to integrate sensing capabilities. Based on these results, a multi-articulated robotic arm is fabricated and mounted on top of an endoscope model to provide a proof of concept of simple robotic mechanisms that could be useful in a surgical scenario.
In this paper we describe an IMU-based iterative controller for hip extension assistance where the onset timing of assistance is based on an estimate of the maximum hip flexion angle. The controller was implemented on a mono-articular soft exosuit coupled to a lab-based multi-joint actuation platform that enables rapid reconfiguration of different sensors and control strategy implementation. The controller design is motivated by a model of the suit-human interface and utilizes an iterative control methodology that includes gait detection and step-by-step actuator position profile generation to control the onset timing, peak timing, and peak magnitude of the delivered force. This controller was evaluated on eight subjects walking on a treadmill at a speed of 1.5 m/s while carrying a load of 23 kg. Results showed that assistance could be delivered reliably across subjects. Specifically, for a given profile, the average delivered force started concurrently with the timing of the maximum hip flexion angle and reached its peak timing 22.7 ± 0.63% later in the gait cycle (desired 23%) with a peak magnitude of 198.2 ± 1.6 N (desired 200 N), equivalent to an average peak torque of 30.5 ± 4.7 Nm. This control approach was used to assess the metabolic effect of four different assistive profiles. Metabolic reductions ranging from 5.7% to 8.5% were found when comparing the powered conditions with the unpowered condition. This work enables studies to assess the biomechanical and physiological responses to different assistive profiles to determine the optimal hip extension assistance during walking.
This paper presents further developments, characterization and initial evaluation of a recently developed assistive soft robotic glove for individuals with hand pathologies. The glove technology utilizes a combination of elastomeric and inextensible materials to create soft actuators that conform to the user's hand and can generate sufficient hand closing force to assist with activities of daily living. User intent (i.e. desire to close or open hand) is detected by monitoring gross muscle activation signals with surface electromyography electrodes mounted on the user's forearm. In particular, we present an open-loop sEMG logic that distinguishes muscle contractions and feeds the information to a low-level fluidic pressure controller that regulates pressure in pre-selected groups of the glove's actuators. Experiments are conducted to determine the level of assistance provided by the glove by monitoring muscle effort and mapping the pressure distribution during a simple grasping task when the glove is worn. Lastly, quantitative and qualitative results are presented using the sEMG-controlled glove on a healthy participant and on a patient with muscular dystrophy.
Recently, there has been a growing interest in moving away from traditional rigid exoskeletons towards soft exosuits that can provide a variety of advantages including a reduction in both the weight carried by the wearer and the inertia experienced as the wearer flexes and extends their joints. These advantages are achieved by using structured functional textiles in combination with a flexible actuation scheme that enables assistive torques to be applied to the biological joints. Understanding the human-suit interface in these systems is important, as one of the key challenges with this approach is applying force to the human body in a manner that is safe, comfortable, and effective. This paper outlines a methodology for characterizing the structured functional textile of soft exosuits and then uses that methodology to evaluate several factors that lead to different suit-human series stiffnesses and pressure distributions over the body. These factors include the size of the force distribution area and the composition of the structured functional textile. Following the test results, design guidelines are suggested to maximize the safety, comfort, and efficiency of the exosuit.
A direct cardiac compression (DCC) device is a non-blood contacting sleeve placed around the failing heart to actively assist blood pumping function. For design optimization of a DCC device, it is necessary to monitor the surface pressure exerted on the heart surface at multiple points during active assist, and to correlate this with device performance and cardiac output. In this paper, we present the design, fabrication and characterization of a soft, elastic, conformable pressure sensing sleeve that is placed at the heart/device interface to monitor device performance without affecting device function. This sleeve enables identification of optimal pre-tensioning, positioning and user-controlled parameters of the DCC device. Individual sensors (8×8×3 mm) were fabricated using a surface mount device (SMD) barometer on a custom double-sided flexible printed circuit board and casting the assembly in urethane rubber. A typical sensor has a dynamic range of 2.5 kPa to 50 kPa with a sensitivity of 11.3 counts per kPa. An array of up to 24 sensors was integrated into a flexible, stretchable circuit embedded in a thin (500 micron) silicone sheet using a multi-step layering fabrication process. Continuous magnet wires were wrapped around an alignment fixture, soldered to individual sensors in place and the entire circuit was transfer printed on to a silicone sheet. This assembly allows stretch corresponding to the fractional shortening of the heart muscles (up to 50%). The sleeve successfully measured static and dynamic pressures with a mechanical tensile tester and did not affect DCC device performance. Preliminary results demonstrated that the sleeve is robust enough to withstand >10000 cycles, compression forces from the DCC device and can achieve sensing range and repeatability suitable for procedural pressure monitoring for a DCC device. In addition to allowing performance measurements for iterating DCC device designs, the sensing sleeve can enable increased understanding of the response of the cardiovascular system to compressive assistance.
