A Blog by Jonathan Low

 

May 31, 2018

The Operating Room Of the Future

The goal is to reduce risk by improving effectiveness. The question is, at what cost? JL

Laura Landro reports in the Wall Street Journal:

There are large variations in outcomes among surgeons, related to judgment, skills and capabilities. Lower-skilled surgeons have higher rates of complications, readmissions and repeat operations. New technology could help the operating room get smarter, more effective—and a lot less risky for patients. Surgeons can control robot cameras with eye movements as they move into patients’ bodies through tiny incisions. Doctors can create a GPS-like map projected onto a patient’s body to virtually see inside the anatomy before an operation, track their surgical tools and help them operate more precisely.
The operating room is getting smarter, more effective—and a lot less risky for patients.
Hospitals are investing in new devices, designs and digital technologies that promise a new era of innovation for surgery. The moves are part of a growing shift away from traditional open procedures that involve big incisions, lots of blood loss and long hospitalizations. They point toward a future where more patients can choose minimally invasive outpatient surgeries, with faster recoveries, fewer complications, and less pain and scarring.
These new technologies cover a range of advances. With some, surgeons can control robot cameras with eye movements as they move into patients’ bodies through tiny incisions. With others, doctors can create a GPS-like map projected onto a patient’s body to virtually see inside the anatomy before an operation, track their surgical tools and help them operate more precisely.
Other advances aim to reshape the operating room itself, by adding more space for surgeons to work as well as imaging equipment that lets patients receive X-rays and other tests on the operating table instead of getting shuttled around the hospital. And machine learning and artificial-intelligence technology is being developed to let surgeons tap into big data before, during and after they work, to get guidance from computer systems that have analyzed the procedures and learned to make recommendations.
If successful, these changes could have a profound effect on patients. Despite years of progress, surgery remains a risky field. Infections are a frequent complication and can cause death. Studies have shown that even in the same hospital there are large variations in outcomes among surgeons, related to differences in judgment, skills and individual capabilities. Lower-skilled surgeons have higher rates of complications, readmissions to the hospital and repeat operations. New technology could help level the playing field.
“The field of surgery is evolving very fast, and technological advances are making it more efficient and effective and improving patient outcomes,” says Santiago Horgan, chief of the division of minimally invasive surgery at the University of California, San Diego, and director of its Center for the Future of Surgery, which is equipped with the latest technology to train surgeons with simulated procedures. While surgery may never be fully automated, Dr. Horgan says, “in the future robots will be smarter and more interactive, bringing as much information to surgeons as possible during surgery.”
Of course, many technologies are still in development, and others have yet to be widely adopted or fully evaluated for safety and cost-effectiveness. And some in the health-care industry warn about embracing new technologies too quickly.
“We don’t want to get into an arms race of creating ever more costly therapies, and we have to be careful we are not adopting technology unless it is more effective and improves outcomes over time,” says Steven J. Corwin, president and CEO of NewYork-Presbyterian Hospital, which is affiliated with Weill Cornell Medicine and Columbia University College of Physicians and Surgeons.
Here’s a look at some of the new technologies out there, and how they promise to reshape patient treatment in years to come.
Expanding operating rooms
One of the most basic changes in store is the redesign of the operating room. Some hospitals are creating “hybrid” facilities that combine conventional operating rooms with imaging equipment used in minimally invasive treatments that rely on tiny tubes inserted in a blood vessel or a body cavity. That way doctors can do both open surgery and minimally invasive procedures instead of scheduling them at different times. For patients, it means avoiding two separate procedures under anesthesia, and less time in the hospital and recovery.
For an idea of how this could improve treatment, consider cardiac catheterization, a so-called interventional procedure, where a tube is inserted through a blood vessel to reach coronary arteries. Doctors might use the catheter to insert a stent to improve blood flow to the arteries, but patients might also need open surgery to bypass the blocked artery. In a hybrid operating room, doctors can immediately shift from the less invasive interventional procedure to open surgery.
Another effort under way is to simply make better use of the typical 600-square-foot operating room. “ORs are often so cramped with no space to walk in and people climbing over carts and bending over equipment, which makes for an extremely unsafe environment,” says Anjali Joseph, director of the Center for Health Facilities Design and Testing at Clemson University. Dr. Joseph is coleading a federally funded project with Scott Reeves, an anesthesiologist at the Medical University of South Carolina, to design an operating room that increases patient safety and is easier for OR teams to maneuver around.
