Modeling of a Symmetric Five-Bar Displacement Amplification Compliant Mechanism for Energy Harvesting.

This paper presents an analytical model to determine a closed form mathematical representation for the output displacement of a displacement amplification compliant mechanism used for energy harvesting. A symmetric five-bar compliant mechanism with right-circular and corner-filleted flexure hinges was mathematically modeled and its displacement was determined using the Castigliano energy theorem. The stresses within the flexure joints, the weakest points in the mechanism body, were calculated. The mathematical model expresses both the displacement amplification and the stresses as functions of the design parameters and the load caused by the harvester. The developed model can be used to optimize the mechanism dimensions for maximum harvested power, while minimizing its structural stresses. The mechanism was also modeled numerically using finite element methods; both the analytical and numerical models were verified experimentally. The mathematical model of the mechanism was integrated with a model representing a piezoelectric energy harvester to calculate the open-circuit voltage. As a proof of concept, experiments were performed using an unimorph piezoelectric cantilever at low-frequency (less than 1 Hz) harmonic excitation inputs. The measured open-circuit voltage was found to be in agreement with that calculated using the proposed model, when integrated with the model representing the piezoelectric beam. The power generated by the piezoelectric harvester, equipped with the proposed displacement amplification mechanism, was more than a hundred times that without amplification.

In vitro and in vivo assessment of a novel ultra-flexible ventriculoamniotic shunt for treating fetal hydrocephalus.

Fetal aqueductal stenosis (AS) is one of the most common causes of congenital hydrocephalus, which increases intracranial pressure due to partial or complete obstruction of cerebrospinal fluid (CSF) flow within the ventricular system. Approximately 2-4 infants per 10,000 births develop AS, which leads to progressive hydrocephalus, which enlarges the head often necessitating delivery by cesarean section. Most babies born with AS are severely neurologically impaired and experience a lifetime of disability. Therefore, a new device technology for venticuloamniotic shunting is urgently needed and has been studied to ameliorate or prevent fetal hydrocephalus development, which can provide a significant impact on patients and their family's quality of life and on the decrease of the healthcare dollars spent for the treatment. This study has successfully validated the design of shunt devices and demonstrated the mechanical performance and valve functions. A functional prototype shunt has been fabricated and subsequently used in multiple in vitro tests to demonstrate the performance of this newly developed ventriculoamniotic shunt. The shunt contains a main silicone-nitinol composite tube, a superelastic 90° angled dual dumbbell anchor, and an ePTFE valve encased by a stainless-steel cage. The anchor will change its diameter from 1.15 mm (collapsed state) to 2.75 mm (deployed state) showing up to 1.4-fold diameter change in human body temperature. Flow rates in shunts were quantified to demonstrate the valve function in low flow rates mimicking the fetal hydrocephalus condition showing "no backflow" for the valved shunt while there is up to 15 mL/h flow through the shunt with pressure difference of 20 Pa. In vivo ovine study results show the initial successful device delivery and flow drainage with sheep model.

A dumbbell rescue stent graft facilitates clamp-free repair of aortic injury in a porcine model.

