Previous soft robotic ventricular assist devices have generally targeted biventricular heart failure and have not engaged the interventricular septum that plays a critical role in blood ejection from the ventricle. We propose implantable soft robotic devices to augment cardiac function in isolated left or right heart failure by applying rhythmic loading to either ventricle. Our devices anchor to the interventricular septum and apply forces to the free wall of the ventricle to cause approximation of the septum and free wall in systole and assist with recoil in diastole. Physiological sensing of the native hemodynamics enables organ-in-the-loop control of these robotic implants for fully autonomous augmentation of heart function. The devices are implanted on the beating heart under echocardiography guidance. We demonstrate the concept on both the right and the left ventricles through in vivo studies in a porcine model. Different heart failure models were used to demonstrate device function across a spectrum of hemodynamic conditions associated with right and left heart failure. These acute in vivo studies demonstrate recovery of blood flow and pressure from the baseline heart failure conditions. Significant reductions in diastolic ventricle pressure were also observed, demonstrating improved filling of the ventricles during diastole, which enables sustainable cardiac output.
Modular robotic systems that integrate with commercially-available endoscopic equipment have the potential to improve the standard-of-care in therapeutic endoscopy by granting clinicians with capabilities not present in commercial tools, such as precision dexterity and motion sensing. With the desire to integrate both sensing and actuation distally for closed-loop position control in fully-deployable, endoscope-based robotic modules, commercial sensor and actuator options that acquiesce to the strict form-factor requirements are sparse or nonexistent. Herein we describe a proprioceptive angle sensor for potential closed-loop position control applications in distal robotic modules. Fabricated monolithically using printed-circuit MEMS, the sensor employs a kinematic linkage and the principle of light intensity modulation to sense the angle of articulation with a high degree of fidelity. On-board temperature and environmental irradiance measurements, coupled with linear regression techniques, provide robust angle measurements that are insensitive to environmental disturbances. The sensor is capable of measuring +/-45 degrees of articulation with an RMS error of 0.98 degrees. An integrated demonstration shows that the sensor can give real-time proprioceptive feedback when coupled with an actuator module, opening up the possibility of fully-distal closed-loop control.
A hybrid manufacturing paradigm is introduced that combines pop-up book microelectromechanical systems (MEMS) manufacturing with soft-lithographic techniques to produce millimeter-scale mechanisms with embedded sensing and user-defined distributed compliance. This method combines accuracy, flexibility in material selection, scalability, and topological complexity with soft, biocompatible materials and microfluidics, paving the way for applications of soft fluid-powered biomedical robotics. This paper proposes two classes of fully soft fluidic microactuators and two integration strategies to demonstrate the hybrid soft pop-up actuators. Fatigue properties, blocked torque, maximum deflection, stiffness, and maximum speed are analyzed and the performance of the hybrid mechanisms is compared to their fully soft counterparts. The manufacturing approach allows integrating capacitive sensing elements in the mechanisms to achieve proprioceptive actuation. Multiple hybrid soft pop-up actuators are combined into a multiarticulated robotic arm that is integrated with current flexible endoscopes to improve distal dexterity and enable tissue retraction in an ex vivo proof of concept experiment.
We introduce an implantable intracardiac soft robotic right ventricular ejection device (RVED) for dynamic approximation of the right ventricular (RV) free wall and the interventricular septum (IVS) in synchrony with the cardiac cycle to augment blood ejection in right heart failure (RHF). The RVED is designed for safe and effective intracardiac operation and consists of an anchoring system deployed across the IVS, an RV free wall anchor, and a pneumatic artificial muscle linear actuator that spans the RV chamber between the two anchors. Using a ventricular simulator and a custom controller, we characterized ventricular volume ejection, linear approximation against different loads and the effect of varying device actuation periods on volume ejection. The RVED was then tested in vivo in adult pigs (n = 5). First, we successfully deployed the device into the beating heart under 3D echocardiography guidance (n = 4). Next, we performed a feasibility study to evaluate the device's ability to augment RV ejection in an experimental model of RHF (n = 1). RVED actuation augmented RV ejection during RHF; while further chronic animal studies will provide details about the efficacy of this support device. These results demonstrate successful design and implementation of the RVED and its deployment into the beating heart. This soft robotic ejection device has potential to serve as a rapidly deployable system for mechanical circulatory assistance in RHF.
Abstract: Flexible endoscopes are still the gold standard in most natural orifice translumenal endoscopic surgery (NOTES) procedures; however their flexibility (necessary for navigating through the GI tract) limits their capabilities in terms of distal manipulation and stability. We propose a deployable endoscopic add-on aimed at locally counteracting forces applied at the tip of an endoscope. We analyze different designs: a fully soft version and two hybrid soft-folded versions. The hybrid designs exploit either an inextensible structure pressurized by a soft actuator or the stiffness provided by the unfolded “magic cube” origami structure. We focus on the fabrication and experimental characterization of the proposed structures and present some preliminary designs and integration strategies to mount them on top of current flexible endoscopes.
