The National Institute of Biomedical Imaging and Bioengineering (NIBIB) within NIH is funding the development of new imaging technology to enable physicians to perform ultrasound-guided procedures involving needle placement such as needle biopsies, central line insertions, and local anesthesia.
The new imaging technology created by Clear Guide Medical of Baltimore at www.clearguidemedical.com enables physicians to plan needle entry with a precise line to the target before the needle enters the patient’s organ or tissue. The result is more efficient, less damaging, and less stressful needle placement procedures for patients.
Currently, physicians use ultrasound to obtain different views of the target to be biopsied. Based on what they see, the physician decides on a point of entry and the angle of needle insertion they believe will allow them to come as close to their target as possible.
The new imaging technology removes the guess work. The physician places the tip of the needle on the surface of the skin above the organ to be biopsied. Using sophisticated software, the Clear Guide system integrates the needle angle and the ultrasound image.
On the screen, the physician sees a visualization of the path the needle will take if inserted at that precise spot. The physician can then adjust the spot and angle of needle insertion until Clear Guide indicates that it is in the position needed to hit the target. Given this precise information, the physician is able to insert the needle and follow the trajectory as shown on the screen, directly to the target.
Clear Guide allows needle movement and repositioning before the needle ever enters the body rather than adjusting the needle while moving through the organ, which is time consuming and can result in damage to surrounding tissue.
The whole system is composed of a small touchscreen module, the handheld probe, and a cable. No new hardware needs to be installed. Guidance information is displayed on the Clear guide unit’s touchscreen. As soon as the unit is switched on, the needle path is immediately shown on the live ultrasound image.
The low cost portable aspect of the design also allows primary care personnel to do needle biopsies in a primary care office or mobile health unit. This is of particular interest to NIBIB whose mission includes the development of technologies to bring improved healthcare to remote areas and underserved populations.
Clear Guide Medical was founded in 2010 as a spinoff from the Johns Hopkins Department of Computer Science and the Radiology Department in the School of Medicine. The sustained development of the technology was made possible with a series of state and federal research and development grants.
From 2012 to the present, the company received several SBIR grants from NIBIB and the National Cancer Institute for assistance with the difficult and expensive process of bringing the product to market and obtaining FDA approval.