With HealthCanada Approval, Project neuroArm Performs Brain Surgery on First “Public Patient”

By John Otrompke

With full approval for marketing and use from the Canadian government, Project neuroArm performed robotic brain surgery on a meningioma patient on May 12. While it was the project’s first “public patient,” according to Dr. Garnette Sutherland, MD, who lead the team, the device had actually been used on several human patients prior to then, Sutherland said.

“We received our HealthCanada approval just last month; that allows us to use the neuroArm on anyone,” Sutherland said. The project is just now planning its FDA strategy, Sutherland said.

For its first public patient, the team chose a young woman with a benign brain tumor called a meningioma. “The nice thing about a meningioma is that it has a benign histology. When you take it out, it’s out,” said Sutherland. “We wanted to do someone who had a more straight-forward thing,” he said.

Despite the benign histology, Sutherland said, the family of tumor may still grow while in place, and eventually the patient can develop headaches or lose her sense of smell, he said.

The procedure was performed on Paige Nickason, 21, at Foothills Medical Centre in Canada. The neuroArm is a robotic surgical tool designed specifically for brain surgery; like the da Vinci surgical system, the neuroArm is controlled by a surgeon from a computer workstation, and works in conjunction with intraoperative MRI. During the recent operation, surgeons performed a mixed procedure, alternating between robotic and manual surgery.

Before taking on another “public patient,” the project is making some adjustments to the equipment, Sutherland said. “Right now we’re upgrading our magnet to 3 Tesla. That should allow us to get faster images and further integration into robotics. It should take a couple of months, and then we’ll go back on stream,” Sutherland said.

http://www.neuroarm.org/project.php

Tacticity Research in Robotic Surgery

Rahuldev Bhalla M.D.
Director of Robotic and Minimally Invasive Surgery
Department of Urology
StonyBrook Medical Center

Prostate cancer is the most common cancer in men in the United States. In 2006, an estimated 234,460 men in US were diagnosed with prostate cancer. Currently, radical prostatectomy is the only treatment that has been shown to decrease disease-specific mortality from prostate cancer. However, concerns over the morbidity of open radical prostatectomy, including pain, blood loss and length of hospital stay, have led the impetus to develop minimally invasive approaches to radical prostatectomy. Laparoscopic radical prostatectomy (LRP) was first reported in 1992. However, this procedure has not gained widespread popularity. Since 2000, robotic assisted radical prostatectomy (RARP) has been adopted as the technique of choice for performing radical prostatectomy. The inherent advantages of RARP include 3-dimensional visualization and endowrist instrumentation, both of which permit a shorter learning curve in addition to a more precise surgery. However, direct haptic (force or tactile) feedback is not available in current commercial robotic surgical systems. The addition of haptic feedback has been proposed as a way to further enhance the performance of these systems. Direct tactile or force feedback is necessary to decrease the number of broken sutures and the number of loose knots as well as limit tissue damage, and will result in a more consistent application of forces. Haptic feedback also increases operator performance and surgeon comfort during telerobotic manipulation. Feedback of grasping pressure is critical in many microsurgical tasks. However, due to limitations in current sensing and control technologies, implementing direct haptic feedback to the surgeon’s hands remains impractical for clinical application. In this project, we intend to investigate a set of effective sensing techniques to provide real-time force feedback for current commercial robotic surgical systems. Here at StonyBrook Medical Center, we are developing a novel haptic system. This is composed of two end effectors on each instrument as well as a single tool effector which will give visual tactile feedback to the user in the form of a color strain gauge. The research is on-going and promising.

Ikonisys Expects to Submit 4th FDA Clearance Application

Cancer Screening Device Described at ASCO
Indicates Breadth Of Medical Robotics Industry

By John J. Otrompke, JD

A medical robot manufactured by Ikonisys was described at this year’s annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago.

Ikonisys is expected to submit its 4th application for a clearance by the Food and Drug Administration (FDA) later this year.

The poster, and abstract 11084, was presented on June 1. While it was apparently the only research presented at ASCO concerning medical robotics, it illustrated the breadth and applicability of the robotics industry in medicine.

“Our developing system uses a robotic approach for magnifying slides with an efficiency and frequency sufficient to allow the detection of cancer cells with a frequency of as little as one in a million,” said Nicholas Romas, founder of Ikonisys, who presented the poster.

The robot works by using a process known as automated fluorescence microscopy, thereby avoiding complex purification procedures which risk cell loss and can create unresolved clusters of normal and cancer cells, according to the abstract, ‘Analysis of circulating tumor cells in prostate, colorectal and ovarian cancer using microscopy.’

In the study, blood samples were collected from seven prostate, ten colorectal and four ovarian cancer patients, as well as 11 healthy controls.

The device found the cells in all of the colorectal and ovarian patients, and five out of seven prostate cancer patients. There were no false positives, the abstract reported.

Since 2002, the Ikonisys system has received FDA approval for use of the device in detecting bladder cancer, as well as prenatal diagnosis of birth defects. The company also has submitted an application for breast cancer clearance, and expects to submit one for cervical cancer by the fall of this year.

Ikonisys currently has systems in place in Belgium and Switzerland, and Great Britain. The largest private lab in Italy, Centro Diagnostico Italiano, in Milan, also uses the Ikonisys system, said Romas, adding that more than 20 devices have been sold since the company began community placements less than a year ago.

The list price in the U.S. is $200,000, he added.