A prototype unveiled in January will allow researchers to perform surgical simulations and test such improvements as reorganizing equipment storage to bring tools closer to the operating table and keep doctors’ focus on the patients, as well as improving traffic flow.
The team is also studying the traditional approach of having a “sterile corridor” between adjacent operating rooms to cut down on infection risk. While the idea is that it reduces infections by decreasing traffic from contaminated areas, the project’s preliminary data suggest that the number of times the door to an operating room is opened and not the presence or absence of a sterile core is what’s important. “This will go against 50 years of conventional OR design,” Dr. Reeves says.
Among other recommendations from the project team are mobile staff workstations, digital displays high on the walls so everyone on the operating-room team can see the procedure in real time, and “plug and play” ceiling-mounted surgical booms to accommodate new technologies such as advanced imaging.
NewYork-Presbyterian has incorporated a number of new approaches into its new David H. Koch Center, opened in April with 12 outpatient operating rooms, interventional radiology, diagnostic imaging and other services.
The facilities also try to address another persistent problem in operating rooms: infection. The floors are terrazzo, which doesn’t support bacterial growth, while a stainless-steel wall system is easy to keep sterile and can be adjusted to accommodate new equipment. Three surgical booms with extra-long reach allow equipment to be suspended from the ceiling, removing the hazard of cords and cables on the floor. LED lights provide illumination with less heat, promoting airflow that minimizes airborne micro-organisms.
Technology will also help patients have a better experience, Dr. Corwin says. Before surgery at the new center, patients and families will be able to complete paperwork remotely and get a personalized “smart band” with information about their schedule and directions to their own pre-op and recovery room. A screen in the room, where families can stay while the patient is in surgery, will display information about the medical team, and families will get electronic updates about the patient’s status and when they are out of the OR.
More responsive robots
Research is mixed on the benefit of robotic-assisted surgery, introduced nearly two decades ago as a more precise alternative to conventional minimally invasive surgeries, or “keyhole” surgeries, in which surgeons make small incisions and use a laparoscope—a thin telescope with light and a video camera—to insert special tools with long, thin instruments. Many studies suggest robotic surgery has fewer complications and shorter hospital stays, but others show lower success rates in some types of surgery and other negatives, including higher costs.
Developers are working to make such systems smarter, cheaper and more autonomous. For example, researchers are working on programming robots to do such tasks as stitch up tissue after a surgeon is done, which could help prevent problems for patients such as leakage from sutures that aren’t consistently tight.
The field is dominated by Intuitive Surgical Inc.’s da Vinci Surgical System, which has been used in more than five million surgeries world-wide. Surgeons sit at a console with a video monitor, using robotic arms to manipulate tiny instruments through small incisions. In addition to better visuals of the patient’s anatomy, it also filters out hand tremors and is designed to keep the surgeon in a relaxed, comfortable position for long, complex procedures. Intuitive is developing enhancements for its systems, including a flexible robotic catheter to make it easier for surgeons to navigate into the lung to obtain tissue samples while reducing the risk of harm to patients.
Intuitive CEO Gary Guthart says the company is also working on more advanced robots that will offer “increasing collaboration and control between the computer and the surgeon,” much like that between aircraft pilots and modern automated control systems.
A number of new companies are also entering the market, including medical-device giant Medtronic PLC and TransEnterix Inc., which received approval from the Food and Drug Administration last year for its Senhance Surgical System in some surgical procedures.
The Senhance system has optical sensors that allow surgeons to move the camera and select commands with eye movements and offers haptic feedback, which provides a sense of touch and feel during surgery based on pressure and tension in the instruments, “much as a driver would feel on a steering wheel going over a speed bump,” says Todd M. Pope, TransEnterix’s founder and CEO.
Better decisions with big data
A new generation of digital surgery tools aims to combine robotics, big data and other technologies to let surgeons make much better decisions when working on patients.
The most closely watched new entrant in this field is startup Verb Surgical Inc., a partnership between Google parent Alphabet Inc.’s Verily Life Sciences unit and Johnson & Johnson ’s Ethicon surgical-equipment division. The partners are referring to their concept as “surgery 4.0,” the next step after traditional open procedures, minimally invasive surgery and the introduction of robotics.
Verb is offering scant details on how the system will work. But the idea involves using a type of artificial intelligence known as machine learning—computer programs that can crunch data from thousands of past surgical procedures to identify best practices and potential errors.
