Controllably Shapeable Overtube for NOTES Access

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Solution Overview

Problem

Current endoscopic techniques for accessing and removing large tissue masses, such as the gallbladder, face limitations in maneuverability, visualization, and tissue dissection, and require skilled closure techniques, which can increase procedure time and risk.

Innovation Solution

An access system that includes a proximal handle, an overtube with inflatable cuffs for securing the distal portion within a body cavity, a controllably shapeable port to direct an endoscope, and a closure mechanism using T-tags for rapid hole closure, allowing for separate insufflation/deflation control of the peritoneal and body cavities.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Object-affected harmful factors

If traditional laparoscopic procedures are used to remove the gallbladder, then the gallbladder can be removed, but the procedure requires a large wound or several holes through the abdominal wall and electrocautery electrodes that remain dangerously hot and may cause damage to adjacent viscera

Engineering Contradiction:
Improvedamage to adjacent visceraVSAvoidlarge wound or several holes through abdominal wall
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The procedure is divided into distinct phases: first creating a subcutaneous tunnel, then introducing instruments through the tunnel to reach the gallbladder, and finally removing the gallbladder through the same tunnel. This segmentation allows the use of a single small incision rather than multiple large wounds, reducing harm to adjacent tissues while maintaining surgical effectiveness.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

A subcutaneous tunnel acts as an intermediary pathway between the skin surface and the gallbladder. This tunnel allows instruments to be introduced through a single small incision rather than requiring direct access through multiple large wounds, thereby reducing damage to adjacent viscera while still enabling complete gallbladder removal.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If current NOTES systems are used to access the peritoneal cavity, then access can be gained through a natural orifice, but the endoscope is limited in maneuverability with only a single axis along which it can be bent to direct instrumentation

Engineering Contradiction:
ImprovemaneuverabilityVSAvoidsingle axis bending limitation
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The endoscope is designed with dynamic multi-axis bending capabilities, allowing it to change direction along multiple axes rather than being limited to a single axis. This dynamic flexibility enables the endoscope to navigate complex anatomical pathways and reach the gallbladder from various angles, significantly improving maneuverability while maintaining a relatively simple overall device structure.

Inventive Principle:
Principle #15Dynamics

3Productivity

If tissue separation and dissection is performed from an endoscopic approach to remove large tissue masses, then the gallbladder can be removed, but the procedure requires extremely skilled closure techniques that increase procedure time and safety risks

Engineering Contradiction:
Improveprocedure timeVSAvoidsafety of patient
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The subcutaneous tunnel is created in advance before the gallbladder removal procedure. This preliminary action provides a pre-formed pathway that simplifies subsequent instrument introduction and tissue manipulation. The tunnel structure also naturally facilitates secure closure after procedure completion, reducing the need for complex closure techniques and thereby decreasing procedure time while maintaining patient safety.

Inventive Principle:
Principle #10Preliminary action

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Facilitates safer and more efficient access and removal of tissue masses by enhancing maneuverability and visualization, reducing procedural complexity and time, and ensuring secure closure of the access site.

Implementation Method 1

The cuffs are coupled to discrete injection ports extending from the handle through the overtube that permit individual pressurization to fixate the cuffs on opposite sides of the anatomical wall

Methodology Applied
Scientific EffectInflation: Pressurisation

Data Source

PatentUS9848763B2Access systems and methods of intra-abdominal surgery
Publication Date: 2017.12.26 BOSTON SCIENTIFIC SCIMED INC
  • US9848763B2 patent drawing
  • US9848763B2 patent drawing
  • US9848763B2 patent drawing

AI summary

An access system includes a proximal handle, an overtube coupled to the handle, and an endoscope port extending through handle and overtube sized for receiving an endoscope therethrough. The overtube includes anatomic wall securing system that secures a distal portion of the overtube within a hole in the anatomic wall. The overtube is provided with a shaped distal portion or a controllably shapeable distal portion that aids in directing an endoscope inserted through the port to a particular location within the peritoneal cavity. The access system includes a system for insufflating/deflating the peritoneal space separately from the body cavity accessible via a natural orifice. The access system includes a closure system to cinch closed the hole made in the anatomical wall after the access system has been removed from the hole. Methods are provided for inserting the access system through the anatomical wall to perform intra-abdominal surgery.