Systems And Methods For Performing Bariatric Surgery

Patent No. US10888446 (titled "Systems And Methods For Performing Bariatric Surgery") was filed by Boehringer Technologies Llc on Oct 11, 2017.

What is this patent about?

’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.

How does this patent fit in bigger picture?

Technical landscape at the time

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.

Novelty and Inventive Step

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.

Claims

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.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Plurality of apertures
(Claim 1)
“The sizing tube comprises an elongated tubular member having a hollow interior, a longitudinal axis, a distal free end and a proximal end portion. The tubular member comprises a sidewall and a large plurality of apertures disposed in an array extending about the periphery of the sidewall from a point adjacent the free end for a portion of the length of the sizing tube that is disposed along the lesser curvature of the patient's stomach. The plurality of apertures is in fluid communication with the hollow interior of the sizing tube.”Multiple openings on the distal end portion of the sizing tube that are in fluid communication with the hollow interior and are directed in different radial directions to apply suction to the stomach.
Sizing tube
(Claim 1)
“In accordance with one aspect of this invention a system for sizing the stomach of a patient for a bariatric procedure is provided. The system comprises a sizing tube that is sufficiently flexible to be introduced through the esophagus into the stomach of the patient so that a portion of said sizing tube is disposed along a lesser curvature of the patient's stomach. The sizing tube comprises an elongated tubular member having a hollow interior, a longitudinal axis, a distal free end and a proximal end portion.”A flexible, non-expandable, elongated member with a hollow interior and apertures, designed to be inserted into the stomach to facilitate bariatric surgery by applying suction and creating a delineation line.
Suction controller
(Claim 1)
“In accordance with another preferred aspect of the invention the system additionally comprises a suction controller for controlling the level of suction provided to said sizing tube and an indicator for indicating the level of suction provided to the sizing tube.”A component that regulates the amount of suction applied from a suction source to the sizing tube.
Visually perceptible delineation line
(Claim 1)
“The sizing tube is connected to a source of suction, whereupon controlled suction is applied from the source of suction via the array of apertures to bring adjacent portions of the patient's stomach into close engagement with portions of the periphery of the sizing tube at the location of the array of apertures and to hold those portions of the patient's stomach in such engagement with the sizing tube to thereby provide a visually perceptible delineation line to enable the patient's stomach to be sized.”A line created on the exterior of the patient's stomach due to the suction applied by the sizing tube, serving as a guide for sizing the stomach during surgery.

Patent Family

Patent Family

File Wrapper

The dossier documents provide a comprehensive record of the patent's prosecution history - including filings, correspondence, and decisions made by patent offices - and are crucial for understanding the patent's legal journey and any challenges it may have faced during examination.

  • Date

    Description

  • Get instant alerts for new documents

US10888446

BOEHRINGER TECHNOLOGIES LLC
Application Number
US15730332
Filing Date
Oct 11, 2017
Status
Granted
Expiry Date
Jun 18, 2035
External Links
Slate, USPTO, Google Patents