Colorectal endoscopic submucosal dissection using novel articulating devices: a comparative study in a live porcine model.

BACKGROUND AND AIMS: Colonic endoscopic submucosal dissection (ESD) is time-consuming and bears a high risk of perforation. The aim of the present study was to compare the safety and efficacy between novel articulating devices and conventional ESD in live porcine colon models. METHODS: Thirty ESDs in ten pigs were carried out at three different locations (15, 25, and 35 cm from the anus) by the conventional method (n = 15) and by the new method (n = 15). Procedure times, adverse events (perforation, bleeding), and damage to the muscular layer were recorded, and the ESD time per unit area of the specimens was calculated. RESULTS: The perforation rate using the conventional method was 6.7% (1/15), whereas that using the new method was 0.0%. The number of sites of muscular damage was significantly lower in the new than conventional method (6 vs. 37, respectively; P = 0.024). The mean procedure time was significantly shorter in the new than conventional method (4.6 ± 2.0 vs. 7.0 ± 4.1 min/cm2, respectively; P = 0.042). CONCLUSIONS: Use of the new ESD method allows for reduced adverse events and a shortened resection time.

A new robotic-assisted flexible endoscope with single-hand control: endoscopic submucosal dissection in the ex vivo porcine stomach.

BACKGROUND: Difficulties in endoscopic operations and therapeutic procedures seem to occur due to the complexity of operating the endoscope dial as well as difficulty in performing synchronized movements with both hands. We developed a prototype robotic-assisted flexible endoscope that can be controlled with a single hand in order to simplify the operation of the endoscope. The aim of this study was to confirm the operability of the robotic-assisted flexible endoscope (RAFE) by performing endoscopic submucosal dissection (ESD). METHODS: Study 1: ESD was performed manually or with RAFE by an expert endoscopist in ex vivo porcine stomachs; six operations manually and six were performed with RAFE. The procedure time per unit circumferential length/area was calculated, and the results were statistically analyzed. Study 2: We evaluated how smoothly a non-endoscopist can move a RAFE compared to a manual endoscope by assessing the designated movement of the endoscope. RESULTS: Study 1: En bloc resection was achieved by ESD using the RAFE. The procedure time was gradually shortened with increasing experience, and the procedure time of ESD performed with the RAFE was not significantly different from that of ESD performed with a manual endoscope. Study 2: The time for the designated movement of the endoscope was significantly shorter with a RAFE than that with a manual endoscope as for a non-endoscopist. CONCLUSIONS: The RAFE that we developed enabled an expert endoscopist to perform the ESD procedure without any problems and allowed a non-endoscopist to control the endoscope more easily and quickly than a manual endoscope. The RAFE is expected to undergo further development.

Improving the strength of sutureless laser-assisted vessel repair using preloaded longitudinal compression on tissue edge.

BACKGROUND AND OBJECTIVE: Little is known about the approximation of coapted edges in sutureless laser-assisted vessel welding. Tissue shrinkage by laser irradiation may cause coapted edges to separate, reducing strength of welding. This may be avoided by preloaded longitudinal compression on the tissue edges to be welded. This study compared welding strength with and without preloaded compression in ex vivo animal experiments. MATERIALS AND METHODS: This study evaluated 24 samples of harvested porcine carotid arteries, each having a length of 3 cm and an inner diameter of 1.0-2.0 mm. A half circumferential incision was made at the center of each sample. A steel shaft 2.0 mm in diameter was inserted into each sample to approximate the incised edges. The samples were longitudinally compressed to 6 mm. Incision sites were repaired by irradiation with a 970-nm diode laser. No glue or die was used. The repair strength was evaluated by measuring the bursting point (BP) of all samples. In a pilot study, the welding conditions, including power, duration, and interval of the laser spots, were tested by trial and error in 18 samples, including six treated under optimum conditions. As a control group, six samples were welded under optimum conditions, but without compression. RESULTS: Optimum conditions, consisting of 2.4 W power, 30-second duration, and 1-mm intervals of laser spots, yielded the highest BP (623 ± 236 mmHg), which was significantly higher than in the control group without compression (204 ± 208 mmHg, P = 0.009). Defining BP > 400 mmHg as successful repair, the success rates in the compression and control groups were 83% and 17%, respectively. CONCLUSION: Preloaded longitudinal compression on the coapted edges may be important for sutureless laser-assisted vessel repair and anastomosis and may affect the strength of welding. Lasers Surg. Med. 49:533-538, 2017. © 2017 Wiley Periodicals, Inc.

