Technical Description
hinotori Surgical Robot System, the First Made-
in-Japan Robotic-Assisted Surgery System
In the medical field, where future development is
anticipated, medical robots have been increasingly
adopted in order to realize a safe and secure remotely-
connected society.
Medicaroid Corporation developed the hinotori
Surgical Robot System, based on the core concepts of
compactness, safety, and high maneuverability. This
system became the first robotic-assisted surgery
system created in Japan to achieve Japanese
regulatory approval in August 2020. The first human
surgery with the system was successfully conducted
in December 2020.
market-in approach. First, we asked domestic and
Introduction international surgeons renowned for robotic-assisted
In the medical field, which is expected to expand surgery about current issues, defined the solutions to
further in the future as society ages, medical robots have these issues to be needs, and created a prototype that
been increasingly adopted as part of efforts to establish a satisfied such needs. Next, we asked surgeons to evaluate
safe and secure remotely-connected society. the prototype, after which we further improved the
prototype by solving the new issues that were identified as
a result of the evaluation. In this project, we executed this
1 Background process annually for five years before completing the
In Japan, excess imports of medical devices totaled hinotori Surgical Robot System. The first prototype was
approximately 1.7 trillion yen in 2019. In particular, the da created in 2015. For the first three years, we executed this
Vinci surgical system from US Intuitive Surgical has process to solidify the concept; for the last two years, we
dominated the market for robotic-assisted surgery executed the process to refine the product.
systems, which are large-scale medical devices. On the
other hand, many Japanese companies develop,
manufacture, and sell world-leading industrial robots, and
3 Concept
these companies have been expected to create This product is a robot system to assist in laparoscopic
domestically-made robotic-assisted surgery systems by surgery. As Fig. 1 shows, surgical instruments (hereafter
leveraging their technological capabilities. referred to as the “instruments”) and endoscope attached
The medical robot market is expanding by the year. to the operation unit are inserted through multiple ports
Robotic-assisted surgery systems are likely to account for (diameter: several millimeters) on the patient’s abdominal
a large part of the global medical robot market, which is wall, and the operating surgeon sitting at the surgical
expected to exceed one trillion yen by 2025 1). In addition, cockpit operates the hand control while watching a 3D
as US-based Intuitive Surgical’s basic patents on its robotic- video feed. This system enables the operating surgeon to
assisted surgery system expire, domestic and international perform surgical operations as if moving his or her hands
companies have accelerated development to gain market within the body cavity and to perform minimally invasive
share. surgery, which minimizes the burden on the patient.
What is important for surgical operations within the
patient’s body cavity is to minimize interferences among
2 Development concept and history the operation arms while allowing the arms to move within
We at Medicaroid developed this system based on the the necessary range. In addition, in a small operating room,
9
Operation arm (arm)
Positioning camera
Arm controller
Arm base
3D viewer
Touch panel
Touch panel
Operation cart
Hand control
Instrument or Foot unit
endoscope
(a) Operation unit (b) Surgical cockpit
Fig. 1 System configuration
a small occupied volume is desirable to ensure handling Also, by maintaining the pivot position through
and workflow lines. It is also important to reduce software control to eliminate the mechanism for retaining a
interferences with the patient and assistants around the tubular device called a trocar sleeve placed on the patient’s
bed and to ensure an ample work area for assistants. abdominal wall, we secure a large workspace around
Because this product is directly linked to human life, assistant surgeon’s hands as shown in Fig. 2.
ensuring the robot is safe is vital. To this end, we decided ( ii ) Control to ensure a large working range while reducing
to proactively adopt the technologies we have arm interferences
accumulated from the development of industrial robots. Each operation arm is a redundant arm that has eight
In addition, because this system is a manipulated robot, joints including a linear axis as shown in Fig. 3 (a).
the operator must be able to operate it comfortably in Redundant control according to multiple constraints
order to complete surgery smoothly and reliably. We must determined based on singular points and required working
also consider usability by assistants and other staff range reduces interferences among arms while ensuring
members as well as the operating surgeon, who operates the working range. The amount of lateral movement of the
the system. arm elbow is also constrained as shown in Fig. 3 (b) to
As described above, we designed the product by restrain extension in the width direction in order to provide
fo c u s i n g o n ① c o m p a c t n e s s , ② s a fe t y , a n d a large space for the assistants and nurses around the bed.
