Tube cavity simulation test strip capable of monitoring penetrability of sterilizer
By designing a cavity simulation test strip with a carrier layer, an indicator ink layer, and a film layer, the problem of difficulty in quantifying the penetration ability of sterilization factors was solved, enabling accurate evaluation of the internal sterilization effect of cavity-type instruments and reducing the risk of cross-infection.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- SHINVA MEDICAL INSTR CO LTD
- Filing Date
- 2025-05-12
- Publication Date
- 2026-05-05
AI Technical Summary
Existing technologies cannot effectively quantify the penetration ability of sterilizing agents into the interior of tubular instruments, resulting in incomplete sterilization and potentially causing cross-infection or product contamination.
A tubular simulation test strip was designed, comprising a carrier layer, an indicator ink layer, and a film layer. The carrier layer and the film layer are open at both ends, and the indicator ink layer is located inside. The penetration distance of the sterilization factor is measured using a ruler.
It enables quantitative measurement of the penetration distance of sterilization agents, ensuring the sterilization effect inside tubular instruments and reducing the risk of cross-infection.
Smart Images

Figure CN224202977U_ABST
Abstract
Description
Technical Field
[0001] This utility model belongs to the field of medical supplies technology, and in particular to a lumen simulation test strip that can monitor the penetration capability of a sterilizer. Background Technology
[0002] Sterilizer: A sterilizer is a device specifically designed to completely kill or remove all microorganisms (including bacteria, viruses, fungi and their spores) to ensure that items or environments reach a sterile state. Its core function is to destroy the survival structure or metabolic capacity of microorganisms through physical or chemical means, thereby eliminating their activity.
[0003] In industries such as medical, pharmaceutical, and food processing, sterilization is a crucial step in ensuring product safety and preventing microbial contamination. As the core equipment for achieving this goal, the performance of the sterilizer directly affects the sterilization effect. The penetration capability of a sterilizer refers to the ability of sterilizing agents (such as high-temperature steam, ethylene oxide, and hydrogen peroxide) to penetrate and effectively kill microorganisms. This capability is particularly important for ensuring the sterilization effect inside complex instruments (such as tubular instruments).
[0004] In the medical industry, the usage rate of tubular instruments (such as endoscopes and catheters) is increasing year by year. Due to their complex internal structure, people are paying more and more attention to their sterilization effect. Currently, tubular instruments on the market vary in length. The sterilization effect of tubular instruments is usually monitored by using a tubular simulation device, such as placing a simulation plate at the end of a 1-meter-long tubular simulation device to observe the sterilization effect of the simulation plate. This method is not only too costly to manufacture, but also cannot specifically quantify the penetration distance of the sterilizing agent, resulting in incomplete sterilization of the inside of the tubular instruments, which may lead to cross-infection or product contamination. Utility Model Content
[0005] The technical problem to be solved by this invention is to overcome the shortcomings of the prior art and provide a lumen simulation test strip that can quantify the penetration ability of sterilization factors.
[0006] The technical solution adopted by this utility model to solve its technical problem is as follows: the cavity simulation test strip that can monitor the penetration ability of sterilizer includes a carrier layer, an indicator ink layer and a film layer. The indicator ink layer is disposed between the carrier layer and the film layer, and the two ends of the carrier layer and the film layer are open in the length direction. A scale is disposed on the carrier layer.
[0007] The carrier layer is made of flexible material, and its length can be set to any length according to the needs of monitoring tubular instruments. It can also be coiled and placed inside the sterilizer like tubular instruments, providing a good simulation effect.
[0008] Preferably, the width of the indicator ink layer is smaller than the width of the carrier layer, and the length is the same as the length of the carrier layer.
[0009] Preferably, the length of the carrier layer is 1~5m.
[0010] Preferably, two scales are provided, one on the upper and one on the lower side of the carrier layer, and the indicator ink layer is provided between the two scales.
[0011] Preferably, the carrier layer and the thin film layer have the same size.
[0012] Preferably, the material of the film layer is PE, PVC or PET.
[0013] Preferably, the carrier layer is made of PET.
[0014] Compared with existing technologies, the beneficial effects of this technical solution are:
[0015] This invention involves setting an indicator ink layer between a carrier layer and a film layer, and setting a scale on the carrier layer. A simulated test strip is placed in a sterilizer for sterilization. The carrier layer and the film layer are open at both ends along their length. The sterilizing agent enters through the openings and comes into contact with the indicator ink. The indicator ink changes color upon contact with the sterilizing agent. The length of the indicator ink layer that changes color is determined by the scale, which indicates the specific penetration distance of the sterilizing agent in the sterilizer. This allows the determination of the specific length of tubular instruments that the sterilizer can sterilize. Attached Figure Description
[0016] Figure 1 This is a front view of a tubular simulation test strip for monitoring the penetration capability of a sterilizer, according to the present invention.
[0017] Figure 2 This is a top view of the present invention.
