David Earle, MD, FACS, Brian Jacob, MD, Karl LeBlanc, MD. Baystate Medical Center.
Objective of the technology:
Despite advantages of the laparoscopic approach to ventral hernia repair, the majority of ventral hernias are repaired in an open fashion. This is partly due to technical difficulties of adequate mesh fixation. Additionally, there is still debate over the amount and type of fixation, i.e. sutures and/or tacks. Further complicating the issue is the debate over whether or not the fixation material should be permanent, absorbable, or some combination thereof. The objective of the FasTouch™ technology is to provide a flexible platform to deliver suture-like fixation of mesh that will increase fixation strength and decrease operative time and difficulty. This device will nearly eliminate the need for utilizing current tacking devices, and is another tool that will help increase the percentage of ventral hernia repairs performed laparoscopically.
Description of the technology:
This is a 5mm device that delivers the fixation fasteners with a typical trigger mechanism. The fasteners are flexible, and designed to have each end lock together after being delivered through the mesh and in to the tissue (Figure 1). The fasteners are provided in exchangeable cartridges of up to 25 fasteners, and can be made from a variety of polymers and come in variable lengths to address the extensive variety clinical fixation requirements. Both permanent and absorbable polymers are available in order to meet the need of the surgeons’ preference and/or clinical scenario.
In a bench test performed on extracted pig abdominal muscle wall, the FasTouch™ fasteners fixation overall strength was between 1.4 – 1.75 times higher than currently available helical or anchor tacks (Table 1), and 2.5 – 6.6 times higher based on strength per mass ratio (Table 2)
The higher fixation strength coupled with a flexible fastener design and cartridge based delivery system and low profile design should improve outcomes from both the surgeon and patient perspective. This type of system would be analogous to the variety of cartridge based surgical stapling devices that allow for use in a variety of clinical scenarios. Additionally, the cartridge based system should allow cost savings to hospitals for situations when only a small number of fixation points are necessary to complete the procedure.
The increased amount of fixation strength per unit area should eliminate the need for suture fixation as currently practiced, thus reducing early and late post-operative pain related to full thickness suture anchors.