Sterility detection equipment for medical apparatus and instruments
By designing sterile detection equipment for medical devices, using reeling and reeling boxes to process sponge strips, combined with sampling components and oscillation mechanisms, the existing sterile detection methods are solved, and the rapid, comprehensive and low-pollution sterile detection effect is achieved.
Patent Information
- Application Number
- CN202510096677.8
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-01-22
- Publication Date
- 2025-03-14
- Estimated Expiration
- 2045-01-22
AI Technical Summary
The existing sterile detection methods have cumbersome operation steps, incomplete sampling, inefficient efficiency, and easy to introduce external contamination.
A sterile detection equipment is designed, using a reel and reel box to roll and place the sponge strips, and combined with the sampling components, the surface of the medical device and the sponge strips are realized to achieve large-scale contact, reduce manual contact, reduce the probability of contamination, and improve the mixing efficiency of the sponge strips and eluent through the oscillation mechanism.
It realizes rapid and comprehensive sterile detection of the surface of medical devices, reduces the risk of external pollution, improves detection efficiency and accuracy, and reduces the internal cleaning frequency of elution tanks.
Smart Images

Figure CN119614352A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to the technical field of microbial testing, in particular to a sterility testing device for medical devices. Background Art
[0002] Sterility testing of medical devices can prevent the introduction of microorganisms during the use of medical devices, thereby reducing the risk of infection for patients. Sterility testing uses scientific testing methods to ensure that medical devices remain sterile throughout the production, packaging, transportation and use process. Effective sterility testing can also verify whether the medical device has been effectively sterilized and check whether there are live bacteria or whether the amount of live bacteria is below a specific standard. This helps ensure that medical devices will not cause infection during clinical use, thereby improving patient safety and treatment effectiveness.
[0003] The detection method in the prior art uses a cotton swab to repeatedly smear the surface of the medical device to be tested to collect samples, then put the cotton swab into a sterile eluent, absorb the inoculation into a culture dish for cultivation, and then calculate the number of colonies to determine whether the medical device to be tested has bacteria. However, the operation steps in this scheme are cumbersome, and the surface smear sampling process of the medical device to be tested is performed manually, the contact area between the swab and the surface of the medical device is small, and the sampling is not comprehensive enough. When sterility testing of multiple different medical devices to be tested is required, a lot of time will be consumed, which is inefficient. Summary of the invention
[0004] In view of the shortcomings of the prior art, the purpose of the present invention is to provide a sterility testing equipment for medical devices to solve the problems raised in the above-mentioned background technology. The present invention rolls up the sponge strips used for smear sampling through the winding box and the unwinding box on the top, and cooperates with the sampling component to quickly bring the surface of the medical device to be tested into contact with the sponge strip over a large area. The whole process does not require manual contact with the sponge strip and the medical device, which reduces the probability of external contamination. The sampling range is larger, and multiple sampling processes can be performed quickly. There is no need to frequently clean the inside of the elution tank, and the efficiency of fully mixing the smear sampling area on the sponge strip with the eluent is also improved.
[0005] In order to achieve the above-mentioned purpose, the present invention is implemented through the following technical scheme: a sterility detection device for medical devices, including a detection device body, the detection device body including an elution tank, a culture box, a sampling assembly and a sponge strip, brackets are welded on both sides of the elution tank, a winding box and a reeling box are welded on the top of the bracket, the two ends of the sponge strip are respectively wound inside the winding box and the reeling box, the bottom of the elution tank is in an open state, and a culture box is inserted into the inner side of the elution tank, the top of the elution tank is screwed with a sampling box, the sampling box is inserted inside the sampling box, the sampling assembly is used to place and support the medical device to be tested, and the sponge strip passes through the top of the medical device to be tested inside the sampling box, the elution tank is installed with an extrusion assembly and an oscillation mechanism, the sponge strip passes through the inside of the extrusion assembly, and the oscillation mechanism is against one side of the sponge strip, and the inside of the culture box is injected with eluent.
[0006] Furthermore, a through-port is provided at the top of the elution tank, a guide rod is installed at the top of the through-port, a through-port is provided at one side of the sampling box, a push port is provided at the front end of the sampling box, and a locking bolt is provided at the side of the elution tank.
[0007] Furthermore, a locking groove is provided on the side of the culture box, and the locking bolt passes through the surface of the elution tank and is embedded in the interior of the locking groove. A connecting hole is provided at the bottom of the sampling box, and the interior of the sampling box is connected to the interior of the elution tank through the connecting hole.
[0008] Furthermore, the unwinding box and the rewinding box are both columnar structures as a whole, the sponge strips pass through the surfaces of the unwinding box and the rewinding box respectively, ultraviolet lamp tubes are screwed on the inner walls of the unwinding box and the rewinding box, and the sponge strips pass around the top of the guide rod.
