THE INTERNATIONAL JOURNAL OF MEDICAL ROBOTICS AND COMPUTER ASSISTED SURGERY ORIGINAL Int J Med Robotics Comput Assist Surg 2016; 12: 132–136. Published online 17 March 2015 in Wiley Online Library (wileyonlinelibrary.com) DOI: 10.1002/rcs.1650

ARTICLE

Clinical application of a vascular interventional robot in cerebral angiography

Wang-sheng Lu1 Wu-yi Xu1 Feng Pan2 Da Liu3 Zeng-min Tian1* Yanjun Zeng4* 1

Department of Neurosurgery, Navy General Hospital of PLA, 6 Fucheng, Road, Beijing 100048, China

Abstract Background Cardiovascular and cerebrovascular diseases have become the leading cause of death for people, and endovascular surgery has become the main therapeutic method. Robot technology would overcome some limitations of conventional surgery, and has good prospects. Methods A total of 15 patients received cerebral angiography assisted by a vascular interventional robot following preoperative examination, with approval from the hospital ethics committee and informed consent by the patients’ families.

2

Department of Neurosurgery, The First People’s Hospital of Tancheng, Shandong 276199, China

3

Robotics Institute, Beijing University of Aeronautics and Astronautics, Beijing 100022, China

4

Beijing University of Technology, 100 Pingleyuan, Chaoyang District, Beijing 100022, China *Correspondence to: Zeng-min Tian, Department of Neurosurgery, Navy General Hospital of People’s Liberation Army, Beijing 100048, China. Email: [email protected] *Yanjun Zeng, Beijing University of Technology, 100 Pingleyuan, Chaoyang District, Beijing 100022, China. Email: [email protected]

Accepted: 10 February 2015

Copyright © 2015 John Wiley & Sons, Ltd.

Results Robot-assisted angiography was performed quickly and smoothly without surgical complications. The remote positioning accuracy was 1.05 ± 0.28 mm. The time staff were exposed to the digital subtraction angiography (DSA) machine was 0 min. The entire experimental process was mechanized and automated. Conclusion This system achieved the preliminary purposes, including a reduction in radiation for the surgeons, facilitation of the application of interventional procedures, a decrease in operation time, and an improvement in operation quality. Copyright © 2015 John Wiley & Sons, Ltd. Keywords

radiology; intervention; minimally invasive; robot; clinical application

Introduction According to the World Health Organization, cardiovascular and cerebrovascular diseases have become the leading cause of death for people. In China, over 3 million people die from such diseases each year. To treat these diseases, endovascular surgery has become the main therapeutic method, while interventional medicine has become the third pillar of medicine as a branch of minimally invasive surgery. In recent years, the widespread development of robot technology, computer technology and telecommunication technology has greatly advanced robotic applications in medical surgery. Robot technology can overcome a poor working environment, achieves precise control, breaks the space limitations of conventional surgery, and widens the application scope of medical expert resources. As a promising technology, a prototype vascular interventional robot (VIR) has been produced and successfully applied in animal experiments (1,2). A remote manipulation of animal angiography was also

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Vascular interventional robot in cerebral angiography

conducted in cooperation with a Japanese research team (3). After receiving approval by the medical ethics committee, this robot was employed in preliminary clinical treatment. Subsequently, 15 cases of cerebral angiography were successfully accomplished, which provides a good foundation for wider clinical applications.

Materials and Methods General information From March 2013 to September 2013, a total of 15 cases received cerebral angiography with robot-assisted endovascular surgery, including nine males and six females, with an average age between 19 and 58. There were six cases of spontaneous cerebral hemorrhage, six cases of review after intracranial aneurysm surgery, and three cases of oculomotor paralysis, which might have an aneurysm. All of the cases were approved by the medical ethics committee and informed consent was provided by the patient’s family.

Treatment VIR-2 robot system The angiographic robot includes a mechanically propelled master–slave system and a three-dimensional image navigation system. The angiographic robot (see Figures 1 and 2) has a mechanically propelled master–slave system designed to assist in the rectilinear and pivoting motions of a catheter during surgery, based on the requirements of the angiographic procedure. The master component, which is located away from the radiation environment, is the remote end connected to the network and is controlled by the surgeon who guides the motions of the slave component. The slave component is the mechanically propelled

Figure 1. Main component of the propulsion system of the vascular interventional robot (top view) Copyright © 2015 John Wiley & Sons, Ltd.

