Many of the devices used in early human NOTES procedures were originally designed for intralumenal work and are therefore limited in functionality due to constraints imposed by current flexible endoscopes. The invention of large diameter flexible trocars, however, has opened the door for delivery of true surgical capabilities such as stapling. Additionally, the transvaginal approach to NOTES procedures allows the surgeon to add long, rigid, instruments to his current flexible toolkit. These new capabilities may enable application of NOTES techniques beyond the current interest in cholecystectomy.
Objective: Leverage rigid and flexible approaches to develop new box stapling devices for tissue apposition and material fixation, i.e., hernia reinforcement mesh, in NOTES procedures.
Materials & Methods:
All staplers were used in IACUC-approved acute porcine labs. Laparoscopic vision and manipulation for mesh placement were employed. The devices were used transgastrically (flexible) and transvaginally (rigid, flexible) to affix the edges of 4cm oval-shaped mesh patches (PROLENE, Ethicon, Inc., Somerville, NJ) to the abdominal wall.
Two rigid box-staple prototypes were used. The first was single-fire, reloadable, 10mm diameter and 40 cm long, firing a titanium staple into a 3x5mm “box” shape. The second was a multi-fire, 12mm diameter device, fitted with a distal articulating, rotating cartridge containing 20 staples that are also formed into 3x5mm shapes.
Three flexible shaft staplers were used through the Steerable Flex Trocar (SFT) from the NOTES Toolbox (Ethicon Endo-Surgery, Cincinnati, Ohio). One device was 12mm diameter and battery-powered; the other two were 8mm and 12mm diameter hand-fired devices. Two of the staplers were single-fire, reloadable, 40cm long and delivered 2x4mm box staples. The third device was a multifire, 120cm long device delivering 3x5mm box staples from the same articulating, rotating, cartridge used on the rigid platform. These flexible staplers were grossly guided to the appropriate anatomical location via the articulation capability of the SFT.
All five stapling devices were used to successfully staple and fix mesh to the abdominal wall. As expected, use of a multi-fire device reduces the amount of time required to affix the mesh. Device rotation and articulation enabled more precise application of the staples. Further improvements in targeting and staple release are still needed.
Transgastric NOTES approaches for affixing hernia mesh to the abdominal wall are feasible using flexible shaft box-stapling devices – described for the first time herein – in conjunction with flexible trocars. Additionally, long, rigid, stapling devices may be used transvaginally. Although additional procedure-specific challenges still need to be addressed, notably sterile mesh delivery, ventral, and potentially inguinal, hernia procedures appear to be feasible from a NOTES approach.
Program Number: P263