Segmented Balloon Catheter for Secure Enema Retention
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Solution Overview
Problem
Conventional transanal irrigation catheters require continuous manual adjustment to maintain a sealed position and are prone to slipping out of the rectum, leading to potential trauma and inefficiencies in enema delivery, especially due to the high filling pressures needed for balloon expansion.
Innovation Solution
A foil-sealed, tear-off pack container with a dumbbell or hourglass-shaped balloon catheter that is preformed to its working size, allowing for atraumatic placement and controlled filling, ensuring secure positioning and reduced pressure requirements, thereby minimizing discomfort and premature emptying.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If conventional transanal irrigation catheters are used with intrarectal balloon components, then sealing effect is improved, but the catheter requires continuous manual repositioning and slips out of the rectum
Solution Approach 1:
The catheter is divided into multiple functional segments: an intrarectal balloon for sealing, an intermediate tapered section for reflex triggering, and a preanal balloon for anchoring. This segmentation allows each part to perform its specific function independently, eliminating the need for continuous manual repositioning while maintaining reliable sealing.
Solution Approach 2:
The balloon elements are inverted on the catheter shaft such that the terminal balloon portions move towards each other in opposite directions when inflated. This inversion configuration enables the balloons to work together synergistically - the intrarectal balloon seals while the preanal balloon anchors, preventing slippage without manual intervention.
2Reliability
If high filling pressures are used for balloon expansion to ensure anchoring, then catheter retention is improved, but trauma risk and patient discomfort increase
Solution Approach 1:
Different regions of the catheter system operate at different pressure levels. The preanal balloon requires high pressure for anchoring, while the intrarectal balloon operates at lower pressure for sealing. The intermediate section is designed to trigger reflexes at moderate pressure. This local differentiation of pressure requirements allows secure retention without excessive trauma risk.
Solution Approach 2:
The inverted configuration of the terminal balloon portions creates a mechanical advantage where the balloons move towards each other during inflation. This arrangement distributes the anchoring force more evenly and reduces peak pressures needed for secure retention, thereby minimizing trauma risk while maintaining catheter stability.
3Ease of operation
If the catheter shaft extends distally beyond the balloon apex, then insertion is simplified, but intestinal wall trauma occurs
Solution Approach 1:
The distal catheter shaft is pre-formed during manufacturing to a tapered shape that naturally guides insertion. This preliminary shaping eliminates the need for the shaft to extend beyond the balloon apex during use, as the tapered form facilitates smooth passage through the anal canal without requiring excessive length that would cause trauma.
4Device complexity
If simple tubular catheters are used, then device complexity is reduced, but catheter retention and sealing capacity are insufficient
Solution Approach 1:
Rather than using a simple tubular design, the catheter is segmented into distinct functional zones with balloon elements at strategic positions. This segmentation provides the necessary retention and sealing capabilities while keeping each individual component relatively simple in design.
Solution Approach 2:
The multi-balloon catheter design makes each balloon element serve multiple functions: the intrarectal balloon provides both sealing and reflex triggering, while the preanal balloon provides anchoring and stabilization. This multi-functionality achieves superior retention without proportionally increasing overall device complexity.
Data Source
Figure 1~1a
Figure 2
Figure 3a
AI summary
The invention relates to a foil-sealed container (39) in the form of a tear-open pack for the ready-to-use storage of various elements for the administration of a trans-anal enema, wherein at least two compartments (42, 44) are formed by planar, spot or linear welding (38) of two foil layers (37a, 37b), wherein two interconnected compartments (42, 44) are provided for receiving an enema catheter, between which a tapered seal (46) of the two foil layers (37a, 37b) is provided, which lies as close as possible to the shaft of the enema catheter, and wherein a gel reservoir (45) is provided in the compartment (44) for receiving the portion of the enema catheter to be placed intra-rectally.