Transsphincteric Balloon Pressure Feedback for Continence Training
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Solution Overview
Problem
Fecal incontinence is prevalent among older individuals and current therapies, including surgical approaches and biofeedback, have been largely unsuccessful in effectively strengthening the anal sphincter muscles to improve continence.
Innovation Solution
A medical device comprising a transsphincteric balloon system with a pressure sensing mechanism that loads and strengthens the anal sphincter muscles by displacing fluid between interconnected balloons, providing real-time feedback on contraction force.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical approaches are used to treat fecal incontinence, then structural repair may be achieved, but treatment success has been limited and unpredictable
Solution Approach 1:
The patent replaces surgical mechanical repair with a non-invasive mechanical training system using balloons and fluid pressure to strengthen muscles, eliminating surgical complexity while achieving reliable treatment results through progressive muscle overload
Solution Approach 2:
The system changes physical parameters (fluid pressure, balloon volume, training frequency) to progressively overload muscles, transforming the treatment approach from static surgical repair to dynamic parameter-adjusted muscle strengthening that achieves predictable improvement
2Strength
If biofeedback methods are used for muscle training, then patient awareness may be improved, but muscle strengthening has been unpredictable
Solution Approach 1:
The system incorporates feedback through pressure sensors that detect muscle contraction forces and provide real-time information to patients and clinicians, enabling adjustment of training parameters to ensure progressive overload and predictable muscle strengthening
Solution Approach 2:
The patent uses hydraulic fluid pressure within balloons to create controlled resistive loads against contracting muscles, providing reliable and measurable mechanical feedback that correlates directly with muscle strength development
3Strength
If progressive muscle overload is implemented, then muscle strength increases, but treatment duration and complexity increase
Solution Approach 1:
The system dynamically adjusts training parameters (pressure, volume, frequency) based on patient progress, allowing intensive progressive overload during acute phases followed by maintenance phases, thereby achieving muscle strengthening in optimized timeframes rather than extended uniform treatment
4Measurement precision
If continuous muscle monitoring is implemented, then training precision is improved, but device complexity increases
Solution Approach 1:
The patent uses fluid pressure as an intermediary medium that translates muscle contraction forces into measurable pressure changes, providing precise measurement through simple pressure sensors rather than complex direct force measurement systems
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 system effectively strengthens the anal sphincter muscles through continuous overloading, enhancing muscle strength and providing feedback on contraction force, thereby reducing fecal incontinence.
Implementation Method 1
The first balloon can be compressed from the contraction of the muscle tissue, which can displace a portion of the fluid within the interior space of the first balloon. The portion of fluid moves towards the second balloon and causes the second balloon to increase in interior volume thereby indicating a contraction force of the muscle tissue.
Data Source
AI summary
A medical device for reducing incontinence can be dimensioned to be placed in an interior region of a subject surrounded by muscle tissue. The medical device can include a first balloon having an interior space containing a fluid. The proximal end of a first fluid conduit can be coupled to an outlet of the first balloon. The medical device can also include a pressure sensing detector coupled to a distal end of the first fluid conduit. The pressure sensing detector can include a second balloon. The second balloon can also be in fluid communication with the interior space of the first balloon. The first balloon can be compressed from the contraction of the muscle tissue, which can displace a portion of the fluid within the interior space of the first balloon. The portion of fluid moves towards the second balloon and causes the second balloon to increase in interior volume thereby indicating a contraction force of the muscle tissue.