2. What is surgery Surgery- Branch of medicine dealing with manual and operative procedures for correction of deformities and defects, repair of injuries, and diagnosis and cure of certain diseases. Minimal invasive surgery - (MIS) (Laparoscopic) Many of the above general procedures are performed by using a rigid scope which is placed into the abdominal cavity. Through the use of small trocars, the mini-scope can be inserted allowing direct visual observation. This would allow other trocars to be used to insert mico-instruments for repair, removal, or diagnosis of the problem without the need for large surgical cutting of the abdomen. Non-invasive surgery - (NIS) Any procedure preformed in the body without an incision.

3. Laparoscopy Abdominal exploration employing a type of endoscope called a laparoscope. Laparoscopy, a technique which permits the examination and surgical treatment of viscera and organs within the peritoneal cavity, is becoming very popular, replacing many procedures which traditionally required open laparotomy. In addition to reducing the morbidity rate, surgical risks, and pain associated with laparotomy, laparoscopy shortens hospital stays and post-operative recovery time. To improve visualization of the peritoneal cavity and facilitate instrument manipulation during laparoscopy, this cavity must first be filled with an insufflating gas, producing a pneumoperitoneum.

5. Insufflators To establish pneumoperitoneum, one end of a piece of low pressure tubing, ranging in length from approximately 8' to 10', is connected to the insufflator's outlet port. The other end of the tube is connected to an insufflation needle, known as a Veress needle. A laparoscopic procedure usually begins with the insertion of the Varess needle into the inferior portion of the umbilicus, since this region of the abdominal wall is usually devoid of major blood vessels and nerves. Furthermore, intra-abdominal structures usually do not adhere to this region of the abdominal wall except in patients who have previously undergone abdominal surgery.

6. Insufflators (cont.) Three liters of gas is usually sufficient to produce a space in the peritoneal cavity to allow for adequate visibility. The exact amount of gas used to establish a pneumoperitoneum depends on the size of the abdominal cavity, development of abdominal musculature, the elasticity of the abdominal wall, as well as the degree of gas leakage and rate of re-absorption. Once the pneumperitoenum is established, the Veress needle is removed from the peritoneal cavity and a trocar in a sleeve is used to enlarge the needle puncture. After completely penetrating the abdominal wall, the trocar is removed, followed by insertion of the laparoscope through the trocar sleeve into the abdomen. Additional trocar punctures are often needed to allow a number of accessory instruments, e.g. biopsy forceps, to be used in the peritoneal cavity without removing the laparoscope. Upon completion of the procedure, most of the insufflating gas is expelled by manually depressing the abdominal wall; any gas remaining in the abdomen is usually innocuously absorbed by the body.

7. Insufflators (cont.) Blind insertion and insufflation with a Veress needle can cause serious complications. If the Veress needle was accidentally inserted into a blood vessel, insufflation could cause the formation of a gas embolism. The introduction of gas through a Veress needle that has not completely penetrated the abdominal wall could also produce a subcutaneous or subfascial emphysea. Moreover, the insertion of any sharp object into the abdomen can perforate the section of the bowel that has adhered to the peritoneum, possibly causing peritonitis. Filling the abdomen with gas after having visually confirmed safe intraperitoneal placement significantly reduces the number of complications associated with the Veress needle.

8. Insufflators (cont.) Rather than use a Veress needle to insufflate the peritoneal cavity, some surgeons prefer to puncture the abdominal wall with a trocar before creation of the pneumoperitoneum. Once the trocar has penetrated the abdominal wall, the laparoscope can be immediately inserted through the trocar sleeve to insure proper intraperitoneal placement. As a result, this procedure enables the surgeon to reduce the number of "blind" insertions from two (Veress needle and trocar) to one (trocar only).

9. Insufflator Accessories If we look back 20 years, would we ever think of what would be happening now? Almost everything we use or rely on has changed; most have evolved. The same thing has happened in the medical device field. Some medical procedures performed today were not thought possible then. The introduction of endoscopic surgery also evolved. The use of scopes to help doctors get to or see areas they didn’t have access to was starting to emerge. It started in the gynocology area and moved quickly into the urological area. The use of rigid telescopes to see areas that normally would require surgery reduced cost and lowered infection rates. After several years, the general surgeons started to become interested in these newer techniques using rigid endoscopes. .

10. Insufflator Accessories (cont.) In the early 1980’s, general surgeons started to use endoscopes for purposes other than diagnosis. They called upon the manufacturers to develop more sophisticated equipment that would reach even further than anyone would realize. Along with these new endoscopes, were the necessary accessories. Everything was being down-sized (or made smaller) so they could reach areas that were harder and harder to reach without surgery. The surgeons then began to realize that these instruments were not only useful for diagnosis but could also be used immediately to resolve certain problems. After the late 1980’s, we started to see all sorts of endoscopes and endoscopic procedures started to become the norm rather than the exception. With every evolution there are always problems. Companies evolved to try to solve and supplement the lack of supply.

11. Endoscopes and insufflation had been used in Europe several years earlier. The difference between the United States and Europe was the accessories. The U.S. wanted as many disposable accessories as they could get while Europe felt they either could not afford or did not need to throw things away. This brings us to the U.S. market for insufflators and accessories . Insufflator Accessories (cont.)