Hydrating Sleeve Catheter Packaging for Sterile Lubricious Insertion

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Solution Overview

Problem

Existing hydrophilic-coated intermittent catheters face challenges in maintaining lubricious coatings in a hydrated state without compromising sterility, especially when water is not readily available, and handling issues lead to potential contamination and urinary tract infections.

Innovation Solution

A catheter assembly featuring a hydrating sleeve and a foil outer layer that maintains the coating in a hydrated state within a sealed, impermeable package, ensuring minimal fluid spillage and user safety.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a catheter shaft is pre-formed into a curved configuration, then it can navigate tortuous anatomical pathways more effectively, but it may engage tissue or vessel walls causing discomfort or damage

Engineering Contradiction:

Improveability to navigate tortuous anatomical pathwaysVSAvoidtissue engagement or vessel wall damage

Core Design Contradiction:

Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The catheter shaft transitions from a static pre-formed curved configuration to a dynamic, reconfigurable structure. The shape memory alloy sleeve allows the shaft to change its curvature and configuration in response to temperature changes or mechanical forces, enabling it to adapt to anatomical pathways without permanently engaging tissue walls.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The catheter shaft utilizes changes in physical parameters (temperature, phase state) of the shape memory alloy material to alter its mechanical properties. By heating or cooling the shaft, the curvature and stiffness can be modified, allowing navigation through tortuous pathways and subsequent straightening to prevent tissue engagement.

Inventive Principle:

Principle #35Parameter changes

2Adaptability or versatility

If a catheter shaft is made more flexible to navigate complex pathways, then navigability improves, but radial force and structural support may be compromised

Engineering Contradiction:

Improvenavigability through complex pathwaysVSAvoidradial force and structural support

Core Design Contradiction:

Adaptability or versatilityVSStrength

Solution Approach 1:

The catheter shaft employs different material properties in different sections or layers. The shape memory alloy sleeve provides localized stiffness and radial force where needed, while other sections maintain flexibility for navigation. This gradient or zoned structure allows simultaneous achievement of navigability and structural support.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The catheter shaft combines shape memory alloy material with other materials to create a composite structure. This composite construction integrates the flexibility needed for navigation with the radial strength required for structural support, with each material contributing its optimal properties to the overall system.

Inventive Principle:

Principle #40Composite materials

3Adaptability or versatility

If a catheter shaft is pre-formed with a curved configuration, then it can access difficult anatomical locations, but the pre-formed shape may cause discomfort during insertion

Engineering Contradiction:

Improveaccess to difficult anatomical locationsVSAvoiddiscomfort during insertion

Core Design Contradiction:

Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The catheter shaft is pre-formed into a curved configuration that can be activated or adjusted during insertion. The shape memory alloy allows the shaft to initially engage the curved configuration for navigation, then automatically or manually transition to a straighter configuration to reduce discomfort, performing the shape change action at the optimal moment.

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 ensures the catheter remains lubricious and sterile, reducing the risk of infections by maintaining the coating's hydration within the package, facilitating easy insertion, and minimizing exposure to contaminants.

Implementation Method 1

The catheter assembly includes a shape memory alloy sleeve disposed about the catheter shaft and configured to change a configuration of the catheter shaft in response to a stimulus

Methodology Applied

Scientific EffectShape memory effect:

Implementation Method 2

The catheter assembly includes a hydrogel coating disposed over the shape memory alloy sleeve

Methodology Applied

Scientific EffectHydrogel hydration: Hydrogel

Data Source

PatentEP2542291B1Catheter assembly/package utilizing a hydrating/hydrogel sleeve and a foil outer layer

Publication Date: 2026.04.29 CR BARD INC

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AI summary

A catheter assembly including an elongate member having a proximal end and a distal end. The distal end has at least one drainage opening. A hydrophilic coating is provided on at least a portion of the elongate end of the catheter. A fluid containing member is provided and is either arranged on the elongate member or within a separate area of the container. The fluid containing member contains sufficient hydrating fluid to hydrate the coating of the catheter. A container contains the elongate member and the fluid containing member and incorporates at least one foil layer to prevent evaporation of the hydrating fluid. A method of using the catheter includes inserting a catheter into a user' s body and draining fluid from the user's body.