LapSurgical Systems, LLC
As seen in General Surgery News, November 2003
Modified slightly to include current success rate
LapSurgical Systems, LLC, was founded by Donald E. Wenner, MD, FACS, a general surgeon specializing in laparoscopic and vascular procedures, and George L. Scott III, an entrepreneur who focuses on the development of laparoscopic surgical tools and related intellectual properties. Together, they invented the Multiple Instrument Guide (MIG), an instrument that facilitates the access of fiber-optic choledochoscopes and surgical tools to the bile duct during laparoscopic common bile duct exploration (LCBDE). The co-founders saw the MIG as a solution to problems inherent in the current method of performing LCBDE. Although laparoscopic biliary exploration procedure has been shown to be superior to endoscopic retrograde cholangiopancreatography (ERCP) in terms of both safety and cost, and equal in efficacy, it is tedious and complex to perform and so has not been widely adopted.
History
After completing his residency in Phoenix, Arizona, Dr. Wenner set up practice in rural Roswell, NM, where gallbladder disease is prevalent among the Native American and Hispanic population. The standard practice was open cholecystectomy with intraoperative cholangiography (IOC) and common bile duct exploration - not ERCP.
"Although widely practiced, ERCP is a dangerous procedure, with a 10% risk of pancreatitis and a 1% mortality," Dr. Wenner points out. "60% of patients are found not to have stones in the bile duct when this procedure is done preoperatively, based on lab and x-ray findings.
When laparoscopic surgery swept the country in the early 1990s, Dr. Wenner took a course in video laparoscopy and laparoscopic cholecystectomy and then began looking for ways of simplifying LCBDE. Working with Mr. Scott, he conceived the idea of a multiple instrument guide that would provide the choledochoscope with more lumens and thus make it more of a "doing" tool. The challenge was to develop a device small enough to fit in the bile duct but with lumens big enough to convey the scope and instruments.
The MIG obtained 510K clearance from the Food and Drug Administration in November 2002 and was introduced at the annual meeting of the Society of Laparoendoscopic Surgeons in Las Vegas in September 2003. The flexible, J-shaped device has three lumens of 3.4, 2.0, and 2.0 mm. It can be used for the vast majority of patients with choledocholithiasis. The choledochoscope and other tools are deployed through a standard 10 mm laparoscopic port site. The surgeon can use several tools simultaneously - for example, balloon catheter, basket, and lithotriptor. Irrigation can be performed while the tool is in use.
Experience Thus Far
Dr. Wenner has used the MIG in more than 50 cases with a 98% success rate. The first two cases were patients in whom ERCP had failed. The success rate of ERCP is about 75% for bile duct clearance. The MIG has reduced the rate of choledochoscope damage during LCBDE from 50% to 5%.
"This is very significant, as a typical choledochoscope repair costs approximately $4,000," Mr. Scott reports. "Also, in no instance so far has it been necessary to convert to an open procedure."
The device is being used by a surgeon in China, where the incidence of bile duct stones is very high. And gastroenterologists are taking notice: In the Roswell area, they routinely refer patients with bile duct stones to Dr. Wenner and other surgeons who use the MIG.
Dr. Wenner is a firm believer in the importance of routine IOC with laparoscopic cholecystectomy. He recently reported a consecutive case study of 52 patients, of whom 15.4% were found to harbor stones. Dr. Wenner showed that dynamic fluoroscopic IOC added a mean time of only four minutes to the procedure. The paper received the "Best General Surgery Paper" award at the September 2003 annual meeting of the Society of Laparoendoscopic Surgeons.
The Future
Well aware of the inadequacies of existing laparoscopic instruments, the LapSurgical team is currently designing new products to address some of the difficulties that laparoscopic surgeons frequently encounter. A device that is under develoment and has already been patented is the Multiple Instrument Centralizer, which has a hollow catheter and expandable wings that keep the catheter in the center of the bile duct.
Another laparoscopic instrument under active development, the Endostonetrap, is deployed to prevent the loss of stones from the gallbladder into the free peritoneal space. Its co-inventors are Dr. Wenner, Mr. Scott, and James Rosser, MD, chief of minimally invasive surgery at Beth Israel Medical Center, New York City. A patent for this device is pending.
The LapSurgical co-founders stress, "With our experience in laparoscopy and patient care, we have intimate knowledge of the real-world challenges that practicing surgeons face."
Donald Wenner: A True Working Class Hero
As seen in General Surgery News, November 2004
It was telling of his future as a mentor that the first "teaching position" Donald Wenner, MD, held in his life was as a tutor for a fellow medical student who was having trouble grasping the course curriculum.
"When I became his tutor, he had failed the PIMP block [pathology, immunology, microbiology, and pharmacology] in his second year of med school and could not afford to fail another block at that point," recalls Dr. Wenner, a general surgeon in private practice in Roswell, New Mexico. "His success from thereon in was nothing short of astounding. He received either a satisfactory or a superior in every course for the remainder of the second year and has gone on to do well as a doctor."
Today, Dr. Wenner is recognized by members of his own 50,000 strong community for, among other things, his efforts encouraging youth to choose the medical profession in general, and surgery in particular.
