Robot Autonomy for Surgery

Autonomous surgery involves having surgical tasks performed by a robot operating under its own will, with partial or no human involvement. There are several important advantages of automation in surgery, which include increasing precision of care due to sub-millimeter robot control, real-time utilization of biosignals for interventional care, improvements to surgical efficiency and execution, and computer-aided guidance under various medical imaging and sensing modalities. While these methods may displace some tasks of surgical teams and individual surgeons, they also present new capabilities in interventions that are too difficult or go beyond the skills of a human. In this chapter, we provide an overview of robot autonomy in commercial use and in research, and present some of the challenges faced in developing autonomous surgical robots

Robustness Evaluation of Computer-aided Clinical Trials for Medical Devices

Medical cyber-physical systems, such as the implantable cardioverter defibrillator (ICD), require evaluation of safety and efficacy in the context of a patient population in a clinical trial. Advances in computer modeling and simulation allow for generation of a simulated cohort or virtual cohort which mimics a patient population and can be used as a source of prior information. A major obstacle to acceptance of simulation results as a source of prior information is the lack of a framework for explicitly modeling sources of uncertainty in simulation results and quantifying the effect on trial outcomes. In this work, we formulate the Computer-Aided Clinical Trial (CACT) within a Bayesian statistical framework allowing explicit modeling of assumptions and utilization of simulation results at all stages of a clinical trial. To quantify the robustness of the CACT outcome with respect to a simulation assumption, we define δ-robustness as the minimum perturbation of the base prior distribution resulting in a change of the CACT outcome and provide a method to estimate the δ-robustness. We demonstrate the utility of the framework and how the results of δ-robustness evaluation can be utilized at various stages of a clinical trial through an application to the Rhythm ID Goes Head-to-head Trial (RIGHT), which was a comparative evaluation of the safety and efficacy of specific software algorithms across different implantable cardiac devices. Finally, we introduce a hardware interface that allows for direct interaction with the physical device in order to validate and confirm the results of a CACT for implantable cardiac devices

Computer- and robot-assisted Medical Intervention

Medical robotics includes assistive devices used by the physician in order to make his/her diagnostic or therapeutic practices easier and more efficient. This chapter focuses on such systems. It introduces the general field of Computer-Assisted Medical Interventions, its aims, its different components and describes the place of robots in that context. The evolutions in terms of general design and control paradigms in the development of medical robots are presented and issues specific to that application domain are discussed. A view of existing systems, on-going developments and future trends is given. A case-study is detailed. Other types of robotic help in the medical environment (such as for assisting a handicapped person, for rehabilitation of a patient or for replacement of some damaged/suppressed limbs or organs) are out of the scope of this chapter.Comment: Handbook of Automation, Shimon Nof (Ed.) (2009) 000-00

3D-printing techniques in a medical setting : a systematic literature review

Background: Three-dimensional (3D) printing has numerous applications and has gained much interest in the medical world. The constantly improving quality of 3D-printing applications has contributed to their increased use on patients. This paper summarizes the literature on surgical 3D-printing applications used on patients, with a focus on reported clinical and economic outcomes. Methods: Three major literature databases were screened for case series (more than three cases described in the same study) and trials of surgical applications of 3D printing in humans. Results: 227 surgical papers were analyzed and summarized using an evidence table. The papers described the use of 3D printing for surgical guides, anatomical models, and custom implants. 3D printing is used in multiple surgical domains, such as orthopedics, maxillofacial surgery, cranial surgery, and spinal surgery. In general, the advantages of 3D-printed parts are said to include reduced surgical time, improved medical outcome, and decreased radiation exposure. The costs of printing and additional scans generally increase the overall cost of the procedure. Conclusion: 3D printing is well integrated in surgical practice and research. Applications vary from anatomical models mainly intended for surgical planning to surgical guides and implants. Our research suggests that there are several advantages to 3D- printed applications, but that further research is needed to determine whether the increased intervention costs can be balanced with the observable advantages of this new technology. There is a need for a formal cost-effectiveness analysis

Computer Aided Clinical Trials for Implantable Cardiac Devices

In this paper we aim to answer the question, ``How can modeling and simulation of physiological systems be used to evaluate life-critical implantable medical devices?\u27\u27 Clinical trials for medical devices are becoming increasingly inefficient as they take several years to conduct, at very high cost and suffer from high rates of failure. For example, the Rhythm ID Goes Head-to-head Trial (RIGHT) sought to evaluate the performance of two arrhythmia discriminator algorithms for implantable cardioverter defibrillators, Vitality 2 vs. Medtronic, in terms of time-to-first inappropriate therapy, but concluded with results contrary to the initial hypothesis - after 5 years, 2,000+ patients and at considerable ethical and monetary cost. In this paper, we describe the design and performance of a computer-aided clinical trial (CACT) for Implantable Cardiac Devices where previous trial information, real patient data and closed-loop device models are effectively used to evaluate the trial with high confidence. We formulate the CACT in the context of RIGHT using a Bayesian statistical framework. We define a hierarchical model of the virtual cohort generated from a physiological model which captures the uncertainty in the parameters and allows for the systematic incorporation of information available at the design of the trial. With this formulation, the CACT estimates the inappropriate therapy rate of Vitality 2 compared to Medtronic as 33.22% vs 15.62% (