Greg Ruff, MD - Plastic Surgeon, Inventor of the Barbed Suture
The narrative of the barbed suture:
The inspiration for the suture goes back long before I was a doctor. I grew up in southern Michigan around Detroit, which is kind of marshy land, and spent a lot of time outdoors pursuing snakes, frogs, toads, turtles, butterflies, and such. I joined the Boy Scouts, and even though we didn’t have it as an official position, I was called the Naturalist of the troop. Then I went to the University of Michigan where I majored in zoology.
Flash forward to when I became a surgeon, I was trying to find a better solution than tying a loop with a knot to secure wounds together. That loop constricts the blood vessels within it. We even have a phrase, I can hear my chief resident growling at me, “Darn it Ruff, approximate, don’t strangulate”. I started to think about porcupines and their quills. I had seen one on a scouting adventure in Philmont Scout ranch in New Mexico and chased it, but I was afraid to get too close, so I and it climbed a tree, and that was the end of that. I heard their quills had multiple barbs along the shaft of this modified hair, and they were reputed to go in and not come out. In fact, if they were in a tissue that was moving a lot, it could actually latch itself, ratchet forward, and come out from the other side.
The “ah-hah” moment came in October 1991 when I realized that you could put a quill like device on one side of the wound and one on the other side and link them together; or better yet, make them out of the same piece of suture material, so one end could anchor the other. At the same time, I thought if you can approximate tissues, you can actually change their relative dimensions. The tissues always want to gather where the barbs change direction, at the so-called transition point. So for my purposes, I thought about putting the transition point at the hairline, with one set of barbs at the scalp, serving as an anchor and bringing the other set of barbs out the cheek, near the jowl. Using this technique, I thought if I held the suture and moved the cheek and jowl up towards the temple, I could do a face lift without any incisions.
I thought my idea was going to avoid the problem of the constricting loop, so I decided to test the idea. It was around 2 in the morning (since I had to wait for our oldest, but only son at that point, to fall asleep), and I got out the tripod and video camera, weedwacker cord, a ruler, a scalpel, and some tape; and I videotaped the first bidirectional barbed suture that I was aware of. I cut the barbs at about a 30-degree angle to the suture, and I cut about a third of the way through the weedwacker cord; then I rotated the cord 120 degrees, and I cut a second barb. That barb did not overlap the first barb, but the deepest part of the second barb’s cut was where the first barb’s cut had begun, and then I rotated it 120 degrees more, and I cut a third barb offset in a similar fashion. One barb didn’t overlap another, but you didn’t leave any part of the suture unbarbed. The reason I made this helix was inspired by the fact that trees would try to maximize the amount of light they received by having an array of branches or leaves in this kind of arrangement, the angle phi. I took the weedwacker cord and went to the grocery store and bought a New York strip steak, stuck the barbed cord segment in the steak, and I realized that it was strong and held well; it was a viable idea. When I was telling this story once, someone asked why I bought such an expensive cut of meat, and I told him, “because I ate it afterwards.”
Original drawing of Dr. Ruff's idea for the barbed suture:
At that point, I was an assistant professor of plastic surgery at Duke University and was trying to get tenure by publishing articles in addition to having my clinical practice. If you had a patentable idea, you were supposed to disclose it to the university’s Technology Transfer office. I told them I had an idea and they sent me a form to fill out pertaining to prior research, but there was no research done. I had thought of this idea while I was working in the yard. I told the university that I had an idea and that I had a partner. A fellow I met who had started his own company, and you may have heard of it, because they’re one of the leading producers of LEDs in the world, CREE Research.
My partner exhorted me to pursue patentable ideas; he was my business half and gave me advice in that regard. He informed me that Duke had to weigh in on this suture to declare whether I owned it, they owned it, or something in between. The in-between zone, at that time at least, was kind of nebulous and stacked in Duke’s favor, because they said that if I used some of Duke’s resources, they could negotiate and take up to 10% of our gross revenue, which was a significant proportion. So, two people had to sign off on this: the Chairman of Surgery, arguably the man who created the best surgical department there ever was and maybe ever will be, Dr. David Sabiston at Duke, and a dean, who was a Radiologist. They had to look over my submission to the Tech Transfer office.
