CHAPTER 5 AT A GLANCE:
SURGICAL ROBOTICS

Overview

Advanced robotic devices and systems which provide more accurate and minimally invasive surgeries continue to develop. A range of robots are available today for tasks such as hip replacement in orthopedics, camera positioning for laproscopic surgery, minimally invasive cardiac surgery, and needle placement for image-guided interventions. To take full advantage of robots, we must employ them to do things that humans cannot do, such as motion scaling and tremor reduction. Experts should also
establish safety protocols for the use of surgical robotics.

Clinical Needs

The main clinical benefit of robotic systems is to improve on the capabilities of surgeons by avoiding problems such as fatigue and error. Robots have been developed for many clinical procedures but the use of robots is still in its infancy. Task-specific micro-robotic applications such as transnasal and transcellular robotic surgeries are among the possible new procedures that might be established.

Technical Requirements

Surgical robotics must build on their unique capabilities including precision, accuracy, strength, and dexterity especially in very small spaces inside of the human body. Technical advancements in robotic surgery must focus on both improved imaging control and process planning to make a better fit of robots in the OR. In addition, improving safety in the OR is one ultimate goal for advanced robotic systems.

Research Priorities

Means for mining the routinely large and complicated streams of surgical data that are generated during each procedure should be investigated by surgical robot system developers. These data can be used to better understand surgical work routines and to create robotic systems that can safely perform tasks that complement and exceed the capabilities of today’s surgeons.

The full report of this Working Group appears below.

CHAPTER 5:
SURGICAL ROBOTICS

…THE REPORT OF WORKING GROUP 4

PARTICIPANTS Phil Corcoran, MD, Walter Reed Army Medical Center (Clinical Leader) Russell Taylor, PhD, Johns Hopkins University (Technical Leader) James Burgess, MD, Inova Fairfax Hospital Craig Carignan, PhD, Georgetown University William DeVries, MD, Walter Reed Army Medical Center John Donlon, Image Guide, Inc. Harvey Eisenberg, MD, Healthview Hiroshi Iseki, MD, PhD, Tokyo Women’s Medical University Amin Kassam, MD, University of Pittsburgh Alois Knoll, PhD, Technical University, Munich, Germany Ron Marchessault, MBA, TATRC Michael Marohn, MD, Johns Hopkins Medical Institutions Mihai Mocanu, PhD, University of Craiova Ryoichi Nakamura, PhD, Toyko Women’s Medical University Michael Saracen, MS, Accuray, Inc. Jonathan Tang, BS, Georgetown University Monty Taylor, Image Guide, Inc. Joerg Traub, Technical University of Munich Vance Watson, MD, Georgetown University Medical Center Robert Webster, MS, Johns Hopkins University

5.1 OVERVIEW: ROBOTS AND THEIR NEEDED SURGICAL ROLES IN TODAY’S OPERATING ROOM

Advanced robotic devices and systems which provide more accurate and less risky surgeries continue to develop. Accepted benefits and advantages of robotic technology include: enhanced manual dexterity; computer scaling to “miniaturize” surgical movements; filtration of ultra-high and high-frequency signaling to reduce or eliminate surgical tremor; and binocular stereoscopic 3D visualization for more accurate surgical field visualization and overall processing of imaging data. Future capabilities which need to be exploited and developed include: integration and automation of all processes in the operating room (OR) environment, from patient flow considerations to workload projections; and incorporation of radiofrequency identification device (RFID) technology to stock and replenish logistical supplies and to track personnel movement in the operating room of the future (ORF). Potential uses of surgical robotics might be limited to performing surgical tasks or be extended to automating all aspects of the ORF.

Current Uses and Capabilities of Surgical Robots

A variety of surgical robotic devices is available today and has a range of functions in the OR environment. Some robots function as surgical assisters in orthopedics, and others can be used as a surgeon’s “third hand” for moving the camera during minimally invasive procedures. Others exist to perform or facilitate telesurgery, telemonitoring, tele-mentoring, or true telepresence instruction. Still other robotic devices perform or assist with image-guided interventions.

