Russ: Hi I’m Russ Capper and this is HXTV, featuring Houston’s innovators and entrepreneurs.  Brought to you by PKF Texas, CPAs and advisors focusing on Houston’s innovators for over 15 years.  Our guest today for this episode comes from a recent visit I had with Dr. Billy Cohn, noted cardiovascular surgeon, vice president for Johnson & Johnson medical devices companies and the executive director for the Center of Device Innovation at the Texas Medical Center.  We enter the discussion where we are talking about this wall, a special wall, in the Center for Device Innovation that features many of Billy’s medical devices.

Billy: There’s some Johnson & Johnson stuff. A lot of that stuff are my early prototypes that came out of my garage at home and shows how they evolved from something kluged together out of stuff from Home Depot or the hobby store, fifty bucks all in, to products that are in every hospital in the medical center now, because I’ve had a couple successes. Some of the things on that wall were in the final analysis, incredible waste of my time and other people’s money, and I show those as well because it’s a journey. In fact, the company that you said that just exited, I have a very first version of it that I made in one evening, $20 all in. It was the first pebble in the avalanche.

Russ: Tell us about that company. What was the company’s name?

Billy: The company was called TVA Medical. TVA. It was for hooking arteries to veins in the arm, so patients could undergo hemodialysis. Your kidneys right now are cleaning out your blood. Your cells make toxins, like smoke from a factory. Your cells, to do the work they need to, make carbon dioxide, which you blow out, and then a lot of other toxic chemicals that you urinate out. While we’re talking, our kidneys are filtering our blood about a liter a minute, which is great, unless your kidneys fail. Kidneys fail, those toxins build up in your blood, and you get sick and you die. That said, in the 1960’s, some brilliant guys, Kolff, figured out how to do hemodialysis. That is, taking your dirty blood out, putting it through a machine, and putting the clean blood back in you. Today, people with no kidney function at all can live happy, productive lives if they have hemodialysis.

Hemodialysis though, and you’re driving around, and you see these dialysis centers all over the place, the patients have to go, they sit in a chair, get hooked to a machine three times a week for three or four hours. That’s kind of a burden but it’s better than dying of kidney failure. The machine has two needles hooked to two long plastic hoses. One to take the dirty blood from you to the machine, one to take the clean blood back from the machine to you. Each one has a needle on the end, and the nurse needs to put those in a blood vessel where she can pull 300 or 400 cc of blood out of you, through the machine, and give 300 or 400 cc a minute of clean blood back to you. Where can she put those needles? Where is there a blood vessel close enough to the surface that she can stick it, stick the needles in it safely, and it has brisk enough flow?

The answer is, there isn’t one. So, we make one. For the last fifty years, we’ve been taking an artery and a vein in the arm, we put on our magnified little telescopes, and use our dexterous fingers, and we make an incision and we dissect out this vein. You can see this vein right here on my forearm, that’s called the cephalic. We swing it up and bring it over to the artery, and with teeny little stitches, hook them together. It becomes a short circuit. Right now, in my arm, that vein probably has 50 or 60 cc per minute flowing through it. If I sew it to the artery and take the clamps off, minutes later, it’s got 500 or 600, and over the next several weeks, even more. That little vein will dilate up, it will enlarge, so it’s as big around as my finger. Maybe you’ve seen people walking around at the store or the airport, they have a huge vein there. That means they’re on hemodialysis and a surgeon has sewed their vein to the artery.

It turns out that half of those don’t work out. Even though we do a brilliant job of sewing it together, a month or two later, the kidney doctor will call us and say, “he needs one of those on the other side, or a temporary access, because it didn’t take.” What’s that mean, not take? Well, it turns out that thin walled vein isn’t used to that brisk flow. Sometimes, when you sew the vein to the artery, the walls get thicker and thicker and thicker and it closes off. It’s a biological process. People have been trying to figure out and solve that for a while. We have some techniques and things that minimize it, but still about half of them don’t work. If we identify it early we can put a balloon in and open it up if we do that every couple of weeks in the first couple months, but still, it’s very challenging.

We noticed that sometimes a patient would get shot or stabbed in the arm, and if the knife or bullet went right through the artery and right through the vein, they would connect. I remember the first time I saw one of these I was still in training. I was in the emergency room and a guy came in who had been stabbed in the arm. He was in a fight over a parking space, someone stabbed him in the parking lot, you know, like you do. I looked at it, and it looked ok, and his hand looked ok, and he had good pulses and good perfusion of his fingertips, he could wiggle and feel. I said, “You’re lucky, you didn’t hit anything.” I gave him a tetanus shot, some antibiotics, I said, “Don’t get in knife fights anymore.” And he said, “No, sir.” And I said, “Come back if you notice anything weird.” Six weeks later, he comes back and all the veins in his arm are huge. When you put your finger lightly on them you can feel the torrential rush of blood, like touching a garden hose.

I went, “Oh my God,” and I looked up in the big textbook of surgery and learned about traumatic AV fistula. Traumatic AV fistula is when an artery and vein get injured and you start bleeding from the artery into the vein and they connect. It said, you have to take these patients to the operating room and open up over the fistula and dissect the vessels apart and very carefully fix them. Don’t do a wait and see, they will never close on their own. And make sure you do a good job, or they’ll reoccur. If you leave any little connection, they’ll reconnect. I said, “Ok, don’t close on their own, and will reopen if you don’t do a good job of closing it.” I thought, wait a second, these ones I make on purpose with my magnified vision and my dexterous heart surgery fingers close off half the time. The one that this assailant did with a pocket knife will never close. And he probably didn’t even go to medical school. So, I tried to find him, because I thought if I could line up my patients…no.

I thought, there was something about the physiology of not dissecting things out, not moving them, not dividing the teeny little blood vessels. So, I said, I’m going to make something that allows me to hook blood vessels together. So, I took a plastic tube and stacked a bunch of magnets in it. I took two of them, one that was going to go in the artery, one that was going to go in the vein. I stuck a nail, quite literally a nail from Home Depot, in the side of each one, and ran a wire, and I thought, I’m going to hook this up to an electrical generator, I’m going to put one in the artery, one in the vein, they’re going to snap together, those two nails are almost going to be touching but they’re in different vessels, and I’m going to zap electricity and blow a hole and then take them out and see if I get a connection. I showed it to some friends and they said, “Well, that’s quite possibly the stupidest thing I’ve ever seen.” I go, “Why?” And they go, “Well, if you’re not hooking the artery to the vein, why isn’t the blood going to just go everywhere?” I go, “Well, you’ve seen patients that get stabbed or shot that have blood that just goes from the artery to the vein.” And they said, “Yeah, but that’s only if it’s right where the blood vessels are together, and the injuries are perfectly aligned.” I held up my magnetic catheters and I go, “You mean, kind of like that?” Anyway, did the first animal, worked great. I hired a CEO, wrote a business plan, and raised money. Now, eight and a half years later, it’s been acquired by Bard, Becton Dickinson, and so it’s going to be in every hospital on the planet. It works really well, we’ve done 500 patients with it.

Russ: That wraps up my discussion with Dr. Billy Cohn and this is HXTV.