Do-it-Yourself Cerebral Hematoma Detection

February 28, 2013 EST at 5:15 pm
Abby small

Abby, from Medlogic, demonstrates the Infrascanner 2000

The Infrascanner™ 2000, a hand-held, NIRS-based, device for detecting subdural hematomas, recently received FDA clearance.

The first showing of the product was at the ICU of the Future meeting in Los Angeles, February 21-22.  The technology inside this product goes back to the late Dr. Britton Chance, a brilliant biophysicist at the University of Pennsylvania.  I worked for Dr. Chance in 1972 while still an electrical engineering student at Penn building amplifiers for oxygen electrodes.  We re-connected a few decades later when we were both at an NIH workshop to assess neonatal neuromonitoring technology.  At that time Dr. Chance’s group had developed technology to use near infrared light to assess cerebral oxygen in a product called RunMan™.  Shortly after that, we got involved in some software development for the device that was being commercialized by a company called NIM run by Dr. Chance’s sons Sam and Peter.  We used RunMan as one of the measurements in our initial multimodal monitor prototype.

NIM never really got off the ground as a business and Dr. Chance’s technology was licensed by Infrascan, Inc a company in Philadelphia run by Baruch Ben Dor.  It seems Baruch’s team has finally gotten it across the finish line.  Baruch and I have known each other for several years as we both run small medical device companies.  We both had an unnecessarily prolonged time getting our products cleared by a dysfunctional FDA process (more on this in another post).

Clarence

Clarence Carlos

A lengthy FDA experience translates into a period where you need to keep your company alive to benefit from your work but can’t sell your product for the income to do it. Knowing what we went through, I’m happy to see their product finally on the market.

A company called Medlogic, based out of Pittsburgh, is now selling the product. Medlogic is run by Clarence Carlos, a fascinating and amazingly connected person who I spent some time with in a bar in LA.  As a former football player he is developing the untapped sports injury market to quickly assess the brain following a blow to the head. He is working with school systems on a national level and already has the device in the hands of the Pittsburgh Steelers.  They are also exploring the obvious applications in pre-hospital and hospital care.

 

No hematomas in this brain

No hematomas in this brain

The current Infrascanner 2000 is easy to operate.  It provides a diagram of the head much like that seen on an EEG headbox with eight positions marked for you to test, four left and four right.  The device steps you through collecting a measurement at each site by holding the unit to the head and pressing a button…very easy. This pattern supposedly will provide a quick assessment of the presence of subdural hematomas across the cortex.  I tried the unit myself.  My do-it-yourself scan was quick and easy and found no hematomas!

BIS and My Butt

February 3, 2013 EST at 7:19 am
Neurotrac

The Neurotrac

I had my first colonoscopy a while back and having had very few surgeries in my lifetime I thought this would be an interesting time to experiment with some “depth of anesthesia” technology.  A product that my pals Gary and Matt and I developed back in the 1980’s (the Neurotrac), had a number on it called the spectral edge frequency (SEF). The SEF was computed from the EEG and indicated the highest frequencies active in the EEG.   The product was the first digital system made for recording and processing continuous EEG in the OR and ICU.  The SEF was sensitive to anesthetic drug action as this edge tends to go through a repeatable change from light anesthesia to deep anesthesia. The Neurotrac was quickly used in studies of depth of anesthesia by academic sites around the world.  So I have followed this field from nearly the beginning.

Aspect Medical Systems was the first company to raise venture capital and fund major investigations into developing a single number that reflected depth of anesthesia and that was independent of the type anesthetic agent.  They were a very cool company with a scientist, Nassib Chamoun, at the helm. The number they computed, called the bispectral index (BIS) pretty accurately monitored the depth of anesthesia and sedation.  They manufactured a small box and sensors to allow anesthesiologists to monitor anesthetic drug action directly, rather than indirectly through vital signs.  It was not without its critics as with any new technology, but it has become a mainstay in many institutions to make sure surgical patients do not wake up during surgery nor suffer the side effects of too much anesthetic.

So…back to my experiment.  The day before the colonoscopy I grabbed an Aspect monitor from the company (we were doing several projects for them) and brought it home for the notorious “night before”.  This is where you take some laxatives and drink a week’s worth of water in an hour until you literally explode with the worst case of colon blow you’ve ever had.  It’s a mess but it does improve the view for the GI docs looking for those pesky polyps.

The day of the ordeal, I put the BIS monitor in a canvas bag and headed into the hospital.  I was “processed” the same as every patient but they saw the bag and said I had to leave my clothes in a locker.  I told them this was a brain monitor and that I wanted to hook myself up and monitor my depth of anesthesia.  It was apparent they had never had this conversation before as they didn’t know how to answer.  The attendant said this wasn’t allowed, but I asked him who was going to monitor my brain…if I didn’t.   He never heard this either.  So he excused himself, returned about ten minutes later and said it was OK.  I asked what had changed his mind.  He said he talked to the head anesthesiologist who ran this out-patient clinic.  As luck would have it, she remembered me when I was a medical student at this same hospital, told the resident that I was a bit “different”…and to just let me do what I wanted.

I entered the room, with my paper gown on (opening to the rear), and put on the BIS sensor and plugged in the monitor.  I had a nice conversation with the nurse anesthetist who was very cooperative and as curious as I was as to what this would show.  He put in an IV line and, I got into position on my side, and watched the display.  I was going to see at what number I blanked out.  The highest value of BIS is 98 so that’s where it started drawing the trend line.  He started to push the Propofol, I felt a slight stinging as it entered and I had no sooner looked at the number when…“poof”….I was out.

I woke up at the end of the procedure to see a perfect “bathtub” curve, as they call it, on the display:  a nice induction followed by a relatively stable surgical level and then a mirror of the induction for the recovery (see the picture).

BIS small

BIS during my colonoscopy

Monitoring the brain makes a lot of sense when you are giving “poisons” that target the brain (as one anesthesiologist described his profession)…and it has amazed me that there was such an initial resistance to monitoring the brain (which is a reason I’m not retired by now).  In spite of this, anesthesia has done a remarkable job of promoting safe practice, probably more so than any other specialty in medicine.  Their Closed Claims Project is similar to the investigation of plane crashes that has made flying so safe.  I have followed that project since its early days with the work of Dr. Karen Domino.

Members of the anesthesia community have policed themselves to where they are the model for other specialties.  It keeps their butt out of trouble and my butt safe.  I like that.