Transforming existing robotic devices into all-purpose devices or systems was a concept that emerged from discussions of this Working Group. This change would be facilitated by integrating both the image and information processing capabilities, and the visualization and task performance systems onto a multi-purpose workbench-like platform. Robotic devices would be designed with automated tool changers, thereby enabling robotic devices to change tools rapidly and precisely in order to perform a multitude of tasks in the OR environment. This capability could easily alter a robotic device’s function and make it a more universal or multi-purpose device. As a result, robots could be made more useful in the neurosurgical, orthopedic, cardio-thoracic, and urological suites.

In addition, the use of these robots need not be limited to surgical task performance. The OR environment is an exceedingly complex environment and requires robots to function with far more capabilities than merely operating as tools to perform simple tasks. Robotics could and should be used to facilitate the overall performance of complex surgical interventions in the technologically advanced environment of the ORF. These capabilities will involve information management, data processing, image processing, image-guided intervention, complex and minimally invasive task performance, and control of the OR assets, supplies, and personnel as well as management of the flow of patients within the process of surgical intervention.

Improving the capabilities of robotic systems must differentiate the machines’ abilities to perform procedures which humans can do from those which humans cannot do. Robots and computer systems can process data and acquire data and images in manners far superior to humans. A challenge is to take the human ability to interact with the surgical environment and make decisions, then to translate these abilities into task performance needs for a surgical robotic system.

5.2 CLINICAL NEEDS: DESIGN ISSUES FOR TARGETING BEST USES FOR SURGICAL ROBOTS

This Working Group generated lists of the potential benefits and advantages as well as drawbacks of robotic systems. These lists facilitated discussion of design issues for targeting the best uses for surgical robot systems in the ORF. Among the positive features are the abilities of robots to:

However, there are drawbacks to the use of robots as they can be:

Needed Improvements

1) Non-specialized robots. Robotic systems must address the varied clinical needs of surgeons and surgical sub-specialists. For instance, ENT surgeons need a specialized set of surgical instruments to accomplish a radical neck dissection as compared to neuro-surgeons, who need a completely different set of instruments to accomplish brain or nerve resections. ENTs or general surgeons need to do conventional cut-and-sew types of procedures while neurosurgeons need to use energy sources to perform ablative procedures. However, because today’s robotic systems are procedure specific rather than being specialty or discipline specific, none of these clinical needs are being met.

Current systems are in fact severely limited in the flexibility or applicability to a broad range of specialties or surgical procedures. To address this problem, this Working Group suggested that if robotic systems were not as specialized, they would be employed by a broader range of operators.

2) Micro-robotic applications. Improvement in robotic systems in the areas of micro-robotics applications would extend the range of surgical possibilities. For instance, micro-robotic applications would enable transnasal, transclival, or transcellar approaches. Using robotic technology under an operating microscope would enable intracranial or base of skull surgeries, which are completely limited by the absence of microscopic instruments. Other applications of robotic microsurgery which should be developed are hemorrhage control and tumor resection.

3) Integrated imaging. Image overlay and imaging with interactive robots are potential areas of improvement in robotic system technology. As a result of using advanced imaging technology, the performance of certain operative interventions may well be conducted in different manners. For example, increased imaging may enable a neurosurgeon to expose an aneurysm at the base of the skull differently. The ability to visualize the brain in different presentations would dramatically alter the approaches to the brain tumor or targets of surgical intervention. Similarly, if a surgeon could visualize a tumor in the lung in 3D and reconstruct the holographic imagery in any way desirable, the tumor could be approached from any number of different angles and possibly increase safety.

4) Increased mobility. Robotic systems must have a higher degree of mobility or transportability than today’s commercially available systems allow. Current systems are not particularly mobile within the human body and are not transportable between OR environments. Without increased mobility, surgeons are constrained by using only port access approaches and a single pivot point from which all manipulations must occur. However, with increased mobility, a heart surgeon could, for example, maneuver through a blood vessel such as a vein, rather than have to operate through a conventional incision in the right atrium of the heart to fix a hole in the heart. Thus, increased mobility would provide better and more minimally invasive access to the human.