Figure 2. The slave component of the propulsion system of the vascular interventional robot

system, which can directly propel the catheter during the interventional operation. The master and slave components can be connected via a wired or wireless network. The three-dimensional image navigation system, which includes visual positioning systems and fast reconstruction of the three-dimensional blood vessel image based on dual-angle digital subtraction angiography (DSA). The use of the visual positioning system to obtain positional parameters of the C-arm is a prerequisite for navigation. The three-dimensional images of blood vessels can be rapidly reconstructed with dual-angle DSA to obtain the position and navigation, which guides the interventional operation.

Surgical procedures The operation was performed by neurosurgeons of the Navy General Hospital, experts of Beihang University and the VIR-2 robot. The remote console was located in the control room outside the operating room, and the slave component was located near the operating table. The patient was in the supine position. After routine disinfection and successful local anesthesia at the right side of the groin, a 5F sheath was artificially inserted into the femoral artery using the Sedinger method, and the 5F single-curve catheter was subsequently fixed at the propulsion system of the robot’s slave end. The propulsion system was fixed by manipulators and adjusted to an appropriate position while a high-pressure syringe and saline drip systems were correctly connected to the catheter. The experts operated the master component of the VIR-2 robot outside the operating room. Under the guidance of the navigational image, the master component was controlled via LAN. Commands were transmitted over the network from the master component to the Int J Med Robotics Comput Assist Surg 2016; 12: 132–136. DOI: 10.1002/rcs

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slave component of the VIR-2 robot, which was placed in the operating room. The trajectory of catheter movement was transmitted directly through the network from the operating scene to the master component. Next, the surgeon performed the required surgical procedure according to the specific condition. If necessary, the route should be plotted or selective angiography should be performed. Three-dimensional imaging for the navigation system was performed to finalize the entire robot-assisted cerebral angiography (Figure 3). Each patient underwent selective angiography of the bilateral carotid artery and vertebral artery, and 3D angiography was performed for suspected aneurysm cases. The operation time of each case was recorded from placement of the femoral artery sheath to the completion of selective cerebral angiography. Simultaneously, the working time of the doctors under DSA, as well as the difference between the target position and actual position of the catheter were recorded (positioning accuracy).

Results Fifteen cases of robot-assisted cerebral angiography were smoothly performed within 25–41 min, with an average

time of 34.4 ± 5.13 min. The cerebral angiogram is shown in Figure 4. Catheter positioning was completed first, with a remote positioning accuracy of 1.05 ± 0.28 mm. The time that staff were exposed to the DSA machine was 0 min. The implanting operation of the femoral artery sheath required direct involvement of the surgeons. With this exception, other surgical procedures were accomplished by the controlled robot. The entire surgical process achieved mechanization and automation. No surgical complications occurred, such as cerebral infarction caused by infection, thrombocytopenia and aortic dissection (see Figure 4).

Discussion Development of robotics and a computer navigation system makes robotic surgery possible. The application of modern robotic surgical systems has rapidly advanced. Currently, medical robotic technology represented by the da Vinci surgical system has been applied in the field of heart surgery, abdominal surgery and urology (4). Vascular interventional medicine, as the third pillar of medicine, enables doctors to manipulate a catheter in human blood vessels under the guidance of digital

Figure 3. (a) 5F single-curve catheter fixed to the slave component of the robot; (b) interventional surgical operating scene; (c) control of the master component of the robot by an expert; (d) intravascular movement of the catheter displayed in the navigation system Copyright © 2015 John Wiley & Sons, Ltd.