Objective: Noncompressible torso hemorrhage is a high-mortality injury. We previously reported improved outcomes with a retrievable rescue stent graft to temporize aortic hemorrhage in a porcine model while maintaining distal perfusion. A limitation was that the original cylindrical stent graft design prohibited simultaneous vascular repair, given the concern for suture ensnarement of the temporary stent. We hypothesized that a modified, dumbbell-shaped design would preserve distal perfusion and also offer a bloodless plane in the midsection, facilitating repair with the stent graft in place and improve the postrepair hemodynamics. Methods: In an Institutional Animal Care and Use Committee-approved terminal porcine model, a custom retrievable dumbbell-shaped rescue stent graft (dRS) was fashioned from laser-cut nitinol and polytetrafluoroethylene covering and compared with aortic cross-clamping. Under anesthesia, the descending thoracic aorta was injured and then repaired with cross-clamping (n = 6) or dRS (n = 6). Angiography was performed in both groups. Operations were divided into phases: (1) baseline, (2) thoracic injury with either cross-clamp or dRS deployed, and (3) recovery, after which the clamp or dRS were removed. Target blood loss was 22% to simulate class II or III hemorrhagic shock. Shed blood was recovered with a Cell Saver and reinfused for resuscitation. Renal artery flow rates were recorded at baseline and during the repair phase and reported as a percentage of cardiac output. Phenylephrine pressor requirements were recorded. Results: In contrast with cross-clamped animals, dRS animals demonstrated both operative hemostasis and preserved flow beyond the dRS angiographically. Recovery phase mean arterial pressure, cardiac output, and right ventricular end-diastolic volume were significantly higher in dRS animals (P = .033, P = .015, and P = .012, respectively). Whereas distal femoral blood pressures were absent during cross-clamping, among the dRS animals, the carotid and femoral MAPs were not significantly different during the injury phase (P = .504). Cross-clamped animals demonstrated nearly absent renal artery flow, in contrast with dRS animals, which exhibited preserved perfusion (P<.0001). Femoral oxygen levels (partial pressure of oxygen) among a subset of animals further confirmed greater distal oxygenation during dRS deployment compared with cross-clamping (P = .006). After aortic repair and clamp or stent removal, cross-clamped animals demonstrated more significant hypotension, as demonstrated by increased pressor requirements over stented animals (P = .035). Conclusions: Compared with aortic cross-clamping, the dRS model demonstrated superior distal perfusion, while also facilitating simultaneous hemorrhage control and aortic repair. This study demonstrates a promising alternative to aortic cross-clamping to decrease distal ischemia and avoid the unfavorable hemodynamics that accompany clamp reperfusion. Future studies will assess differences in ischemic injury and physiological outcomes. Clinical Relevance: Noncompressible aortic hemorrhage remains a high-mortality injury, and current damage control options are limited by ischemic complications. We have previously reported a retrievable stent graft to allow rapid hemorrhage control, preserved distal perfusion, and removal at the primary repair. The prior cylindrical stent graft was limited by the inability to suture the aorta over the stent graft owing to risk of ensnarement. This large animal study explored a dumbbell retrievable stent with a bloodless plane to allow suture placement with the stent in place. This approach improved distal perfusion and hemodynamics over clamp repair and heralds the potential for aortic repair while avoiding complications.

A self calibrating, magnetic sensor approach accurately positions an aortic damage control stent in a porcine model.

Objectives: Non-compressible torso hemorrhage remains a high mortality injury, with difficulty mobilizing resources before exsanguination. Previous studies reported on a retrievable stent graft for damage control and morphometric algorithms for rapid placement, yet fluoroscopy is impractical for the austere environment. We hypothesized that magnetic sensors could be used to position stents relative to an external magnet placed on an anatomic landmark, whereas an electromagnet would allow self-calibration to account for environmental noise. Methods: A magnetic sensor alone (MSA) and with integrated stent (MSIS) were examined in a porcine model under anesthesia. A target electromagnet was placed on the xiphoid process (position 0 cm). Sensors were placed in the aorta and measurements obtained at positions 0 cm, +4 cm, and +12 cm from the magnet and compared with fluoroscopy. Sensors were examined under conditions of tachycardia/hypertension, hypotension, vibration, and metal shrapnel to simulate environmental factors that might impact accuracy. General linear models compared mean differences between fluoroscopy and sensor readings. Results: Both sensors were compatible with a 10 French catheter system and provided real-time assessment of the distance between the sensor and magnetic target in centimeters. Mean differences between fluoroscopy and both magnetic sensor readings demonstrated accuracy within ±0.5 cm for all but one condition at 0 cm and +4 cm, whereas accuracy decreased at +12 cm from the target. Using the control as a reference, there was no significant difference in mean differences between fluoroscopy and both MSA or MSIS readings at 0 cm and +4 cm for all conditions. The system retained effectiveness if the target was overshot. Conclusion: Magnetic sensors achieved the highest accuracy as sensors approached the target. Oscillation of the electromagnet on and off effectively accounts for environmental noise.This approach is promising for rapid and accurate placement of damage control retrievable stent grafts when fluoroscopy is impractical. Level of evidence: Not applicable.

In vitro and In vivo assessment of a novel organ perfusion stent for successful flow separation in donation after cardiac death.

