Robotic catheter brings autonomous navigation into human body

 

Robotic catheter brings autonomous navigation into the human body

Concentric tube robot. In a recent demo, robotic catheter autonomously found its way to a leaky heart valve. Source: Pediatric Cardiac Bioengineering Lab, Department of Cardiovascular Surgery, Boston Children’s Hospital, Harvard Medical School

BOSTON — Bioengineers at Boston Children’s Hospital said they successfully demonstrated for the first time a robot able to navigate autonomously inside the body. In a live pig, the team programmed a robotic catheter to find its way along the walls of a beating, blood-filled heart to a leaky valve — without a surgeon’s guidance. They reported their work today in Science Robotics.

Surgeons have used robots operated by joysticks for more than a decade, and teams have shown that tiny robots can be steered through the body by external forces such as magnetism. However, senior investigator Pierre Dupont, Ph.D., chief of Pediatric Cardiac Bioengineering at Boston Children’s, said that to his knowledge, this is the first report of the equivalent of a self-driving car navigating to a desired destination inside the body.

Pierre Dupont

Pierre Dupont, chief of Pediatric Cardiac Bioengieering at Boston Children’s Hospital

Dupont said he envisions autonomous robots assisting surgeons in complex operations, reducing fatigue and freeing surgeons to focus on the most difficult maneuvers, improving outcomes.

“The right way to think about this is through the analogy of a fighter pilot and a fighter plane,” he said. “The fighter plane takes on the routine tasks like flying the plane, so the pilot can focus on the higher-level tasks of the mission.”

Touch-guided vision, informed by AI

The team’s robotic catheter navigated using an optical touch sensor developed in Dupont’s lab, informed by a map of the cardiac anatomy and preoperative scans. The touch sensor uses artificial intelligence and image processing algorithms to enable the catheter to figure out where it is in the heart and where it needs to go.

For the demo, the team performed a highly technically demanding procedure known as paravalvular aortic leak closure, which repairs replacement heart valves that have begun leaking around the edges. (The team constructed its own valves for the experiments.) Once the robotic catheter reached the leak location, an experienced cardiac surgeon took control and inserted a plug to close the leak.

In repeated trials, the robotic catheter successfully navigated to heart valve leaks in roughly the same amount of time as the surgeon (using either a hand tool or a joystick-controlled robot).

Biologically inspired navigation

Through a navigational technique called “wall following,” the robotic catheter’s optical touch sensor sampled its environment at regular intervals, in much the way insects’ antennae or the whiskers of rodents sample their surroundings to build mental maps of unfamiliar, dark environments. The sensor told the catheter whether it was touching blood, the heart wall or a valve (through images from a tip-mounted camera) and how hard it was pressing (to keep it from damaging the beating heart).

Data from preoperative imaging and machine learning algorithms helped the catheter interpret visual features. In this way, the robotic catheter advanced by itself from the base of the heart, along the wall of the left ventricle and around the leaky valve until it reached the location of the leak.

“The algorithms help the catheter figure out what type of tissue it’s touching, where it is in the heart, and how it should choose its next motion to get where we want it to go,” Dupont explained.

Though the autonomous robot took a bit longer than the surgeon to reach the leaky valve, its wall-following technique meant that it took the longest path.

“The navigation time was statistically equivalent for all, which we think is pretty impressive given that you’re inside the blood-filled beating heart and trying to reach a millimeter-scale target on a specific valve,” said Dupont.

He added that the robot’s ability to visualize and sense its environment could eliminate the need for fluoroscopic imaging, which is typically used in this operation and exposes patients to ionizing radiation.

Robot ercutaneous access to the heart, from Pediatric Cardiac Bioengineering Lab

Robotic catheter enters internal jugular vein and navigates through the vasculature into the right atrium. Source: Pediatric Cardiac Bioengineering Lab

A vision of the future?

Dupont said the project was the most challenging of his career. While the cardiac surgical fellow, who performed the operations on swine, was able to relax while the robot found the valve leaks, the project was taxing for Dupont’s engineering fellows, who sometimes had to reprogram the robot mid-operation as they perfected the technology.

“I remember times when the engineers on our team walked out of the OR completely exhausted, but we managed to pull it off,” said Dupont. “Now that we’ve demonstrated autonomous navigation, much more is possible.”

Some cardiac interventionalists who are aware of Dupont’s work envision using robots for more than navigation, performing routine heart-mapping tasks, for example. Some envision this technology providing guidance during particularly difficult or unusual cases or assisting in operations in parts of the world that lack highly experienced surgeons.

As the U.S. Food and Drug Administration begins to develop a regulatory framework for AI-enabled devices, Dupont said that autonomous surgical robots all over the world could pool their data to continuously improve performance over time — much like self-driving vehicles in the field send their data back to Tesla to refine its algorithms.

“This would not only level the playing field, it would raise it,” said Dupont. “Every clinician in the world would be operating at a level of skill and experience equivalent to the best in their field. This has always been the promise of medical robots. Autonomy may be what gets us there.”

Boston Children's Hospital

Boston Children’s Hospital in the Longwood Medical Area. Photo by Jenna Lang.

About the paper

Georgios Fagogenis, PhD, of Boston Children’s Hospital was first author on the paper. Coauthors were Margherita Mencattelli, PhD, Zurab Machaidze, MD, Karl Price, MaSC, Viktoria Weixler, MD, Mossab Saeed, MB, BS, and John Mayer, MD of Boston Children’s Hospital; Benoit Rosa, PhD, of ICube, Universite? de Strasbourg (Strasbourg, France); and Fei-Yi Wu, MD, of Taipei Veterans General Hospital, Taipei, Taiwan. For more on the technology, contact TIDO@childrenshospital.org.