[0009] Furthermore, a transmission bin is screwed to the outer side of the reel box, a motor is screwed to one end of the outer side of the transmission bin, a drive shaft is inserted into the output end of the motor, a sponge strip is wound on the surface of the drive shaft, and a sterile film is attached to one side of the sponge strip.
[0010] Furthermore, the surface key of the driving shaft is connected to a driving gear, and the side sleeve of the driving gear is provided with a toothed belt. The oscillation mechanism includes a cam and a driven gear. Both ends of the cam are embedded in the inner wall of the elution tank through bearings, and one end of the outer side of the cam is connected to the driven gear, and the driven gear passes through the other end on the inner side of the toothed belt. The cam vibrates the surface of the sterile film after rotating.
[0011] Furthermore, the extrusion assembly includes an extrusion wheel and a lower hanging plate. There are two extrusion wheels, and a gap is set between the two extrusion wheels. The sponge strip passes through the middle of the two extrusion wheels, and a fixing rod is integrally formed on the top of the lower hanging plate.
[0012] Furthermore, the sampling assembly includes a spring rod, a rotating plate and a sliding plate. The bottom of the sampling box is integrally formed with a convex plate. The bottom of the spring rod is inserted into the inner side of the convex plate, and a lifting plate is welded to the top of the spring rod.
[0013] Furthermore, a rotating shaft is inserted at the rear end of the rotating plate, a sliding groove is opened at the top end of the rotating plate, and the bottom of the rotating plate is pressed on the surface of the lifting plate.
[0014] Furthermore, both ends of the rotating shaft are embedded in the inner wall of the sampling box, the bottom of the sliding plate is integrally formed with a slider, the slider is embedded in the interior of the slide groove, a partition is welded on the top of the sliding plate, a pull rod is inserted on the outside of the partition, and the surface of the sliding plate is used to place the medical device to be tested.
[0015] Beneficial effects of the present invention:
[0016] 1. The sterility testing equipment for medical devices rolls up and unrolls the sponge strips for smear sampling through the winding box and the unwinding box on the top. With the sampling component, the surface of the medical device to be tested can be quickly brought into contact with the sponge strips over a large area. The whole process does not require manual contact with the sponge strips and the medical device, which reduces the probability of external contamination. The sampling range can be expanded by producing a scraping effect on the surface of the medical device.
[0017] 2. The sterility testing equipment for medical devices can quickly perform multiple sampling processes. After each sampling is completed, the culture box at the bottom can be directly pulled out. Since the inner wall of the elution tank will not directly contact the sponge strip, the medical device to be tested, and the eluent body, there is no need to frequently clean the inside of the elution tank, so that multiple sampling processes for sterility testing can be achieved in a short time.
[0018] 3. The sterility testing equipment for medical devices can control the reeling of the sponge strip inside the reeling box through a motor, and can also drive the vibration component to move through the transmission compartment. The vibration component can provide a vibration effect from the top and the sponge strip part, thereby improving the efficiency of fully mixing the sampling area on the sponge strip with the eluent, and improving the accuracy of the final sterility test. BRIEF DESCRIPTION OF THE DRAWINGS
[0019] Figure 1 A schematic structural diagram of the appearance of a sterility detection device for medical devices according to the present invention;
[0020] Figure 2 is a side sectional view of the detection device of the present invention;
[0021] Figure 3 for Figure 2 A magnified image of area A;
[0022] Figure 4 It is a split diagram between the elution tank and the culture box of the present invention;
[0023] Figure 5 It is a front cross-sectional view of the oscillating mechanism part of the present invention;
[0024] Figure 6 This is a split diagram of the sampling component part;
[0025] Figure 7 It is a structural diagram of the extrusion component part of the present invention;
[0026] In the figure: 1, elution tank; 2, bracket; 3, culture box; 4, unwinding box; 5, rewinding box; 6, transmission compartment; 7, sampling box; 8, sampling assembly; 9, extrusion assembly; 10, eluent; 11, ultraviolet lamp; 12, oscillation mechanism; 13, sponge strip; 14, through-port; 15, convex plate; 16, spring rod; 17, rotating plate; 18, sliding plate; 19, locking groove; 20, locking bolt; 21, driven gear; 22, cam; 23, through-port; 24, guide rod; 25, connecting hole; 26, push port; 27, motor; 28, driving shaft; 29, driving gear; 30, toothed belt; 31, sterile film; 32, lifting plate; 33, slide groove; 34, rotating shaft; 35, slider; 36, partition; 37, pull rod; 38, extrusion wheel; 39, lower hanging plate; 40, fixing rod. DETAILED DESCRIPTION
[0027] In order to make the technical means, creative features, objectives and effects achieved by the present invention easy to understand, the present invention is further explained below in conjunction with specific implementation methods.