Shortage of healthy donors' organs has appeared as one of the main challenges for organ transplantation. This study focuses on the novel endovascular device development to increase the number of available organs from cardiac death donors. The primary objective of this study is the design validation of a newly developed stent graft for the abdominal organ perfusion with cardiac blood flow isolation. In this paper, the effectiveness of the device design has been validated via the assessment of the device performance both in vitro and in vivo. The radial force of stent structure was first numerically analyzed using finite element method, then was quantified experimentally. The blood perfusion parameters were investigated to demonstrate their effect on the blood delivered to the abdominal organs, maintaining the organs healthy for donation. In vitro flow leakage was measured using a 3-D printing-based silicone aortic model to evaluate the isolation between cardiac flow and perfusion flow with minimum values. Following the design validation process, a functional prototype stent graft has been successfully fabricated using optimized laser welding conditions and subsequent joining processes. In vivo porcine study results have demonstrated smooth delivery and successful placement of the device showing complete cardiac flow separation isolating abdominal regions only with the oxygenated blood flow.

A retrievable, dual-chamber stent protects against warm ischemia of donor organs in a model of donation after circulatory death.

BACKGROUND: Ischemic injury during the agonal period of donation after circulatory death donors remains a significant barrier to increasing abdominal transplants. A major obstacle has been the inability to improve visceral perfusion, while at the same time respecting the ethics of the organ donor. A retrievable dual-chamber stentgraft could potentially isolate the organ perfusion from systemic hypotension and hypoxia, without increasing cardiac work or committing the donor. METHODS: Retrievable dumbbell-shaped stents were laser welded from nitinol wire and covered with polytetrafluoroethylene. Yorkshire pigs were assigned to either agonal control or dumbbell-shaped dual-chamber stentgraft. A central lumen maintained aortic flow, while an outer visceral chamber was perfused with oxygenated blood. A 1-hour agonal phase of hypoxia and hypotension was simulated. Stents were removed by simple sheath advancement. Cardiac monitoring, labs, and visceral flow were recorded followed by recovery of the animal to a goal of 48 hours. RESULTS: Cardiac stress did not increase during stent deployment. Visceral pO2 and flow were dramatically improved in stented animal relative to control animals. Five of 7 control animals were killed after renal failure complications, whereas all stent animals survived. Histology confirmed increased ischemic changes among control kidneys compared to stented animals. CONCLUSION: A dual-chamber stent improved outcomes after a simulated agonal phase. The stent did not increase cardiac work, thus respecting a key ethical consideration. The ability of a dual-chamber stent to prevent ischemia during organ recovery may become a powerful tool to address the critical donor organ shortage.

Fully implantable batteryless soft platforms with printed nanomaterial-based arterial stiffness sensors for wireless continuous monitoring of restenosis in real time.

Atherosclerosis is a common cause of coronary artery disease and a significant factor in broader cardiovascular diseases, the leading cause of death. While implantation of a stent is a prevalent treatment of coronary artery disease, a frequent complication is restenosis, where the stented artery narrows and stiffens. Although early detection of restenosis can be achieved by continuous monitoring, no available device offers such capability without surgeries. Here, we report a fully implantable soft electronic system without batteries and circuits, which still enables continuous wireless monitoring of restenosis in real-time with a set of nanomembrane strain sensors in an electronic stent. The low-profile system requires minimal invasive implantation to deploy the sensors into a blood vessel through catheterization. The entirely printed, nanomaterial-based set of soft membrane strain sensors utilizes a sliding mechanism to offer enhanced sensitivity and detection of low strain while unobtrusively integrating with an inductive stent for passive wireless sensing. The performance of the soft sensor platform is demonstrated by wireless monitoring of restenosis in an artery model and an ex-vivo study in a coronary artery of ovine hearts. The capacitive sensor-based artery implantation system offers unique advantages in wireless, real-time monitoring of stent treatments and arterial health for cardiovascular disease.

Bioabsorbable, elastomer-coated magnesium alloy coils for treating saccular cerebrovascular aneurysms.

