Closing small defects in the body typically requires stitching of tissues during surgery. Toward a minimally invasive approach, Roche et al. engineered a balloon catheter with a reflective surface coating that could be used to adhere biodegradable patches to tissues. The device unfolds the patch and its adhesive, delivers ultraviolet (UV) light, and then applies pressure to stabilize the adhesive as the light cures the polymer. The authors demonstrated catheter-mediated application of the photocurable polymer patch in vivo in rat tissue, with minimal inflammation and complete animal survival, as well as in a challenging septal defect in the beating hearts of pigs. The device was also used to seal porcine stomach ulcers and abdominal hernias ex vivo, suggesting versatility of this approach in repairing defects more easily and atraumatically than sutures.A congenital or iatrogenic tissue defect often requires closure by open surgery or metallic components that can erode tissue. Biodegradable, hydrophobic light-activated adhesives represent an attractive alternative to sutures, but lack a specifically designed minimally invasive delivery tool, which limits their clinical translation. We developed a multifunctional, catheter-based technology with no implantable rigid components that functions by unfolding an adhesive-loaded elastic patch and deploying a double-balloon design to stabilize and apply pressure to the patch against the tissue defect site. The device uses a fiber-optic system and reflective metallic coating to uniformly disperse ultraviolet light for adhesive activation. Using this device, we demonstrate closure on the distal side of a defect in porcine abdominal wall, stomach, and heart tissue ex vivo. The catheter was further evaluated as a potential tool for tissue closure in vivo in rat heart and abdomen and as a perventricular tool for closure of a challenging cardiac septal defect in a large animal (porcine) model. Patches attached to the heart and abdominal wall with the device showed similar inflammatory response as sutures, with 100% small animal survival, indicating safety. In the large animal model, a ventricular septal defect in a beating heart was reduced to <1.6 mm. This new therapeutic platform has utility in a range of clinical scenarios that warrant minimally invasive and atraumatic repair of hard-to-reach defects.
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.
In this work we investigate the influence of fiber angle on the deformation of fiber-reinforced soft fluidic actuators and examine the manner in which these actuators extend axially, expand radially and twist about their axis as a function of input pressure. We study the quantitative relationship between fiber angle and actuator deformation by performing finite element simulations for actuators with a range of different fiber angles, and we verify the simulation results by experimentally characterizing the actuators. By combining actuator segments in series, we can achieve combinations of motions tailored to specific tasks. We demonstrate this by using the results of simulations of separate actuators to design a segmented wormlike soft robot capable of propelling itself through a tube and performing an orientation-specific peg insertion task at the end of the tube. Understanding the relationship between fiber angle and pressurization response of these soft fluidic actuators enables rapid exploration of the design space, opening the door to the iteration of exciting soft robot concepts such as flexible and compliant endoscopes, pipe inspection devices, and assembly line robots.
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 details the design, analysis, fabrication, and validation of a deployable, atraumatic grasper intended for retraction and manipulation tasks in manual and robotic minimally invasive surgical (MIS) procedures. Fabricated using a combination of shape deposition manufacturing (SDM) and 3D printing, the device (which acts as a deployable end-effector for robotic platforms) has the potential to reduce the risk of intraoperative hemorrhage by providing a soft, compliant interface between delicate tissue structures and the metal laparoscopic forceps and graspers that are currently used to manipulate and retract these structures on an ad hoc basis. This paper introduces a general analytical framework for designing SDM fingers where the desire is to predict the shape and the transmission ratio, and this framework was used to design a multijointed grasper that relies on geometric trapping to manipulate tissue, rather than friction or pinching, to provide a safe, stable, adaptive, and conformable means for manipulation. Passive structural compliance, coupled with active grip force monitoring enabled by embedded pressure sensors, helps to reduce the cognitive load on the surgeon. Initial manipulation tasks in a simulated environment have demonstrated that the device can be deployed though a 15 mm trocar and develop a stable grasp using Intuitive Surgical's daVinci robotic platform to deftly manipulate a tissue analog.
