Sculptura robot-assisted system is shaping intraoperative radiotherapy
Sensus Healthcare is on the way to revolutionizing cancer therapy with the Sculptura medical device. Sculptura can be used to carry out pinpoint irradiation of tumors in the body and thus protect surrounding healthy tissue. The integrated KUKA LBR Med robot for medical technology plays a decisive role here.
Sensus Healthcare specializes in the development of highly effective, non-invasive, minimally invasive and cost-effective treatments for oncological and non-oncological conditions. Based in Boca Raton, Florida, the company has developed the SculpturaTM, which is a system for directional anisotropic (meaning irregular) radiation therapy (ART) and a product that is both exceptional and unique in many respects. It enables the targeted treatment of cancer patients in an intraoperative manner. “It is also the first system that enables doctors to shape the beams into specific geometries, execute a three-dimensional alignment, and effectively and intensively irradiate a tumor or tumor areas. That minimizes the impact on surrounding organs and tissue,” explains Kal Fishman, co-founder of Sensus Healthcare.
Precision and flexibility thanks to robot-assisted radiation system
Fishman also stresses that there would be no SculpturaTM in this form without the LBR Med. “The robot allows us to achieve anatomically exact positioning of the beam source. No one else on the market offers this kind of precision and flexibility,” explains the co-founder of Sensus Healthcare. The cooperation between Sensus and KUKA has become closer over the years. A partnership has developed that goes well beyond the development of the ART system. “KUKA was very patient with us and provided us with a lot of support during development – particularly when it came to the integration of the robot and the collaboration,” notes a contented Fishman.
Protect the surrounding tissue with robot-assisted intraoperative radiotherapy
Other systems work with a linear beam that is directed at the tumor from outside and radiates through the tissue. This makes it hard to focus the maximum dose precisely at the tumor. The system from Sensus, however, aligns the radiation three-dimensionally so that the maximum dose reaches the tumor and does not affect the surrounding tissue. Sensus calls this “triple modulation”. Within the 3D cone, the dose can be individually adjusted in any desired area. Tumors in the spinal column, brain and female breast can thus be treated.
Successfully passed the complicated approval process for robot-assisted systems for medical applications
The uniqueness of SculpturaTM, however, proved to be an obstacle in gaining approval from the U.S. Food and Drug Administration (FDA). “Since our approach and the technology differed greatly from the conventional, we really had to work hard at convincing people,” Fishman recalls. The LBR Med’s CB certification, which is the certification for use in medical products, was very helpful in this process. “That saved us a lot of time and headaches. Throughout the process, KUKA was a big help to us and always had an open ear for our needs,” the Sensus co-founder notes.
User-friendliness thanks to robot for medical applications
The tracking of breathing motions was also a challenge. Usually when a patient moves, the beam has to stop, the body must brought back to the original position, and the beam is switched on again. The LBR Med allows SculpturaTM to follow the breathing motion while the patient breathes under anesthesia. Treatment can be carried out without interruption. The beam follows the anatomy and remains aligned with the tumor, without endangering the surrounding tissue. This allows the system to always execute the treatment plan exactly.
Simple start-up thanks to the integrated lightweight robot
The integrated LBR Med has assisted in automating many tasks – such as the introduction of the radiation source into the calibration chamber. SculpturaTM also carries out the calibration of a phantom. “We guide the system into the starting position. From there, SculpturaTM takes over and the dance begins. The beam source is controlled by software as well as by sensors on the phantom. No one has to intervene manually. That is an important factor for the hospital,” notes Fishman in explaining the procedure.
Clinical trial of the robot-assisted system for intraoperative radiotherapy
The patients’ safety is ensured with SculpturaTM. The planned beam can be activated in a closed chamber, allowing for a check of the geometry. Sensus, however, has established a more innovative method of inspection: augmented reality. Using special glasses, the doctor looks through the patient’s body and sees the shape and distribution of the radiation cloud in the anatomy directly in front of him on a small display – if necessary, from different perspectives
The KUKA technicians were a big help to us with everything related to the collaboration between humans and machines as well as controlling the robot as part of the medical product. Without them, we would not have made it this far.
In the next step, Sensus Healthcare will enter clinical trials with experienced SculpturaTM users. The system has already been delivered to three institutes in the U.S. The experiences are to be presented at next year’s meeting of the American Society for Radiation Oncology.