Having not heard back three months after submission, we decided that it was time to call the reviewers. I spoke with the woman at the Tech Transfer office by phone, and she said that a memo was sent to me acknowledging that it was my idea, but I had not received this memo. In her next breath, she said that they were going to show my idea to Johnson & Johnson (J&J) when they visited Duke in the next few weeks. I asked her to send me a copy of the alleged memo and to cancel the meeting. The bottom line was that I never got a copy of the memo. So, I went to private attorneys to patent this idea. I submitted two patents: one was a barbed tissue connector and the second one was an inserting device for a barbed tissue connector, which was kind of a curved tube with a flared end like a trumpet to insert the bidirectional barbed device into the tube.
The inserting device for the barbed tissue connector patent had nine claims and the examiner, the lawyer at the Patent and Trademark Office, told me that he would allow me the first claim, but the others were too common. But he said if I put the barbed suture inside the tube and claimed a combination, then I could have all my claims. The guy who was the lawyer for the barbed tissue connector patent said that there were other devices out there. For example, in reference to my helical array of barbs, he showed me a patent from the early 1900s which alluded to a reflector you see in the middle of the road; and said there's a shaft on the reflector with barbs arranged in a helical array. After several such instances, we sent a letter to this patent lawyer acknowledging that the arguments presented were not an analogous art; all we wanted to do was to close wounds with our device. He fought us for two years before finally retiring. The guy who came in after him granted all the patents and claims, and we got the barbed tissue connector approved.
So, I had these 2 patents, and my partner has 2 brothers. He started CREE with one brother, and his other brother wanted to start an offshoot of CREE because the silicon carbide crystals they made could be fashioned into gemstones that were superior to diamonds in almost every respect. This led to my partner informing me that he only wanted to participate in my venture to a limited extent, so we agreed to rearrange the stock to do an 80/20 split. I trusted him as my business half. I got a letter from him that I didn’t vet with an attorney; which was a mistake. He later stopped participating in the business, became nearly impossible to reach, but still owned 20% of the stock.
Naturally, now I needed another partner, and after talking to a few prospective partners, I eventually connected with Matt, a businessman from the Bay area. Coincidentally, his family had just moved here from the west coast and our sons happened to be playing on the same soccer team. Our wives initially met each other because they would carpool our kids to the games. They started talking and eventually I connected with Matt. With some of his resources and my 2 patents, we formed a company called Quill Medical, Inc. Matt had previous experience with a law firm in North Carolina and we decided to use them since they also had a lot of contacts who were interested in startups. We presented our case before a number of the law firm’s clients and ended up raising $2 million at that meeting including input from family and friends.
I want to go back to what transpired clinically since the steak. Being a conservative surgeon, I sought to use that on a human being during surgery. You can modify a device that’s been cleared by the FDA to accommodate a patients’ needs, like using a drug off-label. The FDA calls these custom-concept devices. I had an operation planned, and I thought I would carry the operation out the conventional way while also making a barbed suture; cutting the barbs one at a time on a stainless-steel pan while I’m scrubbed in. To help support the tissues, I was going to use this as a way to prevent the swelling from causing my repair to relapse to an extent. The first patient I did was a man who was injured in a shotgun incident while hunting. I designed a procedure to elevate the corner of his mouth and I augmented it by the barbed sutures. On a second patient I used barbed sutures to support her lower eyelid suspension, a very delicate procedure. I got more adventurous as time went on, and I did a brow lift on a young man and another patient allowed me to use these on her neck as well.
