A transoral highly flexible robot: Novel technology and application.

OBJECTIVES/HYPOTHESIS: Organ preservation surgery is a major focus in head and neck oncology. Current approaches are aimed toward improving quality of life and decreasing treatment-related morbidity. Transoral robotic surgery was developed to overcome the limitations of traditional surgical approaches. The most widely used robotic system is the da Vinci Surgical System. Although the da Vinci offers clear surgical advantages over traditional approaches, its rigid operative arms prevent complex maneuverability in three-dimensional space. The ideal surgical robot would configure to the anatomy of the patient and maneuver in narrow spaces. We present the first cadaveric trials of the use of a highly flexible robot able to traverse the nonlinear upper aerodigestive tract and gain physical and visual access to important anatomical landmarks without laryngeal suspension. STUDY DESIGN: Feasibility. METHODS: Using human cadavers, we investigated the feasibility of visualizing the endolarynx transorally with a highly flexible robot without performing suspension of the larynx. Two fresh and four preserved human specimens were used. RESULTS: Unhampered visualization of the endolarynx was achieved in all specimens without performing laryngeal suspension. Standard mouth retractors facilitated the delivery of the robot into the endolarynx. CONCLUSIONS: The flexible robot technology mitigates laryngeal suspension and the limitations of current robotic surgery with rigid line-of-sight-directed instruments. Having demonstrated the feasibility of physical and visual access to the endolarynx, future work will study the feasibility of using the highly flexible robot in transoral robotic procedures with flexible instrumentation placed in the robot's available working ports.

Effects of cyclic flexural fatigue on porcine bioprosthetic heart valve heterograft biomaterials.

Although bioprosthetic heart valves (BHV) remain the primary treatment modality for adult heart valve replacement, continued problems with durability remain. Several studies have implicated flexure as a major damage mode in porcine-derived heterograft biomaterials used in BHV fabrication. Although conventional accelerated wear testing can provide valuable insights into BHV damage phenomena, the constituent tissues are subjected to complex, time-varying deformation modes (i.e., tension and flexure) that do not allow for the control of the amount, direction, and location of flexure. Thus, in this study, customized fatigue testing devices were developed to subject circumferentially oriented porcine BHV tissue strips to controlled cyclic flexural loading. By using this approach, we were able to study layer-specific structural damage induced by cyclic flexural tensile and compressive stresses alone. Cycle levels of 10 x 10(6), 25 x 10(6), and 50 x 10(6) were used, with resulting changes in flexural stiffness and collagen structure assessed. Results indicated that flexural rigidity was markedly reduced after only 10 x 10(6) cycles, and progressively decayed at a lower rate with cycle number thereafter. Moreover, the against-curvature fatigue direction induced the most damage, suggesting that the ventricularis and fibrosa layers have low resistance to cyclic flexural compressive and tensile loads, respectively. The histological analyses indicated progressive collagen fiber delamination as early as 10 x 10(6) cycles but otherwise no change in gross collagen orientation. Our results underscore that porcine-derived heterograft biomaterials are very sensitive to flexural fatigue, with delamination of the tissue layers the primary underlying mechanism. This appears to be in contrast to pericardial BHV, wherein high tensile stresses are considered to be the major cause of structural failure. These findings point toward the need for the development of chemical fixation technologies that minimize flexure-induced damage to extend porcine heterograft biomaterial durability. (c) 2010 Wiley Periodicals, Inc. J Biomed Mater Res, 2010.

In vivo dynamic deformation of the mitral valve annulus.