Gastric endoscopic submucosal dissection using novel 2.6-mm articulating devices: an ex vivo comparative and in vivo feasibility study.

BACKGROUND AND STUDY AIMS: The conventional procedure of endoscopic submucosal dissection (ESD) is technically demanding. This study investigated the efficiency of novel articulating devices (maximum diameter 2.6 mm), which can be used with commercially available, standard endoscopes. PATIENTS AND METHODS: In an ex vivo comparative study, eight endoscopists were divided into novices and experienced operators, and performed ESD using new devices and the conventional setup. An in vivo animal experiment was performed by two experts. Procedure times for incision and dissection were recorded, and unit times for circumferential length and area of specimens were calculated. RESULTS: All procedures were successfully completed with en bloc resection. In the ex vivo study, the unit procedure times for incision and dissection by novices were significantly shorter using the new system (P < 0.01 and P < 0.05), whereas there was no significant difference for experienced endoscopists. Perforation occurred during one procedure in which the new system was used. The in vivo experiments were successfully completed without adverse events. CONCLUSIONS: ESD using novel articulating devices was feasible. These devices were able to reduce the procedure time for novices.

Next-generation robotic surgery--from the aspect of surgical robots developed by industry.

At present, much of the research conducted worldwide focuses on extending the ability of surgical robots. One approach is to extend robotic dexterity. For instance, accessibility and dexterity of the surgical instruments remains the largest issue for reduced port surgery such as single port surgery or natural orifice surgery. To solve this problem, a great deal of research is currently conducted in the field of robotics. Enhancing the surgeon's perception is an approach that uses advanced sensor technology. The real-time data acquired through the robotic system combined with the data stored in the robot (such as the robot's location) provide a major advantage. This paper aims at introducing state-of-the-art products and pre-market products in this technological advancement, namely the robotic challenge in extending dexterity and hopefully providing the path to robotic surgery in the near future.

Active Range of Motion Measurement System Using an Optical Sensor to Evaluate Hand Functions.

Impairment of hand function greatly affects the independence of a human being. Proper assessment of hand function before and after any treatment for functional restoration is important to decide better treatment strategies. Despite traditional techniques of hand function evaluation, individual joint based assessment is vital to better track the details of the hand function. Current clinical assessments with goniometers are labour intensive, cumbersome and highly depend on the skill level of the practitioner. This study introduces an active range of motion (AROM) measurement system to measure individual range of motion of finger joints using an optical sensor. The proposed method is highly efficient, and the results demonstrated that the measurements are instant, repeatable and can successfully be employed in a clinical setup for patient evaluations.Clinical Relevance-Closely working with clinician to develop rehabilitation systems, we have identified that the assessment of patient hand functions is time consuming, and accuracy can be depended on the skill level of the practitioner in measuring joint range of motions (ROM). System introduced in this study can measure the joint AROMs instantly and independent of the practitioner's skill level and hence can provide a reliable, repeatable assessment of patient's hand function.

2.5-mm articulated endoluminal forceps using a compliant mechanism.

PURPOSE: Gastrointestinal cancer can be treated using a flexible endoscope through a natural orifice. However, treatment instruments with limited degrees of freedom (DOFs) require a highly skilled operator. Articulated devices useful for endoluminal procedures, such as endoscopic submucosal dissection and biopsy, have been developed. These devices enable dexterous operation in a narrow lumen; however, they suffer from limitations such as large size and high cost. To overcome these limitations, we developed a 2.5-mm articulated forceps that can be inserted into a standard endoscope channel based on a compliant mechanism. METHODS: The compliant mechanism allows the device to be compact and affordable, which is possible due to its monolithic structure. The proposed mechanism consists of two segments, 1-DOF grasping and 2-DOF bending, that are actuated by tendon-sheath mechanisms. A prototype was designed based on finite element analysis results. RESULTS: To confirm the effectiveness of the proposed mechanism, we fabricated the prototype using a 3D printer. A series of mechanical performance tests on the prototype revealed that it achieved the following specifications: (1) DOF: 1-DOF grasping + 2-DOF bending, (2) outer diameter: 2.5 mm, (3) length of the bending segment: 30 mm, and (4) range of motion: [Formula: see text] to [Formula: see text] (grasping) and [Formula: see text] to [Formula: see text] (bending). Finally, we performed a tissue manipulation test on an excised porcine colon and found that a piece of mucous membrane tissue was successfully resected using an electric knife while being lifted with the developed forceps. CONCLUSION: The results of the evaluation experiment demonstrated a positive feasibility of the proposed mechanism, which has a simpler structure compared to those of other conventional mechanisms; furthermore, it is potentially more cost-effective and is disposable. The mechanical design, prototype implementation, and evaluations are reported in this paper.