"Students who have had the chance to work with Dr. Wenner have felt they'd like to be the kind of doctor he is - a very ethical and highly impressive character," lauds Nola Miller, coordinator of the Roswell Independent School District's mentorship program. High school juniors and seniors in that program thinking about pursuing a career in medicine often choose to spend their 55 internship hours with Dr. Wenner.
"What's unusual about Dr. Wenner is that he doesn't just let students do office work," Mrs. Miller notes. "They have a chance to experience everything from diagnosis to surgery to working with the families. Dr. Wenner wants students to be involved in every aspect of his practice." She notes that several of his students have gone on to medical school, and that one is now doing his surgical residency at the prestigious Mayo Clinic.
Dr. Wenner's efforts to inspire children to do medicine don't stop there, however.
Every year since 1992, fifth and sixth grade elementary school students in the Roswell School District have tried their hands at simulated laparoscopic surgery, compliments of Dr. Wenner. As part of the District's "Super Day" career and enrichment program, students have an opportunity to move through five stations using laparoscopic trainers. These range from simple double-mirrored boxes to a full-scale picture-in-picture laparoscopic video system, a video choledochoscope and a laparoscopic common bile duct exploration training model.
Dr. Wenner's efforts have inspired not only children, but the likes of prominent medical figures. As part of his stated mission to promote laparoscopic surgery in the United States, James "Butch" Rosser Jr., MD, the charismatic director of minimally invasive surgery at Beth Israel Medical Center in New York, has adapted his own "Top Gun" competition - popular at surgery conventions for pitting some of the fastest hands in surgery against each other - to children in elementary school, hoping to recruit some of the nation's brightest minds and quickest fingers at an early age. He cites Dr. Wenner's work in the Roswell school system as the inspiration for his approach.
Family Guy
Not surprisingly, Dr. Wenner's own passion for surgery has rubbed off on at least one of his four children. Donnie, 21, has just been accepted to the University of New Mexico's medical school, Dr. Wenner's own alma mater (class of '79). Nathan, 20, and Teddy, 17, have yet to decide where their career paths will take them. However, daughter Andrea, 24, has opted against surgery in favor of a position as team leader for account maintenance at Ford. Dr. Wenner's wife, Laurie, helps him with the administrative side of the practice and also helps keep him "organized, focused and fed."
Dr. Wenner admits that he is sometimes happy that his home is becoming more of a sea of tranquility, particularly now that his children are moving out on their own. However, he says, he still manages to see them.
As a member of Safari Club International, he has traveled with his wife or his children to exotic locales: he and his son have climbed Mt. Kilimanjaro in Kenya; they've hunted water buffalo in the Australian outback, and explored the New Zealand countryside. These excursions, he says, are "motivational rewards" for his children.
A Hectic Practice
One of only four surgeons in Roswell, Dr. Wenner was first introduced to the General Surgery News readership through a report we published on a study he conducted in his own clinic (see GSN 2003;30(12):18). That study concluded that intraoperative cholangiograms during laparoscopic cholecystectomy are both inexpensive and quick, and that the number of gallstones found as a result render arguments against doing the procedure irrelevant.
"When laparoscopy first came out, surgeons who were doing laparoscopic cholecystectomy referred patients with bile duct stones to gastroenterologists who performed ERCP," Dr. Wenner says. "But since we didn't have an ERCP-equipped gastroenterologist for two-hundred miles, my partner and I started doing laparoscopic common bile duct explorations ourselves. We just pushed and learned new tricks, adapting the open procedure to the laparoscopic technique."
One of these new tricks was a device he developed and today manufactures. The "multiple instrument guide (MIG)," received clearance from the Food and Drug Administration in November 2002. The MIG allows surgeons to introduce a choledochoscope, stone basket, irrigation catheter and lithotripter into a single 10 mm laparoscopic port. "It effectively changes a 2.8 mm choledochoscope into a 7 mm choledochoscope with three working channels," Dr. Wenner says.
He maintains that his favorite procedure is the carotid endarterectomy, which he says is a "nice, clean case that patients do well with, but still is a challenge." On call once every 3-4 days, however, he also has an opportunity to perform many other procedures, some admittedly more mundane.
Apart from having a large population of patients to tend to, Dr. Wenner says one of the most challenging elements of practicing rural surgery is adapting to innovations in an ethical manner.
"I have an obligation to provide modern care that keeps up with the times," Dr. Wenner explains. Typically, he said, when a new procedure that improves patient care is introduced to the wider surgical community, he does a lot of reading, attends workshops and listens to what the experts have to say. Sometimes, as with sentinel lymph node dissection (SLND), he also validates his results, in that case by comparing the SLND results to those with axillary dissections in the same patient. "Unfortunately most new procedures don't lend themselves to such immediate feedback," he said.
Of the professional issues in the news lately, Dr. Wenner takes special interest in the controversial quantity-quality relationship. However, he told General Surgery News that he has his own formula for ensuring quality.
"How do you decide whether somebody's competent at a specific procedure?" he asks. "I don't have a good answer for that. Maybe the only way to figure out if you're doing things correctly or not is to constantly monitor your outcomes."
"Teach a surgeon to do a procedure properly, to frankly assess his performance and to be a good and honest person. What else can you do?"
LapSurgical Staff
