Elastomeric Catheter Retaining Device with Clip Closure
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Solution Overview
Problem
Existing external retaining devices (ERDs) for catheters, such as PEG and G-tubes, fail to provide secure and comfortable retention while allowing easy cleaning and adjustment, and are not suitable for catheters of varying diameters and rigidity, often leading to accidental displacement or friction issues.
Innovation Solution
A one-component ERD with a base plate, guiding part, and fixation part, featuring a clip closure with interlocking rigid polymeric elements and an elastomeric hinge, which provides a secure lock without causing pain and allows easy cleaning, accommodating different catheter diameters through overmoulding and flexible design.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the ERD provides strong holding forces to retain the catheter securely, then the catheter cannot migrate out of the stomach, but the catheter creates friction with the stoma during insertion and adjustment
Solution Approach 1:
The ERD features a curved, arc-shaped design that follows the natural contour of the stoma and abdominal wall. This curvature allows the device to accommodate the catheter at an angle that reduces friction during insertion and adjustment, while the arch structure provides mechanical leverage for secure retention without excessive pressure on the stoma tissue.
Solution Approach 2:
The ERD is constructed from flexible elastomeric material that can deform and conform to the contours of the patient's body and the catheter. This flexibility allows the device to provide secure holding forces while adapting to movements and adjustments, reducing friction and discomfort during catheter manipulation.
2Ease of operation
If the ERD is designed to easily displace along the catheter for cleaning purposes, then the skin around the stoma can be properly cleaned, but the catheter may slide uncontrollably out of the device
Solution Approach 1:
The ERD incorporates a dynamic locking mechanism with movable arms that can transition between locked and unlocked states. During cleaning, the arms can be temporarily displaced to allow catheter movement, while during normal use, the arms engage with retention elements on the catheter to prevent unintended displacement, thus balancing cleaning accessibility with secure retention.
Solution Approach 2:
The ERD is divided into modular components including a body portion and movable retention arms. This segmentation allows the retention arms to be independently positioned and adjusted, enabling easy displacement for cleaning while maintaining secure engagement with the catheter during normal operation through separate locking and retention mechanisms.
3Reliability
If the ERD uses a complex locking mechanism to prevent accidental displacement, then the catheter cannot be pulled out of the bracket, but the device becomes difficult to operate and clean
Solution Approach 1:
The ERD employs a self-locking mechanism where the retention arms automatically engage with the catheter upon insertion and maintain retention through elastic memory of the elastomeric material. The arms return to their engaged position automatically after displacement, providing secure retention without requiring complex manual locking operations, thus simplifying both operation and cleaning.
Solution Approach 2:
The ERD uses small retention elements or features on the catheter that serve as intermediaries between the elastomeric arms and the catheter body. These intermediaries provide positive engagement points that enhance retention reliability while keeping the overall mechanism simple, allowing the arms to secure the catheter through straightforward geometric interlocking rather than complex mechanical systems.
4Reliability
If the ERD is made from rigid material to provide secure locking, then the catheter is retained firmly, but the device causes pain and discomfort to the patient
Solution Approach 1:
The entire ERD is constructed from flexible elastomeric material that conforms to the patient's skin and abdominal wall contours. This flexibility eliminates pressure points and discomfort associated with rigid materials, while the elastomeric properties provide sufficient mechanical strength for secure catheter retention through elastic deformation and memory effects.
Solution Approach 2:
The ERD utilizes composite construction combining elastomeric polymer material with integrated retention features. The elastomeric base provides comfort and flexibility, while strategically placed retention elements or surface treatments on the catheter interface enhance gripping force, achieving both patient comfort and reliable retention through material composition rather than rigid structure.
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 ERD securely retains catheters without causing discomfort, allows easy cleaning and adjustment, and is suitable for various catheter sizes due to its flexible and secure locking mechanism, reducing the risk of accidental displacement and friction-related issues.
Implementation Method 1
at least the base plate and the hinge comprise an elastomeric polymer
Implementation Method 2
The clip closure comprises two interlocking elements and a hinge therebetween, wherein at least one of the elements comprises rigid polymeric material
Data Source
Figure 1A~1B
Figure 2A
Figure 2B
AI summary
An ERD for securing a catheter exiting a stoma. The ERD comprises a base plate for engagement with the abdomen of a patient, a guiding part comprising a concave channel open to the top side thereof, for guiding the catheter from the base plate through a first curved section of the concave channel to a substantially parallel position relative to the base plate in a second section of the concave channel and a fixation part. The fixation part has an open state in which a catheter may be introduced into the channel and a closed state for encircling and fixing the catheter within the second section of the guiding part. The fixation part comprises a clip closure comprising two interlocking elements and a hinge therebetween, wherein at least one of the elements comprises rigid polymeric material and at least the base plate and the hinge comprise an elastomeric polymer.