Cerebral aneurysm embolization is a therapeutic approach to prevent rupture and resultant clinical sequelae. Current, non-biodegradable metallic coils (platinum or tungsten) are the first-line choice to secure cerebral aneurysms. However, clinical studies report that up to 17% of aneurysms recur within 1 year after coiling, leading to retreatment and additional surgery. It would be ideal for the aneurysm coiling material to induce acute thrombotic occlusion, contribute to a tissue development process to fortify the degenerated vessel wall, and ultimately resorb to avoid leaving a permanent foreign body. With these properties in mind, a new fatty amide-based polyurethane urea (PHEUU) elastomer was synthesized and coated on biodegradable metallic (Mg alloy) coils to prepare a bioabsorbable cerebral saccular aneurysm embolization device. The chemical structure of PHEUU was confirmed using two-dimensional nuclear magnetic resonance spectroscopy. PHEUU showed comparable physical properties to elastomeric biodegradable polyurethanes lacking fatty amide immobilization, modest enzymatic degradation profiles in the first 8 wks, inherent antioxidant activity (>70% at 48 h), no cytotoxicity, and better protection for the underlying Mg alloy than poly(lactic-co-glycolic acid) (PLGA) against surface corrosion and cracking. Rat aortic smooth muscle cell attachment and platelet deposition were higher with the PHEUUs compared to bare or PLGA coated Mg alloy in vitro. PHEUU-coated Mg alloy coils showed the potential to design a fully bioabsorbable embolization coil amenable to clinical placement conditions based on computational mechanics modeling and blood-contacting test using an in vitro aneurysm model. In vivo studies using a mouse aneurysm model elicited comparable inflammatory cytokine expression to a commercially available platinum coil.

Assessment of mechanical and biocompatible performance of ultra-large nitinol endovascular devices fabricated via a low-energy laser joining process.

Nitinol is an excellent candidate material for developing various self-expanding endovascular devices due to its unique properties such as superelasticity, biocompatibility and shape memory effect. A low-energy laser joining technique suggests a high potential to create various large diameter Nitinol endovascular devices that contain complex geometries. The primary purpose of the study is to investigate the effects of laser joining process parameters with regard to the mechanical and biocompatible performance of Nitinol stents. Both the chemical composition and the microstructure of the laser-welded joints were evaluated using scanning electron microscopy (SEM) and energy-dispersive X-ray spectroscopy (EDS). In vitro study results on cytotoxicity demonstrated that the joining condition of 8 Hz frequency and 1 kW laser power showed the highest degree of endothelial cell viability after thermal annealing in 500°C for 30 min. Also, in vitro study results showed the highest oxygen content at 0.9 kW laser power, 8 Hz frequency, and 0.3 mm spot size after the thermal annealing. Mechanical performance test results showed that the optimal condition for the highest disconnecting force was found at 1 Hz frequency and 1 kW power with 0.6 mm spot size. Two new endovascular devices have been fabricated using the optimized laser joining parameters, which have demonstrated successful device delivery and retrieval, as well as acute biocompatibility.

A three-tier Rescue stent improves outcomes over balloon occlusion in a porcine model of noncompressible hemorrhage.

BACKGROUND: Noncompressible hemorrhage remains a high-mortality injury, and aortic balloon occlusion poses limitations in terms of distal ischemic injury. Our hypothesis was that a retrievable Rescue stent would confer improved outcome over aortic balloon occlusion. METHODS: A three-tier, retrievable stent graft was laser welded from nitinol and polytetrafluoroethylene to provide rapid thoracic and abdominal coverage with an interval bare metal segment to preserve visceral flow. Anesthetized swine had injury of the thoracic or abdominal aorta followed by balloon occlusion or a Rescue stent. A 1-hour long damage-control phase with blood repletion was used to simulate the prolonged interval between injury and repair, especially in the battlefield setting. Following the damage-control phase, the balloon or stent were retrieved followed by vascular repair and recovery to 48 hours. Animals were compared in terms of hemodynamics, blood loss, neurophysiologic spinal cord ischemia, ischemic organ injury, and survival. RESULTS: Despite antegrade hemorrhage control, balloon occlusion averaged 3.5 L of retrograde hemorrhage, loss of visceral perfusion, and permanent spinal cord ischemia by neurophysiology in six of seven animals. After permanent repair, all balloon occlusion animals died with only a single short term (5 hours) survivor. Conversely, Rescue stent animals revealed rapid hemorrhage control (in under 2 minutes) whether the injury was thoracic or abdominal with improved hemodynamics, preserved visceral flow, reduced spinal cord ischemia, negligible histologic organ injury and survival to end of study in all abdominal injured animals (n = 6) and four of six thoracic injured animals, with two deaths related to arrhythmia. CONCLUSION: Compared with aortic balloon occlusion, a Rescue stent offers superior hemorrhage control and survival by virtue of reduced ischemic injury and direct control of the hemorrhagic injury. The Rescue stent may become a useful tool for damage control, especially on the battlefield where definitive repair presents logistical challenges.

Comprehensive assessment of mechanical behavior of an extremely long stent graft to control hemorrhage in torso.

