Inflatable Sheath for Tissue Protection in Endoluminal Procedures

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Solution Overview

Problem

Existing non-invasive procedures, such as endoluminal and laparoscopic procedures, face the risk of hollow organ perforation due to the lack of effective protection for tissues during device introduction and navigation, with existing solutions not adequately addressing the need for a flexible structure to absorb forces exerted by instruments.

Innovation Solution

A protecting means comprising a sheath with inflatable channels, including annular and longitudinal segments forming a frame, which can be deflated for minimization and inflated with a fluid to provide protection and absorb forces, featuring an outer and inner sleeve structure for deployment within the body.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a rigid protective structure is used during endoluminal procedures, then tissue protection is improved, but device complexity and difficulty of introduction increase

Engineering Contradiction:
Improvetissue protectionVSAvoiddevice complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The protective structure transitions from a deflated flexible state during introduction to an inflated rigid state during the procedure. The sheath includes inflatable channels that can be filled with fluid to transform the structure dynamically, providing rigidity when needed while maintaining flexibility for easy introduction through natural orifices.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The physical state of the protective structure is changed by altering its volume through inflation and deflation. By controlling the volume of the sheath via fluid injection into inflatable channels, the structure can adapt between a compact form for introduction and an expanded form for tissue protection, resolving the contradiction between ease of introduction and protective capability.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If the sheath is inflated to protect tissues, then tissue protection is improved, but the transversal dimension increases making introduction difficult

Engineering Contradiction:
Improvetissue protectionVSAvoidtransversal dimension
Core Design Contradiction:
ReliabilityVSVolume of moving object

Solution Approach 1:

The protective structure is divided into multiple independent inflatable segments (first inflatable segment, second inflatable segment, third inflatable segment) that can be inflated separately or in combination. This segmentation allows selective inflation of only the portions needed for protection while keeping other portions collapsed, reducing the overall transversal dimension during introduction.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The sheath transitions dynamically between deflated and inflated states. During introduction, the sheath remains deflated to minimize transversal dimension and pass through natural orifices easily. Once positioned, specific segments are inflated to provide localized tissue protection without expanding the entire structure.

Inventive Principle:
Principle #15Dynamics

3Reliability

If a flexible structure is used to absorb forces, then tissue protection is improved, but structural strength decreases

Engineering Contradiction:
Improveforce absorptionVSAvoidstructural strength
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The structure dynamically adjusts its mechanical properties by transitioning from a flexible deflated state to a rigid inflated state. When deflated, the sheath is flexible and can absorb forces through deformation. When inflated, the sheath becomes rigid and structurally strong, providing both force absorption capability and structural strength as needed.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The mechanical properties of the sheath are changed by altering its volume and internal pressure. By controlling the inflation state of the sheath and its segments, the structure can switch between being flexible (for force absorption) and rigid (for structural strength), resolving the contradiction between these two opposing requirements.

Inventive Principle:
Principle #35Parameter changes

4Adaptability or versatility

If multiple inflatable segments are used for selective isolation, then functional versatility is improved, but device complexity increases

Engineering Contradiction:
Improveselective isolation capabilityVSAvoiddevice complexity
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The sheath is divided into multiple independently controllable inflatable segments (first, second, and third inflatable segments) that can be inflated separately. This segmentation enables selective isolation of different anatomical regions or segments of the hollow organ, providing functional versatility for different procedural needs while maintaining a relatively simple overall structure.

Inventive Principle:
Principle #1Segmentation

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

The inflatable sheath effectively protects tissues during procedures by expanding to absorb instrument forces and maintain lumen diameter, reducing the risk of perforation and facilitating the passage of endoscopic instruments through tight body pathways.

Implementation Method 1

the sheath comprises at least one inflatable channel having an opening and being suitable for receiving a fluid (liquid or gas) injected through said opening whereby said fluid injected into the inflatable channel through said opening inflates at least one portion of the sheath

Methodology Applied
Scientific EffectFluid pressure inflation: Pressure Increase

Data Source

PatentEP1929936B1Protecting means in particular for non-invasive procedures
Publication Date: 2014.11.19 ETHICON ENDO SURGERY INC
  • EP1929936B1 patent drawingFigure 1~2
  • EP1929936B1 patent drawingFigure 3~4
  • EP1929936B1 patent drawingFigure 5

AI summary

A protecting means for non-invasive procedures, for example endoluminal or laparoscopic procedures, comprises a sheath (10) extending from a distal end (10a) to a proximal end, in which the sheath comprises at least one inflatable channel (12) having an opening and being suitable for receiving a fluid injected through said opening whereby said fluid injected into the inflatable channel through said opening inflates at least one portion of the sheath. The inflatable channel (12) comprises a plurality of longitudinal inflatable segments (14) and a plurality of annular inflatable segments (16) connected to the longitudinal inflatable segments in shape of a frame or net of the sheath (10). The protecting means further comprises an outer sleeve (20) and an inner sleeve (22) forming a gap (24) that comprises the plurality of longitudinal inflatable segments (14) and the plurality of annular inflatable segments (16) connected to the longitudinal inflatable segments. The sleeves are made by a transparent material.