Innovative Devices Address Long-Standing Neurological Care Challenges, From Bedside to OR

Two innovations developed at Cleveland Clinic address these challenges at different points in neurological care.

• The Ambulatory Cerebrospinal Fluid (CSF) Management Device reduces the need for constant hands-on monitoring during spinal fluid drainage trials.
• The Anti-Brain Shift Device helps keep air from entering the skull during stereotactic surgery.

Hear from the clinician inventors behind them, Sean Nagel, MD, Staff, Neurological Institute, and Andre Machado, MD, PhD, Institute Chair, Neurological Institute, in the video below:

A New Approach to Managing Cerebrospinal Fluid in Hospital Care

Normal pressure hydrocephalus (NPH) is a brain condition where excess cerebrospinal fluid builds up in the brain’s ventricles. It’s a potentially treatable cause of gait impairment, incontinence and dementia-like symptoms in adults over 60. Current diagnostic standard-of-care involves draining spinal fluid with a lumbar catheter, but it’s time- and labor-intensive for hospitals, and uncomfortable for patients.

Dr. Nagel’s invention addresses both problems head-on. With the Ambulatory CSF Management Device:

• Patients will no longer be bed-bound and can move freely during the evaluation period. The device, about the size of a computer mouse, will be situated on the lumbar spine, and patients can move freely throughout the hospital.
• The device does not require specialized nursing care. It will drain excess fluid continuously, rather than hourly; its monitoring system pairs with an iPhone and can notify nurses if canisters are full or have a blockage.
• In the future, these treatments may be able to take place outside the hospital, including in patient homes.

“Currently, a very small number of patients are actually being seen and evaluated for NPH,” says Dr. Nagel. “Part of that is because it’s not recognized, but part of that is because there’s not expertise or experience with managing these patients. Bed availability also creates some challenges. So, if you have a system that is easier to use, we anticipate that we’ll be able to take care of many more patients than are currently being looked after right now.”

Preventing Brain Shift During Stereotactic Surgery

When performing stereotactic surgery, surgeons rely on pre-operative imaging to accurately target hard-to-reach areas of the brain. But when they open the skull, cerebrospinal fluid can leak out and air can enter, causing the brain to shift in unpredictable ways.

“That brain shift can lead to losses of precision of our targeting of specific brain structures,” says Dr. Machado, inventor of the Anti-Brain Shift Device. “If I’m doing a biopsy of a very small, difficult to reach area, and the brain moves as that biopsy is being done, the ideal location can be missed.”

Dr. Machado’s device supplies a steady flow of sterile fluid at the burr hole, the small opening through which surgeons access the brain. By replacing fluid with fluid instead of air, it maintains a controlled pressure at the opening, thus minimizing brain shift.

The Anti-Brain Shift Device is distinct in several ways:

• Some alternative approaches to managing brain shift rely on intraoperative MRI to detect brain shift as it occurs. These systems are costly, resource intensive, and do not prevent brain shift from occurring.
• Existing burr hole devices are typically designed to anchor or guide surgical instruments. According to Dr. Machado, his device performs these functions while also managing fluid and pressure at the opening. In phantom testing, using a realistic brain model, the Cleveland Clinic prototype limited intracranial air accumulation over 30 minutes compared to existing burr hole devices.

Cleveland Clinic Innovations is seeking licensing and co-development partners to advance these technologies toward clinical adoption. Learn more here.