5) Creative design for practice use. Today’s robotic system technology is limited by its being viewed simply as surgical task performance devices. Robots are understood as being tools that are attached to effector arms in a manner exactly analogous to a human being with arms attached to the body and run by direct neural attachments. However, broader and more creative concepts need to be explored. Among these is the concept of remote control of devices which could swim through the vascular tree or crawl through the gastrointestinal tract and accomplish diagnostic or therapeutic tasks. New systems might automate certain robotic tasks, and include a drivable visualization system to move the optics to another anatomical location.

Design and Planning Efforts

An optimal or “dream system” for surgical robotics in the future would have many applications in the ORF. This Working Group discussed design and planning efforts in terms of needed uses and tasks of robots, as well as educational needs.

1) Uses and tasks of robots in the ORF. Design of robotic systems for the ORF needs to focus on whether robots will be used in only some or all of the surgical process. Decisions have to be made about possibly limiting the uses of robots to the pre-operative planning stage or the post-operative assessment. The group suggested using surgical robotics as assistants that perform time consuming tasks. For example, a robotic system could prepare the hundreds of sutures needed during a protracted open heart surgical procedure. A more ambitious goal for surgical robotics would be to make the entire OR intervention completely robotic and automated in nature. As such, procedures in the ORF would be analogous to work on an assembly line in the automobile manufacturing industry. These systems would extend the use of surgical robotics from simple task achievement or task performance to a highly automated process for handling patients, utilizing OR personnel, accounting for and reducing error in OR supplies, and streamlining and improving overall OR efficiency and utilization.

2) The role of robots in simulation and education. Although not a primary focus of this working group, surgical simulation and surgical planning were discussed. While most of this Working Group’s members felt that surgeons had neither time for nor interest in pre-surgical simulation exercises, planning for more effective use of surgical simulation as a mode of training, teaching, or readiness is needed. Suggestions for providing training were as follows.

Figure 5: CyberKnife® stereotactic radiosurgery system.
The system consists of a linear accelerator mounted on a six degree of freedom robot arm, along with two flat panel detectors and corresponding x-ray cameras. (courtesy of Accuray, Inc.)

Surgical simulation incorporating robotic systems as learning or training devices could borrow concepts and technology from the airline industry. The use of airplane simulation training is highly advanced and is absolutely an industry standard. Imaging technology would need to be combined with surgical simulation software so that images such as catherization data, x-ray, CT, PET, MRI scans, and sonography data could be loaded into the robotic visualization system preoperatively, and the operative team could practice tumor removal or reconstruction techniques prior to performing the procedure. “No fly zones” for the instrumentation could be defined to limit any collateral damage. The procedure could even be recorded for playback on the actual patient. The surgical operator could be present, but the robotic system would perform the “learned” task of surgical extirpation of the tumor. The operator would simply have the ability to abort the procedure with a “stop” button during periods of hazard.

Similarly, simulation could provide remote learning exercises. By electronically linking two surgical robots, a surgical trainee could experience the movements of an experienced surgeon at a different site, seeing what the experienced surgeon is visualizing and feeling the hand movements of the experienced surgeon in a remote telementoring or teleprompting scenario. The use of surgical “tele-illustration” may also be a potentially valuable tool for training and improving surgical skills without having to practice on human beings. An entire library of “virtual simulation” cases could be developed and archived to comprise the learning materials that are needed for an entire virtual surgical training experience and perhaps even for an entire surgical residency training period.

In addition, the concept of a completely virtual hospital environment was discussed as a means for simulating all manner of surgical interactions with patients. Virtual anatomical surgical atlases and training tools for surgical instruction must be developed to initiate this effort. Subsequently, the integration of virtual surgical texts into the surgical decision making process might facilitate decision making. For example, with a host of anatomical and surgical information available, surgical operators could more easily make decisions about the modification of their own surgical techniques. This new means for practice and decision making will likely reduce operative time, increase operative efficiency and reduce costs of surgical intervention. Use of this technology would, however, require adopting principles of economy of scale as well as process improvement from industry and to treat surgical robotics more like industrial robotics.