Though mitral valve (MV) repair surgical procedures have increased in the United States [Gammie, J. S., et al. Ann. Thorac. Surg. 87(5):1431-1437, 2009; Nowicki, E. R., et al. Am. Heart J. 145(6):1058-1062, 2003], studies suggest that altering MV stress states may have an effect on tissue homeostasis, which could impact the long-term outcome [Accola, K. D., et al. Ann. Thorac. Surg. 79(4):1276-1283, 2005; Fasol, R., et al. Ann. Thorac. Surg. 77(6):1985-1988, 2004; Flameng, W., P. Herijgers, and K. Bogaerts. Circulation 107(12):1609-1613, 2003; Gillinov, A. M., et al. Ann. Thorac. Surg. 69(3):717-721, 2000]. Improved computational modeling that incorporates structural and geometrical data as well as cellular components has the potential to predict such changes; however, the absence of important boundary condition information limits current efforts. In this study, novel high definition in vivo annular kinematic data collected from surgically implanted sonocrystals in sheep was fit to a contiguous 3D spline based on quintic-order hermite shape functions with C(2) continuity. From the interpolated displacements, the annular axial strain and strain rate, bending, and twist along the entire annulus were calculated over the cardiac cycle. Axial strain was shown to be regionally and temporally variant with minimum and maximum values of -10 and 4%, respectively, observed. Similarly, regionally and temporally variant strain rate values, up to 100%/s contraction and 120%/s elongation, were observed. Both annular bend and twist data showed little deviation from unity with limited regional variations, indicating that most of the energy for deformation was associated with annular axial strain. The regionally and temporally variant strain/strain rate behavior of the annulus are related to the varied fibrous-muscle structure and contractile behavior of the annulus and surrounding ventricular structures, although specific details are still unavailable. With the high resolution shape and displacement information described in this work, high fidelity boundary conditions can be prescribed in future MV finite element models, leading to new insights into MV function and strategies for repair.

A highly articulated robotic surgical system for minimally invasive surgery.

PURPOSE: We developed a novel, highly articulated robotic surgical system (CardioARM) to enable minimally invasive intrapericardial therapeutic delivery through a subxiphoid approach. We performed preliminary proof of concept studies in a porcine preparation by performing epicardial ablation. DESCRIPTION: CardioARM is a robotic surgical system having an articulated design to provide unlimited but controllable flexibility. The CardioARM consists of serially connected, rigid cyclindrical links housing flexible working ports through which catheter-based tools for therapy and imaging can be advanced. The CardioARM is controlled by a computer-driven, user interface, which is operated outside the operative field. EVALUATION: In six experimental subjects, the CardioARM was introduced percutaneously through a subxiphoid access. A commercial 5-French radiofrequency ablation catheter was introduced through the working port, which was then used to guide deployment. In all subjects, regional ("linear") left atrial ablation was successfully achieved without complications. CONCLUSIONS: Based on these preliminary studies, we believe that the CardioARM promises to enable deployment of a number of epicardium-based therapies. Improvements in imaging techniques will likely facilitate increasingly complex procedures.

A novel highly articulated robotic surgical system for epicardial ablation.

We have developed a novel, highly articulated robotic surgical system to enable minimally invasive intrapericardial interventions through a subxiphoid approach and have performed preliminary tests of epicardial left atrial ablation in porcine (N=3) and human cadaver (N=2) preparations. In this study, the novel highly articulated robotic surgical system successfully provided safe epicardial ablations to the left atrium in porcine beating heart models via a subxiphoid approach. We have also performed complex guidance of the robot and subsequent ablation in a cadaveric preparation for successful pulmonary vein isolation.

Highly articulated robotic probe for minimally invasive surgery.

We have developed a novel highly articulated robotic probe (HARP) that can thread through tightly packed volumes without disturbing the surrounding tissues and organs. We use cardiac surgery as the focal application of this work. As such, we have designed the HARP to enter the pericardial cavity through a subxiphoid port. The surgeon can effectively reach remote intrapericardial locations on the epicardium and deliver therapeutic interventions under direct control. Our device differs from others in that we use conventional actuation and still have great maneuverability. We have performed proof-of-concept clinical experiments to give us preliminary validation of the ideas presented here.

Prevention of oxidative degradation of polyurethane by covalent attachment of di-tert-butylphenol residues.