Traumatic vascular injuries, resulting from either civilian accidents or wounded soldiers, require new endovascular devices (i.e., stent graft) to rapidly control the excessive internal hemorrhage in torso region. Current stent designs are limited by their permanent nature, which is note well suited for emergent placement. A retrievable stent graft could regulate the internal bleeding temporarily, as fast as possible with the most feasible performance, until the patients arrive the hospital to receive the proper treatment. The novel endovascular device of this study is designed according to the anatomy of a porcine model with plans to transition to a human model in the future. The stent graft is manufactured using a substantially long nitinol backbone and covered selectively based on anatomic measurements, with highly stretchable expanded-polytetrafluoroethylene (ePTFE). In this study, our group comprehensively explored designing and manufacturing methods, and their impact on the stent graft performance. Geometric parameters and heat treatment conditions were investigated to show their effect on the radial force of the metallic backbone. As a retrievable device, the resistance force for retrieval as well as deployment were measured, and analyzed to be manipulated through ePTFE covering configurations. In vitro measurements for bleeding were measured using swine aorta to show the functionality of the stent graft under the simulated pulsatile flow circulation. Finally, the stent graft showed substantial effectiveness for hemorrhage control in vivo, using swine model. The new design and fabrication methods enable rapid hemorrhage control that can be removed at the time of a dedicated surgical repair.

In vitro and in vivo experiments of a novel intra-arterial neurovascular decompressor for treating neurovascular compression syndromes: a brief report.

Objectives: Neurovascular compression syndromes (NVCS) could be cured with an intravascular device that releases compression of the root entry zone of cranial nerves by changing the course of offending vessels. The purpose of this study was to report our results of in vitro and in vivo experiments with a novel intra-arterial neurovascular decompressor (IA-NVD) for NVCS. Methods: A nitinol-based IA-NVD was developed to release pressure applied to the root entry zone of cranial nerves by changing the course or angle of an offending vessel, which can possibly cure NVCS. We performed in vitro tests for safety and feasibility and preliminary in vivo tests up to 4 weeks for safety. Results: The bending stiffness of the device was similar to but slightly stronger than that of current, closed-cell intracranial stents. Hemocompatibility tests showed no significant thrombogenesis in whole blood. After the 4-week follow-up, all animals (20-month-old female Gottingen mini-pigs weighing 15-18 kg, n = 4) had a normal upright position and gait. Scanning electron microscopy images and H&E staining of arteries containing the devices showed good neointima formation on the devices. Intima hyperplasia occurred over wires and connecting tubes, but it did not interrupt the patency of the arterial lumen. Discussion: An IA-NVD was created and tested to demonstrate its functionality and biocompatibility in the present experiments. The device may be safely applied to intracranial arteries, providing us a chance to test the efficacy of an upgrade version of the device on changing the course of an artery that compresses a cranial nerve. Abbreviations: CN = cranial nerve; EVT = endovascular treatment; H&E = hematoxylin and eosin; HFS = hemifacial spasm; IA-NVD = intra-arterial neurovascular decompressor; MVD = microvascular decompression; NVCS = neurovascular compression syndrome; REZ = root entry zone; SEM = scanning electron microscopy; TN = trigeminal neuralgia.

Use of Superelastic Nitinol and Highly-Stretchable Latex to Develop a Tongue Prosthetic Assist Device and Facilitate Swallowing for Dysphagia Patients.

We introduce a new tongue prosthetic assist device (TPAD), which shows the first prosthetic application for potential treatment of swallowing difficulty in dysphagia patients. The native tongue has a number of complex movements that are not feasible to mimic using a single mechanical prosthetic device. In order to overcome this challenge, our device has three key features, including (1) a superelastic nitinol structure that transfers the force produced by the jaws during chewing towards the palate, (2) angled composite tubes for guiding the nitinol strips smoothly during the motion, and (3) highly stretchable thin polymeric membrane as a covering sheet in order to secure the food and fluids on top of the TPAD for easy swallowing. A set of mechanical experiments has optimized the size and angle of the guiding tubes for the TPAD. The low-profile TPAD was successfully placed in a cadaver model and its mobility effectively provided a simplistic mimic of the native tongue elevation function by applying vertical chewing motions. This is the first demonstration of a new oral device powered by the jaw motions in order to create a bulge in the middle of the mouth mimicking native tongue behavior.