5.3 TECHNICAL REQUIREMENTS: NEEDED IMPROVEMENTS AND SAFETY ISSUES

Definitions of the surgical robotic system and the robotics process (current or futuristic) are needed at the outset of discussion of technical needs for robots in the ORF. Unique capabilities of surgical robots today (compared to humans) were identified by this Working Group and include advanced

Whether or not the surgical robot or the robotics system is defined as a single tool for task completion or an entire process in the ORF, a central enabling concept has not been agreed upon as of yet. An example of a robotic surgical system actually “capturing the surgeon” and providing the central direction in the OR was discussed. However, while the robotic system can be a central enabling element in the surgical process, the human control interface is and must be the focus of the total surgical process.

What can surgical robots do? Envisioning improvements and advancements in surgical robots requires, first of all, building on their unique capabilities, as indicated in the bulleted list above. Design should not be bound by the current surgical paradigm (a surgical operator with two arms and two eyes). This is a highly limiting proposition. One participant, a surgeon, stated, “You do not need just two arms…You may need ten arms to complete a task.” Designing the robotic systems around the surgical functions required is a vital and pressing research need, this Working Group concluded.

Technical research needs for improving robotic surgery were identified as follows. Research must focus on: (1) Improved image control coupled with the surgical capabilities of robotics; and (2) Means for improving process planning to make a better “fit” of robots in the OR. Improved process planning requires that robots be programmed with uniform validation tools (e.g., standard benchmark tests, safety guidelines, and efficacy tests, which will vary with each surgical specialty). Development of an architecture of standard interfaces for robots is key, once the role(s) that robots or surgical robotic systems can play in the overall architecture of the ORF are defined.

Incorporating surgical robotics with surgical ontology is an important goal, both for defining the role of robots in the ORF and for achieving needed standardization of tools and processes. This development would involve using similar or comparable terms and definitions for robotics as are used for conventional surgery. In addition, definitions and standards for accuracy and precision as they relate to clinical tasks must be developed and standardized. Designing robotic procedures such as characteristic motions and task segmentation, and establishing a relationship of the robotic systems to anatomical models in the context of surgical processes and needs also must be undertaken. The end result, it is hoped, will be the development of robots not in the vacuum of what they can do, but in terms of what is needed in surgical procedures. The robotic systems could then be used in a more efficient and effective manner and have a better “fit” in the ORF environment.

Safety Issues

All of the technical needs that were identified by this Working Group could be focused towards an overarching goal: to improve the safety of surgeries and to reduce complications. Safety issues direct much of robotic systems’ development today. On the one hand, safety issues place constraints on the design of these systems as they are required to conform to certain safety standards, which can limit new designs. FDA approval of any robotic system is a limiting factor because it is a driving force in bringing any new technology to market. New technology with new surgical capabilities could possibly introduce completely new risks or hazards from a safety standpoint.

On the other hand, the routine use of surgical robotics may well reduce risk and hazard, while increasing or at least enhancing patient safety in the ORF. In particular, surgical robotic systems may reduce individual variance and operator error. For some in the Working Group, achieving a degree of safety in the OR environment is a matter of understanding the risk/benefit ratios and tradeoffs of using new technologies. Such concerns lead into the area of risk assumption and product liability with regard to class action lawsuits or corporate governance issues. There is, therefore, a pressing need for engineers, technicians, and designers to work closely with surgeons to identify the potential risk and benefit ratios in using these systems.

Addressing risk and safety issues related to surgical robotic systems requires that surgeons and other OR personnel be educated about the needs for:

Recording these surgical procedures (as is done with airline flight data recorders) may be one way to improve safety and promote safe surgical practices when robotic systems are employed in the ORF. Such records of surgical data and operative interventions could be mined expressly for uncovering detail concerning practice processes and safe procedures. The issues of process improvement, total quality management, and performance improvement and modification when surgical robotics systems are employed are significant. In fact, the need for such mechanisms to be in place is absolutely vital to insuring patient safety at institutions where surgical robotics systems are routinely employed in the future.

5.4 RESEARCH PRIORITIES

There are many potential areas of research in the surgical robotics arena as the field is still developing. It was suggested that achieving error-free surgical intervention could be a “grand challenge for the field”. Research areas suggested by this Working Group also included: