Yohan Noh, Chunbao Wang, Mitsuhiro Tokumoto, Yusuke Matsuoka, Terunaga Chihara, Hiroyuki Ishii, Atsuo Takanishi, Toshiyuki Takayama, and Satoru Shoji, Development of the Airway Management Training System WKA‐5: Improvement of Mechanical Designs for High‐Fidelity Patient Simulation, 2012 IEEE International Conference on Robotics and Biomimetics (ROBIO 2012), Guangzhou, China, 11‐14 Dec., (DOI: 10.1109/ROBIO.2012.6491137). (c) 2012, IEEE. Personal use of this material is permitted. Permission from IEEE must be obtained for all other users, including reprinting / republishing this material for advertising or promotional purposes, creating new collective works for resale or redistribution to servers or lists, or reuse of any copyrighted components of this work in other works. This is a self‐archived copy of the submitted version of the above paper. There are minor differences between this and the published version.
Development of the Airway Management Training System WKA-5: Improvement of Mechanical Designs for High-Fidelity Patient Simulation Yohan Noh, Chunbao Wang, Mitsuhiro Tokumoto, Yusuke Matsuoka, Terunaga Chihara, Hiroyuki Ishii, Atsuo Takanishi, Toshiyuki Takayama, and Satoru Shoji
Abstract- In recent years advanced robotic technology has seen more use in the medical field to assist in the development of Active Training systems. Such training systems must fulfill the following criteria: they must provide quantitative information, must simulate the real-world conditions of the task, and assure training effectiveness. For these reasons, we have developed WKA (Waseda Kyotokagaku Airway) series which can satisfy the above three conditions. However, the mechanical mechanisms of the previous system WKA-4 were not designed to consider internal organs and external appearance. As a result, it cannot simulate high fidelity anatomical organs including tongue, oral cavity, nasal cavity, upper airway and esophagus. Therefore, we are proposing WKA-5 (Waseda Kyotokagaku Airway No. 5), which improves those mentioned defects of the WKA-4. In this paper, we present mechanical mechanism designs such as a mandible and a tongue mechanism which consider internal organs such as upper airway, tongue, nasal cavity, esophagus and external appearance. Finally, a set of experiments was carried out to doctor subjects in order to verify the usefulness of our proposed mechanism, and discuss the doctors on the results of the experiments. I. INTRODUCTION Recently, the purposes of medical training are to prevent accidents due to the unskilled operation and to train people to do the right thing at the right time. There are many medical training methods such as reading medical literatures, watching video instructed by medical specialists, and medical training with SP (Simulated Patient). Although reading medical literature and watching videos also assist the trainee in medical training indirectly, those methods have no interaction between the trainees and the patients directly. Namely, the above two methods do not provide effective medical training to the trainees. The best way is for the trainee to be trained with SP [1-2]. It uses a trained role-player to act the part of a patient with a specific medical condition (The role-players are often professional actors, sometimes working under equity contract). However, it has an ethical problem, high cost (to volunteer acting simulated patients), and Manuscript received October 1, 2012. This work was supported in part by Kyoto Kagaku Co. Ltd., Kyoto, Japan Mitsuhiro Tokumoto, Chunbao Wang, Yusuke Matsuoka, and Terunaga Chihara are with Graduate School of Science and Engineering, Waseda University, 2-2 Wakamatsu-cho, Shinjyuku-ku Tokyo, 162-8480, Japan. Yohan Noh, Hiroyuki Ishii, and Atsuo Takanishi are with Faculty of Science and Engineering, Waseda University, 2-2 Wakamatsu-cho, Shinjyuku-ku, Tokyo, 162-8480, Japan. (
[email protected]) Satoru Shoji and Toshiyuki Takayama are with Kyoto Kagaku Co. Ltd., 15 Kitanekoya-cho Fushimi-ku Kyoto, Japan 612-8388
difficulty for the trainee to perform dangerous medical tasks such as invasive procedures with the volunteer. Therefore, recently in the various fields of medicine, for the medical training, medical simulators have been used by the trainees. In the fields of the medical simulators, two kinds of the medical simulators are classified: mechanical simulator, and virtual simulator. The medical simulator allows students to use mock (i.e., artificial) parts adequately mimicking the experience that would be gained from interacting with a real patient’s body, organs, or tissues. Numerous types of clinical scenarios can be replicated by mechanical simulators [3-5]. The virtual simulator shows the patient’s physiologic responses to the student’s care such as hemorrhage and injury in real time. The simulation provides detailed information of the trainee’s performance by the virtual simulation. However, the mechanical simulator has several drawbacks: it provides subjective assessments by the supervisor, and it provides little feedback information of the trainee’s performance to the trainee due to the relatively few sensors that are embedded into the system. The virtual simulator also has several drawbacks: it provides subjective assessments by the supervisor, it provides little quantitative information of performance of the task to the trainee, and it cannot simulate real world conditions because of the use of sensors and/or haptic devices attached to the instrument. In order to attach such devices, the medical instrument would be modified in terms of weight, size, shape, etc [6]. Those issues may affect considerably the performance of trainees when they are requested to perform with real patients in the field [7-9]. For these reasons, using RT (Robot Technology) we are proposing an Active Training system for effective medical training. The Active Training system has the following characteristics: reproduces real world conditions, simulates various patient patterns (patient diseases and patient symptoms) and patient scenarios, provides quantitative information to trainee, and provides objective assessments of the training progress without a supervisor [10]. In order to fulfill the basic criteria of the Active Training system, we are Intubation Consciousness Normal loss
Laryngeal Mask
AWS Bag valve mask Laryngoscope Tube
Tongue
□Patient can not breath
□ A tube is inserted into the airway
Fig.1 Necessity of airway management with various medical devices
X
300
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700 Fig. 2 Overview of WKA-5 Torque Sensor x 1 Force Sensor x 1
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Torque Sensor x 1
Fig. 3 Sensors for Motion of WKA-5 Teeth Force Sensor x 2
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Tongue Tactile Sensor x 4
Airway Position Sensor x 3 Bronchus Flow Sensor x 2
Airway Force Sensor x 6 Esophagus Flow Sensor x 1
Fig. 4 Sensors for Measurement of WKA-5
proposing a patient robot. The concept of the patient robot is designed to emulate the human body (both anatomically and physiologically). In addition, it is designed to embed sensors and actuators in the human body (not in the instrument) in order to provide quantitative information of the trainee’s task to the trainee, and implement Impedance Control on each of the joints in order to simulate human muscle stiffness. Moreover, it is designed to interact with the trainee using verbal communication. Based on the concept of the patient robot, we have proposed the development of an Airway Management Training System [11]. Below, we present the details of the Airway Management Training System. Airway management is a basic skill that it is provided during emergency situations such as cardiopulmonary arrest and multiple injuries. In general, airway management is not only provided in order to supply oxygen to the lungs but also to prevent gastric foreign bodies and blood from external wounds from entering the lungs (Figure 1). Even though it is a basic medical operation, different complications may arise due to unskilled application. As a result, technicians and students are required to practice airway management for several years in order to achieve proficiency. For the achievement of the proposed concept of the Active Training system, we have proposed the development of an Airway Management Training System, Waseda Kyotokagaku Airway No.4 (WKA-4) which satisfies the characteristics of the Active Training system [11]. To verify the usefulness of the WKA-4, a set of the experiments were carried out with both novice subjects and doctor subjects to confirm the effectiveness of training with the WKA-4 on medical student performance during airway management. From the results of the data analysis, providing useful feedback tended to close
the gap between the data from the novice group with feedback and the data from the doctor group since providing the useful feedback improves the performance. From the result of the experiments, we verified that our proposed Active Training system WKA-4 improves the effectiveness of training [12]. However, the WKA-4 could consider mainly a skeletal structure, and did not consider internal organs and external appearance for the mechanical mechanism design. This is because the internal organs such as the upper airway, the esophagus, and the nasal cavity could be represented by partially anatomically connected skeletal portions, and cannot simulate the external appearances such as facial skin and the head of the average human size. During the administration of the airway management, there are many methods for the airway management using endotracheal tube, Laryngeal Mask Airway (LMA), Airway Scope (AWS), and Bag Valve Mask (BVM). However, due to the low-fidelity simulation such as the internal organs and the external appearances, the WKA-4 was designed to perform the airway management using only endotracheal tube. In addition, the tongue mechanism of the WKA-4 could simulate back placement of tongue and various patient tongue situations of Mallampati Classification (a rough estimate of the tongue size relative to the oral cavity), but due to the self deformable tongue mechanism of the WKA-4 by pneumatic system, it could deform only z-direction, and it could not deform a variety of directions as well as an amount of the air was getting leaked slowly. Moreover, the tongue mechanism used many DOF, and this is because the overall size of the neck is bigger than that of the average human. In this paper, we present mechanical mechanism designs such as mandible and tongue mechanisms which consider internal organs such as the upper airway, nasal cavity, esophagus and external appearance as well as improve the above defects of the mandible mechanism and the tongue mechanism. Finally, a set of experiments was carried out to doctor subjects in order to verify the usefulness of our proposed mechanism in the mechanical aspects and medical aspects, and discuss the doctors on the results of the experiments. II. WASEDA KYOTOKAGAKU AIRWAY NO.5 A. Design Concept The design concept of the WKA-5 aims to fulfill the following conditions: firstly, it should have average human size and should be designed to consider the internal organs such as nasal cavity, oral cavity, esophagus, upper airway, tongue, and vocal cords, and external organs such as facial and chest mask as shown in Table 2 and Fig. 5. Secondly, in order to provide quantitative information of the trainee’s performance of the task, and in order to simulate human muscle stiffness by Impedance Control, all of the mechanisms should be redesigned to embed sensors. Thirdly, the tongue and mandible mechanisms can simulate various anatomical patient conditions which contribute to difficult airway management situations. For these reasons, we propose new mechanisms including mandible, neck, trachea, and vocal cord based on medical literature as well as MRI images.
1.1) Four Link Mechanism and Crank Link Mechanism When humans are opening mouth, the active motion of the mandible can be modeled by 6-DOF [14-15]. However, under general anesthesia, patient’s muscles may be paralyzed (relaxed) in order to facilitate airway management. At this time, the patient’s mouth is opened passively by operator’s external force. During the administration of the airway management, all of the passive motions of the mandible can be simplified into 2-DOF which represent the rotational motion (θ) and translational one (L) as shown in Fig. 6. For these reasons, mandible mechanism should have at least 2-DOF to simulate the passive motion of the human mandible. In addition, the mandible mechanism can simulate various anatomical patient conditions which contribute to difficult airway management situations such as restricted opening mouth (lock jaw), protrusion (a case that the incisor teeth of the mandible protrudes from the incisor teeth of the upper jaw), retrusion (a case that the incisor teeth of the mandible retrudes from the incisor teeth of the upper jaw) during the administration of the airway management. Therefore, we adopted four link mechanism and crank link mechanism to simulate the rotational and translational motions as shown in Fig. 6, and referring to medical literature and doctors’ opinion, the range of the mandible motion is decided as shown in Table 3-4. In addition, in order to simulate the human muscle stiffness (depending on the patient states such as consciousness or unconsciousness, the patient muscle stiffness is different), the two TCDSS are embedded on the crank link mechanism and the four link TABLE I HARDWARE CONFIGURATION OF WKA-5 Sensor for DOF Sensor for Motion Measurement Force Sensor 2 Incisor Teeth 2 Jaw 2 (TCDSS) (TCDSS) Airway 6 Tongue 1 (TCDSS) Neck 1 Force Sensor 1 Airway 3 2* (TCDSS) (PDSS) Tongue 4 Vocal cords 1 (Tactile sensor) Jaw Lock 1 Esophagus 1 Mechanism (Airflow Sensor) Bronchus 2 (Airflow Sensor) Total 8 Total 3 Total 18 * Passive
A
X Z
Fig. 5 Design specification of the head size of the WKA-5 TABLE II REQUIRED SPECIFICATION FOR HEAD SIZE Average WKA-4 WKA-5 men Head A [mm] 161 164 161 Head B [mm] 232 236 232 Head C [mm] 189 222 189
θjaw Ljaw
1) Mandible Mechanism
B
C
B. Configuration of Hardware The WKA-5 has eight degrees of freedom (six active). WKA-5 consists of nine parts: the head, mandible, tongue, vocal cord, trachea, upper airway, nasal cavity, incisor teeth, and, and neck (Figure 2). The WKA-5 has force sensors and torque sensors which are called TCDSS on the each of its joints for Impedance Control [11 and 13]. This control can reproduce human muscle stiffness and respond to the operator’s external force. Moreover, in order to provide objective assessments of training progress, and must provide useful feedback to trainees. We also embedded various sensors into the redesigned organs (Figure 3-4 and Table 1).
Fig. 6 Passive motion of human mandible TABLE III REQUIRED SPECIFICATION FOR TRANSLATIONAL MOTION Retrusion Ljaw [mm] -13 Normal Ljaw [mm] -1 Protrusion Ljaw [mm] 12 TABLE IV REQUIRED SPECIFICATION FOR MANDIBLE ROTATIONAL MOTION θ < 30 Lock jaw θjaw [deg] Normal θjaw [deg] θ = 45
mechanism (Figure 7) for implementing the Impedance Control, and by attaching a constant force spring, the weight is canceled. As a result of the fact, an amount of the initial torque which is exerted on the actuators attaching on the mandible can be decreased. 1.2) Lock Mechanism By implementing Impedance Control, and by adjusting spring constant and damper constant, the human muscle stiffness can be simulated. However, the patients who have restricted mouth opening (lock jaw) due to Temporomandibular Joint disorder (TMJ), cannot open the mouth greater than the certain amount [mm] (depending on the patient, the degree of mouth opening is different). At this time, small mouth opening cannot make a medical device such as the laryngoscope inserted into the oral cavity safely [16-17]. By adjusting high spring constant and high damper constant, the TMJ can be simulated by the position control of the actuator, but at this time, in proportion to external force, the actuator generates great amount of the current. Too much electrical current causes heat that can damage an electrical circuit of the actuator. Therefore, we are proposing a lock mechanism which consists of adjustment pin, a worm gear, and a worm wheel by the actuator to simulate TMJ mechanically. By adjusting the position of the adjustment pin,
the degree of the TMJ can be simulated (Figure 7a and Figure 7c). 2) Tongue mechanism During the airway management, clinicians face to many patient tongue situations in the surgical operations and in the emergent situation. Depending on the patient tongue situations, it may be easy for trainee to perform airway management or it may be difficult to do it. For these reasons, in the medical fields, the patient tongue situations are classified into several definitions called Mallampati Classification. The Mallampati Classification is classified depending on the degree of the visualization of palatine uvula in the oral cavity as shown in Fig. 8. It can predict and measure degree of airway difficulty before operator performs the airway management (Particularly, Class III or IV result is likely to be difficult to perform airway management) [17]. In addition, under general anesthesia or during cardiopulmonary arrest, patient tongue is placed backward, and it causes the airway to be blocked by the tongue. The design specification of tongue mechanism is decided as followed. For the simulation of the back placement of the tongue, x-direction should be deformed as shown in Fig. 8, and Table VI, and for the simulation of Mallampati Classification, not only x-direction but also z-direction should be deformed as shown in Fig. 8 and Table VI. The new tongue mechanism consists of a slide screw, actuator, gears, and rotational axis based on a cam and gear mechanism as s shown in Fig. 9. As shown in Fig. 9, the actuator attached with the a slide screw moves rotational axis o1 and o2 along z-direction as shown in Fig. 9-11, the deformation of z-direction of the tongue can be simulated. While the actuator moves along z-direction, p1 and p2 rotate along the circle on the X-Y plane which has radius r1 and r2. According to the point A, B, C, and D, the various shapes of the tongue can be simulated as shown in Table V. In order to change the various patterns of the tongue, the rotational angle p1 and p2 and translational motion o1 and o2 are adjusted as shown in Fig. 11. In addition, tactile sensors are embedded on the tongue in order to measure the position of laryngoscope’s Constant force spring Y
Crank link mechanism
TCDSS
TCDSS
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Space for nasal cavity
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Fig. 8 Design specification of simulation of back placement of tongue and simulation of Mallampati Classification X Ｚ
Fig. 9 Tongue mechanism with the upper airway and esophagus
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x y p2