Polyurethane (PU) components of cardiovascular devices are subjected to oxidation-initiated surface degradation, which leads to cracking and ultimately device failure. In the present study, we investigated a novel bromoalkylation chemical strategy to covalently attach the antioxidant, di-tert-butylphenol (DBP), and/or cholesterol (Chol) to the PU urethane nitrogen groups to hypothetically prevent oxidative degradation. These experiments compared PU, PU-DBP, PU-Chol, and PU-Chol-DBP. A series of comparative oxidative degradation studies involved exposing PU samples (modified and unmodified) to H2O2-CoCl2 for 15 days at 37 degrees C, to cause accelerated oxidative degradation. The extent and effects of degradation were assessed by attenuated total reflectance Fourier transformation infrared spectroscopy (FTIR), scanning electron microscopy (SEM), surface contact angle measurements, and mechanical testing. Both the Chol and DBP modification conferred significant resistance to oxidation related changes compared to unmodified PU per FTIR and SEM results. SEM demonstrated cavitation only in unmodified PU. However, contact angle analysis showed significant oxidation-induced changes only in the Chol-modified PU formulations. Most importantly, uniaxial stress-strain testing revealed that only PU-DBP demonstrated bulk elastomeric properties that were minimally affected by oxidation; PU, PU-Chol, PU-Chol-DBP showed marked deterioration of their stress-strain properties following oxidation. In conclusion, these results demonstrate that derivatizing PU with DBP confers significant resistance to oxidative degradation compared with unmodified PU.

Epicardial Atrial Ablation Using a Novel Articulated Robotic Medical Probe Via a Percutaneous Subxiphoid Approach.

OBJECTIVE: Minimally invasive epicardial atrial ablation to cure atrial fibrillation through the use of a percutaneous subxiphoid approach currently has a lack of dedicated technology for intrapericardial navigation around the beating heart. We have developed a novel articulated robotic medical probe and performed preliminary experiments in a porcine preparation. METHODS: In five large, healthy pigs, the teleoperated robotic system was introduced inside the pericardial space through a percutaneous subxiphoid approach. Secondary visualization of the left atrium and left atrial appendage was achieved with the use of a 5-mm scope inserted through a left thoracic port. The operator actively controlled the path of the robot by using a master manipulator. The catheter, with an irrigated radiofrequency tip, was guided through the working port of the robot to achieve epicardial ablation of the left atrium. RESULTS: Access to the pericardial space and progression around the left atrium was successful in all cases, with no interference with the beating heart such as a fatal arrhythmia, unexpected bleeding, and hypotension. Epicardial ablation was successfully performed in all five cases. No adverse hemodynamic or electrophysiological events were noted during the trials. When the animals were killed, there was no visually detected injury on the surrounding mediastinal structures caused by ablation. Transmural ablation was confirmed by histopathology of the left atrium. CONCLUSIONS: We have developed a dedicated articulated robotic medical probe and successfully performed epicardial left atrial radiofrequency ablation. Based on the feedback from these preliminary experiments, the radius of curvature and proper visualization of the device are being improved in the next generation prototype.

Highly Articulated Robotic Probe for Minimally Invasive Surgery.

We have developed a novel highly articulated robotic probe (HARP) that can thread through tightly packed volumes without disturbing the surrounding tissues and organs. We use cardiac surgery as the focal application of this work. As such, we have designed the HARP to enter the pericardial cavity through a subxiphoid port. The surgeon can effectively reach remote intrapericardial locations on the epicardium and deliver therapeutic interventions under direct control. Our device differs from others in that we use conventional actuation and still have great maneuverability. We have performed proof-of-concept clinical experiments to give us preliminary validation of the ideas presented here.

Stability and function of glycosaminoglycans in porcine bioprosthetic heart valves.

Glycosaminoglycans (GAGs) are important structural and functional components in native aortic heart valves and in glutaraldehyde (Glut)-fixed bioprosthetic heart valves (BHVs). However, very little is known about the fate of GAGs within the extracellular matrix of BHVs and their contribution to BHV longevity. BHVs used in heart valve replacement surgery have limited durability due to mechanical failure and pathologic calcification. In the present study we bring evidence for the dramatic loss of GAGs from within the BHV cusp structure during storage in saline and both short- and long-term Glut fixation. In order to gain insight into role of GAGs, we compared properties of fresh and Glut-fixed porcine heart valve cusps before and after complete GAG removal. GAG removal resulted in significant morphological and functional tissue alterations, including decreases in cuspal thickness, reduction of water content and diminution of rehydration capacity. By virtue of this diminished hydration, loss of GAGs also greatly increased the "with-curvature" flexural rigidity of cuspal tissue. However, removal of GAGs did not alter calcification potential of BHV cups when implanted in the rat subdermal model. Controlling the extent of pre-implantation GAG degradation in BHVs and development of improved GAG crosslinking techniques are expected to improve the mechanical durability of future cardiovascular bioprostheses.