Fully Wearable Actuated Soft Exoskeleton for Grasping Assistance in Everyday Activities.

Worldwide, over 50 million people suffer from persistent hand impairments after stroke or spinal cord injury (SCI). This results in major loss of independence and quality of life. Robotic hand exoskeletons can compensate for lost motor function and assist in grasping tasks performed in everyday activities. Several recent prototypes can partially provide this assistance. However, it remains challenging to integrate the dexterity required for daily tasks in a safe and user-friendly design that is acceptable for daily use in subjects with neuromotor hand impairments. We present the design of RELab tenoexo; a fully wearable assistive soft hand exoskeleton for daily activities. We present sleek mechanisms for a hand module that generates the four most frequently used grasp types, employing a remote actuation system that reduces weight on the hand. For optimal assistance and highest adaptability, we present various design and control options to customize the modular device, along with an automated tailoring algorithm that allows automatically generated hand modules for individual users. Mechanical evaluation shows that RELab tenoexo covers the range of motion and the fingertip forces required to assist users in up to 80% of all grasping activities. In user tests, we find that the low weight, unintrusive size, high wearing comfort, and appealing appearance are beneficial for user acceptance and usability in daily life. Finally, we demonstrate that RELab tenoexo leads to an immediate improvement of the functional grasping ability in a subject with SCI.

Surgical Robot for Intraluminal Access: An Ex Vivo Feasibility Study.

Early-stage gastrointestinal cancer is often treated by endoscopic submucosal dissection (ESD) using a flexible endoscope. Compared with conventional percutaneous surgery, ESD is much less invasive and provides a high quality of life for the patient because it does not require a skin incision, and the organ is preserved. However, the operator must be highly skilled because ESD requires using a flexible endoscope with energy devices, which have limited degrees of freedom. To facilitate easier manipulation of these flexible devices, we developed a surgical robot comprising a flexible endoscope and two articulating instruments. The robotic system is based on a conventional flexible endoscope, and an extrapolated motor unit moves the endoscope in all its degrees of freedom. The instruments are thin enough to allow insertion of two instruments into the endoscope channel, and each instrument has a bending section that allows for up-down, right-left, and forward-backward motion. In this study, we performed an ex vivo feasibility evaluation using the proposed robotic system for ESD in a porcine stomach. The procedure was successfully performed by five novice operators without complications. Our findings demonstrated the feasibility of the proposed robotic system and, furthermore, suggest that even operators with limited experience can use this system to perform ESD.

Towards Control of a Transhumeral Prosthesis with EEG Signals.

Robotic prostheses are expected to allow amputees greater freedom and mobility. However, available options to control transhumeral prostheses are reduced with increasing amputation level. In addition, for electromyography-based control of prostheses, the residual muscles alone cannot generate sufficiently different signals for accurate distal arm function. Thus, controlling a multi-degree of freedom (DoF) transhumeral prosthesis is challenging with currently available techniques. In this paper, an electroencephalogram (EEG)-based hierarchical two-stage approach is proposed to achieve multi-DoF control of a transhumeral prosthesis. In the proposed method, the motion intention for arm reaching or hand lifting is identified using classifiers trained with motion-related EEG features. For this purpose, neural network and k-nearest neighbor classifiers are used. Then, elbow motion and hand endpoint motion is estimated using a different set of neural-network-based classifiers, which are trained with motion information recorded using healthy subjects. The predictions from the classifiers are compared with residual limb motion to generate a final prediction of motion intention. This can then be used to realize multi-DoF control of a prosthesis. The experimental results show the feasibility of the proposed method for multi-DoF control of a transhumeral prosthesis. This proof of concept study was performed with healthy subjects.