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Figure 4. Cerebral angiography: (a) internal carotid artery in the right side; (b) internal carotid artery in the right side; (c) vertebral artery in the left side; top and bottom images show the anteroposterior phase and lateral phase).

subtraction angiography, to treat the embolization of vascular malformations, to dissolve blood clots or to expand narrow blood vessels. Compared with conventional surgery, the vascular interventional technique has several advantages, such as minimal invasion, a high level of safety and effectiveness, rapid recovery and fewer complications. However, there are obvious defects, such as exposure to radiation, instability caused by manual operation and surgeons’ fatigue. Thus, to overcome these limitations, robot technology has been introduced in the field of vascular interventional procedures. Wider clinical application will become possible with progress in medical robot technology. Currently, there are a few relevant studies abroad regarding vascular intervention robots, i.e. Japan, the United Kingdom and Israel, which perform preliminary research in this field (5–7), and the robot is gradually applied to clinical research. However, no domestic research has been conducted. On the basis of more than 1400 cases of successful tele-operations of robot-assisted stereotactic surgery (8,9), the design of the robot was generated by analyzing the basic steps of vascular interventional surgery and discussing the features and functions of the robot. Finally, an interventional robot prototype with independent intellectual property rights was developed. After successful animal experiments and the tele-operation of animal angiography collaboration with Japan, we began to focus on preliminary clinical application. We selected the main branches of the cerebral vessel (bilateral carotid and vertebral artery, with a diameter of 4–6 mm) as the target. All robot-assisted cerebral angiography Copyright © 2015 John Wiley & Sons, Ltd.

surgery was performed smoothly, without surgical complications, and the average time for cerebral angiography was 34.4±5.13 min. The exposure time of the staff under the DSA machine was 0 min. These results indicate that the robot system in vascular interventional surgery is safe and feasible. This system achieves remote operation of the catheter, avoids radiation damage to staff, and meets the requirements of cerebral angiography, as well as providing a solid foundation for further in-depth clinical applications. The vascular interventional robot system uses a new configuration of robot with included redundancy, and introduces a posture-adjustable robot that can be positioned over a large spatial range, which increase the rigidity and flexibility of the robot. The remote positioning accuracy of the catheter is 1.05 ± 0.28 mm, which meets the needs of vascular interventional surgery (10) and lays a good foundation for expanding the application.

Comprehensive analysis of the characteristics and advantages of VIR-2 systems Master-slave robot mechanism On the basis of the ergonomic principle, the master component of the robot conforms to the operating habits of the surgeons, and thus surgeons can easily manipulate the terminal. The movement of the slave component is more flexible (11), and better meets the needs of vascular interventional surgery. Under the guidance of threeInt J Med Robotics Comput Assist Surg 2016; 12: 132–136. DOI: 10.1002/rcs

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dimensional medical image navigation, the surgeon can quickly and precisely propel the catheter into the specified lesion location to successfully perform the operation. It is a rapid 3D-image reconstruction based on dual-angle DSA. By combining the technologies of integration and matching between virtual images and the actual image, the three-dimensional navigation goal based on twodimensional images is ultimately realized. Thus, the operation of the catheter in the target vessel is smoother and simpler. The high-sensitivity force sensor is installed in the tip of the catheter in animal experiments. Surgical information regarding collisions between the catheter and blood vessels can be fed back in real time to effectively reduce the risk during surgery. There will be an intervention and alarm when necessary (12). However, it was not used in this present work due to space limitations and security considerations. From a security perspective, the application of this technology is necessary, but further technological breakthroughs are required. Overall, the system has achieved the object of reducing exposure of the surgeons to radiation. In addition, by manipulating the slave component of the robot, surgeons can completely control catheter movement, thereby reducing the effect of surgeon hand tremor. Moreover, on the basis of strengthened image navigation, the intervention is more convenient, improving the surgical quality. However, the system still has some disadvantages, such as inconvenience in holding the catheter, and irrationality in the spatial arrangement of the robotic system and operating table. Thus, the vascular interventional robot system needs to be improved by further study.

Acknowledgements This work was supported by the National High Technology Project ‘Research on Vascular Interventional Robot’ (Grant No. 2009AA044002).

Conflict of Interest The authors have stated explicity that there are no conflicts of interest in connection with this article.

Copyright © 2015 John Wiley & Sons, Ltd.

Ethics committee Department of Neurosurgery, Navy General Hospital of People’s liberation Army.

Funding No specific funding.

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Int J Med Robotics Comput Assist Surg 2016; 12: 132–136. DOI: 10.1002/rcs

Clinical application of a vascular interventional robot in cerebral angiography.

Cardiovascular and cerebrovascular diseases have become the leading cause of death for people, and endovascular surgery has become the main therapeuti...
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