Natural orifice surgery. Now that’s a concept.
The human body has a fair number of such entry points. But, for spine surgery?
In March 2015 a patent was issued to an inventor of just such a procedure. (See patents 8, 979, 861 and 9, 155, 633) and it was one of the more interesting new concepts we uncovered on the floor of the American Academy of Orthopaedic Surgeons (AAOS) last week.
According to the inventor, natural orifice spine surgery is less invasive, cheaper and may be safer.
At least, in theory.
Accessing the Body Through Natural Orifices
Gastrointestinal surgeons have been at the forefront of natural orifice access for several years.
In late 2008 surgeons from Johns Hopkins School of Medicine removed a healthy kidney from a woman donor using a transvaginal approach.
On June 25, 2007 The Oregon Clinic announced that Dr. Lee Swanstrom had performed the first transgastric endoscopic cholecystectomy in the U.S. at Legacy Good Samaritan Hospital in Portland, Oregon. Subsequently, Dr Swanstrom and his surgical team completed two additional procedures as part of an IRB (Institutional Research Board) approved research study.
According to Dr. Swanstrom, a natural orifice approach to remove the gall bladder eliminates the need to make traditional incisions on the surface of the skin, resulting in less pain, lower risk of infection and a reduced recovery time as compared to traditional minimally invasive surgery (MIS).
Natural Orifice Trans-luminal Endoscopic Surgery (NOTES), as this procedure has become known, uses flexible surgical tools and a camera which are introduced through a patient’s natural orifice—like the mouth. From the mouth, as was demonstrated at The Oregon Clinic, surgeons can reach the abdominal cavity by an incision made from within the stomach. Once the operation is over, surgeons withdraw any removed tissue back through the patient’s mouth and close the hole in the stomach.
To facilitate this approach, Dr Swanstrom’s team used the EndoSurgical Operating System or EOS (USGI Medical, Inc.).
Abdominal Surgery Without an Entry Incision
NOTES fans say it will revolutionize minimally invasive surgery by eliminating abdominal incisions. If so, it would be a paradigm shift comparable to the introduction in the 1980s of laparoscopy surgery.
Potential advantages include lower anesthesia requirements; faster recovery and shorter hospital stays; avoidance of the potential complications of transabdominal wound infections (e.g., hernias); less immunosuppression; better postoperative pulmonary and diaphragmatic function; and the potential for “scarless” abdominal surgery.
Critics challenge the safety and advantages of this technique in the face of effective minimally invasive surgical options such as laparoscopic surgery.
Within the GI community, NOTES or derivatives of it are being touted as the newest frontier in minimally invasive surgery.
Anterior Spine Surgery Through a Natural Orifice
Dr. Sang-Hyeop Jeon of Wooridul Spine Hospital, Korea, has performed anterior spine surgeries (e.g., ALIF, TDR, etc.) using the NOTES approach. He posted a video of his surgeries on YouTube last year.
The patent holders of spine surgery performed through a natural orifice are Raymond Cloutier and Larry Hickey.
Here is an excerpt from their primary patent (submitted November 17, 2011 and issued March 17, 2015):
“A type of minimally invasive surgery that is being developed currently involves using naturally occurring orifices to access internal cavities and organs within subjects. Natural orifice transluminal endoscope surgery (“NOTES”) uses natural orifices to access, for example, the abdomen. This obviously has even greater benefits in that at least one fewer artificially created surgical opening is required to conduct a minimally invasive surgery, and thus reduced trauma to the subject. A further practical consequence and advantage of using NOTES is that fewer surgeons may be required to perform the actual procedure. Currently an access surgeon is needed during certain surgical procedures in order to assist a primary surgeon tasked with conducting the actual procedure.
In some embodiments, a method may include positioning at least a portion of at least one surgical instrument in at least one naturally occurring orifice of a human by a user. In some embodiments, a method may include accessing an interior space of the human using at least one of the surgical instruments. The method may include performing at least a portion of a spinal surgical procedure using at least one of the surgical instruments positioned in at least one of the naturally occurring orifices of the human. In some embodiments, the method may include removing at least one of the surgical instruments from at least one of the naturally occurring orifices upon completion of at least a portion of the spinal surgical procedure.
The phrase “naturally occurring orifice” as used herein generally refers to any opening in a subject which occurs naturally (i.e., not created by a surgeon) including, but not limited to, an umbilical orifice, a vaginal orifice, a rectal orifice, an esophageal orifice, or a nasal orifice.”
Setting Standards for the NOTES Approach
Recognizing that this approach could attract substantial interest among surgeons, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) organized a working group of surgeons and gastroenterologists in 2006 to develop standards for the practice of this emerging technique.
This group is known as the Natural Orifice Surgery Consortium for Assessment and Research – NOSCAR (No Scar, get it?).
NOSCAR issued a NOTES White Paper in two medical journals in May 2006. The paper identified the major areas of research needed to be addressed before NOTES can become a viable clinical application for human patients. These areas included development of a reliable closure technique for the internal incision, prevention of infection, and creation of advanced endoscopic surgical tools.
Here is the citation for NOSCAR’s white paper: Surg Endosc (2006) 20: 329–333 Gastrointestinal Endoscopy: Volume 63, No.2; 2006
The Future of Natural Orifice Surgery
According to one of the inventors of NOTES for spine surgery, Raymond Cloutier, his approach will likely have several clear advantages over current spine surgery methods based on outcome studies for other types of NOTES surgeries that demonstrate:
- Lower pain scores and quicker return to work
- Shorter time to return to normal activities
- Reduced OR time
- High levels of patient acceptance since their perception is that it provides reduced recovery time and postoperative pain and improved cosmetics (no abdominal scars).
Could natural orifice surgery become the next wave of procedural innovation in spine?
At a time when many industry veterans are bemoaning the lack of innovation, here comes an unexpected or surprising but entirely reasonable approach which could certainly drive instrument innovation and create, who knows, a spine procedural revolution comparable to the lateral approaches.
For more information, contact Raymond Cloutier at raymond@novapproachspine.com