Laparoscopic ultrasound manipulator with a spring-based elastic mechanism.

PURPOSE: Image guidance is a key technology that can improve the outcome of laparoscopic surgery. However, due to the large deformation caused by digestive organs, a computer-aided navigation system based on preoperative imaging data cannot indicate the correct target position of the lesion (e.g., liver tumors and vessels invisible from the organ surface). To overcome this issue, we developed a laparoscopic ultrasound manipulator with two motorized degrees of freedom at the tip, allowing for the performance of a dexterous ultrasound scan in a confined laparoscopic surgical area. METHOD: The developed manipulator consists of a compact and elastic structure using springs, enabling a safe ultrasound scan and avoiding excess force on the inspected organs. The manipulator is a handheld device equipped with four buttons at the handle, which the surgeon directly grasps to send a motion command to the tip structure. The developed prototype realizes two motorized degree-of-freedom motion at the tip. The size of prototype is 15.0 mm in diameter that is usable in conventional laparoscopy. The tip of the manipulator was carefully designed by considering the kinematic model and the results of the finite element analysis. RESULTS: To assess the prototype, accuracy and rigidity were measured by using a motion processing microscope. The accuracy test showed that the proposed device has a fairly accurate characteristic as a handheld device. This was supposedly caused by the nature of compliant mechanism, which does not have mechanical play in motion. In addition, the intrinsic elastic structure (approximately 2.0 N/mm in most of the range of motion) allowed the ultrasound probe to adequately fit on the curved organ surface without extra effort of manipulation during the inspection. In the in vivo experiment, the yaw motion was found to be effective for investigating the vascular network because the manipulator allows the probe to be rotated while maintaining the same position. CONCLUSION: The mechanical evaluation and in vivo test results showed high feasibility of the prototype. We are currently working on further mechanical improvement for commercialization and development of a real-time navigation system that can perform three-dimensional reconstruction of ultrasonographic images by implementing a magnetic position sensor at the tip of the manipulator.

A multichannel-near-infrared-spectroscopy-triggered robotic hand rehabilitation system for stroke patients.

There is a demand for a new neurorehabilitation modality with a brain-computer interface for stroke patients with insufficient or no remaining hand motor function. We previously developed a robotic hand rehabilitation system triggered by multichannel near-infrared spectroscopy (NIRS) to address this demand. In a preliminary prototype system, a robotic hand orthosis, providing one degree-of-freedom motion for a hand's closing and opening, is triggered by a wireless command from a NIRS system, capturing a subject's motor cortex activation. To examine the feasibility of the prototype, we conducted a preliminary test involving six neurologically intact participants. The test comprised a series of evaluations for two aspects of neurorehabilitation training in a real-time manner: classification accuracy and execution time. The effects of classification-related factors, namely the algorithm, signal type, and number of NIRS channels, were investigated. In the comparison of algorithms, linear discrimination analysis performed better than the support vector machine in terms of both accuracy and training time. The oxyhemoglobin versus deoxyhemoglobin comparison revealed that the two concentrations almost equally contribute to the hand motion estimation. The relationship between the number of NIRS channels and accuracy indicated that a certain number of channels are needed and suggested a need for a method of selecting informative channels. The computation time of 5.84 ms was acceptable for our purpose. Overall, the preliminary prototype showed sufficient feasibility for further development and clinical testing with stroke patients.

Articulated minimally invasive surgical instrument based on compliant mechanism.

PURPOSE: In minimally invasive surgery, instruments are inserted from the exterior of the patient's body into the surgical field inside the body through the minimum incision, resulting in limited visibility, accessibility, and dexterity. To address this problem, surgical instruments with articulated joints and multiple degrees of freedom have been developed. The articulations in currently available surgical instruments use mainly wire or link mechanisms. These mechanisms are generally robust and reliable, but the miniaturization of the mechanical parts required often results in problems with size, weight, durability, mechanical play, sterilization, and assembly costs. METHODS: We thus introduced a compliant mechanism to a laparoscopic surgical instrument with multiple degrees of freedom at the tip. To show the feasibility of the concept, we developed a prototype with two degrees of freedom articulated surgical instruments that can perform the grasping and bending movements. The developed prototype is roughly the same size of the conventional laparoscopic instrument, within the diameter of 4 mm. The elastic parts were fabricated by Ni-Ti alloy and SK-85M, rigid parts ware fabricated by stainless steel, covered by 3D- printed ABS resin. The prototype was designed using iterative finite element method analysis, and has a minimal number of mechanical parts. RESULTS: The prototype showed hysteresis in grasping movement presumably due to the friction; however, the prototype showed promising mechanical characteristics and was fully functional in two degrees of freedom. In addition, the prototype was capable to exert over 15 N grasping that is sufficient for the general laparoscopic procedure. The evaluation tests thus positively showed the concept of the proposed mechanism. CONCLUSION: The prototype showed promising characteristics in the given mechanical evaluation experiments. Use of a compliant mechanism such as in our prototype may contribute to the advancement of surgical instruments in terms of simplicity, size, weight, dexterity, and affordability.

