Intermittent Catheter Assembly With Controlled Wetting Release
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Solution Overview
Problem
Existing catheters face issues with inadequate wetting of the catheter tube due to exposure to moisture, leading to difficulty in handling and potential trauma or infection, especially during self-catheterization, and insufficient wetting agent volume in packaging resulting in incomplete wetting, particularly affecting the tip end.
Innovation Solution
A catheter assembly with a cap and main body forming a sterile cavity, featuring a wetting agent storage chamber sealed by a movable insert and a seal element, allowing controlled release of the wetting agent directly to the catheter tube, ensuring complete wetting and minimizing exposure to moisture.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the catheter is submerged in wetting agent within the packaging, then the catheter tube is adequately wetted prior to use, but other components such as gripper element or funnel become wetted making it difficult to hold and direct the catheter tube
Solution Approach 1:
The packaging is divided into separate compartments: one for the catheter tube and another for the wetting agent. The catheter tube can be removed and wetted without other components being exposed to the wetting agent, thus maintaining handling ease while ensuring adequate wetting of the catheter tube.
Solution Approach 2:
The catheter tube is extracted from the packaging container before wetting. This allows the catheter tube to be wetted independently without other components like gripper elements or funnels being exposed to the wetting agent, solving the handling difficulty problem.
2Reliability
If the catheter is submerged in wetting agent within the packaging, then the catheter tube is adequately wetted prior to use, but the shelf-life of the catheter is reduced due to long-term exposure of components to moisture
Solution Approach 1:
The packaging is segmented into separate compartments for the catheter tube and wetting agent. This prevents long-term moisture exposure of catheter components while ensuring the catheter tube can be adequately wetted when needed, thus preserving shelf-life.
Solution Approach 2:
The catheter tube is prepared for wetting by removing it from the packaging before use. This preliminary action prevents premature moisture exposure during storage while ensuring the catheter tube is ready for adequate wetting at the point of use.
3Quantity of substance
If a rupturable container or sachet is used to release wetting agent, then the wetting agent can be supplied to the catheter tube, but the wetting agent may come into contact with other components of the catheter
Solution Approach 1:
The packaging uses separate compartments to isolate the wetting agent from other catheter components. The wetting agent is supplied to the catheter tube through a controlled mechanism that prevents contact with gripper elements or funnels, thus avoiding component contamination.
Solution Approach 2:
The catheter tube is extracted from the packaging before wetting, allowing the wetting agent to be applied solely to the catheter tube without contacting other components. This extraction step prevents component contamination while ensuring adequate wetting.
4Reliability
If the catheter tube is moved through a wetting device during removal from packaging, then the catheter tube is wetted, but the amount of wetting agent is limited due to packaging constraints
Solution Approach 1:
The catheter tube is removed from the packaging before wetting, allowing sufficient wetting agent to be applied to the catheter tube without packaging constraints. This preliminary removal enables adequate wetting effectiveness.
Solution Approach 2:
The wetting process is separated from the packaging removal process. The catheter tube is first removed from packaging, then wetted in a separate step, allowing unlimited wetting agent volume to be applied without packaging constraints affecting wetting effectiveness.
5Quantity of substance
If wetting agent is supplied from the distal end, then the catheter tube can be wetted, but the tip end may not be wetted at all resulting in increased trauma risk
Solution Approach 1:
The catheter tube is removed from packaging before wetting, allowing the wetting agent to be applied from the proximal end through to the distal tip. This preliminary removal ensures complete wetting distribution including the tip end, reducing trauma risk.
Solution Approach 2:
Instead of supplying wetting agent from the distal end, the process is inverted by removing the catheter tube first and then applying wetting agent from the proximal end, ensuring complete coverage including the tip end, thus reducing trauma risk.
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 assembly ensures thorough wetting of the catheter tube, reducing the risk of trauma and infection, maintaining sterility, and optimizing packaging size by minimizing wetting agent volume while ensuring effective wetting even at the end of shelf life.
Implementation Method 1
A catheter assembly with a sealed wetting agent storage chamber and a movable insert that axially aligns with the chamber wall to maintain the seal
Implementation Method 2
the catheter tube itself comprises, is integrated with or is coated with a hydrophilic component (e.g. a hydrophilic polymer) which serves to reduce friction further upon application of the wetting agent
Data Source
AI summary
An intermittent catheter, preferably a female intermittent catheter, is provided in an assembly. The assembly may include a cap which may be attachable to the base of the assembly in use, and/or a seal which misaligns with sealing surfaces of a chamber wall and a moveable insert in use. It may have a two-step deployment, and/or a sheath that pulls out a storage chamber. Internal and external housing may define the storage chamber. The housing may have a filling aperture and/or the storage chamber may comprise an insert configured to move axially in response to rotation.