③ maneuverability as important concepts during
development. Furthermore, we strove to apply new (2) Safety
technologies. ( i ) Mutual monitoring module to ensure safety
The technology of the functional safety operation
monitoring unit Cubic-S 2) that we have accumulated
4 Details of development through the development of industrial robots is used to
(1) Compactness control the actuator and input/output. Safety is enhanced
( i ) Compact arm structure that does not obstruct by a mutual monitoring module separate from the
For compactness, this product’s combination of a controller for motor control.
motor and deceleration mechanism is designed to be ① Functions involving robot operation are permitted
suitable for movement during surgery. The main body of only when an enable switch on each arm or at the
the robot to operate instruments has eight movable axes, operation section at the rear of the operation cart is
each of which requires a different speed and torque. We pressed, or when the operating surgeon looks into
identified the required speed and torque from simulated the 3D viewer and the Cubic-S redundantly confirms
surgical operations and determined a motor size and speed the sensor input. If movement of an arm that is not
reduction ratio that satisfied the conditions. being operated is detected, such movement is
Kawasaki Technical Review No.183 10
March 2022
Technical Description
Eliminated retention mechanism
Trocar sleeve
Patient’s abdominal wall Port
Fig. 2 Elimination of retention mechanism
J2
J1
J3
J7 J8a
J6
J4
J5 J8b
Elbow extension amount
(a) Placement of axes in the redundant arm (b) Restraint of elbow extension amount
Fig. 3 Arm structure
immediately judged to be an error organs. Therefore, the system generates operation
② As described above, maintaining the pivot position specification values that reduce vibration by applying a
through software control leads to ensuring a notch filter and various compensation to the operations
workspace for assistants. However, if the pivot inputted by the operating surgeon. In addition, because
position shifts, the patient’s abdominal wall may be interferences between arms may generate large vibration
damaged. As shown in Fig. 4, when generating the at instrument tips and damage tissue, operation is
position command, the primary controller confirms restricted so that instruments do not move in the collision
that the pivot position has not changed from the set direction.
value, and the Cubic-S also monitors and redundantly
confirms the pivot position to improve safety. (3) Maneuverability
( ii ) Actuator control to reduce the risk of tissue damage ( i ) Structure and compensated control for comfortable
Endoscope vibration causes shaky video and hampers operability
surgery. Instrument vibration may damage delicate body What is important for smooth operations is not to
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Instrument
Primary controller Robot controller (each arm)
Trocar sleeve
Overall control Motor control
software software
Pivot position
Cubic-S
Double check of pivot position.
Fig. 4 Pivot position monitoring by Cubic-S
hamper the intended operations inputted. We developed a field during laparotomy, or a posture in which the upper
drive train that combines a high-power motor and a body is raised to reduce a burden on the shoulder and
reduction gear that has a low reduction gear ratio with the neck. Adjustment mechanisms include armrest height
arm on the operation input side to reduce the friction adjustment and foot unit depth adjustment performed by
resulting from the reduction gear. We also designed the touch panel operations, and manually operated 3D viewer
system to perform gravity, inertia, and friction position adjustment performed using an electromagnetic
compensation. Doing so achieved light, comfortable clutch equipped with an unlocking mechanism. The
operability. surgeon can fine-tune the system according to his or her
( ii ) Adjustment mechanism to reduce fatigue body shape and preferences.
When operating a surgeon cockpit, a surgeon can take ( iii ) Operation input section for simple operations
a forward leaning posture as if looking into the operative The arm controller shown in Fig. 5 is attached to each
Mode select switch
Joystick-type operation switch
Operation switch*
Enable switch*
*The same switches are placed
on both sides.
Fig. 5 Arm controller
Kawasaki Technical Review No.183 12
March 2022
Technical Description
arm on the patient side so that an assistant by the bed can section inside the shaft is twisted as a result of shaft
change the posture when, for example, teaching the pivot rotation, the wire tension changes, causing the
position. grasping force to fluctuate. This product can maintain
The simple joystick-type operation system has a a certain amount of grasping force by performing
bilaterally symmetric section, and the same switches are compensation according to the shaft’s rotation angle.
placed on both sides so that the system can be easily ② Tip shape: Through repeated evaluation by surgeons,
operated even when the direction to approach the bed is we have improved the instrument’s tip shape to
changed for reasons such as surgical site or flow lines. optimize it for application. For example, the needle
Moreover, the positioning camera for acquiring an holder, which holds and operates the needle, has been
overall view is attached at the center of the arm base so improved by attaching an anti-slip sheet to the
that the relative positional relationship with the bed or grasping surface in order to reduce needle slippage,
patient can be adjusted while watching the video feed on and by designing the tip round so as not to damage
the touch panel of the cart’s rear section. This ensures the thread during suturing. Because the grasping
maneuverability when the system approaches the bed. forceps adopt a jaw shape (i.e., the forceps are closed
from the tip), leaving a gap at the base, they can stably
(4) Striving to apply new technologies grasp targets from thin membranes to thick tissue.
