Some of us still remember the time when people used to darn socks. People would sit and strain their eyes in order to stitch up a threadbare sock to keep it wearable for few months longer. It would obviously hold up to start with, but at some point the tear just got bigger, and eventually the cloth disintegrated and the whole thing came apart again. It was at this stage that the patch usually came in.
Exactly the same thing happens when tears inside the body are repaired, explains Dr. Amir Szold, one of the founders of medical device start-up Hernia Solutions Ltd. These hernias happen when, for one reason or another, a hole develops in the abdominal wall, as a result of which the intestine (or another organ) protrudes outward, an unpleasant situation that can cause considerable problems, from pain to intestinal obstruction.
The first mode of treatment for the problem was the most obvious - surgeons gently pushed the intestine back into abdomen, took a needle and stitched the two sides of the tear together. This procedure is called a "stress repair", but as in the case of socks, the tissue surrounding the tear in the abdominal wall is not always strong enough to withstand the strain, and sometimes the hernia is simply too large to be stitched. There are other problems too. "The stress the tissue is under weakens it," explains Szold. "The bloodstream to the sutured area is cut off, and the sutures themselves get weaker. This can explain the rate of recurring hernias - 15-20% of hernias reopen." So the second generation of hernia treatments was a natural follow-on from the first - covering the tear with a patch.
This is the most commonly used procedure today - an incision is made through the skin overlying the tissue and a mesh is inserted between the skin and tissue to cover the hernia. The incision is then stitched up. But over time, it transpired that because of the continuous outward pressure on the abdominal wall, the most suitable place for the mesh is actually on the inner side of the abdominal wall. The internal pressure that is created pushes the peritoneum (the layer of tissue covering the intestine) aside, allowing the mesh to fit in between. A great idea, but how is a surgeon supposed to insert the mesh and stitch it to the inner part of the wall, without cutting a huge hole in the patient's innards and shoving almost his entire hand inside?
It would make sense to think that if a hole has already been made, the mesh would be inserted through it. For example, in a laparoscopic procedure - which was designed to be as minimally invasive as possible - the mesh is rolled up like a mat and inserted through the hole into the abdominal cavity through a special hollow cylinder called a trocar which serves as port inside the abdominal cavity. The mesh insertion and stitching are performed by implements introduced through the hole or through small holes specially made for the purpose. Mounted on one of the implements is a miniature camera that gives the surgeon a view of the area on which he needs to place the mesh and stitch it afterwards.
Sounds complicated? It is very complicated, since the surgeon has to navigate his way into the stomach cavity and manipulate the surgical tools with the utmost accuracy on the basis of a highly indistinct two-dimensional image. "It's like trying to use chopsticks to spread out a napkin with your eyes half-shut," says Szold. For this reason, the procedure is only used in 18-20% of hernia operations.
Putting a tire in the stomach
Hernia Solutions, which entered Meytav Technological Enterprises Innovation Center Ltd. this year, was founded by Szold, himself a laparoscopic surgeon, and chairman of the Israeli Society of Endoscopic Surgery, and Dr. Ibrahim Matar, head of the division of laparoscopic surgery at the Bnei Zion Medical Center. The company's CEO is Itay Barnea, formerly a marketing manager at Johnson & Johnson Israel. Meytav has invested $600,000 in Hernia Solutions so far, and is currently raising several hundred thousand dollars more for the company.
Szold and Matar believe in laparoscopy and wanted to simplify the process to make it more popular, as well as solve the problem involved in locating meshes behind muscle. The idea was to create a mesh that was easy to place. They initially thought of developing a mesh in a "scroll form" - meaning a mesh attached to two sticks which would then be used to roll it out inside. However, this still left the task of maneuvering the sticks inside the stomach and locating the mesh at the correct spot. At this point, the two doctors came up with a new idea - a product very similar to the inner tube of a bicycle tire.
Szold explains, "The product is a round mesh layered by an inflatable balloon with a thin tube at the end. The mesh is inserted into the stomach rolled up, and then slowly inflated using the tube. This rolls out the mesh inside the stomach. The mesh is then pinned in place with a stapler introduced through the same laparoscopic cylinders. The process takes just a few seconds, instead of the half an hour using existing laparoscopic methods." Less skill is needed too.
Surgery in the groin is especially complicated, since it is a dense area with tissue that has to be moved in order to manipulate the mesh and roll it out. As a result, although 70% of hernias develop in the groin, laparoscopy is not commonly used in groin surgery. Hernia Solutions has developed a second product for inguinal hernias, which, according to Szold, is the more interesting of the two.
The device consists of two balloons joined together. After they are inserted into the stomach, the first balloon is inflated, forcing the impeding tissue aside, and then the second balloon is inflated in the space that has been created. The first balloon is then released and retracted. In this case, there is no need to pin the mesh since it is held in place between the peritoneum and the muscle wall. Over time, new tissue grows over the mesh strengthening the abdominal wall, and closing the hole.
Globes: What would be the regulatory track for a device like yours?
Szold: "Our device would qualify under the fast track process for medical devices, so the device for ventral hernia surgery could be on the market within a year, with the device for inguinal hernia following a few months after. We've carried out a highly successful trial on a pig, an animal sufficiently similar to humans for an indication like this, so we won't even need to conduct trials on a single person."
Are there any rival products on the market that offer different methods of rolling out mesh?
Itay Barnea: "There are products in the ventral hernia market that can make a partial roll-out, with laparoscopic devices still used at certain stages in the process. We're pretty much on our own in the inguinal hernia market.
"Most companies today focus on producing the best and the cheapest mesh, but these are becoming more and more alike, and there is not much difference between them. Our device can carry all types of mesh. It represents a long-awaited breakthrough."
Published by Globes [online], Israel business news - www.globes.co.il - on January 10, 2008
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