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Fig. 10 Tongue mechanism with silicon tongue
y Ａ
(dx_max, dy_max)
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Fig. 11 Trajectory p1 and p2 along the circle on the X-Y plane which has radius r1 and r2 for various tongue patterns TABLE V RELATIONSHIP BETWEEN VARIOUS TONGUE PATTERNS AND ROTATION ANGLE Pin Position Tongue state Rotation angle θdeg A Deformed tongue dx_max, dy_max 45 + n·360 B Normal tongue dx_min, dy_max 135 + n·360 Back placement C dx_min, dy_min 225 + n·360 of tongue Deformed tongue D and back placement dx_max, dy_min 315 + n·360 of tongue *n = revolution
Lock mechanism
TCDSS
TCDSS Four links mechanism
(a) Worm gear Gear
θ jaw
Parallel link mechanism
(b) Actuator
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Worm wheel
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Adjustment Pin
(c) Fig. 7 Mandible mechanism of WKA-5 (a) Four link mechanism (b) Crank link mechanism (c) Lock Mechanism
TABLE VI COMPARISON BETWEEN DESIGN SPECIFICATION AND MESURED VALUE Design Specification Measured Value 17 dx [mm] 17 (Tongue swallowing) 8 dy [mm] 10 (Inflated tongue) 15 dz [mm] 16 (Inflated tongue)
blade on the tongue (Figure 4) [18]. The tongue mechanism attaches the outside of the upper airway and esophagus which include oral cavity, tongue, and larynx inside as shown in Fig. 9. The upper airway and esophagus organ have been designed based on the MRI image, and it can reproduce not only high fidelity simulated internal
organs, but also it enables the trainee to perform the airway management training using the endotracheal tube, LMA, AWS and BVM. Moreover, the tongue mechanism used only 1-DOF, and this is because the overall size of the neck can be realized in the neck of the average human size. III. EXPERIMENTS AND RESULTS A .Verification of Proposed Mandible Mechanism Preliminary experiments have been carried out to verify whether our proposed mandible mechanism satisfies the design specification or not. As shown in Table 3 and 4, the range of the motion of the mandible is satisfied with the design specification. As stated in the design specification of the airway difficulties by the mandible mechanism, in medical literature, the protrusion defines that the incisor teeth of the mandible protrudes from the incisor teeth of the upper jaw, and the retrusion defines that the incisor teeth of the mandible retrudes from the incisor teeth of the upper jaw. Using the WKA-5, we can reproduce the protrusion which has distance from 0 to 20 [mm], and we can also reproduce the retrusion which has distance form 0 [mm] to -13 [mm] as shown in Fig. 12a and 12b. By adjusting the various cases of the protrusion and the retrusion, we can also reproduce the individual difference of the patients. In addition, by implementing Impedance Control, the human muscle stiffness can be simulated as shown in Fig. 13a, and by the lock mechanism as shown in Fig. 13b, the TMJ can be x
20mm
z
z
-13mm
y
(a)
(b)
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45 °
(c) (d) Fig. 12 Range of the mandible motion and airway difficulties reproduced by the mandible mechanism (a) Protrusion (b) Retrusion (c) Normal (d) Range of opening mouth dd jaw=56.7[mm] jaw
X Z
X Z Y
ddjawjaw=31.5[mm]
F
F
X
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(a) (b) Fig. 13 Mandible lock mechanism (a) Normal opening mouth (b) Restricted opening mouth (TMJ)
simulated. Although great amount of the external force is applied on the mandible, the proposed mechanism limits the maximum opening of the mouth as shown in Fig. 13b. From the result of the experiments, the effectiveness of the mandible mechanism and the lock mechanism has been verified. B. Verification of Proposed Tongue Mechanism Preliminary experiments have been carried out to verify whether our proposed tongue mechanism satisfies the design specification or not. Using the tongue mechanism, the back placement of the tongue and Mallampati Classification can be simulated. As stated in the design specification of the back placement of the tongue as shown in Table VI, the shape of the tongue should be deformed x-direction dx =17 [mm]. From