Single-fold system for tissue approximation and fixation

Abstract

A single fold system for tissue approximation and fixation is described herein. The devices are advanced in a minimally invasive manner within a patient's body to create at least one fold within a hollow body organ. The system comprises a tissue acquisition and folding device and a tissue stapling or fixation device, each of which is used together as a system. The acquisition device is used to approximate a single fold of tissue from within the hollow body organ and the stapling device is advanced through a main lumen defined through the acquisition device and is used to affix the tissue. The stapling device is keyed to maintain its rotational orientation relative to the acquisition device and to provide the user positional information of the stapling device. The acquisition device is also configured to provide lateral stability to the stapling device prior to the stapling device being clamped onto tissue.

Description

FIELD OF THE INVENTION [0001] The present invention relates generally to medical apparatus and methods. More particularly, it relates to devices and methods for approximating portions of a hollow body organ, particularly a stomach, intestine, or other region of the gastrointestinal tract, while affixing the tissue. BACKGROUND OF THE INVENTION [0002] In cases of severe obesity, patients may currently undergo several types of surgery either to tie off or staple portions of the large or small intestine or stomach, and / or to bypass portions of the same to reduce the amount of food desired by the patient, and the amount absorbed by the gastrointestinal tract. The procedures currently available include laparoscopic banding, where a device is used to “tie off” or constrict a portion of the stomach, vertical banded gastroplasty (VBG), or a more invasive surgical procedure known as a Roux-En-Y gastric bypass to effect permanent surgical reduction of the stomach's volume and subsequent bypass...

AI Technical Summary

Benefits of technology

[0011] One or more vacuum tubes may be routed through the length, or a partial length, of the working body for communication with the pod member. The proximal ends of the vacuum tubes may be connected to one or more vacuum pumps. Furthermore, the vacuum tubes may utilize braided materials, e.g., stainless steel or superelastic materials such as Nickel-Titanium alloy, integrated throughout to prevent kinking or pinching of the tubes.

[0012] The fixation assembly comprises, in part, a manipulatable stapler assembly connected via a flexible shaft to a stapler handle. The stapler assembly itself generally comprises a staple cartridge housing within which one or more staples are housed. A corresponding anvil is positioned in apposition to the staple cartridge housing and may be used to provide a staple closure surface when tissue to be affixed is adequately positioned between the staple cartridge housing and the anvil. With the stapler assembly connected at the distal end of a flexible shaft, a handle is connected at the proximal end of the shaft. The handle itself may allow the surgeon or user to hold and manipulate the fixation assembly while articulating the stapler assembly between an open and closed configuration. Moreover, the configuration of the handle allows the surgeon or user to actuate the stapler assembly as well as deploy the staples from the staple cartridge housing.

[0013] In use, the fixation assembly may be advanced within the folder assembly main lumen with the fixation assembly configured in a closed configuration. To maintain an orientation, i.e., rotational stability, of the fixation assembly relative to the folder assembly and the approximated tissue, the fixation assembly may be configured to have a shape which is keyed to a cross-sectional area of the folder assembly main lumen. The keyed configuration helps to ensure that as the fixation assembly is advanced t...

Problems solved by technology

Although the outcome of these stomach reduction surgeries leads to patient weight loss because patients are physically forced to eat less due to the reduced size of their stomach, several limitations exist due to the invasiveness of the procedures, including time, use of general anesthesia, time and pain associated with the healing of the incisions, and other complications attendant to major surgery.

In addition, these procedures are only available to a small segment of...

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