‘Snap-On’ robotic modules that can integrate distally with existing commercially-available endoscopic equipment have the potential to provide new capabilities such as enhanced dexterity, bilateral manipulation and feedback sensing with minimal disruption of the current clinical workflow. However, the desire for fully-distal integration of sensors and actuators and the resulting form factor requirements preclude the use of many off-the-shelf actuators capable of generating the relevant strokes and forces required to interact with tools and tissue. In this work, we investigate the use of millimeter-scale, optimally-packed helical shape memory alloy (SMA) actuators in an antagonistic configuration to provide distal actuation without the need for a continuous mechanical coupling to proximal, off-board actuation packages to realize a truly plug-and-play solution. Using phenomenological modeling, we design and fabricate antagonistic helical SMA pairs and implement them in an at-scale roboendoscopic module to generate strokes and forces necessary for deflecting tools passed through the endoscope working port, thereby providing a controllable robotic ‘wrist’ inside the body to otherwise passive flexible tools. Bandwidth is drastically improved through the integration of targeted fluid cooling. The integrated system can generate maximum lateral forces of 10N and demonstrates an additional 96 degrees of distal angulation, expanding the reachable workspace of tools passed through a standard endoscope.
Recent advances in medical robotics have initiated a transition from rigid serial manipulators to flexible or continuum robots capable of navigating to confined anatomy within the body. A desire for further procedure minimization is a key accelerator for the development of these flexible systems where the end goal is to provide access to the previously inaccessible anatomical workspaces and enable new minimally invasive surgical (MIS) procedures. While sophisticated navigation and control capabilities have been demonstrated for such systems, existing manufacturing approaches have limited the capabilities of millimeter-scale end-effectors for these flexible systems to date and, to achieve next generation highly functional end-effectors for surgical robots, advanced manufacturing approaches are required. We address this challenge by utilizing a disruptive 2D layer-by-layer precision fabrication process (inspired by printed circuit board manufacturing) that can create functional 3D mechanisms by folding 2D layers of materials which may be structural, flexible, adhesive, or conductive. Such an approach enables actuation, sensing, and circuitry to be directly integrated with the articulating features by selecting the appropriate materials during the layer-by-layer manufacturing process. To demonstrate the efficacy of this technology, we use it to fabricate three modular robotic components at the millimeter-scale: (1) sensors, (2) mechanisms, and (3) actuators. These modules could potentially be implemented into transendoscopic systems, enabling bilateral grasping, retraction and cutting, and could potentially mitigate challenging MIS interventions performed via endoscopy or flexible means. This research lays the ground work for new mechanism, sensor and actuation technologies that can be readily integrated via new millimeter-scale layer-by-layer manufacturing approaches.
Light-Intensity Modulated (LIM) force sensors are seeing increasing interest in the field of surgical robotics and flexible systems in particular. However, such sensing modalities are notoriously susceptible to ambient effects such as temperature and environmental irradiance which can register as false force readings. We explore machine learning techniques to dynamically compensate for environmental biases that plague multi-axis optoelectronic force sensors. In this work, we fabricate a multisensor: three-axis LIM force sensor with integrated temperature and ambient irradiance sensing manufactured via a monolithic, origami-inspired fabrication process called printed-circuit MEMS. We explore machine learning regression techniques to compensate for temperature and ambient light sensitivity using on-board environmental sensor data. We compare batch-based ridge regression, kernelized regression and support vector techniques to baseline ordinary least-squares estimates to show that on-board environmental monitoring can substantially improve sensor force tracking performance and output stability under variable lighting and large (>100C) thermal gradients. By augmenting the least-squares estimate with nonlinear functions describing both environmental disturbances and cross-axis coupling effects, we can reduce the error in Fx, Fy and Fz by 10%, 33%, and 73%, respectively. We assess viability of each algorithm tested in terms of both prediction accuracy and computational overhead, and analyze kernel-based regression for prediction in the context of online force feedback and haptics applications in surgical robotics. Finally, we suggest future work for fast approximation and prediction using stochastic, sparse kernel techniques.
The innovation in surgical robotics has seen a shift toward flexible systems that can access remote locations inside the body. However, a general reliance on the conventional fabrication techniques ultimately limits the complexity and the sophistication of the distal implementations of such systems, and poses a barrier to further innovation and widespread adoption. In this paper, we present a novel, self-assembling force sensor manufactured using a composite lamination fabrication process, wherein linkages pre-machined in the laminate provide the required degrees-of-freedom and fold patterns to facilitate self-assembly. Using the purely 2-D fabrication techniques, the energy contained within a planar elastic biasing element directly integrated into the laminate is released post-fabrication, allowing the sensor to self-assemble into its final 3-D shape. The sensors are batch-fabricated, further driving down the production costs. The transduction mechanism relies on the principle of light intensity modulation, which allows the sensor to detect axial forces with millinewton-level resolution. The geometry of the sensor was selected based on the size constraints inherent in minimally invasive surgery, as well as with a specific focus on optimizing the sensor's linearity. The sensor is unique from the fiber-based force sensors in that the emitter and the detector are encapsulated within the sensor itself. The bare sensor operates over a force range of 0-200 mN, with a sensitivity of 5 V/N and a resolution of 0.8 mN. The experimental results show that the sensor's stiffness can be tuned using a thicker material for the spring layer and/or encapsulation/integration with soft materials. The empirical validation shows that the sensor has the sensitivity and the resolution necessary to discern the biologically relevant forces in a simulated cannulation task.
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.
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 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.