the result of the experiments, the tongue mechanism could deform maximum x-direction dx =17 [mm], and could satisfy the design specification of the back placement of the tongue as shown in Fig. 14 and “measured value” Table VI. In addition, as stated in the design specification of the simulation of the Mallampati Classification IV (those instances where no soft palate is visible at all), the shape of the tongue should be deformed y-direction 8 [mm] z-direction 15 [mm] as shown in Table VI and Fig. 8. From the result of the experiments, the tongue mechanism could deform maximum y-direction 10 [mm] and z-direction 16 [mm], could satisfy the design specification of the simulation of the Mallampati Classification IV as shown in “measured value” Fig. 15 and Table VI. In order to verify the proposed tongue mechanism, a set of experiments has been carried out to ten doctor (4-15 years experiences) subjects who are working in the department of anesthesiology whether it can simulate Mallampati Classification or not. From the result of the experiments, the tongue mechanism could simulate the four kinds of the tongue patterns which are classified by the Mallampati Classification I to IV. Although doctor’s opinions have deviation on each of the Mallampati Classification, as θ lowers, they are similar with the Mallampati Classification I, and as θ rises, they are similar with the Mallampati Classification IV as shown in Fig. 15-16. However, many doctors perform airway management using medical devices such as a laryngoscope, LMA, AWS, and BVM to lift the tongue in order to observe the vocal chord. However, as the tongue is hollow, the feeling of the tongue differs to that of a human. The subject doctors provided feedback that due to the different shapes of the tongue, that the feeling is not changeable. IV. CONCLUSIONS AND FUTURE WORK In this paper, we have presented the mechanical mechanism designs of the WKA-5 such as mandible and tongue mechanisms which consider internal organs such as the upper airway, nasal cavity, esophagus and external appearance as well as improve the above defects of the mandible mechanism and the tongue mechanism of the WKA-4. Finally, a set of experiments was carried out to doctor subjects in order to verify the usefulness of our proposed mechanism, and discuss the doctors on the results of
X
X Z
components necessary for the development of the motor driver.
Z
REFERENCES [1] dx
(a) (b) Fig. 14 Reproduction of back placement of the tongue (a) Normal tongue (b) back placement of the tongue
[2]
[3]
[4] [5]
[6] Fig. 15 Reproduction of the various tongue patterns of Mallampati Classification by tongue mechanism [7] [8] [9] [10]
Fig. 16 Results of the experiments by the doctor subjects on the Reproduction of the various shapes of the tongue patterns by tongue mechanism
the experiments. Preliminary experiments have been carried out to verify whether our proposed tongue mechanism satisfies the design specification or not. From the experiments, the design specification of the tongue mechanism could be satisfied in mechanical aspects. Finally, we asked ten doctors about the simulation of Mallampati Classification, discussed the result of the experiments, and received their variable opinions in medical aspects. Their opinions will be considered in future works. In the future, we will propose a new mechanism that can reproduce various shapes of tongue patterns and simulate the feeling of the human tongue and also attach the lung mechanism for the simulation of the real world condition of the task. Moreover, we will also include evaluations of training effectiveness compared to existing methods. (It is difficult, though, at least comparison to mannequins is indispensable.)
[11]
[12]
[13]
[14] [15]
[16]
ACKNOWLEDGMENT We would like to thank the doctors from the Department of Anesthesiology at the Tokyo Women’s Medical University for their valuable time in providing medical knowledge for our new system. In addition, we would like to thank Waseda University GCOE Global Robot Academia. Finally, we also would like to thank STMicroelectronics which supplied the electronic
[17]
[18]
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