Exosuits represent a new approach for applying assistive forces to an individual, using soft textiles to interface to the wearer and transmit forces through specified load paths. In this paper we present a body-worn, multi-joint soft exosuit that assists both ankle plantar flexion and hip flexion through a multiarticular load path, and hip extension through a separate load path, at walking speeds up to 1.79m/s (4.0mph). The exosuit applies forces of 300N in the multiarticular load path and 150N in hip extension, which correspond to torques of 21% and 19% of the nominal biological moments at the ankle and hip during unloaded walking. The multi-joint soft exosuit uses a new actuation approach that exploits joint synergies, with one motor actuating the multiarticular load paths on both legs and one motor actuating the hip extension load paths on both legs, in order to reduce the total system weight. Control is accomplished by an algorithm that uses only a gyroscope at the heel and a load cell monitoring the suit tension, and is shown to adapt within a single step to changes in cadence. Additionally, the control algorithm can create slack in the suit during non-level-ground walking motions such as stepping over obstacles so that the system can be transparent to the wearer when required. The resulting system consumes 137W, and has a mass of 6.5kg including batteries.
This paper presents advancements in the design of a portable, soft robotic glove for individuals with functional grasp pathologies. The robotic glove leverages soft material actuator technology to safely distribute forces along the length of the finger and provide active flexion and passive extension. These actuators consist of molded elastomeric bladders with anisotropic fiber reinforcements that produce specific bending, twisting, and extending trajectories upon fluid pressurization. In particular, we present a method for customizing a soft actuator to a wearer's biomechanics and demonstrate in a motion capture system that the ranges of motion (ROM) of the two are nearly equivalent. The active ROM of the glove is further evaluated using the Kapandji test. Lastly, in a case study, we present preliminary results of a patient with very weak hand strength performing a timed Box-and-Block test with and without the soft robotic glove.
In this paper we have rapidly prototyped customized, highly-sensitive, mm-scale multi-axis force sensors for medical applications. Using a composite laminate batch fabrication process with biocompatible constituent materials, we have fabricated a fully-integrated, 10×10 mm three-axis force sensor with up to 5 V/N sensitivity and RMS noise on the order of ~1.6 mN, operational over a range of -500 to 500 mN in the x- and y-axes, and -2.5 to 2.5 N in the z-axis. Custom foil-based strain sensors were fabricated in parallel with the mechanical structure, obviating the need for post-manufacturing alignment and assembly. The sensor and its custom-fabricated signal conditioning circuitry fit within a 1×1×2 cm volume to realize a fully-integrated force transduction platform with potential haptics and control applications in minimally-invasive surgical tools. The form factor, biocompatibility, and cost of the sensor and signal conditioning makes this method ideal for rapid-prototyping low-cost, mm-scale distal force sensors. Sensor performance is validated in a simulated tissue palpation task using a robotic master-slave platform.
Lower-limb wearable robots have been proposed as a means to augment or assist the wearer's natural performance, in particular, in the military and medical field. Previous research studies on human-robot interaction and biomechanics have largely been performed with rigid exoskeletons that add significant inertia to the lower extremities and provide constraints to the wearer's natural kinematics in both actuated and non-actuated degrees of freedom. Actuated lightweight soft exosuits minimize these effects and provide a unique opportunity to study human-robot interaction in wearable systems without affecting the subjects underlying natural dynamics. In this paper, we present the design and control of a reconfigurable multi-joint actuation platform that can provide biologically realistic torques to ankle, knee, and hip joints through lower extremity soft exosuits. Two different soft exosuits have been designed to deliver assistive forces through Bowden cable transmission to the ankle and hip joints. Through human subject experiments, it is demonstrated that with a real-time admittance controller, accurate force profile tracking can be achieved during walking. The average energy delivered to the test subject was calculated while walking at 1.25 m/s and actuated with 15% of the total torque required by the biological joints. The results show that the ankle joint received an average of 3.02J during plantar flexion and that the hip joint received 1.67J during flexion each gait cycle. The efficiency of the described suit and controller in transferring energy to the human biological joints is 70% for the ankle and 48% for the hip.
Magnetic localization systems based on passive permanent magnets (PM) are of great interest due to their ability to provide non-contact sensing and without any power requirement for the PM. Medical procedures such as ventriculostomy can benefit greatly from real-time feedback of the inserted catheter tip. While the effects of the number of sensors on the localization accuracy in such systems has been reported, the spatial design of the sensor layout has been largely overlooked. Here in this paper, a framework for determining an optimal sensor assembly for enhanced localization performance is presented and investigated through numerical simulations and direct experiments. Two approaches are presented: one based on structured grid configuration and the other derived using Genetic Algorithms. Simulation results verified by experiments strongly suggest that the layout of the sensors not only has an effect on the localization accuracy, but also has an effect far more pronounced than improvements brought by increasing the number of sensors.