Robotically enhanced rubber hand illusion.

The rubber hand illusion is a well-known multisensory illusion. In brief, watching a rubber hand being stroked by a paintbrush while one's own unseen hand is synchronously stroked causes the rubber hand to be attributed to one's own body and to "feel like it's my hand." The rubber hand illusion is thought to be triggered by the synchronized tactile stimulation of both the subject's hand and the fake hand. To extend the conventional rubber hand illusion, we introduce robotic technology in the form of a master-slave telemanipulator. The developed one degree-of-freedom master-slave system consists of an exoskeleton master equipped with an optical encoder that is worn on the subject's index finger and a motor-actuated index finger on the rubber hand, which allows the subject to perform unilateral telemanipulation. The moving rubber hand illusion has been studied by several researchers in the past with mechanically connected rigs between the subject's body and the fake limb. The robotic instruments let us investigate the moving rubber hand illusion with less constraints, thus behaving closer to the classic rubber hand illusion. In addition, the temporal delay between the body and the fake limb can be precisely manipulated. The experimental results revealed that the robotic instruments significantly enhance the rubber hand illusion. The time delay is significantly correlated with the effect of the multisensory illusion, and the effect significantly decreased at time delays over 100 ms. These findings can potentially contribute to the investigations of neural mechanisms in the field of neuroscience and of master-slave systems in the field of robotics.

Surgical bedside master console for neurosurgical robotic system.

PURPOSE: We are currently developing a neurosurgical robotic system that facilitates access to residual tumors and improves brain tumor removal surgical outcomes. The system combines conventional and robotic surgery allowing for a quick conversion between the procedures. This concept requires a new master console that can be positioned at the surgical bedside and be sterilized. METHODS: The master console was developed using new technologies, such as a parallel mechanism and pneumatic sensors. The parallel mechanism is a purely passive 5-DOF (degrees of freedom) joystick based on the author's haptic research. The parallel mechanism enables motion input of conventional brain tumor removal surgery with a compact, intuitive interface that can be used in a conventional surgical environment. In addition, the pneumatic sensors implemented on the mechanism provide an intuitive interface and electrically isolate the tool parts from the mechanism so they can be easily sterilized. RESULTS: The 5-DOF parallel mechanism is compact (17 cm width, 19cm depth, and 15cm height), provides a 505,050 mm and 90° workspace and is highly backdrivable (0.27N of resistance force representing the surgical motion). The evaluation tests revealed that the pneumatic sensors can properly measure the suction strength, grasping force, and hand contact. In addition, an installability test showed that the master console can be used in a conventional surgical environment. CONCLUSION: The proposed master console design was shown to be feasible for operative neurosurgery based on comprehensive testing. This master console is currently being tested for master-slave control with a surgical robotic system.

Neurosurgical robotic system for brain tumor removal.

PURPOSE: Brain tumor (e.g., glioma) resection surgery, representing the first step for many treatments, is often difficult and time-consuming for neurosurgeons. Thus, intelligent neurosurgical instruments have been developed to improve tumor removal. METHODS: The concept and robotic structure of intelligent neurosurgical instruments were introduced. These instruments consist of a surgical robot, a master device and operating software. The robot incorporates a surgical motion base and tool manipulator, including a volume control suction tool. Open Core Control software was developed for connecting intelligent neurosurgical instruments through a network connection and integrating the instruments into a system. RESULTS: Mechanical evaluation tests on the components and a preliminary system evaluation were performed. A phantom model was fixed on a head frame, and a tumor-removal procedure was successfully performed using prototype intelligent neurosurgical instruments. CONCLUSION: Intelligent neurosurgical instruments are feasible and suitable for on-going evaluation in practical tasks, including in-vivo animal testing.

