Hemostatic Fabric Sheet Delivery via Endoscopic Catheter

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Solution Overview

Problem

Translumenal procedures face challenges in providing a suitable conduit for medical devices to internal body cavities, maintaining sterility, and effectively managing bleeding complications, such as perforating blood vessels or small intestines, which can lead to infection and bleeding.

Innovation Solution

A medical device comprising a catheter with a hemostatic fabric sheet and collapsible forceps, where the sheet is hydrated with an evaporative fluid to facilitate loading into the catheter, and then deployed to a bleeding site via an endoscope's accessory channel, allowing for hemostasis and sealing of the site.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a hemostatic sheet is delivered through an endoscope accessory channel, then the procedural invasiveness is reduced and recovery time is shortened, but the device must be compact and maneuverable within tight spatial constraints

Engineering Contradiction:
Improveprocedural minimally invasive natureVSAvoiddevice compactness and maneuverability
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The hemostatic sheet is nested within a delivery catheter, which itself is passed through the endoscope's accessory channel. The sheet is initially compressed and contained within the catheter lumen, allowing it to be delivered through tight spatial constraints while maintaining its functional integrity upon deployment

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The hemostatic sheet transitions from a compressed, confined state within the catheter to an expanded, deployed state at the target site. This dynamic transformation allows the device to adapt to spatial constraints during delivery while providing full functionality when needed

Inventive Principle:
Principle #15Dynamics

2Volume of moving object

If the hemostatic sheet is compressed within the catheter for delivery, then it can be delivered through the endoscope channel, but the sheet must subsequently expand to function effectively at the bleeding site

Engineering Contradiction:
Improvesheet compressed volumeVSAvoidsheet hemostatic effectiveness
Core Design Contradiction:
Volume of moving objectVSStrength

Solution Approach 1:

The hemostatic sheet undergoes a parameter change in its physical state, transitioning from a compressed, low-volume configuration during delivery to an expanded, high-volume configuration at the target site. This parameter change enables the sheet to fit within the catheter for delivery while providing sufficient surface area and structural integrity for effective hemostasis

Inventive Principle:
Principle #35Parameter changes

3Manufacturing precision

If forceps are used to grasp and deploy the hemostatic sheet, then precise placement at the bleeding site is achieved, but the forceps mechanism adds complexity to the device

Engineering Contradiction:
Improvesheet placement precisionVSAvoidforceps mechanism complexity
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The forceps serve multiple functions: they grasp the hemostatic sheet during loading, manipulate it during delivery, and position it precisely at the target site. This multi-functionality justifies the added complexity by providing precise placement capability while reducing the need for separate mechanisms

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 delivery of hemostatic fabric directly to internal bleeding sites through an endoscope, reducing the risk of infection and bleeding complications while maintaining procedural sterility and allowing for cauterization, thus enhancing the safety and efficacy of translumenal procedures.

Implementation Method 1

The sheet is initially hydrated with an evaporative fluid, such as isopropyl alcohol, to facilitate loading the sheet into the catheter

Methodology Applied
Scientific EffectHydration: Absorption (physical)

Implementation Method 2

The sheet is initially hydrated with an evaporative fluid, such as isopropyl alcohol, to facilitate loading the sheet into the catheter

Methodology Applied
Scientific EffectEvaporation: Evaporation

Data Source

PatentEP2349012B1Endoscopic sheet delivery
Publication Date: 2014.11.19 COOK MEDICAL TECHNOLOGIES LLC
  • EP2349012B1 patent drawingFigure 1
  • EP2349012B1 patent drawingFigure 2~5
  • EP2349012B1 patent drawingFigure 6~8

AI summary

Medical devices and related methods are provided for treating a bleeding side of an internal bodily organ that are robust and versatile for use in a variety of endoscope applications. One embodiment of a medical device includes a catheter, a sheet and elongated forceps. The catheter defines a catheter lumen and is sized to be received within the accessory channel of the endoscope. The sheet is formed of hemostatic fabric formed into a tubular configuration having opposing first and second ends. The elongated forceps have a pair of collapsible grasping jaws. The grasping jaws are collapsed around the first end of the sheet, and the grasping jaws and sheet are received within the catheter lumen.