1,2Yoshihiro Muragaki, 1Jun Okamoto, 2Taiichi Saito, 1Ken Masamune, 1Hiroshi Iseki, 3Kaoru Kurisu, 4Tetsuya Goto, 4Kazuhiro Hongo
1Institute of Advanced Biomedical Engineering & Science, Tokyo Women's Medical University
2Department of Neurosurgery, Tokyo Women's Medical University
3Department of Neurosurgery, Graduate School of Biomedical and Health Sciences, Hiroshima University
4Department of Neurosurgery, Shinshu University School of Medicine
Surgical navigation devices are no longer a rarity and are now routinely used in the fields of neurosurgery, otolaryngology and orthopedics. Furthermore, with the appearance of intraoperative MRI operating rooms and hybrid operating rooms, development of new treatment methods utilizing intraoperative diagnostic imaging is now underway. Similarly, the equipment used during surgery has also shown remarkable development. However, the same cannot be said for the role of the treatment room itself; remaining solely a space for equipment to be used and surgery or treatment to be carried out. With the exception of the automatic anesthesia recording system, no data coordination or system coordination yet exists among the various pieces of equipment used within the treatment room.
At present both the medical actions of physicians and nurses during treatment, along with the resulting patient monitoring data, are all stored in specific formats determined by the manufacturer of that particular device. Currently this information, in addition to any imaging data, video data, handwritten notes, etc, is collected and recorded in a variety of differing formats. However, due to small discrepancies between the system clocks of each device, for continuous data each sampling cycle also differs, thus making comparison of multiple pieces of data extremely difficult. This in turn makes these forms of intraoperative data poor in terms of their reliability, usefulness and objectivity as actual medical information. This means that during times of medical error occurrence due to systematic defect (personnel, organization, equipment, etc.), utilization of such data for causal investigation, finding the source of and solutions to complications arising from surgery, or extraction of potential solutions is particularly difficult. The same is also true for usage of such data in the creation of a composite information-based decision support system.
Since 2014 we have been developing the Smart Cyber Operating Theater (SCOT), the next generation treatment room. This has been done through the AMED1) (Japan Agency for Medical Research and Development) project; “Research and development of advanced medical devices and systems to achieve the future of medicine / Development of a smart treatment chamber for the improvement of both medical safety and efficiency”. AMED is a new funding organization established by the Japanese government in 2015. It engages in research and development in the field of medicine, establishing and maintaining an environment for this R&D, and providing funding, in order to promote integrated medical R&D from basic research to practical applications, to smoothly achieve application of outcomes, and to achieve comprehensive and effective establishment / maintenance of an environment for medical R&D.
Fig. 1 The Hyper SCOT prototype introduced at Tokyo Women's Medical University.
Within the SCOT project we developed a treatment room communication interface, “OPeLiNK”, allowing online uniform management of devices within the treatment room and enabling time synchronization and relocation of their data. Using OPeLiNK we are able to collect various data, such as images obtained from intraoperative modalities and surgical instrument position from surgical navigation systems, as well as surgical field images and biometric patient data. Surgically relevant information from these sources can then be sent through an application and displayed to the surgeon and surgical staff.
The new “SCOT” has been brought about by combining the existing intelligent operating rooms which conduct information guided surgery2-4), adding intraoperative imaging diagnostic devices and each of the modules, and then enabling online connection of the equipment necessary for synchronization of the combined data. As the treatment room is not simply a room but is an integrated system with clear functions, it enables precision medical treatment with low risk and high therapeutic effect.
In order to network these previously unconnected devices, the SCOT project uses the middleware ORiN (Open Resource Interface for the Network) 5-6) as the core technology of OPeLiNK. ORiN is a promising interface for realizing the Japanese version Industry 4.0 and is in wide commercial usage domestically. We believe that ORiN has a number of benefits which make it advantageous for usage within the treatment room: it can deal flexibly with various communication standards; it has high reliability shown by its active usage within industry; various general equipment providers for connecting with ORiN have already been developed (device drivers are referred to as providers in ORiN); and ORiN has already been adopted by the international standard for industrial networks (ISO 20242-4). ORiN supports various protocols and does not regulate LAN or serial communication, etc, as a communication method. However as it is impossible to connect medical equipment which does not provide data output in the first place; in such cases addition of a data output function is to be conducted in parallel with provider development. The current project uses a network connection through ORiN to connect to the equipment shown in the "Physical Space" portion of Fig. 2 below.
Fig. 2 Coordination between the Physical space (treatment room) and Cyber space aimed for in the SCOT project.
The surgical strategy application “OPeLiNK Eye” has been developed for the current project - intended to enable the sharing of information between surgeons, assistants, nurses, anesthesiologists, and technicians and thereby achieving risk reduction (Fig. 3). This is done through consolidation of surgical field images, the patient’s biological information and treatment device data gathered through OPeLiNK - and enables clear visualization of treatment progression. By collecting together and displaying information from the surgical navigation system, intraoperative flow cytometer7), brain function monitoring / mapping etc. (morphological information, organizational information, and functional information) through this application, functional information on each part of an organ or malignancy of a tumor can be taken in at a glance by surgical personnel. The aim of this function is to aid in determining the appropriate range of resection for malignant brain tumor removal. In addition to this, displaying the information in this way makes it possible for another experienced doctor, aware of the entire range of information displayed, to provide direct advice to the surgeon. This application is intended to enable provision of "uniformly high standards of treatment" not dependent solely on the skill and experience of the doctors. Furthermore, we are also developing a “Device operation monitoring system” that can collectively check the setting values and any error information from each device as well as a “Precision guided treatment system” which integrates surgical navigation and surgical support robot system (See the upper part of Fig. 2). All the data groups collected through OPeLiNK are time synchronized, stored, and used for causal relation analysis of treatment contents and results.
Fig. 3 The surgical strategy desk OPeLiNK Eye displayed on a 4K · 70 inch display developed with the Denso Corporation. The desk includes the functionality of “displaying integrated intraoperative information”, “heterogeneous information integrated navigation” and “remote supervisor monitoring”. At the present stage approximately 20 types of equipment are currently connected to the system.
In this project, we developed two types of SCOT treatment room. The Hyper SCOT prototype (Fig. 1) was introduced at the Institute of Advanced Biomedical Engineering & Science, Tokyo Women's Medical University8) at the same time as the Basic SCOT was introduced at Hiroshima University Hospital in March 2016. The Basic SCOT is an actual operating room which packages together basic equipment and has intraoperative MRI at its core. Although the networking has not yet been completed, the room is intended as a field for testing new functions developed within the project. In the future, we plan to conduct testing of the surgical strategy desk in the operating room. In addition to this the Hyper SCOT is a “near future” operating room and includes new experimental equipment (e.g. a surgical cockpit currently under development and a robotic bed), and also new technologies (e.g. organic EL lighting). The Hyper SCOT is to be introduced in Tokyo Women's Medical University Hospital in 2018. Moreover, the "Standard SCOT", which is the completed networked version of the Basic SCOT, is currently being introduced to Shinshu University Hospital, and clinical use should start in 2018.
In the future the variety of connected equipment in the operating theater will be increasingly complex. Currently it is possible to connect about 35 types of equipment used in treatment rooms domestically and internationally; however, this number will increase rapidly. In the future we plan to establish a method for stability and risk assessments as part of the integrated system, aimed at creating an environment where “vendor-free” system integration is possible.