Flexible Enterostomy Prosthesis with Inflatable Balloon Occlusion
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Solution Overview
Problem
Existing enterostomy prostheses cause discomfort, restrict movement, require frequent maintenance, and are costly due to complex surgery, adhesive issues, and frequent bag changes, limiting social reintegration and increasing healthcare costs.
Innovation Solution
A flexible, monolithic prosthesis with inflatable balloons and a flange element made of silicone-based polymeric materials, allowing for adjustable sealing and easy insertion/extraction, reducing discomfort and maintenance needs, and enabling use of standard toilets without collection bags.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If traditional collection bags are used for enterostomy patients, then fecal contents can be collected and contained, but the patient experiences aesthetic problems, requires frequent maintenance and changes, and suffers from skin irritation due to bonding agents
Solution Approach 1:
The prosthesis is divided into two separate functional components: an internal occluding element that can be implanted once to provide long-term fecal containment, and external collection bags that are used temporarily and discarded. This segmentation eliminates the need for frequent changes of the implanted device while maintaining reliable fecal containment, reducing maintenance frequency from daily bag changes to occasional external bag replacements.
Solution Approach 2:
The patent introduces an intermediate occluding element (plug or sphincter) that acts as a mediator between the stoma and the external collection bag. This intermediate device provides a reliable sealing interface that eliminates the need for bonding agents to attach the collection bag directly to the skin, thereby preventing skin irritation while maintaining effective fecal containment.
2Ease of operation
If artificial occluding prostheses are implanted to provide voluntary continence control, then fecal outflow can be prevented, but complex surgery with infection risks and frequent bowel irrigations are required
Solution Approach 1:
The occluding element is designed with self-occluding capabilities through inherent mechanical properties (elasticity, shape memory, or magnetic attraction) rather than requiring complex surgical implantation of active control systems. The device automatically occludes the stoma based on physiological conditions or simple user activation, eliminating the need for complex surgery and frequent medical interventions like bowel irrigations.
Solution Approach 2:
The patent replaces complex surgical mechanical systems (surgically implanted occluders requiring irrigation) with simpler magnetic or elastic mechanical systems that achieve the same occlusion function through passive physical principles, reducing surgical complexity and maintenance requirements.
3Stability of the object's composition
If rigid monolithic prostheses are used for enterostomy, then structural stability is provided, but patient comfort is reduced during flexion movements and prolonged sitting
Solution Approach 1:
The prosthesis transitions from a static rigid structure to a dynamic system where the occluding element can change its state (occluded/occluding) and the external collection bag can be adjusted or removed. This dynamic capability allows the prosthesis to adapt to patient movements and positions, maintaining structural stability when needed while providing comfort during flexion and sitting by allowing movement and pressure distribution.
Solution Approach 2:
The patent employs flexible materials for the occluding element and external collection bag, replacing rigid monolithic structures. These flexible components can deform with patient movements, conform to body contours, and distribute pressure evenly, thereby maintaining adequate structural stability while significantly improving comfort during flexion movements and prolonged sitting.
4Reliability
If frequent bag changes are required for enterostomy patients, then fecal containment can be maintained, but time expenditure and disposal difficulties increase
Solution Approach 1:
By segmenting the prosthesis into a permanent implanted occluding element and temporary external collection bags, the system maintains reliable fecal containment through the implanted component while reducing the frequency of changes needed for the external bags, thereby decreasing time expenditure on bag changes and simplifying disposal routines.
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 flexible prosthesis provides comfortable, adaptable continence control, reducing the need for frequent replacements and irrigation, enhancing quality of life and social integration for enterostomy patients while lowering healthcare costs.
Implementation Method 1
The tubular element has occluding means comprising a balloon that, when inflating, allows the occlusion of the stoma
Implementation Method 2
The tubular element has, at its second end, a flange element adapted to abut against the patient's abdominal wall
Data Source
Figure 1~2
Figure 3~4
Figure 5
AI summary
The prosthesis (1) for enterostomy patients comprises: - a tubular element (2) of elongated shape and insertable substantially to size inside of a stoma (3) made on the abdominal wall (4) of a patient; - a first obstruction means (8) to obstruct at least one area of the stoma (3), associated with a first end (6) of the tubular element (2) and movable between a restricted configuration (9) and an enlarged configuration (10) to allow the insertion/extraction into/from the stoma (3) respectively, and to prevent leakage of feces from the stoma itself; - a first through duct (13) made on the tubular element (2), communicating with the first obstruction means (8) and having valve means (14) connectable to forced introduction/extraction means (15) of a fluid into/from the first obstruction means (8); - a second through duct (19) made on the tubular element (2), communicating with the inside of the stoma (3) and having filtering means (20) for the outflow of gases from the stoma itself; and - an external retaining element (11) associated with a second end (7) of the tubular element (2) opposite to the first end (6) and able to cooperate with at least one portion of the abdominal wall (4) and having at least two through holes (16, 21) arranged at the first duct (13) and the second duct (19); in which at least one of the tubular element (2) and the retaining element (11) is made at least partially of a flexible material.