The system, Verb says, could let surgeons train before an operation, and then assess how they did after the operation, measuring things like procedure time, economy of motion, and the number and type of instruments used. Eventually, the company says, the system will help surgeons make decisions in the midst of an operation, from suggesting the right technique in a particular surgery to warning of potential mistakes such as the severing of a blood vessel.
Verb plans to release its first product in 2020, and says it has already demonstrated a fully working system to its parent companies. “Right now, we have a very disconnected OR, with isolated equipment and robots, like a disconnected 1970s car without any sensors or connectivity,” says Verb Surgical CEO Scott Huennekens. “Our vision is that eventually a connected system will be in every OR, giving surgeons the tools to take the variability out of surgery.”
Some surgeons have expressed interest in the possibilities. “Decisions need to be made in a matter of minutes during surgery, and there is an unmet need in translating existing data on outcomes to the immediate needs of surgeons,” says Umamaheswar Duvvuri, a head and neck surgeon at the University of Pittsburgh and medical director of its new surgical innovation center. “If we could have big data crunched and available at the time we are doing surgery,” he adds, it would be akin to being able to say, ‘Hey Siri, if I cut this nerve, what happens?’ ”
Clearer views inside the patient
A variety of technologies aim to let surgeons better see what they are working on inside patients as they operate.
Take the case of cancer surgeons. Removing a tumor is a delicate balancing act between cutting out disease and leaving healthy parts of the anatomy intact. But the contrast dye often used to light up diseased areas must be injected into patients well in advance, and may not always work as hoped for. The dyes are also toxic and can cause allergic reactions.
The University of Pittsburgh is working with ChemImage Corp. , which is developing a method that it says lets doctors better visualize organs and tissues in real time, such as showing where a tumor ends and healthy tissue begins. Its technology, Molecular Chemical Imaging, or MCI, combines spectroscopy, the use of light to measure materials, and digital imaging.
Patrick Treado, founder and chief technology officer of ChemImage, says the technology is broadly applicable and will be designed in the future for use with endoscopy procedures, in which doctors insert a tube with a camera that allows them to view and operate on organs. It produces images in real time based on the evaluation of distinct colors in the visible light spectrum and beyond what the eye can see in the near-infrared light spectrum. MCI uses more colors overall than current cameras, which only use red, blue and green in the visible light spectrum.
“Our objective is to provide advanced visualization to the surgeon without changing how the surgeon currently performs surgery, but rather to provide them more and better information, on demand,” Mr. Treado says. For example, the images could make it easier during a hysterectomy to identify the tubes that carry urine from the kidney to the bladder so surgeons don’t inadvertently cut one. In addition to seeing tissues better through fat, overlying tissue and blood, MCI has the potential to make surgeons more efficient with less training.
Another effort to improve what surgeons can see is under development by a Cleveland Clinic spinoff, Centerline Biomedical. The idea is an alternative to fluoroscopy guided procedures, the X-ray technology that doctors now use to place a stent graft within an artery.
The traditional approach not only relies on contrast dyes but also exposes doctors and patients to continuous high doses of radiation. The images produced by fluoroscopy are also only 2-D grayscale images.
So, Centerline is developing a system to reduce the need for fluoroscopy and prevent the harmful effects of radiation. Using a mathematical algorithm and safe electromagnetic tracking, it provides 3-D color visualization and allows a surgeon to follow the position of instruments within the patient’s anatomy on a screen with a high level of accuracy—similar to GPS for cars.
With a new federal grant, Centerline is now testing the system with HoloLens, the mixed-reality smart glasses made by Microsoft Corp. The glasses will superimpose a 3-D outline of the patient’s vascular system onto a doctor’s field of view, “like having X-ray vision,” says Karl West, a mechanical engineer and director of medical-device solutions for Cleveland Clinic and scientific adviser to Centerline.
At Lucile Packard Children’s Hospital, affiliated with Stanford University, Frandics Chan, a pediatric radiologist, worked with EchoPixel Inc.to develop an augmented-reality technology called True3D. The technology converts MRI, CT and ultrasound scans into a 3-D image that can be viewed with polarized glasses that filter the images to the left and right eye in front of a monitor while operating. Surgeons use a stylus to rotate and examine every layer of anatomy, getting more information than from 2-D imaging. The system was used in the 17-hour 2016 separation of conjoined twins at Packard Children’s.
EchoPixel has since found a way for surgeons to see the images without the glasses by using a monitor that can channel the correct images to the left and right eyes. Dr. Chan says that eliminates the need to change glasses during the operation and the risk of contaminating the sterile surgical field. The new approach will be used in the hospital’s new surgery center opening in July.
“We are really hoping that this technology will help surgeons be secure at every step so there is no need to guess something,” Dr. Chan says.

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