The study was funded by the National Institutes of Health (R01HL124020), with partial support from the ANR/Investissement d’avenir program. Dupont and several of his coauthors are inventors on U.S. patent application held by Boston Children’s Hospital that covers the optical imaging technique.

About Boston Children’s Hospital

Boston Children’s Hospital, the primary pediatric teaching affiliate of Harvard Medical School, said it is home to the world’s largest research enterprise based at a pediatric medical center. Its discoveries have benefited both children and adults since 1869. Today, more than 3,000 scientists, including 8 members of the National Academy of Sciences, 18 members of the National Academy of Medicine and 12 Howard Hughes Medical Investigators comprise Boston Children’s research community.

Founded as a 20-bed hospital for children, Boston Children’s is now a 415-bed comprehensive center for pediatric and adolescent health care. For more, visit the Vector and Thriving blogs and follow it on social media @BostonChildrens@BCH_Innovation, Facebook and YouTube.

FDA warns about using surgical robots for cancer treatment



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The U.S. Food and Drug Administration (FDA) has issued a warning against the use of surgical robots in mastectomies and other surgeries for the treatment or prevention of cancer.

The FDA said the safety and effectiveness of surgical robots have not been established for use in mastectomies or for surgeries to prevent or treat breast and other cancers. The FDA said it “encourages health care providers who use robotically-assisted surgical devices to have specialized training and practice in their use.”

The warning follows the publication of a study in the New England Journal of Medicine that said robot-assisted cervical cancer surgeries had reduced survival than open abdominal radical hysterectomies among women with early-stage cervical cancer. The journal article noted that other researchers have reported no statistically significant difference in long-term survival when these types of surgical procedures are compared.

Separately, a New Jersey hospital suspended robot-assisted mastectomy after it publicized two such procedures performed by one of its surgeons, concluding the surgery needs further review, according to a report in the Asbury Park Press. Long Island, N.Y.-based Northwell Health also touted the robot-assisted double mastectomy performed on a woman who carried the BRCA gene, which is associated with developing breast cancer.

Advocates of such robot-assisted surgery say it’s less invasive and causes less pain and fewer scars for patients. Critics such as Hooman Noorchashm, a Philadelphia-area surgeon-turned-patient-advocate, say that robot-assisted procedures are very different from standard surgery.

“If you’re dramatically changing existing standards of care… you better demonstrate that it’s not inferior to existing standards before you advertise it,” Noorchashm said in an interview with Medical Design & Outsourcing, a sister website of The Robot Report.

Demonstrating non-inferiority would traditionally require clinical trials comparing the outcomes of robotic-assisted versus standard surgery. Such studies on breast cancer patients are underway in France and Italy, but none have occurred in the United States. French investigators are comparing outcomes using traditional surgery and Intuitive Surgical’s da Vinci Robot Xi, according to the trial’s listing on clinicaltrials.gov.

“To date, the FDA’s evaluation of robotically assisted surgical devices has generally focused on determining whether the complication rate at 30 days is clinically comparable to other surgical techniques,” the agency’s warning says. “To evaluate robotically-assisted surgical devices for use in the prevention or treatment of cancer, including breast cancer, the FDA anticipates these uses would be supported by specific clinical outcomes, such as local cancer recurrence, disease-free survival, or overall survival at time periods much longer than 30 days.”

The agency has not granted marketing authorization for any robot-assisted surgical device for use in the United States for the prevention or treatment of cancer, including breast cancer. The labeling for robotic surgical devices that are legally marketed in the United States includes statements that cancer treatment outcomes using the device have not been evaluated by FDA.

“Health care providers and patients should consider the benefits, risks and alternatives to robotically assisted surgical procedures and consider this information to make informed treatment decisions,” the agency’s warning said.

The industry leader in robot-assisted surgery, Intuitive promotes the use of its robots for hysterectomies, both benign and cancer-related, on its website. The company does not list mastectomy among da Vinci’s recommended procedures and FDA did not mention Intuitive or any other surgical robotics company in its warning.

“Minimally invasive surgical devices, including robotic-assisted surgical systems and laparoscopic surgical tools, are cleared by the FDA for specific procedures, such as prostatectomy and hysterectomy, not specifically for cancer prevention or treatment,” Intuitive Surgical said in an email. “To date, there are more than 15,000 peer-reviewed articles that, in aggregate, support the safety and effectiveness of robotic-assisted surgery. We value the FDA’s role in protecting and promoting public health, and will continue to look to the agency for guidance as we develop innovative solutions for surgeons and their patients.”

A Danish study published this week in JAMA Surgery said that the risk of severe complications among early-stage endometrial cancer patients who underwent surgery after the national introduction of minimally invasive robotic surgery was significantly reduced. The patients with better outcomes included those whose procedures were minimally invasive laparoscopic surgeries and those who underwent robot-assisted surgeries. Patients were followed for 90 days post-procedure.

Intuitive Surgical recommended that surgeons discuss all treatment options with their patients and that patients ask surgeons about their training, experience, and patient outcomes.

Noorchashm’s wife, Dr. Amy Reed, died in 2017, four years after a myomectomy of fibroid tumors using a power morcellator. The tumors turned out to be a malignant form of cancer called uterine sarcoma that’s difficult to distinguish from benign tumors.

Noorchashm said he’s not anti-innovation but wants surgeons to proceed with caution. “They should slow the hell down,” he said.

Editor’s Note: This article was originally published on our sister website Medical Design & Outsourcing.

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