Exoskeletons comprised of rigid load-bearing structures have been developed for many years, but a new paradigm is to create “exosuits” that apply tensile forces to the body using textiles and utilize the body’s skeletal structure to support compressive forces. Exosuits are intended to augment the musculature by providing small to moderate levels of assistance at appropriate times in the walking cycle. They have a number of substantial benefits: with their fabric construction, exosuits eliminate problems of needing to align a rigid frame precisely with the biological joints and their inertia can be extremely low. In this paper, we present a fully portable hip-assistance exosuit that uses a backpack frame to attach to the torso, onto which is mounted a spooled-webbing actuator that connects to the back of the users thigh. The actuators, powered by a geared brushless motor connected to a spool via a timing belt, wind up seat-belt webbing onto the spool so that a large travel is possible with a simple, compact mechanism. Designed to be worn over the clothing, the webbing creates a large moment arm around the hip that provides torques in the sagittal plane of up to 30% of the nominal biological torques for level-ground walking. Due to its soft design, the system does not restrict the motion of the hip in the ab- and adduction directions or rotation about the leg axis. Here we present the design of the system along with some initial measurements of the system in use during walking on level ground at 1.25 m/s, where it creates a force of up to 150 N on the thigh, equivalent to a torque of 20.5 Nm to assist hip extension.
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.
We report a new method for fabricating textile integrable capacitive soft strain sensors based on multicore–shell fiber printing. The fiber sensors consist of four concentric, alternating layers of conductor and dielectric, respectively. These wearable sensors provide accurate and hysteresis-free strain measurements under both static and dynamic conditions.
We present the design and evaluation of a multi-articular soft exosuit that is portable, fully autonomous, and provides assistive torques to the wearer at the ankle and hip during walking. Traditional rigid exoskeletons can be challenging to perfectly align with a wearer’s biological joints and can have large inertias, which can lead to the wearer altering their natural motion patterns. Exosuits, in comparison, use textiles to create tensile forces over the body in parallel with the muscles, enabling them to be light and not restrict the wearer’s kinematics. We describe the biologically inspired design and function of our exosuit, including a simplified model of the suit’s architecture and its interaction with the body. A key feature of the exosuit is that it can generate forces passively due to the body’s motion, similar to the body’s ligaments and tendons. These passively generated forces can be supplemented by actively contracting Bowden cables using geared electric motors, to create peak forces in the suit of up to 200 N. We define the suit–human series stiffness as an important parameter in the design of the exosuit and measure it on several subjects, and we perform human subjects testing to determine the biomechanical and physiological effects of the suit. Results from a five-subject study showed a minimal effect on gait kinematics and an average best-case metabolic reduction of 6.4%, comparing suit worn unpowered versus powered, during loaded walking with 34.6 kg of carried mass including the exosuit and actuators (2.0 kg on both legs, 10.1 kg total).
The spectrum of ischaemic cardiomyopathy, encompassing acute myocardial infarction to congestive heart failure is a significant clinical issue in the modern era. This group of diseases is an enormous source of morbidity and mortality and underlies significant healthcare costs worldwide. Cardiac regenerative therapy, whereby pro-regenerative cells, drugs or growth factors are administered to damaged and ischaemic myocardium has demonstrated significant potential, especially preclinically. While some of these strategies have demonstrated a measure of success in clinical trials, tangible clinical translation has been slow. To date, the majority of clinical studies and a significant number of preclinical studies have utilised relatively simple delivery methods for regenerative therapeutics, such as simple systemic administration or local injection in saline carrier vehicles. Here, we review cardiac regenerative strategies with a particular focus on advanced delivery concepts as a potential means to enhance treatment efficacy and tolerability and ultimately, clinical translation. These include (i) delivery of therapeutic agents in biomaterial carriers, (ii) nanoparticulate encapsulation, (iii) multimodal therapeutic strategies and (iv) localised, minimally invasive delivery via percutaneous transcatheter systems.
Soft fluidic actuators consisting of elastomeric matrices with embedded flexible materials are of particular interest to the robotics community because they are affordable and can be easily customized to a given application. However, the significant potential of such actuators is currently limited as their design has typically been based on intuition. In this paper, the principle of operation of these actuators is comprehensively analyzed and described through experimentally validated quasi-static analytical and finite-element method models for bending in free space and force generation when in contact with an object. This study provides a set of systematic design rules to help the robotics community create soft actuators by understanding how these vary their outputs as a function of input pressure for a number of geometrical parameters. Additionally, the proposed analytical model is implemented in a controller demonstrating its ability to convert pressure information to bending angle in real time. Such an understanding of soft multimaterial actuators will allow future design concepts to be rapidly iterated and their performance predicted, thus enabling new and innovative applications that produce more complex motions to be explored.