I was cutting these all by hand, very crudely, but it validated the concept for me. When Matt invested his resources in this venture, the first thing we did was go to an engineering firm and have a device made to cut the barbs in a uniform fashion. It took about 2 minutes to make a suture on that device, but the point was that we could now start doing research. We showed that the design, angle, depth, etc. were all important, and we were always trying to weigh breaking strength and tensile strength. The helical array of the barbs was a powerful one. We started making patents and claims, and Matt made the astute decision to stay under the radar of big medical device companies. So we raised the rest of our capital through angel investors via some of Matt’s connections.
We got to the point where we had FDA clearance for the device to both lift facial tissues and to close wounds. At this point, we had two paths: we could try to sell our company, or we could try to make it bigger, which would take $30-40 million. The company would need to have sales, manufacturing, marketing, and R&D (which was me). We decided to sell it, and if no one made us an offer, we would try to run it ourselves. We received an offer from Ethicon, the branch of J&J that does sutures, and they made us an offer which was offensively low.
Fortunately, the best textiles school in the world is North Carolina State University, and there were many textile engineers in the area whose talent we could tap into. At that point, there was a small company in Redding, PA, called Surgical Specialties Corporation, and they controlled a small percentage of the suture market in the US. We wanted to keep the wound closure suture, but we let them make the suture to lift the face. They took control of the deal and paid us 30+% commission on their sales, which was much better than Ethicon’s offer from earlier. They also decided to call the sutures Contour Threads. Eventually they came up with a ridiculously high price tag for the device and the training they provided for surgeons who wanted to use the device was inadequate. Additionally, we learned that there were only 2 advisors available for all of the 2000 trained surgeons. The bottom line was that it was poorly handled.
Meanwhile, there was a company called Angiotech from Vancouver, Canada, which was unbelievably successful for creating a stent called the Taxis Stent, used in the treatment of coronary artery stenosis. The stent was sold by Boston Scientific and in its first year, it had the highest revenues of any drug or device sold in the history of the world. It turns out that this company wanted to buy another company that made sutures so they could put drugs on them. So they went to Surgical Specialties and made an offer. Next thing we know, they found that Quill, from North Carolina, actually owned the intellectual property for these Contour Threads and they wanted to make us an offer too, even though they had never heard of the barbed suture before. They were making so much money, they made us an offer which was worth potentially 200 million dollars, pending a few contingencies.
The issue was that the Taxis Stent started to have reports of problems. So the money Angiotech was getting from stent sales plummeted, and they started going bankrupt. They also claimed that the Contour Threads were generating a bad buzz on the internet and they were worried that if enough momentum was generated online, the FDA wouldn't let us sell the sutures for wound closure, which was a huge part of the market. So they discontinued Contour Threads. It later dawned on me how significant the loss of this deal truly was. Unfortunately Angiotech didn’t get back to baseline; they went bankrupt and sold the patents to J&J. Meanwhile, they improved manufacturing, added claims, and handled complaints, none of which I’m privy to.
The upshot of all this was that J&J said we could keep selling Quills, and they were going to call their product Stratafix. They said we could still cut the barbs, make sutures for ourselves and them, but they wanted their needles. I later went to speak in front of the global head of product development for Ethicon sutures, whose needles are renowned for being the best in the industry. I told them “There's a suture material I think your company should have. It's made in Massachusetts and sold by a company named Tepha. It lasts 4 times longer than your dissolving suture, in fact, it lasts so long that you would never use a permanent suture again, and you can make a huge profit.” The global head of new product development to the largest medical device company in the world looked at me and said, “Who is Tepha?” As it turns out, Tepha’s product was being sold by B.Braun, the biggest suture manufacturer in Europe, Ethicon’s direct competitor there, and Ethicon seemed unaware of this unique suture. At the same meeting, I showed Ethicon’s engineers a tissue simulant, which was far superior and cheaper than what they had been using to demonstrate technique. I left it with them and they ignored its virtues as well.
