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Background
Devices used for flexible intralumenal procedures are inadequate when used for intraperitoneal surgical procedures such as cholecystectomy.
Objective
To assess/address limitations of flexible endoscopic devices in intraperitoneal surgery.
Design
To describe processes used to invent new devices to facilitate this new surgical genre.
Setting
Engineering laboratory.
Patients
None.
Interventions and inventions
Reviews of the limitations of flexible endoscopic instruments and instrumentation/invention needs for a “NOTES cholecystectomy” were completed.
Main outcome measures
The appropriateness of existing methods of device innovation was evaluated against an inventory of new technologies necessary to perform NOTES. The deficiencies in traditional innovation methods led to the creation of a novel process for invention of new medical devices: the “Inventorama.”
Methods
Cooperation between clinicians and industry to develop device concepts to enable NOTES.
Results
The devices included: (1) steerable flex trocar, (2) rotary access needle, (3) bipolar hemostasis forceps, (4) Maryland dissectors, (5) articulating hook knife, (6) rotating hook knife, (7) articulating graspers, (8) scissors, (9) ligating clip applier, and (10) tissue apposition system. Six of these ten were built and tested as initial crude prototypes in the Inventorama process; two underwent major modifications. Three were invented via alternate methods, including by independent clinicians.
Conclusions
A new method for efficient medical device invention and development was created to address key technology needs for NOTES. The result was a “toolbox” of devices designed to address the key surgical activities necessary for advanced intralumenal and translumenal flexible endoscopic procedures.