Expandable Catheter Sheath for Low Profile Multi-Lumen Delivery

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Solution Overview

Problem

Existing catheters with multiple lumens have a high profile, making them challenging to deploy endoluminally, especially in difficult procedures, as they increase in size due to fixed lumen diameters, limiting their efficiency and accuracy in delivering fluids to multiple locations within the body.

Innovation Solution

A catheter assembly with an expandable sheath that transitions from a relaxed to a pressurized configuration, forming multiple fluid channels along its length, allowing for efficient delivery of fluids to various body lumens while maintaining a low profile, using a sheath with macroscopic apertures that occupy less than 20% of the surface area, attached to an elongated member at circumferential ends, enabling fluid delivery through pressurization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If multiple fixed lumens are added to a catheter, then multi-channel fluid delivery capability is improved, but catheter profile increases

Engineering Contradiction:
Improvemulti-channel fluid delivery capabilityVSAvoidcatheter profile
Core Design Contradiction:
Adaptability or versatilityVSLength of moving object

Solution Approach 1:

The catheter employs a dynamic lumen structure where the second lumen can expand from a compressed state during navigation to an expanded state for fluid delivery. This dynamic transformation allows the catheter to maintain a low profile during insertion while providing multi-channel capability when needed at the treatment site.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The catheter design nests the second lumen within the first lumen when compressed, similar to nested dolls. The expandable second lumen is contained within the catheter body during navigation, allowing passage through small access vessels, then expands at the target location to provide additional fluid delivery channels.

Inventive Principle:
Principle #7Nested doll (Nesting)

2Length of moving object

If an expandable sheath is used as a secondary lumen, then catheter profile is reduced, but device complexity increases

Engineering Contradiction:
Improvecatheter profileVSAvoiddevice complexity
Core Design Contradiction:
Length of moving objectVSDevice complexity

Solution Approach 1:

The catheter utilizes a flexible expandable sheath made of compliant material that can transition between compressed and expanded states. This flexible shell structure provides the secondary lumen functionality while maintaining structural integrity, reducing the need for complex rigid mechanisms.

Inventive Principle:
Principle #30Flexible shells and thin films

Solution Approach 2:

The expandable sheath incorporates dynamic properties allowing it to change shape and volume in response to internal pressure or external forces, enabling the catheter to transition from a low-profile navigation state to a functional delivery state without complex mechanical actuators.

Inventive Principle:
Principle #15Dynamics

3Adaptability or versatility

If macroscopic apertures are added to the sheath, then fluid delivery to multiple locations is improved, but sheath structural integrity may be compromised

Engineering Contradiction:
Improvefluid delivery to multiple locationsVSAvoidsheath structural integrity
Core Design Contradiction:
Adaptability or versatilityVSStrength

Solution Approach 1:

The sheath is designed with non-uniform properties, incorporating macroscopic apertures at specific locations where fluid delivery is needed while maintaining intact structure in other regions. This localized modification allows fluid egress at targeted sites without compromising the overall structural integrity of the sheath.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The sheath incorporates macroscopic apertures that function as controlled porous structures, allowing fluid passage while the surrounding sheath material maintains structural strength. The apertures are strategically positioned and sized to provide fluid delivery functionality without creating weak points that would compromise sheath integrity.

Inventive Principle:
Principle #31Porous materials

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 catheter assembly effectively delivers fluids to multiple locations within the body, such as the vasculature, with enhanced accuracy and efficiency, reducing the risk of adhesion and facilitating the deployment of implantable devices by maintaining a low profile and allowing for precise fluid distribution.

Implementation Method 1

the sheath comprises a wall thickness, an outer surface area, a first relaxed configuration and a second pressurized configuration

Methodology Applied
Scientific EffectPressure-induced expansion: Pressure Increase

Data Source

PatentUS20220001137A1Catheter assembly
Publication Date: 2022.01.06 WL GORE & ASSOC INC
  • US20220001137A1 patent drawing
  • US20220001137A1 patent drawing
  • US20220001137A1 patent drawing

AI summary

A multi lumen catheter assembly. The assembly provides an expandable, low profile, fixed length sheath and catheter, with fixed infusion ports. The assembly has an expandable outer sheath that expands upon pressure activation with a fluid and the sheath allows the fluid to exit from at least one predetermined fixed location from a distal end of the catheter assembly. The catheter assembly can be used in various medical device procedures, such as a TIPS (Transjugular Intrahepatic Portosystemic Shunt) procedure, or anywhere a low profile, multi lumen, infusion catheter system is desired.