Systems And Methods For Performing Bariatric Surgery

Patent No. US12303415 (titled "Systems And Methods For Performing Bariatric Surgery") was filed by Boehringer Technologies Llc on Dec 29, 2020.

What is this patent about?

’415 is related to the field of bariatric surgery, specifically methods and instruments 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 resection, leading to potential complications like the instrument getting stuck.

The underlying idea behind ’415 is to use a flexible sizing tube with multiple apertures connected to a suction source to draw the stomach wall against the tube , creating a clear visual delineation line for resection. The suction also holds the tube in place, simplifying the surgical procedure. This eliminates the need for constant manipulation and provides a more precise guide for stapling.

The claims of ’415 focus on a method of sizing a patient's stomach using a non-expandable sizing tube with a continuous circular outer surface and multiple apertures. The method involves introducing the tube into the stomach, applying controlled suction through the apertures to pull the stomach wall against the tube, creating a visually perceptible delineation line, and then laparoscopically sealing the stomach along a seal line adjacent to the delineation line.

In practice, the surgeon inserts the sizing tube into the stomach and applies suction. The suction draws the stomach wall against the tube, creating a clear visual guide for the surgeon to follow when resecting the stomach. The tube's flexibility allows it to conform to the stomach's curvature, while the suction ensures it stays in place. The apertures are designed to prevent tissue damage and clogging.

This approach differs from prior methods that rely on bougies or other instruments that may not provide as clear a visual guide or as secure a hold on the stomach. The use of suction to create the delineation line and stabilize the stomach simplifies the procedure, potentially reducing the risk of complications such as leaks or strictures. The one-way valves prevent the tube from getting stuck and allow for fluid infusion for leak testing or unfolding the stomach.

How does this patent fit in bigger picture?

Technical landscape at the time

In the early 2010s when ’415 was filed, bariatric surgical procedures were typically performed laparoscopically at a time when systems commonly relied on mechanical staplers and bougies for gastric resectioning. At that time, integrating multiple functions into a single device for bariatric surgery was a design goal, when hardware or software constraints made precise control of suction and fluid dynamics within the stomach non-trivial.

Novelty and Inventive Step

The claims were amended during prosecution. Arguments were presented to overcome rejections based on anticipation and obviousness. The application was subject to a final rejection under pre-AIA 35 U.S.C. 102 and 103, as well as 35 U.S.C. 112. The prosecution record does describe claim changes and technical reasoning that led to the rejection.

Claims

There are 12 claims in total. Claim 1 is the only independent claim, and it focuses on a method for sizing a patient's stomach for a bariatric procedure using a non-expandable instrument and controlled suction. The dependent claims generally elaborate on and refine the method described in the independent claim, adding details regarding resection, sealing, testing for leakage, managing folds in the stomach, and specifying suction force ranges.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Controlled suction
(Claim 1)
“The sizing tube is arranged to be coupled to a source of suction, whereupon controlled suction is applied to the hollow interior of the sizing tube to effect the drainage of gastric fluids from the patient's stomach through at least some of the apertures of the array of apertures and 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 to enable the patient's stomach to be sized.”Suction applied to the interior of the patient's stomach via the plurality of apertures of the sizing tube to pull the lesser curvature of the patient's stomach into engagement with a portion of the sizing tube.
Plurality of apertures
(Claim 1)
“The sizing tube comprises an elongated member having a distal end portion including a large plurality of apertures disposed in an array extending about the periphery of the sizing tube. Suction is applied to the sizing tube to decompress the patient's stomach. At least one procedure is performed on the patient's stomach while maintaining the sizing tube in the patient's stomach, with or without suction applied thereto.”A set of openings disposed about the circular outer surface of the distal end portion of the sizing tube, directed in different radial directions from the longitudinal axis, and in fluid communication with the passageway of the sizing tube.
Seal line
(Claim 1)
“In accordance with another preferred aspect of this invention the method entails resecting the patient's stomach along a resection line. The resection line is located adjacent the delineation line, whereupon when the patient's stomach is resected along the resection line that action creates a residual portion of the patient's stomach. The residual portion of the patient's stomach can then be sealed along the resection line to produce a seal line.”A line along which the patient's stomach is sealed laparoscopically from the outside, adjacent to the visually perceptible delineation line.
Sizing tube
(Claim 1)
“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. 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.”A non-expandable instrument comprising a single elongated member with a circular cross-section, a hollow interior, a distal end portion with a free end tip, and a proximal end portion. It has a predetermined outside diameter and a plurality of apertures disposed about the circular outer surface of the distal end portion. The circular outer surface is entirely continuous along an entire length of the sizing tube between the apertures.
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 along a portion of the entirely continuous circular outer surface of the sizing tube facing the greater curvature of the patient's stomach, resulting from the application of controlled suction.

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US12303415

BOEHRINGER TECHNOLOGIES LLC
Application Number
US17136407
Filing Date
Dec 29, 2020
Status
Granted
Expiry Date
Nov 5, 2034
External Links
Slate, USPTO, Google Patents