Multi-Segment Haemostatic Valve for Wire Separation

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Solution Overview

Problem

The cannulation of multiple branch vessels during thoracoabdominal aneurysm treatment is challenging due to entanglement and identification issues of preloaded guide wires, which complicates the delivery of fenestrated stent grafts and increases exposure to contrast and x-rays.

Innovation Solution

A brachial access port with a haemostatic valve arrangement featuring independent silicone-like leaflets separates and marks preloaded wires, preventing entanglement and facilitating identification, allowing for separate management of each wire.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If multiple preloaded guide wires are delivered through the vasculature to exit at the brachial artery, then the cannulation of branch vessels is enabled, but the wires become entangled and difficult to identify

Engineering Contradiction:
Improvecannulation capabilityVSAvoidwire management
Core Design Contradiction:
Adaptability or versatilityVSEase of operation

Solution Approach 1:

The valve assembly is divided into multiple independent valve segments (first valve segment, second valve segment, third valve segment, fourth valve segment) that separately receive and hold each guide wire. This segmentation prevents wire entanglement by providing dedicated spaces for each wire while maintaining the ability to perform multiple cannulations simultaneously.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The valve segments act as an intermediary structure between the guide wires and the external environment. Each valve segment provides a separate receiving space that holds the wires in an organized manner, preventing entanglement while allowing the wires to be easily accessed and identified for cannulation procedures.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If a preloaded delivery system with four lumens for four catheters is used, then the cannulation process is simplified, but the delivery device becomes unacceptably large (28 Fr)

Engineering Contradiction:
Improvecannulation processVSAvoiddelivery device size
Core Design Contradiction:
Ease of operationVSVolume of moving object

Solution Approach 1:

Instead of using a single large delivery device with four lumens, the system segments the wire management function across multiple separate valve segments. Each valve segment handles one wire independently, allowing the use of a smaller access port while maintaining the capability to manage multiple wires simultaneously.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent transitions from a single large delivery device operating in one dimension to a distributed system where multiple valve segments manage wires in separate spatial regions. This dimensional redistribution allows the access port to remain small while accommodating multiple wires through the valve segment structure.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

3Volume of moving object

If individually cannulated branches are used, then the delivery device size is reduced, but the preloaded wires must be tracked through the abdominal and thoracic aorta which increases procedure complexity

Engineering Contradiction:
Improvedelivery device sizeVSAvoidwire tracking requirement
Core Design Contradiction:
Volume of moving objectVSDevice complexity

Solution Approach 1:

The valve segments serve as an intermediary organizing structure that receives and holds the preloaded wires after they exit the brachial artery. This intermediary structure eliminates the need for complex wire tracking through the aorta by providing immediate organized holding spaces for each wire, simplifying the overall procedure.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The wires are preloaded and organized within the valve segments before the cannulation procedure begins. This preliminary organization of wires in separate, identifiable spaces eliminates the need for complex tracking and management during the procedure, reducing procedural complexity.

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

The solution effectively prevents wire entanglement and simplifies the identification process, enhancing the efficiency of thoracoabdominal aneurysm treatment by maintaining wire separation and providing a haemostatic seal, thereby reducing procedural complexity and patient exposure to contrast and x-rays.

Implementation Method 1

Each valve segment is formed from a resilient material, whereby the plurality of valve segments when assembled form the substantially cylindrical valve assembly and defining between adjacent valve segments a plurality resilient interface regions to receive and grip a medical device therebetween in use

Methodology Applied
Scientific EffectElasticity: Elasticity

Implementation Method 2

a haemostatic valve comprising a housing, the housing comprising a tubular body with an internal lumen and a first end and a second end, the first end being connected to the sheath and the sheath lumen and the internal lumen being in fluid communication

Methodology Applied
Scientific EffectValve sealing: Valve

Data Source

PatentEP2666512B1Port comprising a multi-segment haemostatic valve
Publication Date: 2018.11.14 COOK MEDICAL TECHNOLOGIES LLC
  • EP2666512B1 patent drawingFigure 1
  • EP2666512B1 patent drawingFigure 2~3C
  • EP2666512B1 patent drawingFigure 4~5C

AI summary

An endoscopic access port and sheath assembly or laparoscopic port (10) comprises a sheath (12) and a haemostatic valve. The sheath has an elongate tubular body and a sheath lumen through it. The haemostatic valve comprises a housing (14) and the housing comprises a tubular body with an internal lumen (18). A first end of the housing (14) is connected to the sheath, and the sheath lumen and the internal lumen are in fluid communication. The second end of the housing (14) has an access aperture. There is a substantially cylindrical valve assembly (27) within the housing (14) at the second end of the housing (14). The substantially cylindrical valve assembly (27) is formed from a plurality of valve segments (28). Each valve segment (28) has an elongate body being in cross-section a sector of a circle. Each valve segment (28) is formed from a resilient material. The plurality of valve segments (28), when assembled, form the substantially cylindrical valve assembly (27) and define between each other a plurality of resilient interface regions (29) to receive and grip a medical device between them in use.