New Laparoscopic Device Stops Harpooning of Patients
While at the Global Congress of Gyn Endoscopy I saw a really neat new device called LapCap designed to reduce the risk of entering the abdomen in laparoscopic surgery.
What is the problem- why is this needed? In laparoscopy the first step where the surgeon gains access the abdominal cavity is often a blind entry step.Â There is a risk of injury to internal organs such as the bowel, bladder, or blood vessels.Â While rare, these injuries can be severe or even life threatening.Â If you want to readÂ more about laparoscopic access and the risks of entry into the abdomen here isÂ a link to an article I wrote forÂ a Master’s Class in Gyn Surgery on this topic.
What is done in standard surgery: The most common method used by gyn surgeons is the insertion of a needle (the veress needle) which fills the abdomen with carbon dioxide gas (called insufflation).Â Then a tool called a trocar is inserted into this space and the instruments go through this.Â The needle insertion step is the most dangerous because it is the blind step.Â various techniques are used including elevation of the abdominal wall to lift it off of and away from the underlying organs expecially the large vessels like the aorta nad vena cava.Â The second common methodÂ is the open or Hasson technique (invented by my good friend Gyn surgeon Harry Hasson) where the surgeon opens a small 10 mm incision and then inseted the trocar.Â Injuries occur with all known techniques.
The New System:Â The LapCap is a new system that puts a plastic dome on the abdomen attached to suction that then pulls a full thickness of the abdominal wall high up into it then allowing the veress needle to be inserted into a potentially larger and they claim safer spot.Â The LapCap device received 510(k) approval from the FDA and is sold by Aragon Surgical.Â It won an award from the SLS for new device innovation.Â Here is a video from the company of it in operation.Â I know surgeons who have used and were quite impressed and I will likley be involved with surgery using it soon. Â I know that laparoscopic innovator and friend of mine Camran Nezhat is one of their advisors.Â I will be speaking with him more about his experience.
Potential problems:Â Two major issues- first statistical proof of demonstration of increased safety is nearly impossible for access devices such as this because the injury it might reduce so very rarely happens.Â One study on this problem estimated that it would take a study of more than 200,000 people having the operation to adequately demonstrate reduced injuries statistically.Â Second- one of the major risks for this sort of injury is when the bowel is adherent to the abdominal wall at the site of entry from previous surgery.Â I would not expeect this device to help at all in this situation because the adherent bowel will be picked up with the abdominal wall.Â However it is the vessel injuries that ar emost dangerous and this device might reduce the risk of those if it places the needle much farther away.
About the company:Â They appear to have acquired the device via an acquisistion of starup Verisure. It was reported last month that they “raised $25 million in a Series B round of venture capital with the hopes of having five products on the market within two years.Â In a statement on Monday, Jan. 7, Aragon said new investors Bay City Capital of San Francisco and Integral Capital Partners of Menlo Park, Calif., joined original investors Delphi Ventures and Onset Ventures, both of Menlo Park. They formed Palo Alto, Calif.-based Aragon in May 2005 to advance radio frequency technology developed at Stanford University Medical School for use in laproscopic and other surgeries. Bay City Capital was the lead investor in the most recent round.”Â
I have spoken about the use of RFID for surgical and laproscopic procedures for several years and look forward to seeing where they go with it.Â I know they also have tissue sealing and dividing technology and are part of the Delphi portfolio.Â I had a phone call with Delphi last year as part ofÂ due diligence they were doing for another company and did think highly of them and their approach.Â More details of the deal are here.