Disposable Endoscope Sheath for Sterility and Cost Reduction
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Solution Overview
Problem
Current methods for sterilizing medical devices, such as endoscopes, are either impractically time-consuming or damaging due to caustic germicidal solutions, and the use of disposable instruments is costly.
Innovation Solution
A sanitary disposable sheath for medical devices, specifically an endoscope sheath with a relatively inelastic body and a distal tip that allows energy transmission, featuring an evacuation fitting for fluid removal and a secondary tube for additional functionality, providing a cost-effective and efficient barrier against contamination.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If gas sterilization is used, then sterilization effectiveness is improved, but time consumption increases to twenty-four hours
Solution Approach 1:
The patent applies the disposable principle by using a single-use sheath that is discarded after one use, eliminating the need for time-consuming sterilization processes. The sheath is provided in a sterile state and disposed of after use, reducing sterilization time from 24 hours to minimal preparation time while maintaining sterilization effectiveness through the barrier property of the sheath itself.
2Loss of time
If germicidal solution soaking is used, then time consumption is reduced to at least ten minutes, but device damage increases due to caustic solutions
Solution Approach 1:
The disposable sheath eliminates the need for chemical sterilization processes that expose devices to caustic germicidal solutions. By providing a pre-sterilized single-use sheath, the patent avoids device damage from chemical exposure while maintaining rapid preparation (less than 10 minutes) through simple sheath application rather than solution soaking.
Solution Approach 2:
The sheath acts as an intermediary barrier between the medical device and the contaminated environment. Instead of treating the device with harmful chemicals, the sheath provides a physical barrier that prevents contamination, eliminating the need for caustic germicidal solutions and their associated device damage.
3Reliability
If disposable instruments are used, then contamination risk is reduced, but cost increases unjustifiably
Solution Approach 1:
The patent applies segmentation by separating the disposable component (sheath) from the expensive reusable component (endoscope). Only the outer sheath is discarded after one use, while the expensive endoscope is retained and reused. This segmented approach reduces contamination risk through disposable barriers while avoiding the unjustified cost of disposing of entire expensive instruments.
Solution Approach 2:
The patent uses a disposable sheath that is inexpensive compared to the endoscope itself. The sheath provides the necessary single-use barrier function at minimal cost, while the expensive endoscope is protected and reused, achieving contamination prevention without the prohibitive cost of entirely disposable instruments.
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 endoscope sheath effectively creates a fluidtight seal, maintains sterility, and allows for energy transmission, reducing the risk of contamination and damage while being more cost-effective than disposable instruments.
Implementation Method 1
an evacuation fitting in fluid communication with the sheath lumen that is configured for selective removal of fluid from the sheath lumen
Implementation Method 2
the relatively inelastic sheath body will substantially maintain its thickness when positive or negative pressure is applied to it
Data Source
AI summary
A medical device sheath that includes a relatively inelastic body having a proximal end longitudinally separated from a distal end and defining a first lumen, an aperture located at the proximal end in fluid communication with the lumen and configured to admit an elongate endoscope body into the first lumen, and a transparent tip located longitudinally adjacent to an endoscope lens when the elongate endoscope body is located within the first lumen. The endoscope sheath may also include an elongate secondary tube defining a secondary lumen. A method of using the medical device sheath is also described.