Gastric Sizing Systems Including Instruments For Use In Bariatric Surgery

Patent No. US10932937 (titled "Gastric Sizing Systems Including Instruments For Use In Bariatric Surgery") was filed by Boehringer Technologies Llc on May 31, 2018.

What is this patent about?

’937 is related to the field of bariatric surgery, specifically systems and instruments used in procedures like sleeve gastrectomies. These procedures reduce stomach size to treat morbid obesity. Traditionally, a bougie is inserted to guide the resection, but existing instruments lack integration of multiple functions and clear visual guidance.

The underlying idea behind ’937 is to use a flexible sizing tube with suction to delineate the resection line during a sleeve gastrectomy. The tube is inserted into the stomach and positioned along the lesser curvature. Applying suction through apertures in the tube's sidewall draws the stomach wall into close contact with the tube, creating a clear visual guide for the surgeon.

The claims of ’937 focus on a system for sizing a patient's stomach. The system includes a flexible, non-expandable sizing tube designed to be inserted into the stomach and positioned along the lesser curvature. The tube has a series of apertures around its periphery that are connected to a suction source. The suction is applied to draw the stomach tissue against the tube, creating a delineation line for resection, and the suction force is the only means of holding the tube in place.

In practice, the surgeon inserts the sizing tube through the esophagus into the stomach. Once positioned along the lesser curvature, suction is applied. This not only decompresses the stomach by removing fluids and air but also pulls the stomach wall against the tube, creating a clear visual marker. The surgeon then uses this marker to guide a cutting stapler, resecting the stomach along the desired line. The suction ensures the tube remains in place during the procedure.

This approach differs from prior methods that rely on bougies or other static guides. The use of suction to actively engage the stomach wall provides a more precise and adaptable delineation line. Furthermore, the system can include features like one-way valves to prevent the tube from getting stuck and a suction controller to regulate the applied force, enhancing safety and ease of use. The aperture design is also crucial, balancing flexibility for insertion with sufficient suction force to hold the tube in place.

How does this patent fit in bigger picture?

Technical landscape at the time

In the early 2010s when ’937 was filed, bariatric surgery commonly relied on tools like bougies to guide stomach resection during sleeve gastrectomies. At a time when minimally invasive techniques were increasingly adopted, integrating multiple functions into a single device and ensuring clear visual guidance during resection were non-trivial challenges. Systems commonly relied on manual manipulation and visual estimation rather than integrated suction and precise delineation methods.

Novelty and Inventive Step

The examiner approved the claims because the prior art (Saadat, Ortiz and Shlain) did not disclose, teach, or fairly suggest a system for sizing a patient's stomach for a bariatric procedure. The approved system includes a sizing tube configured for introduction through the esophagus, residing in the stomach, with a portion along the lesser curvature. Controlled suction applied through apertures serves as the sole means of holding the one-piece device in place against the lesser curvature, in combination with other claim features.

Claims

This patent includes 26 claims, with claims 1 being independent. The independent claims are directed to a system for sizing a patient's stomach during a bariatric procedure using a sizing tube with suction. The dependent claims generally elaborate on the features and configurations of the sizing tube, suction mechanisms, and related components of the system.

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.”Regulated vacuum pressure applied to the sizing tube's hollow interior, drawing gastric fluids and bringing the stomach walls into contact with the tube.
Flexible non-expandable material
(Claim 1)
“said sidewall being formed of a flexible non-expandable material, whereupon said portion of said sidewall is always able to bend into said curved shape to conform with the lesser curvature of the patient's stomach”The material forming the sidewall of the sizing tube, allowing it to bend and conform to the stomach's curvature without stretching or increasing in size.
Lesser curvature
(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 inner, shorter curve of the stomach, along which the sizing tube is positioned during the bariatric procedure.
Plurality of apertures
(Claim 1)
“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 in the sidewall of the sizing tube that allow for fluid communication between the hollow interior of the tube and the stomach, enabling suction to be applied to the stomach walls.
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 tube with a hollow interior and apertures, designed to be inserted into the stomach to assist in bariatric procedures by applying suction to the stomach walls.

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US10932937

BOEHRINGER TECHNOLOGIES LLC
Application Number
US15994490
Filing Date
May 31, 2018
Status
Granted
Expiry Date
Feb 10, 2035
External Links
Slate, USPTO, Google Patents