[0028] See also Figures 1 to 7The present invention provides the following technical solutions: a sterility detection device for medical devices, comprising a detection device body, the detection device body comprising an elution tank 1, a culture box 3, a sampling assembly 8 and a sponge strip 13, brackets 2 are welded on both sides of the elution tank 1, a winding box 4 and a winding box 5 are welded on the top of the bracket 2, and the two ends of the sponge strip 13 are respectively wound inside the winding box 4 and the winding box 5, the bottom of the elution tank 1 is in an open state, and the inner side of the elution tank 1 is inserted with a culture box 3, the top of the elution tank 1 is screwed with a sampling box 7, and the sampling assembly 8 is inserted inside the sampling box 7, the sampling assembly 8 is used to place and support the medical device to be tested, and the sponge strip 13 passes through the top of the medical device to be tested inside the sampling box 7, the elution tank 1 is installed with an extrusion assembly 9 and an oscillation mechanism 12, the sponge strip 13 passes through the inside of the extrusion assembly 9, and the oscillation mechanism 12 is against one side of the sponge strip 13, and the inside of the culture box 3 is injected with an eluent 10. The sterility testing equipment is used to detect whether there are bacteria and other microorganisms on the surface of medical devices such as medical forceps and scalpels.
[0029] When the present invention is used, the internal sampling assembly 8 is first pulled out and pressed from the push port 26, and then the medical device to be tested is directly placed inside the sampling assembly 8. After the sampling assembly 8 and the medical device to be tested are pushed into the sampling box 7, the culture box 3 injected with the eluent 10 is inserted from the bottom into the elution tank 1, and the culture box 3 is fixed with the locking bolt 20. Then, the motor 27 can be started, and the sponge strip 13 inside the winding box 4 is pulled by the rotation of the motor 27, and the sponge strip 13 is pulled out from the winding box 4, so that The sponge strip 13 can move along the inside of the sampling box 7 and the elution tank 1. During the movement, the sampling component 8 is synchronously controlled to be pulled forward and backward, so that the sponge strip 13 can wipe and slide along the surface of the medical device to be tested, and the wiped sponge strip 13 part is embedded in the eluent 10. The wiped sponge strip 13 part is squeezed and shaken by the extrusion component 9 and the oscillation mechanism 12 to obtain the sampling liquid. At this time, the culture box 3 is taken out for culture, and the subsequent detection of the culture liquid is used to determine whether the surface of the corresponding medical device to be tested is in a sterile state.
[0030] In this embodiment, a through-hole 23 is provided on the top of the elution tank 1, a guide rod 24 is installed on the top of the through-hole 23, a through-hole 14 is provided on one side of the sampling box 7, a push port 26 is provided on the front end of the sampling box 7, and a locking bolt 20 is passed through the side of the elution tank 1. A locking groove 19 is provided on the side of the culture box 3, and the locking bolt 20 is inserted into the inside of the locking groove 19 after passing through the surface of the elution tank 1. A connecting hole 25 is provided on the bottom of the sampling box 7, and the inside of the sampling box 7 is connected to the inside of the elution tank 1 through the connecting hole 25. The unwinding box 4 and the rewinding box 5 are both columnar structures as a whole, and the sponge strip 13 passes through the surface of the unwinding box 4 and the rewinding box 5 respectively. The inner walls of the unwinding box 4 and the rewinding box 5 are both screwed with ultraviolet lamps 11, and the sponge strip 13 passes around the top of the guide rod 24. Multiple sampling processes can be performed quickly. After each sampling is completed, the culture box 3 at the bottom can be directly pulled out. Since the inner wall of the elution tank 1 will not directly contact the sponge strip 13, the medical device to be tested, and the eluent 10 body, there is no need to frequently clean the inside of the elution tank 1, so that multiple sampling processes for sterile testing can be achieved in a short time.
[0031] Specifically, by placing the culture box 3 inside the elution tank 1 and fixing it with the locking bolt 20, the elution tank 1 can be used for support, and then the sponge strip 13 is passed over the surface of the medical device to be tested with the help of the motor 27 and multiple internal guide structures, and then directly wrapped around the connecting hole 25 to enter the eluent 10, so that the sampling liquid can be quickly prepared. After the sampling is completed, there is no need to clean the inside of the elution tank 1. Only the internal extrusion component 9 needs to be sterilized by ultraviolet light irradiation, and then a new culture box 3 and the medical device to be tested can be replaced to continue sampling and testing.
