TOP Stapler feasibility study

Inleiding

Surgical staple devices are used in surgery to close skin wounds, connect or remove parts of the bowels or lungs with specialized staples used instead of sutures. Stapling is much faster than suturing by hand, as well as it is more accurate and consistent.

Circular Staplers

In intestinal surgery, so-called circular staplers are used to construct an anastomosis, i.e., connection between two ends of the intestine, following for example a resection of a bowel part. In circular stapling, a circular ring of staples is released in one action, holding both intestinal ends together (Figure 1A).

Complications

Although the safety of a mechanical anastomosis is comparable to hand-sewn anastomoses, complications do occur in technically challenging anastomoses. These complications can result in:

• Leakage of the anastomosis (Figure 1B)
• Stricture formation (obstructing passage)

Figure 1

• A: Stapling mechanism schematically depicted.
• B: Insufficient blood and oxygen supply to the anastomotic site causes tissue ischemia and necrosis, which leads to anastomosis leakage and other postoperative complications.

Anastomotic Leakage Rate

Although stapling techniques used to anastomose gastrointestinal organs are considered safe enough, the anastomotic leakage rate is still considerable, ranging from 5 to 30% depending on the type of organ and circumstances.

Conventional Circular Staplers

Conventional circular staplers use two (or three) separate concentric rows of overlapping placed staples parallel to the cut end of the gut segments to be anastomosed. Compression forces are high in the stapled tissue parts, meaning that the perpendicular blood vessels that are vital for gut wall perfusion are completely compressed by the overlapping concentric staple lines.

Consequences of High Compression

As a result of the high compression, these staple lines obstruct blood flow to the anastomotic area and cut ends, thereby leading to:

1. Ischemia
2. Necrosis
3. Fibrosis

Clinically, this can lead to leakage, stricture, and adhesions. Anastomotic healing is dependent on basic wound healing principles – i.e., blood supply is of utmost importance as it provides the oxygenation, nutritional supply, and cells needed for tissue repair and renewal.

Innovatie in Stapeltechniek

We believe that changing the stapling technique, in particular the way the staples are arranged, will significantly reduce ischemia and necrosis by ensuring sufficient blood supply and thus boost the wound healing capacity of the anastomotic site.

Feasibility Study

A feasibility study will help develop a thorough understanding of how successful our innovation may be and where we may encounter challenges.