Long-Lumen Sterilization Using Pressure-Driven Hydrogen Peroxide Vapor
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Solution Overview
Problem
Existing sterilization methods for medical articles with long and narrow lumens, such as endoscopes, are inefficient, leading to incomplete sterilization and potential patient infections due to occluded connection points and the use of toxic or lengthy processes.
Innovation Solution
An apparatus and method involving a first chamber connected to a pump and a sterilant source, with a second chamber and article connector forming a fluid path through the lumen, allowing pressure differences to force sterilant flow and using hydrogen peroxide vapor for effective sterilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of manufacture
If diffusion-based sterilization techniques are used for long and narrow lumens, then the sterilization process can be simple, but the sterilization is incomplete and ineffective
Solution Approach 1:
The patent employs pneumatic principles by using pressure differentials to force sterilant through the lumen. A pump creates negative pressure in the distal chamber to draw sterilant through the lumen, while positive pressure is applied in the proximal chamber to push sterilant toward the distal end. This mechanical force-based approach overcomes the limitations of diffusion-based methods for long and narrow lumens, ensuring complete sterilization while maintaining process simplicity.
Solution Approach 2:
The patent changes the physical parameters of the sterilization process by applying controlled pressure differentials rather than relying on diffusion. The system dynamically adjusts pressure parameters in different chambers to control sterilant flow through the lumen, transforming the sterilization mechanism from passive diffusion to active pressure-driven flow, thereby improving sterilization effectiveness.
2Adaptability or versatility
If connection points are used to attach sterilization apparatus to articles, then the apparatus can be configured for sterilization, but connection points become occluded and create non-sterilized areas
Solution Approach 1:
The patent segments the sterilization system into multiple isolated chambers (proximal chamber and distal chamber) that can be independently pressurized. This segmentation allows sterilant to be forced through the lumen from one end to the other without requiring connections at intermediate points, thereby eliminating occluded connection points and ensuring complete sterilization while maintaining apparatus configurability.
Solution Approach 2:
The patent introduces an intermediary fluid path system using flexible conduits and pressure-driven flow to transport sterilant through the lumen. Instead of direct rigid connections that can become occluded, the system uses pressure differential as an intermediary mechanism to force sterilant through, eliminating the need for traditional connection points and preventing non-sterilized areas.
3Reliability
If ethylene oxide gas sterilization is used, then sterilization can be achieved, but toxic and carcinogenic products are generated
Solution Approach 1:
The patent changes the chemical parameter of the sterilant from ethylene oxide gas to hydrogen peroxide vapor. This parameter change eliminates the generation of toxic and carcinogenic products while maintaining sterilization effectiveness. The system uses controlled temperature and pressure parameters to generate hydrogen peroxide vapor that effectively sterilizes without creating harmful byproducts.
Solution Approach 2:
The patent employs hydrogen peroxide, a strong oxidant, as the sterilant. The oxidizing action of hydrogen peroxide provides effective sterilization without the toxic side effects of ethylene oxide. The system utilizes the accelerated oxidation properties of hydrogen peroxide to achieve reliable sterilization while avoiding harmful chemical byproducts.
4Object-generated harmful factors
If hydrogen peroxide vapor sterilization is used for long and narrow lumens, then no toxic residues are left, but sterilization has been limited success
Solution Approach 1:
The patent combines hydrogen peroxide vapor sterilization with pneumatic pressure differential technology. By applying negative pressure in the distal chamber and positive pressure in the proximal chamber, the system forces hydrogen peroxide vapor through long and narrow lumens, overcoming the limited effectiveness of hydrogen peroxide vapor alone while maintaining the advantage of no toxic residues.
Solution Approach 2:
The patent changes the delivery parameters of hydrogen peroxide vapor from passive diffusion to active pressure-driven flow. By controlling pressure parameters in different chambers and using temperature control to regulate vapor generation, the system enhances the effectiveness of hydrogen peroxide vapor sterilization for long and narrow lumens while preserving the benefit of no toxic residues.
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
Ensures thorough sterilization of long and narrow lumens, reduces cycle time, and avoids toxic residues, providing real-time verification and minimizing non-sterilized areas.
Implementation Method 1
a pump for adjusting an internal pressure in the first chamber... allowing pressure differences to force sterilant flow
Implementation Method 2
using hydrogen peroxide vapor for effective sterilization
Implementation Method 3
the chamber connector being selectively sealable to fluidly isolate the first and second chambers
Implementation Method 4
an article connector configured to fluidly connect the second open end of the article to the second chamber to form a fluid path extending from the first chamber to the second chamber through the lumen of the article
Data Source
AI summary
An apparatus and method for sterilization of an article which has a first open end, a second open end and a lumen extending therebetween. The apparatus comprises a first chamber for receiving the article. The first chamber has an outlet fluidly connectable to a pump for adjusting an internal pressure in the first chamber; and an inlet fluidly connectable to a sterilant source for supplying sterilant to the first chamber. The apparatus includes a second chamber fluidly connectable to the first chamber by a chamber connector fluidly sealable to isolate the first and the second chamber; and an article connector for fluidly connecting the second open end of the article to the second chamber to form a fluid path from the first to the second chamber through the lumen. Also included is an article connector for connecting an open end of an article to be sterilized to a sterilization apparatus.