( i ) Instrument development ③ Ease of cleaning and sterilization: The instrument can
The instruments move inside the patient’s body to be used 10 times by cleaning and sterilizing it each
perform necessary procedures, such as grasping or time. Therefore, we needed a structure that allows for
retraction of tissue, cutting and coagulation using an cleaning and sterilization not only of the tip, where
electrical cautery, and suture ligature using a suture and tissue and blood attach during surgery, but also the
needle during surgery. Therefore, they require the highest inside of the shaft and housing. To achieve ease of
level of functionality and performance for medical devices. cleanliness, we analyzed where water accumulates
Though Kawasaki did not have experience in designing and by, for example, simulating the water flow inside the
developing surgical devices, the company has gradually shaft and observing the interior when water passes
accumulated the required technologies and expertise by using a transparent housing cover, and we realized a
repeatedly developing elements. structure that inhibits contamination. Regarding ease
Figure 6 shows the appearance of an instrument that of sterilization, we confirmed that autoclaving using a
has been designed with consideration given to the biological indicator sufficiently sterilizes germs.
grasping force, tip shape, and ease of cleaning. ( ii ) Rulemaking strategies
① Grasping force: The most important function of the As part of rulemaking strategies for commercialization,
instrument is to grasp and manipulate tissue or a Medicaroid continues to participate in the development of
needle. When the hand control grip is tightened to the international standards.
specified angle, the tip of the jaw closes. When the Because the regulatory authorities in each country are
grip is further tightened, the required grasping force is very concerned about the safety of medical electrical
generated. When the wire in the drive transmission devices, each country has legislated technical
Housing
Jaw
Tip
Shaft Connector
Wrist
Fig. 6 Example of surgical instrument
13
requirements for medical electrical devices mainly based
on the IEC 60601 series of standards issued by the Hiroaki Kitatsuji
Medicaroid Corporation
International Electrotechnical Commission (IEC). However,
when Medicaroid started to develop the hinotori Surgical
Robot System, there were no safety standards for medical
electrical devices using robotics technology.
To address this issue, the IEC has developed a standard Hiroshi Ura
that applies only to the robotic-assisted surgery system Strategic Safety Standardization Department,
Medicaroid Corporation
product group and issued it as IEC 80601-2-77:2019. During
the development of this standard, Medicaroid participated
in the writing of the standard as a member of the Japanese
delegation and encouraged the introduction of safety
technologies already in use in industrial robots. Many of Takahiro Ueda
Development Department,
the company’s proposals were adopted. Medicaroid Corporation
Only six months after this standard was issued,
Medicaroid completed conformity assessment with the
standard and filed an application for pharmaceutical
approval using conformity to this new standard as the Yu Usuki
basis of product safety. This quick application was possible Development Department,
Medicaroid Corporation
because the technologies of Kawasaki are included in the
standard, and some of us participated in the creation of the
standard and are familiar with the requirements. We
believe that this is one piece of evidence that our
rulemaking strategies have borne fruit.
Tsuyoshi Tojo
Medical Robot Department,
Medical Robot Group, Robot Business Division,
Precision Machinery & Robot Company
Conclusion
The hinotori Surgical Robot System is a completely new
product that we plan to further grow and develop. We will Hirofumi Yamamori
first increase the range of target surgical procedures and Medical Robot Department,
Medical Robot Group, Robot Business Division,
expand the market by globally launching the product in the Precision Machinery & Robot Company
US, Europe, Asia, and other regions. Meanwhile, we plan
to adopt many new technologies to make the product
more attractive. In particular, by connecting digital
Wataru Doi
information inside and outside the robot to a network and Medical Robot Department,
accumulating it in a database, we are focusing on efforts to Medical Robot Group, Robot Business Division,
make the information useful in providing guidance for more Precision Machinery & Robot Company
efficient surgery, in improving and transferring medical
skills, and in providing support for remote robot surgery, in
which a surgeon in a remote location supports surgery
over a network.
References Realizes Production Systems That Are Safe for Human
1) “2015-2025 Global Surgical Robots Market Forecast Beings,” Kameyama, Tagashira, Nakada, Takami,
and Opportunities,” TechSci Research (2020) Yamamori, Mase, Hashimoto, Ueno, Kawasaki
2) “A Robot Operation Safety Monitoring Unit, Cubic-S, Technical Review No. 178, pp. 45-50 (2017)
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