Submucosal Bleb and Tunnel Instruments for Safe Endoscopic Resection

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Solution Overview

Problem

Current endoscopic techniques for accessing and resecting large or irregularly shaped lesions in the digestive tract are limited by the size of lesions that can be resected, uncertainty in the resection area, and risks of needle perforation and muscular layer injury, particularly when attempting to dissect submucosal connective tissue.

Innovation Solution

A safe access needle injection instrument with a flexible tubular member and coaxial needle system that allows controlled suction and injection to create a submucosal bleb, combined with a submucosal tunneling instrument using an expandable member to form a tunnel beneath the mucosal layer, facilitating safe dissection and reducing the risk of perforation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional needle injection techniques are used to access the submucosal layer, then injection can be performed, but the risk of needle perforation and muscular layer injury increases

Engineering Contradiction:

Improvesafety of needle injectionVSAvoidrisk of needle perforation and muscular layer injury

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent introduces a safe access needle injection instrument with a tubular member and tissue holding member that acts as an intermediary system. The tissue holding member engages the mucosal tissue and the needle member is advanced through the tubular member to pierce the mucosal layer and inject fluid into the submucosal layer. This structured intermediary system provides controlled access and reduces the risk of uncontrolled needle perforation and muscular layer injury.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Area of stationary object

If large or irregularly shaped lesions are resected using conventional EMR techniques, then some lesions can be removed, but the resection is limited to lesions less than 2 cm in diameter and may require piecemeal resection

Engineering Contradiction:

Improvesize of resectable lesionVSAvoid完整性 of resection (en bloc vs piecemeal)

Core Design Contradiction:

Area of stationary objectVSManufacturing precision

Solution Approach 1:

The patent segments the resection process into distinct phases: first creating a submucosal bleb to lift and stabilize the large lesion, then forming a submucosal tunnel to provide controlled access to the lesion base, and finally performing dissection within the tunnel. This segmentation allows for safe en bloc resection of large, irregularly shaped lesions that would be impossible with conventional single-step EMR techniques.

Inventive Principle:

Principle #1Segmentation

3Object-affected harmful factors

If the mucosal layer is elevated to improve visualization and safety, then the risk of muscular layer injury is reduced, but additional steps and instruments are required

Engineering Contradiction:

Improverisk of muscular layer injuryVSAvoidnumber of instruments and steps

Core Design Contradiction:

Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The patent merges multiple functions into an integrated safe access needle injection instrument and submucosal tunneling instrument system. The needle injection instrument combines tissue holding, needle advancement, and fluid injection capabilities in one device. The tunneling instrument integrates balloon expansion and tunnel formation functions. This merging reduces the number of separate instruments needed while achieving mucosal elevation and controlled access for safer resection.

Inventive Principle:

Principle #5Merging (Combining)

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

Enables the safe and effective resection of large, irregularly shaped lesions en bloc by creating a submucosal bleb and tunnel, improving visualization and reducing the risk of muscular layer injury, thereby enhancing the precision and safety of submucosal dissection.

Implementation Method 1

When a vacuum source connected to the proximal end of the tubular member is activated the vacuum causes the mucosal tissue to be suctioned within the window member of the tissue holding member

Methodology Applied

Scientific EffectVacuum: Vacuum

Implementation Method 2

the expandable member, when dilated, forms a submucosal tunnel

Methodology Applied

Scientific EffectMechanical expansion: Mechanical Force

Data Source

PatentUS8491472B2Methods and systems for submucosal implantation of a device for diagnosis and treatment with a therapeutic agent

Publication Date: 2013.07.23 BOSTON SCIENTIFIC SCIMED INC

AI summary

Instruments, systems, implants, and methods are provided for performing submucosal medical procedures in a desired area of the digestive tract using endoscopy. Instruments include a safe access needle injection instrument, a submucosal tunneling instrument, a submucosal dissection instrument, and a mucosal resection device. A submucosal implant device for diagnosing and treating disorders of the body may be implanted. A passive submucosal implant device may take the form of a drug delivery depot in which a therapeutic agent within the depot elutes from the depot according to a predetermined elution profile. An active submucosal implant device may take the form of a drug delivery device that incorporates a self-contained diagnostic system to determine the appropriate delivery time and dosage of a therapeutic agent to be administered.