Open core control software for surgical robots.

OBJECT: In these days, patients and doctors in operation room are surrounded by many medical devices as resulting from recent advancement of medical technology. However, these cutting-edge medical devices are working independently and not collaborating with each other, even though the collaborations between these devices such as navigation systems and medical imaging devices are becoming very important for accomplishing complex surgical tasks (such as a tumor removal procedure while checking the tumor location in neurosurgery). On the other hand, several surgical robots have been commercialized, and are becoming common. However, these surgical robots are not open for collaborations with external medical devices in these days. A cutting-edge "intelligent surgical robot" will be possible in collaborating with surgical robots, various kinds of sensors, navigation system and so on. On the other hand, most of the academic software developments for surgical robots are "home-made" in their research institutions and not open to the public. Therefore, open source control software for surgical robots can be beneficial in this field. From these perspectives, we developed Open Core Control software for surgical robots to overcome these challenges. MATERIALS AND METHODS: In general, control softwares have hardware dependencies based on actuators, sensors and various kinds of internal devices. Therefore, these control softwares cannot be used on different types of robots without modifications. However, the structure of the Open Core Control software can be reused for various types of robots by abstracting hardware dependent parts. In addition, network connectivity is crucial for collaboration between advanced medical devices. The OpenIGTLink is adopted in Interface class which plays a role to communicate with external medical devices. At the same time, it is essential to maintain the stable operation within the asynchronous data transactions through network. In the Open Core Control software, several techniques for this purpose were introduced. Virtual fixture is well known technique as a "force guide" for supporting operators to perform precise manipulation by using a master-slave robot. The virtual fixture for precise and safety surgery was implemented on the system to demonstrate an idea of high-level collaboration between a surgical robot and a navigation system. The extension of virtual fixture is not a part of the Open Core Control system, however, the function such as virtual fixture cannot be realized without a tight collaboration between cutting-edge medical devices. By using the virtual fixture, operators can pre-define an accessible area on the navigation system, and the area information can be transferred to the robot. In this manner, the surgical console generates the reflection force when the operator tries to get out from the pre-defined accessible area during surgery. RESULTS: The Open Core Control software was implemented on a surgical master-slave robot and stable operation was observed in a motion test. The tip of the surgical robot was displayed on a navigation system by connecting the surgical robot with a 3D position sensor through the OpenIGTLink. The accessible area was pre-defined before the operation, and the virtual fixture was displayed as a "force guide" on the surgical console. In addition, the system showed stable performance in a duration test with network disturbance. CONCLUSION: In this paper, a design of the Open Core Control software for surgical robots and the implementation of virtual fixture were described. The Open Core Control software was implemented on a surgical robot system and showed stable performance in high-level collaboration works. The Open Core Control software is developed to be a widely used platform of surgical robots. Safety issues are essential for control software of these complex medical devices. It is important to follow the global specifications such as a FDA requirement "General Principles of Software Validation" or IEC62304. For following these regulations, it is important to develop a self-test environment. Therefore, a test environment is now under development to test various interference in operation room such as a noise of electric knife by considering safety and test environment regulations such as ISO13849 and IEC60508. The Open Core Control software is currently being developed software in open-source manner and available on the Internet. A communization of software interface is becoming a major trend in this field. Based on this perspective, the Open Core Control software can be expected to bring contributions in this field.

OpenIGTLink: an open network protocol for image-guided therapy environment.

BACKGROUND: With increasing research on system integration for image-guided therapy (IGT), there has been a strong demand for standardized communication among devices and software to share data such as target positions, images and device status. METHOD: We propose a new, open, simple and extensible network communication protocol for IGT, named OpenIGTLink, to transfer transform, image and status messages. We conducted performance tests and use-case evaluations in five clinical and engineering scenarios. RESULTS: The protocol was able to transfer position data with submillisecond latency up to 1024 fps and images with latency of <10 ms at 32 fps. The use-case tests demonstrated that the protocol is feasible for integrating devices and software. CONCLUSION: The protocol proved capable of handling data required in the IGT setting with sufficient time resolution and latency. The protocol not only improves the interoperability of devices and software but also promotes transitions of research prototypes to clinical applications.