Patent No. US10888446 (titled "Systems And Methods For Performing Bariatric Surgery") was filed by Boehringer Technologies Llc on Oct 11, 2017.
’446 is related to the field of bariatric surgery, specifically systems and methods for performing sleeve gastrectomies. The background involves reducing stomach size by resecting a portion of it, typically using a bougie as a guide. Existing methods lack integration of functions and a clear visual indication for the resection line, potentially leading to complications.
The underlying idea behind ’446 is to use a flexible sizing tube with multiple apertures connected to a suction source to draw the stomach wall against the tube . This creates a clear visual delineation line on the stomach's exterior, guiding the surgeon during resection. The suction also anchors the tube in place, eliminating the need for other fixation methods.
The claims of ’446 focus on a system comprising a suction controller and a non-expandable, flexible sizing tube. The tube has a plurality of apertures around its distal end, designed to apply controlled suction. This suction pulls the stomach's lesser curvature into contact with the tube and anchors the tube in place, creating a visually perceptible delineation line for guiding the stomach resection. The suction force is controlled within a specific range.
In practice, the surgeon inserts the sizing tube into the stomach and activates the suction. The suction draws the stomach wall against the tube, creating a clear visual guide for the resection. The controlled suction force, ranging from 0.05 to 200 pounds, ensures the tube remains anchored. The suction force per unit length, between 0.02 and 21 pounds per inch, optimizes the tissue engagement and delineation .
This approach differs from prior methods that rely on bougies or other fixed guides. The suction-based system provides a dynamic and adaptable guide, conforming to the stomach's shape and providing a clear visual indication of the resection line. The controlled suction also minimizes trauma to the stomach tissue and reduces the risk of complications associated with traditional methods, such as leaks or strictures. The unencumbered tip of the tube also facilitates atraumatic insertion.
In the early 2010s when ’446 was filed, bariatric surgery, particularly sleeve gastrectomy, was typically implemented using bougies as a guide for stomach resection. At a time when surgeons commonly relied on visual estimation and manual manipulation to size the stomach, hardware or software constraints made precise and consistent sizing non-trivial. Systems commonly relied on manual stapling techniques after resection rather than integrated devices for multiple functions.
The examiner allowed the claims because the amended claim 1 includes the limitation of "the suction force applied per unit length is in a range of 0.02 to 21 pounds per inch based upon an aperture area of 1.2 square inches." While a prior art reference (Zadno-Azizi) teaches applying a suction force per unit length in a range of 0.02 to 21 pounds per inch, it does not teach or suggest that the suction force is based upon an aperture area of 1.2 square inches.
This patent includes 14 claims, with claim 1 being the only independent claim. Independent claim 1 is directed to a system for sizing the stomach of a patient for a bariatric procedure using a suction-based sizing tube. The dependent claims elaborate on specific features and configurations of the system, such as valves, controllers, springs, aperture sizes, and flow meters.
Definitions of key terms used in the patent claims.

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