[0018] Figure 3 The image shows the test results of this utility model.
[0019] The components are: 1. Thin film layer; 2. Indicator ink layer; 201. Color-changing area; 202. Uncolored area; 3. Carrier layer; 4. Scale. Detailed Implementation
[0020] Figures 1-3 This is the preferred embodiment of the present invention, which is described below in conjunction with the appendix. Figures 1-3 The present invention will be further described below.
[0021] Reference Figure 1This tubular simulation test strip, capable of monitoring the penetration capability of a sterilizer, comprises a carrier layer 3, an indicator ink layer 2, and a film layer 1. The indicator ink layer 2 is disposed between the carrier layer 3 and the film layer 1, with openings at both ends along their length. When the test strip is placed in the sterilizer, sterilizing agents enter the space between the carrier layer 3 and the film layer 1 through the openings at both ends, contacting the indicator ink layer 2 and causing it to change color. The film layer 1 is made of a transparent material, preventing the sterilizing agents from penetrating it, allowing for direct observation of the color change distance of the indicator ink. The indicator ink layer 2 can be an indicator ink such as hydrogen peroxide, low-temperature formaldehyde vapor, peracetic acid, ethylene oxide, or pressurized steam, which is printed onto the carrier in this invention.
[0022] The carrier layer 3 of this invention is made of PET, and the film layer 1 is made of PE, PVC or PET. The carrier layer 3 and the film layer 1 can be made of any material that can achieve this function.
[0023] Reference Figure 2 The carrier layer 3 and the film layer 1 have the same dimensions. The width of the indicator ink layer 2 is smaller than the width of the carrier layer 3, and the length is the same as the length of the carrier layer 3. The indicator ink is printed in the middle of the carrier layer 3. A scale 4 is set on the upper and lower sides of the carrier layer 3. The indicator ink layer 2 is set between the two scales 4. The scales 4 are in opposite directions, so that the operator can easily read the length of the color-changing indicator ink from any direction.
[0024] The length of the carrier layer 3 is 1~5m, which can be selected according to requirements. The test strip of this utility model is set as a plane, which reduces manufacturing costs, and experiments have shown that it does not affect the test effect. If necessary, a rigid film can be selected to form a semi-circular shape with the carrier layer 3 for monitoring.
[0025] Work process:
[0026] 1. Preparation
[0027] Check the integrity of the lumen simulation test strip.
[0028] 2. Sterilization procedure execution
[0029] Start the sterilization program and select the appropriate hydrogen peroxide, low-temperature steam formaldehyde, peracetic acid, ethylene oxide, or pressurized steam circulation sterilization.
[0030] 3. Post-sterilization treatment
[0031] After sterilization, remove the test strip from the lumen.
[0032] 4. Reading results:
[0033] Reference Figure 3The sterilizing agent enters from both ends of the test strip and comes into contact with the indicator ink. The distance of the color-changing ink on the indicator ink layer 2 is observed. The length of the color-changing area 201 is obtained by subtracting the length of the uncolored area 202 from the total length of the scale 4, thereby determining the specific penetration ability of the sterilizing agent of the sterilizer.
[0034] The above description is merely a preferred embodiment of this utility model and is not intended to limit the utility model in any other way. Any person skilled in the art may make changes or modifications to the disclosed technical content to create equivalent embodiments. However, any simple modifications, equivalent changes, and modifications made to the above embodiments based on the technical essence of this utility model without departing from its scope of protection shall still fall within the protection scope of this utility model.
Claims
1. A lumen simulation test strip for monitoring the penetration capability of a sterilizer, characterized in that: It includes a carrier layer (3), an indicator ink layer (2) and a film layer (1). The indicator ink layer (2) is disposed between the carrier layer (3) and the film layer (1), and the two ends of the carrier layer (3) and the film layer (1) are open in the length direction. A scale (4) is disposed on the carrier layer (3).
2. The lumen simulation test strip for monitoring the penetration capability of a sterilizer according to claim 1, characterized in that: The width of the indicator ink layer (2) is smaller than the width of the carrier layer (3), and the length is the same as the length of the carrier layer (3).
3. The lumen simulation test strip for monitoring the penetration capability of a sterilizer according to claim 1, characterized in that: The length of the carrier layer (3) is 1~5m.
4. The lumen simulation test strip for monitoring the penetration capability of a sterilizer according to claim 1, characterized in that: Two scales (4) are set on the upper and lower sides of the carrier layer (3), and the indicator ink layer (2) is set between the two scales (4).
5. The lumen simulation test strip for monitoring the penetration capability of a sterilizer according to claim 1, characterized in that: The carrier layer (3) has the same size as the thin film layer (1).
6. The lumen simulation test strip for monitoring the penetration capability of a sterilizer according to claim 1, characterized in that: The material of the thin film layer (1) is PE, PVC or PET.
7. The lumen simulation test strip for monitoring the penetration capability of a sterilizer according to claim 1, characterized in that: The carrier layer (3) is made of PET.