A handheld, portable cranial drilling tool for safely creating holes in the skull without damaging brain tissue is presented. Such a device is essential for neurosurgeons and mid-level practitioners treating patients with traumatic brain injury. A typical procedure creates a small hole for inserting sensors to monitor intra-cranial pressure measurements and/or removing excess fluid. Drilling holes in emergency settings with existing tools is difficult and dangerous due to the risk of a drill bit unintentionally plunging into brain tissue. Cranial perforators, which counter-bore holes and automatically stop upon skull penetration, do exist but are limited to large diameter hole size and an operating room environment. The tool presented here is compatible with a large range of bit diameters and provides safe, reliable access. This is accomplished through a dynamic bi-stable linkage that supports drilling when force is applied against the skull but retracts upon penetration when the reaction force is diminished. Retraction is achieved when centrifugal forces from rotating masses overpower the axial forces, thus changing the state of the bi-stable mechanism. Initial testing on ex-vivo animal structures has demonstrated that the device can withdraw the drill bit in sufficient time to eliminate the risk of soft tissue damage. Ease of use and portability of the device will enable its use in unregulated environments such as hospital emergency rooms and emergency disaster relief areas.
J. Gafford, S. B. Kesner, R. J. Wood, and C. J. Walsh, “Microsurgical devices by Pop-up Book MEMS,” in Proceedings of the ASME 2013 International Design Engineering Technical Conferences & Computers and Information in Engineering Conference IDETC/CIE 2013, Portland, Oregon, USA, 2013.PDF
In this paper, we present the design and evaluation of a novel soft cable-driven exosuit that can apply forces to the body to assist walking. Unlike traditional exoskeletons which contain rigid framing elements, the soft exosuit is worn like clothing, yet can generate moments at the ankle and hip with magnitudes of 18% and 30% of those naturally generated by the body during walking, respectively. Our design uses geared motors to pull on Bowden cables connected to the suit near the ankle. The suit has the advantages over a traditional exoskeleton in that the wearer's joints are unconstrained by external rigid structures, and the worn part of the suit is extremely light, which minimizes the suit's unintentional interference with the body's natural biomechanics. However, a soft suit presents challenges related to actuation force transfer and control, since the body is compliant and cannot support large pressures comfortably. We discuss the design of the suit and actuation system, including principles by which soft suits can transfer force to the body effectively and the biological inspiration for the design. For a soft exosuit, an important design parameter is the combined effective stiffness of the suit and its interface to the wearer. We characterize the exosuit's effective stiffness, and present preliminary results from it generating assistive torques to a subject during walking. We envision such an exosuit having broad applicability for assisting healthy individuals as well as those with muscle weakness.
The small scale of minimally-invasive surgery (MIS) presents significant challenges to developing robust, smart, and dexterous tools for manipulating millimeter and sub-millimeter anatomical structures (vessels, nerves) and surgical equipment (sutures, staples). Robotic MIS systems offer the potential to transform this medical field by enabling precise repair of these miniature tissue structures through the use of teleoperation and haptic feedback. However, this effort is currently limited by the inability to make robust and accurate MIS end effectors with integrated force and contact sensing. In this paper, we demonstrate the use of the novel Pop-Up Book MEMS manufacturing method to fabricate the mechanical and sensing elements of an instrumented MIS grasper. A custom thin-foil strain gage was manufactured in parallel with the mechanical components of the grasper to realize a fully-integrated electromechanical system in a single manufacturing step, removing the need for manual assembly, bonding and alignment. In preliminary experiments, the integrated grasper is capable of resolving forces as low as 30 mN, with a sensitivity of approximately 408 mV/N. This level of performance will enable robotic surgical systems that can handle delicate tissue structures and perform dexterous procedures through the use of haptic feedback guidance.
Established design and fabrication guidelines exist for achieving a variety of motions with soft actuators such as bending, contraction, extension, and twisting. These guidelines typically involve multi-step molding of composite materials (elastomers, paper, fiber, etc.) along with specially designed geometry. In this paper we present the design and fabrication of a robust, fiber-reinforced soft bending actuator where its bend radius and bending axis can be mechanically-programed with a flexible, selectively-placed conformal covering that acts to mechanically constrain motion. Several soft actuators were fabricated and their displacement and force capabilities were measured experimentally and compared to demonstrate the utility of this approach. Finally, a prototype two-digit end-effector was designed and programmed with the conformal covering to shape match a rectangular object. We demonstrated improved gripping force compared to a pure bending actuator. We envision this approach enabling rapid customization of soft actuator function for grasping applications where the geometry of the task is known a priori.