SafeStitch Medical®, Inc AMID™ Hernia Fixation Device
For decades, the Lichtenstein method has been the gold standard for repair of inguinal hernias. To perform this technique, a surgeon secures surgical mesh onto the abdominal wall, over the hernia, to act as a scaffold for new tissue growth. The surgical mesh is commonly secured via sutures, but staples have become increasingly popular. This poses a problem for the surgeon and the patient as traditional staplers have a straight shaft, making avoidance of the femoral artery, vein, and nerve difficult. Synectic was approached to develop a surgical stapler for fixating mesh, during inguinal hernia repair, using the Lichtenstein method. The biggest challenge was that the shaft needed to incorporate a 45° angle but still advance staples down the shaft without binding.
Synectic first developed and tested staple concepts that could correctly adhere surgical mesh to intestinal tissues. Once a staple design was selected and refined, the shaft and handle were developed. To combat the 45° angle staple deployment issue, a separate see-through rack was developed that fit under the shaft. This allowed for the staples to advance in a straight line without affecting the angle of the shaft It also gave surgeons a visual window of how many staples were deployed. Two additional features went into the stapler's mechanical design. The first, was adding prongs onto the end of the stapler shaft to aide in mesh manipulation. Second, feedback features were added to the handle and staple applier. When the handle was squeezed it created a clicking sound letting surgeons know that the handle was fully pressed. The staple applier was developed in such a way that the staple itself "popped" when it formed correctly. The surgeon could feel this "popping" happen. Additionally, human factors engineering and clinician feedback were used in the industrial design of the handle. Finally, packaging was designed and tested for optimal sterility and ease of use.
- A surgical stapler that has a 45° angled shaft and distal prongs for safe and efficient securing of surgical mesh during inguinal hernia repair.
- A handle and shaft design that gives the surgeon both haptic, auditory, and visual feedback when staples are deployed.