This paper presents a portable, assistive, soft robotic glove designed to augment hand rehabilitation for individuals with functional grasp pathologies. The robotic glove utilizes soft actuators consisting of molded elastomeric chambers with fiber reinforcements that induce specific bending, twisting and extending trajectories under fluid pressurization. These soft actuators were mechanically programmed to match and support the range of motion of individual fingers. They demonstrated the ability to generate significant force when pressurized and exhibited low impedance when un-actuated. To operate the soft robotic glove, a control hardware system was designed and included fluidic pressure sensors in line with the hydraulic actuators and a closed-loop controller to regulate the pressure. Demonstrations with the complete system were performed to evaluate the ability of the soft robotic glove to carry out gross and precise functional grasping. Compared to existing devices, the soft robotic glove has the potential to increase user freedom and independence through its portable waist belt pack and open palm design.
Exosuits show much promise as a method for augmenting the body with lightweight, portable, and compliant wearable systems. We envision that such systems can be further refined so that they can be sufficiently low profile to fit under a wearer's existing clothing. Our focus is on creating an assistive device that provides a fraction of the nominal biological torques and does not provide external load transfer. In early work, we showed that the system can substantially maintain normal biomechanics and positively affect a wearer's metabolic rate. Many basic fundamental research and development challenges remain in actuator development, textile innovation, soft sensor development, human-machine interface (control), biomechanics, and physiology, which provides fertile ground for academic research in many disciplines. While we have focused on gait assistance thus far, numerous other applications are possible, including rehabilitation, upper body support, and assistance for other motions. We look forward to a future where wearable robots provide benefits for people across many areas of our society.
Soft sensors comprising a flexible matrix with embedded circuit elements can undergo large deformations while maintaining adequate performance. These devices have attracted considerable interest for their ability to be integrated with the human body and have enabled the design of skin-like health monitoring devices, sensing suits, and soft active orthotics. Numerical tools are needed to facilitate the development and optimization of these systems. In this letter, we introduce a 3D finite element-based numerical tool to simultaneously characterize the mechanical and electrical response of fluid-embedded soft sensors of arbitrary shape, subjected to any loading. First, we quantitatively verified the numerical approach by comparing simulation and experimental results of a dog-bone shaped sensor subjected to uniaxial stretch and local compression. Then, we demonstrate the power of the numerical tool by examining a number of different loading conditions. We expect this work will open the door for further design of complex and optimal soft sensors.
Cell delivery to the infarcted heart has emerged as a promising therapy, but is limited by very low acute retention and engraftment of cells. The objective of this study was to compare a panel of biomaterials to evaluate if acute retention can be improved with a biomaterial carrier. Cells were quantified post-implantation in a rat myocardial infarct model in five groups (n = 7–8); saline injection (current clinical standard), two injectable hydrogels (alginate, chitosan/β-glycerophosphate (chitosan/ß-GP)) and two epicardial patches (alginate, collagen). Human mesenchymal stem cells (hMSCs) were delivered to the infarct border zone with each biomaterial. At 24 h, retained cells were quantified by fluorescence. All biomaterials produced superior fluorescence to saline control, with approximately 8- and 14-fold increases with alginate and chitosan/β-GP injectables, and 47 and 59-fold increases achieved with collagen and alginate patches, respectively. Immunohistochemical analysis qualitatively confirmed these findings. All four biomaterials retained 50–60% of cells that were present immediately following transplantation, compared to 10% for the saline control. In conclusion, all four biomaterials were demonstrated to more efficiently deliver and retain cells when compared to a saline control. Biomaterial-based delivery approaches show promise for future development of efficient in vivo delivery techniques.
Accurately targeting multi-adjacent points (MAPs) during image-guided percutaneous procedures is challenging due to needle deflection and misalignment. The associated errors can result in inadequate treatment of cancer in the case of prostate brachytherapy, or inaccurate diagnosis during biopsy, while repeated insertions increase procedure time, radiation dose, and complications. To address these challenges, we present an image-guided robotic system capable of MAP targeting of irregularly shaped volumes after a single insertion of a percutaneous instrument. The design of the compact CT-compatible drive mechanism is based on a nested screw and screw-spline combination that actuates a straight outer cannula and a curved inner stylet that can be repeatedly straightened when retracted inside the cannula. The stylet translation and cannula rotation/translation enable a 3-D workspace to be reached with the stylet's tip. A closed-form inverse kinematics and image-to-robot registration are implemented in an image-guided system including a point-and-click user interface. The complete system is successfully evaluated with a phantom under a Siemens Definition Flash CT scanner. We demonstrate that the system is capable of MAP targeting for a 2-D shape of the letter “H” and a 3-D helical pattern with an average targeting error of 2.41 mm. These results highlight the benefit and efficacy of the proposed robotic system in seed placement during image-guided brachytherapy.