Self-Inflating Anorectal Balloon for Radiation-Free Expulsion Testing
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Solution Overview
Problem
Existing methods for diagnosing anorectal disorders, such as obstructed defecation, are cumbersome, costly, and expose patients to radiation, with difficulties in device insertion and expulsion time measurement.
Innovation Solution
Development of self-inflating anorectal expulsion devices using self-expanding materials, compressed gas cylinders, chemical reactions, or fluid transfer to inflate a balloon within the rectum, allowing for easy insertion and precise expulsion time measurement without external devices or radiation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If a fluid-filled balloon is inserted into the patient's rectum to assess expulsion ability, then the diagnosis can be performed with low cost, but the insertion and inflation process becomes difficult and untidy
Solution Approach 1:
The balloon is pre-assembled with the anorectal expulsion device before insertion, eliminating the need for difficult in-situ inflation. The balloon is inserted in its assembled state and then inflated within the rectum using simple fluid transfer through the catheter, making the process tidy and easy to perform.
2Measurement precision
If radiography is used to image the simulated stool device in situ, then precise information about device deformation during expulsion can be obtained, but the technique becomes cumbersome and expensive requiring external devices
Solution Approach 1:
The balloon is made translucent or transparent, allowing direct visual observation of the balloon and its deformation during expulsion without requiring radiography or other complex imaging devices. This enables precise measurement of expulsion characteristics while eliminating the need for expensive external equipment.
3Measurement precision
If radiography is used to image the simulated stool device, then deformation information is obtained, but the patient is exposed to potentially harmful radiation
Solution Approach 1:
The translucent or transparent balloon material allows direct visual observation of expulsion without radiography, providing the needed deformation information while completely eliminating harmful radiation exposure to the patient.
4Ease of operation
If the balloon may be temporarily hidden from view during expulsion, then the clinician's position relative to the patient is constrained, but precise determination of expulsion completion becomes difficult
Solution Approach 1:
The translucent balloon allows the clinician to visually confirm expulsion completion regardless of positioning, as the balloon remains visible throughout the expulsion process. This eliminates the uncertainty of whether the balloon has been passed while maintaining clinician positioning flexibility.
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
Facilitates easier and cleaner insertion and removal of the device, provides precise expulsion time information, and offers a low-cost solution without the need for X-ray machines.
Implementation Method 1
the distal balloon is at least partially filled with a self-expanding, low compression-set material
Implementation Method 2
compressed gas cylinders, or chemical reactions, to expand a balloon within the rectum
Implementation Method 3
chemical reactions, to expand a balloon within the rectum
Implementation Method 4
fluid transfer to inflate a balloon within the rectum
Data Source
AI summary
An anorectal expulsion device includes a balloon having a wall that extends between proximal and distal ends of the balloon and defines a balloon interior. The balloon interior contains a self-expanding, low compression-set material (e.g., open cell foam). The device also includes a catheter that extends through the proximal end of the balloon and at least a portion of the balloon interior. An interior of the catheter is in fluid communication with the balloon interior. The device also includes a termination component (e.g., a cap or a valve) coupled to the catheter at a position along the catheter that is outside of and proximal to the proximal end of the balloon (e.g., at the proximal end of the catheter). The physical configuration of the termination component is adjustable, and controls whether the balloon interior is in fluid communication with the external environment.