Most minimally invasive surgery involves a surgeon guiding a laparoscope into the patient’s body with limited visual and force guidance. Many robotic surgical tools add a layer of technology between the surgeon and patient that can make operations harder rather than easier, but that is changing.
Medical Surgery Technologies Ltd. (MST) has unveiled AutoLap, an image-guided laparoscope positioning system. The company said that AutoLap is more affordable and user-friendly than other robotic systems.
Laparoscopic operations are less invasive than other surgery, allowing for faster recovery. About 7.5 million laparoscopic procedures are performed annually worldwide, and that number is growing, according to Yokneam, Israel-based MST. The market for surgical devices is expected to grow from $3.2 billion in 2014 to $20 billion by 2021.
In a demonstration of the increasing sophistication of minimally invasive surgery, Virtual Incision Corp. in Pleasanton, Calif., recently announced the first successful use of its miniaturized Robotic Assisted Surgical Device (RASD) in a living human patient for a colon resection.
Adding autonomy to surgical tools
Until now, surgeons had to guide laparoscopes into patient abdominal cavities through indirect control and with only a partial view of the area. Teleoperation also moves doctors from the patient’s side to a control booth, requires more training, and places a cognitive burden on the operator.
“Devices in the past were merely extensions of the surgeon’s hands,” said Motti Frimer, CEO of MST. “Ours is the first full system that actually works with the surgeon. It takes the image, performs analysis, and controls movement and position without the surgeon’s direction.”
“The surgeon sits at a console, and 95 percent of the market is for high-volume, low- to mid-complexity procedures,” Frimer noted.
“While these procedures still require dexterity, focus, and precision, they don’t justify the purchase of multimillion-dollar systems,” he said. “There is a gap of stability — you can’t use an HD screen or 3D imaging now on the market without giving the surgeon headaches, or if the line of sight keeps moving.”
“Our device comes right in the center, between the patient and human operator who in the foreseeable future will still work with his or her own two hands,” Frimer asserted. “AutoLap will work in different settings, like operating rooms in Tier 1 to 3 hospitals that can’t afford the high capital expense or recurring disposable price of full surgical systems.”
Another challenge is that surgeons may work at multiple facilities, he said. “With AutoLap, surgeons get quality and self-control. They don’t have to worry about random assistants depending on the facility,” Frimer said.
Three modes of operation
With AutoLap, doctors have a variety of robotic-assisted modes to choose from.
“AutoLap’s three modes of operation are easily switchable,” explained Frimer. “In image-guided mode, the system interacts with the surgeon to home in according to the surgical tool’s actions. A virtual marker [appears on the screen] that indicates a reference point to move the tool to; we control trajectory and speed.”
“In joystick mode, [the laparoscope] can move in line of sight with lateral movement,” Frimer told Robotics Business Review. “We can zoom in and out, and it can work to see structures in the cavity with precision.”
“In direct mode, the surgeon’s hand is placed on the robotic arm itself, and the arm senses the applied force of the hand to maneuver the laparoscope,” he said.
AutoLap has three components and can work alongside existing patient-side hardware such as screens and scopes.
The first part is the laparoscope positioner. “The arm can be mounted on any frame and has degrees of freedom,” Frimer said. “It can hold laparoscopes from different providers.”
The second part of AutoLap is a wireless interface for the dynamic laparoscope positioning. It can be configured as a ring or as a surgical tool clip that mounts on an existing scope.
“We’ve devised the first approved sterile, disposable, wearable control,” Frimer said. “With the press of a button, the surgeon can wirelessly enable or disable [autonomous] movement.”
The third component is the computing box and image-analysis software to guide the laparoscope without the need for direct control.
It includes automatic zoom and warnings to prevent the camera from colliding with tissue and smudging the lens.
“The software for analysis and motion is robust; the surgical tools are recognized in real time,” Frimer said. “AutoLap provides a GUI [graphical user interface] overlay onto the screen already in the operating room.”
“We want to keep the system in the surgeon’s full control, without interrupting their field of view or workflow,” he added. “By using universal adaptors, AutoLap allows surgeons to use the tools already available to them.”
The “Follow-Me” software portion of the system has clearance from the U.S. Food and Drug Administration (FDA), and it has CE marking in Europe.
So far, AutoLap has been approved for general surgery, as well as gynecological and urological procedures.
“We expect to submit and receive approval for additional domains,” Frimer said.
Not only does FDA approval legitimize usage of medical robotics, but it can also help a company financially. For instance, shares in Mountain View, Calif.-based Hansen Medical Inc. jumped by 50 percent after its Magellan robotic catheter technology received FDA approval.
Short learning curve
“Minimally invasive surgery has been around for 25 years and is now in 90 percent of procedures,” Frimer said. “It hasn’t changed much — new tools have been introduced, but the triangle of human operator, assistant, and patient hasn’t changed.”
“Surgeons need some training, but the good thing is that our system provides low latency and a stable image,” Frimer said. “They don’t need an assistant to hold and guide the laparoscope because positioning is easier.”
“The surgeons are still doing the same procedures; we’re not forcing them to change practices,” he said. “What’s more, it takes only a few hours for surgeons and staff to learn how to use AutoLap, position it on the rail bed, and get used to full control.”
“From our experience, the surgeon performs a few procedures — four or five gallbladder removals — then they’re ready to go,” Frimer noted.
MST isn’t alone in the minimally invasive surgical market. Toronto-based Titan Medical Inc., which is developing its SPORT system, is hoping to raise $10.6 million to $12.1 million in stock shares.
Israeli innovation, global markets
Israel’s community of entrepreneurs and technology experts is relatively small, but that can offer an advantage, Frimer said.
“An innovator with an idea can reach out to a surgeon he knows, an engineer friend, or neighbor with ease and without too much formality,” he said. “This way, small groups form very rapidly and initiate startups in conjunction with the venture capital community.”
“Israel is a hub of innovation in software, robotics, imaging, and homeland security,” said Frimer. “An immense amount of knowledge feeds the startup community, and information is shared between players. These are key factors enabling us to develop new ideas and cutting-edge technology and to get results at a rapid pace.”
MST is also an example of ties between Israel and China. Last year, Sichuan Haisco Pharmaceutical Co. led MST’s $12.5 million investment round.
“We were the first Israeli robotics company that our distribution partner Haisco invested in,” Frimer said.
“We started marketing at the end of 2015, and we are scaling up,” Frimer said. MST is already making sales directly in the U.S. and through distributors in Europe and Asia. The company expects approval for marketing in China in 2017.
Asia is an emerging market for surgical robotics. “For certain procedures, the volume there exceeds the traditional separation between the U.S. and the rest of the world,” he said.
“We hope to expand usage to a larger surgical community,” Frimer said.
Adding situational awareness
“We’re on the cusp of introducing additional technologies, including software with situational awareness in real time that can be added to any robotic medical systems,” he said. “Looking forward, this is something that every medical device will need at some point.”
AutoLap’s image-guidance technology could have other applications.
“I truly believe that we are setting a gold standard in the way that imaging is being used. It’s our core capability,” Frimer said.
“The current status of all robotics, regardless of cost and footprint, is that they act as slaves,” he said. “We want to give additional autonomous features — of course with safety and surgeon control — to lower the cognitive load.”
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