By Jeffrey Berg
NEW YORK — The annual meeting of the Society of Laparoscopic Surgeons (SLS; Miami) drew attendees from more than 47 countries. Laparoscopic surgery has undergone a range of modifications in minimally invasive access since its initial entry into general surgery over 25 years ago. These include mini laparoscopy, computer-assisted robotic surgery, single incision laparoscopic surgery (SILS) and natural orifice transluminal endoscopic surgery (NOTES). The lack of clear improvement in overall safety, effectiveness and clinical benefit have kept these approaches from replacing conventional laparoscopy.
Mini laparoscopy was initially introduced in the mid-1990s and was promoted to minimize scarring, reduce postoperative pain and improve surgical results. However, the devices lacked performance, i.e., their shafts were flimsy, causing them to bend or break and the working end of these tools did not function to the satisfaction of surgeons. Renewed interest is now being shown by surgeons and companies in mini laparoscopy which uses 2mm-3mm mini instruments, due to technological advances that have made these instruments perform significantly better than the early generation products. A new generation of mini instruments are being developed which have improved functionality, durability and ease of use.
Paul Wetter, chairman of SLS, explained to MDD that a “big problem with mini laparoscopy is the misunderstanding of what it is, because there have always been very small, 3mm instruments, but they weren’t useful for doing anything but a few minor procedures. However, now there are 3mm instruments that work as well as, or better than, the older large 5mm-7mm instruments, and in many cases don’t require the use of a trocar. All surgery is headed towards smaller and smaller instruments and less invasive procedures and ultimately there will be surgery without any incision using various different energy modalities.” As patients demand less and less pain and scarring, innovation will be in the direction of “non-surgery,” using molecular energy technology adopted originally from the aviation industry. Wetter noted that “in 20-30 years this kind of non-surgery will allow us to heal patients at the level of the individual cell.”
Mini laparoscopy is also known by other names, such needloscopy. microlaparoscopy. Dr Wetter prefers the term BOSSI (Big Operations with Small Surgical Instruments) which he views as a huge improvement over single-port laparoscopic surgery. He said that BOSSI combines the best aspects of laparoscopy (good visibility, better angles and good ergonomics) and single-port surgery (small instruments and one incision). Also, less energy is used by bipolar cauterizing instruments, resulting in less tissue damage. The instruments are so small (3mm) that they are referred to as needle-size and healing occurs with almost no scar or pain.
Gustavo Stringel, professor of Surgery and Pediatrics at New York Medical College (Valhalla, N.Y.), said that “with adults we use very large instruments. For children, smaller incisions are very important because there is less pain, something children can have a tough time dealing with. When parents see the advantages, they are the best advocates for this kind of new
GETTING IN ON THE MINI LAPAROSCOPY ACT
Teleflex (Wayne, Pa.), a provider of mini laparoscopic instruments, featured its portfolio of Percuvance and MiniLap percutaneous surgical systems, mini-polar electrocautery instruments, Hem-o-lok polymer locking ligation system, and the EFx Shield, its new generation fascial closure device that was just launched. Upvan Narang, VP, Global Marketing at Teleflex, highlighted the company’s products for percutaneous laparoscopic surgery that is “a continuum of making minimally invasive surgery even less invasive.” This approach involves the percutaneous insertion of a less than 3mm shaft into the abdomen without needing a trocar, allowing for more angles, greater visibility and easier surgery. These devices offer the functionality and performance of traditional 5mm and larger tools. Narang further noted that “there is renewed interest in the category of smaller instruments due to technological advances that have made these instruments perform significantly better that the early generation products.”
Gustavo Carvalho, professor of Surgery at Pernambuco University (Recife, Brazil), is a leading advocate of mini laparoscopic surgery. He led a roundtable discussion in which he dismissed as myths the many misconceptions about this surgery. He observed that “we are able to perform larger operations with smaller instruments, which decreases pain, eliminates scarring and makes the operation much less tedious, so that it’s easier to learn.” Carvalho presented results of his clinical trial on a novel design of mini instruments that are precisely manufactured to minimize friction between instruments and trocars and outperform regular 5mm and 3mm instruments. His study will be published in an upcoming issue of the SLS’s Journal of the Society of Laparoscopic Surgeons. The low friction 3mm instruments for mini laparoscopy are reusable and are in widespread use in Latin America and Asia. They are sold by Karl Storz (Tuttlingen, Germany).
Carefusion (San Diego), which was acquired by BD (Franklin Lakes, N.J.) in March 2015, is the exclusive U.S. distributor of a line of MicroLap instruments having outer diameters of 2.8mm and 2.9mm from Gimmi (Tuttlingen, Germany). The AlphaDur micro instruments are very rigid and are constructed using ceramic-titanium composite. The 2.9mm device is new. It is bipolar and can be disassembled. Roberto Gallardo, a key opinion leader in mini laparoscopic surgery at Cirugia Mini in Guatemala, uses these devices and asserted that “mini laparoscopic procedures are less painful, yield better cosmetic results and a faster recovery.”
New products for use in conventional laparoscopic surgery were on display and several were recognized at SLS’s Innovations of the Year award program. One such product is the CapSure permanent fixation device for inguinal hernia repair from Davol (Cranston, R.I.), a subsidiary of CR Bard (Murray Hill, N.J.), which was introduced in July 2015. The company’s OptiFix device is used for fixation of surgical mesh during open or laparoscopic hernia repair. Its Phasix absorbable mesh is made from poly-4- hydroxybutyrate.
Genicon (Winter Park, Fla.) won an innovation award for its GeniStrong Bag for retrieving a specimen from a patient during laparoscopic surgery. It is designed to minimize contamination of the abdominal cavity. EFI (Enschede, the Netherlands) was another award recipient for its endoscopic force-reflecting instrument, OptiGrip, a grasper that provides haptic feedback for surgeons during minimally invasive surgery. It employs optical sensor technology to translate the visco-elastic tissue feeling in the grasper tip back into the trigger of the instrument, thereby providing feeling in the fingers of the surgeon when manipulating tissue. Michel Vleugels, the company’s founder, said that “surgery is learned by touching and feeling resistance of the tissue.“ The company has applied for the CE mark for and for clearance from the FDA which it expects to receive early next year. Bovie Medical (Clearwater, Fla.) markets the J-Plasma hand piece with retractable cutting feature. It is used for soft tissue coagulation and cutting during surgery. J-Plasma utilizes a helium ionization process to produce a stable, focused beam of ionized gas. The company recently received clearance for six new hand piece configurations for its J-Plasma pistol grip for use with instrument lengths ranging from 15cm to 27cm.
Source: Medical Device Daily