Device for Hernia Mesh/Tissue Graft Positioning and Placement

Summary

Developed by a Vanderbilt surgeon, this device is used to accurately size and position a mesh during herniorrhaphy, particularly when using minimally invasive approaches. For abdominal wall defects, this approach facilitates determination of the appropriate size mesh, as well as simplifying the positioning of the mesh. In addition, it obviates the need for use of multiple instruments, allowing for adaptation with less invasive procedures (NOTES & SILS).

This invention is a pre-formed ring structure made of a flexible material, such as Nitinol, interspaced with magnetic material. The dimensions are such to allow for its passage through any 5mm or greater laparoscopic/endoscopic access (trocar) device. By introducing the ring into the peritoneal cavity, it can simply be used as a sizer, assuring the appropriate selection of material coverage/size. The ring can then be placed on the outer edge between two layers of the surgical mesh (skirted) to permit easy positioning. With the mesh expanded taut by the flexible ring, it can then be positioned against the abdominal wall using transcutaneous magnets. The mesh material can then be secured to the abdominal wall with a fixation device and/or sutures. Following this, the ring can be removed from the abdominal cavity via laparoscopic/endoscopic access (trocar) device with the assurance of having selected an appropriate size material and having it well positioned with the desired coverage area. This device and technique can be adapted to any hernia material, prosthetic or biological.

Hernia repair is one of the most common operations done in the United States; about 750,000 people have hernia repairs each year. Hernia recurrence rates have been shown to be higher for operations that do not use mesh (a synthetic patch). Mesh patches made of synthetic material (ePTFE, polypropylene, polyester, biologics) are now being widely used to repair hernias (hernioplasty). This is especially true for recurrent hernias, as well as for larger hernias. Using current medical devices and methods, the surgeon typically has to deal with a large number of surgical instruments in order to achieve precise and accurate placement and positioning of the surgical prosthesis. This new device is simple, low cost, and it eliminates the need for multiple devices and allows for enhanced precision. Laparoscopic hernia repairs can be broken down into five steps:

1) Gaining access to the peritoneal cavity
2) Lysis of adhesions
3) Selection of appropriate size mesh material
4) Appropriate positioning of the material
5) Fixation

This device is valuable to the surgeon since it markedly simplifies steps 3 and 4.

Vanderbilt solicits interest from surgical device manufacturers for further development and commercialization of this device based on licensing of the intellectual property.

Pending worldwide patent application.