Nevertheless, Surgical Specialties resurrected itself when Angiotech went bankrupt, and that's the company that’s now officially making the Quill suture. They were acquired by another company, who’s now ready to resume R&D. In fact, just recently I met with one of their executives, and he said to me, “Dr. Ruff, it’s a pleasure to meet you, I understand you made this suture, do you have any new ideas?”
Career path:
Fast forward to my automatic acceptance into Michigan Medical School. I had two electives, one of which was plastic surgery because Teddy Kennedy was talking about socializing medicine, and I’d heard plastic surgeons didn’t take insurance. I initially wanted to stay in Ann Arbor because I loved the university and that was home, but the chairman reneged on his agreement with me, so I scrambled around and got a spot at Duke. I met a woman at The Cat’s Cradle and married her and I’ve lived here ever since.
Dr. Donald Serafin, the chairman at Duke who hired me was also the one who asked me to do craniofacial surgery. I came to him after a 6-month hand fellowship with Dr. Harold Kleinert in Louisville, Kentucky. While there, I was asked by Dr. Graham Lister, one of the most impressive surgeons and surgical minds ever, to apply for a new position they were creating. He told me I would be like a “super fellow” and would oversee the clinic while also doing my own research. The unsaid part of that offer was that, if I did well, I would be asked to become a partner in this incredible practice. So I went back to Duke, excited about Dr. Lister’s request, and told Dr. Serafin that I wanted to try the position in Louisville. Dr. Serafin advised me that it was too early in my career to pigeonhole myself as a hand surgeon, and in the next breath he said, “and here at Duke, we need a craniofacial surgeon, and we want you to be that guy.” So, I looked up what craniofacial surgery was, gave a grand rounds on it in plastic surgery shortly thereafter, and realized how much I would enjoy it.
I found that the hand was functional, but the face was aesthetic as well as functional. I was, however, a little leery about the fact that we did a lot of the surgery on children. Earlier at Michigan I had worked with a lot of ill and leukemic children who were so sick they were dying, and I found that very depressing. During my craniofacial fellowship at NYU, however, they would bring patients in every Monday for meetings. The children would come in with their parents, and I saw that they were actually happy to see the doctor, because he made them look better. And what did the exam entail: “Let me feel your head, and look at your teeth, and by the way, we’re not going to draw any blood.” So, my pediatric misgivings were allayed and the children were delightful.
After doing reconstructive surgery at Duke, I left and went into private practice in 2001 because I broke both of my wrists a month before 9-11. I also saw Quill coming to fruition and wanted to devote more time to it. It was a great thing to be a craniofacial surgeon at Duke, partly because I was the only one doing it so there were no ‘turf’ battles. I’m seriously lucky because Michigan is a great medical school, and I did my residency at St. Joe’s. Additionally, Duke was probably the best plastic surgery program in the country, NYU is the best craniofacial program, and Dr. Kleinert’s hand program was the best hand surgery practice in the world. So, I’ve been fortunate enough to have some incredible training.
Advice for medical students:
What I would say to medical student with ideas is to be careful about sharing your ideas with others unless they sign a confidential disclosure agreement. The sharing of ideas is even more risky today because a couple years ago you had the right to patent ideas if you were the first to come up with them. Now however, as in Europe, it only matters who the first person is to send the idea to the patent office. So, you need to guard your idea. It’s uncomfortable, but you need to either keep quiet or have others sign this agreement. You can even write your ideas in a notebook and have them notarized if possible. I would also recommend that you search the US Patent office and see if anyone else has ever had the same idea.
In terms of medicine, find something that you love doing. If there are two alternatives and one can avoid dealing with the insurance industry, like aesthetics, pick that one, just like I did. Insurance companies play a big role in dictating how you can run your clinic. What's more, you might be bought out by a big institution, and then they become the ones to tell you how many patients you can see, and what tests you have to order, etc. So, a few of the things I would consider, which get you out of that morass of being told what to do are: plastic surgery, ENT, ophthalmology, and dermatology. I don’t think it’s being self-centered, I think it’s self-preservation.