[0032] In this embodiment, the outer side of the reel box 5 is screwed with a transmission bin 6, and one end of the outer side of the transmission bin 6 is screwed with a motor 27. The output end of the motor 27 is inserted with a drive shaft 28, and a sponge strip 13 is wound on the surface of the drive shaft 28, and a sterile film 31 is attached to one side of the sponge strip 13. The surface of the drive shaft 28 is keyed to a driving gear 29, and a toothed belt 30 is sleeved on the side of the driving gear 29. The oscillation mechanism 12 includes a cam 22 and a driven gear 21. Both ends of the cam 22 are embedded in the inner wall of the elution tank 1 through bearings. The outer end of the cam 22 is connected to the driven gear 21, and the driven gear 21 passes through the other end of the inner side of the toothed belt 30. The cam 22 vibrates the surface of the sterile film 31 after rotating. The extrusion assembly 9 includes an extrusion wheel 38 and a lower hanging plate 39. There are two extrusion wheels 38, and a gap is set between the two extrusion wheels 38. The sponge strip 13 passes through the middle of the two extrusion wheels 38. The top of the lower hanging plate 39 is integrally formed with a fixing rod 40. While the motor 27 controls the sponge strip 13 inside the reel box 5 to be reeled, the transmission bin 6 can also be used to drive the vibration assembly to move. With the help of the vibration assembly, a vibration effect can be provided from the top and the sponge strip 13 part, which improves the efficiency of fully mixing the rubbed sampling area on the sponge strip 13 with the eluent 10, and improves the accuracy of the final sterility test.
[0033] Specifically, after starting the motor 27, the driving shaft 28 rotates to pull the sponge strip 13 on the surface, and the sponge strip 13 is pulled out from the inside of the winding box 4, first moved into the inside of the sampling box 7 from the penetration port 14, and in the sampling box 7, cooperates with the sampling assembly 8 to fully contact and wipe different areas of the surface of the medical device to be tested, and then directly passes through the connecting hole 25 to enter the inside of the elution tank 1, and is immersed in the eluent 10 in the culture box 3 at an inclined angle, and the eluent 10 and the sponge strip 13 are rinsed, contacted and mixed, until they pass through the inside of the two extrusion wheels 38, and then with the help of the extrusion effect provided by the extrusion wheels 38. The sponge strip 13 that has absorbed the eluent 10 and reached a saturated state squeezes out the liquid again. During this process, if there are bacteria on the medical device to be tested, the bacteria can be mixed into the eluent 10 with the help of the absorption and extrusion process. At the same time, the liquid drives the cam 22 to rotate with the help of the transmission effect of the driving gear 29, the toothed belt 30 and the driven gear 21 on the driving shaft 28. After the cam 22 rotates, it hits the sterile film 31 on one side of the sponge strip 13, which can make the sponge strip 13 within the range produce an oscillation effect. With the help of this oscillation effect, the efficiency of the bacteria adhered to the sponge strip 13 entering the eluent 10 can be further accelerated.
[0034] In this embodiment, the sampling assembly 8 includes a spring rod 16, a rotating plate 17 and a sliding plate 18. The bottom of the sampling box 7 is integrally formed with a convex plate 15. The bottom of the spring rod 16 is inserted into the inner side of the convex plate 15. The top of the spring rod 16 is welded with a lifting plate 32. The rear end of the rotating plate 17 is inserted with a rotating shaft 34. The top of the rotating plate 17 is provided with a sliding groove 33. The bottom of the rotating plate 17 is pressed on the surface of the lifting plate 32. The two ends of the rotating shaft 34 are embedded in the inner wall of the sampling box 7. The bottom of the sliding plate 18 is integrally formed with a sliding block 35. The sliding block 35 is embedded in the inside of the sliding groove 33. The top of the sliding plate 18 is welded with a partition 36. The outer side of the partition 36 is inserted with a pull rod 37. The surface of the sliding plate 18 is used to place the medical device to be tested. The sponge strip 13 for smear sampling is rolled up and unrolled through the top reel-in box 5 and the unwinding box 4, and the sampling component 8 can be used to quickly bring the surface of the medical device to be tested into contact with the sponge strip 13 over a large area. The entire process does not require manual contact with the sponge strip 13 and the medical device, which reduces the probability of external contamination and can make the sampling range larger by producing a scraping effect on the surface of the medical device.
[0035] Specifically, first pull the pull rod 37 to pull the sliding plate 18 from the surface of the rotating plate 17 and pull it out from the push port 26, and apply downward pressure to compress the spring rod 16 and slightly move the sliding plate 18 downward. At this time, place the medical device to be tested on the surface of the sliding plate 18 and push the sliding plate 18 back into the sampling box 7. After releasing the pull rod 37, use the spring rod 16 to push it upward, and then push the rotating plate 17 and the sliding plate 18 upward again until the surface of the placed medical device to be tested is against the bottom of the sponge strip 13 passing above. At this time, after starting the motor 27, pull the pull rod 37 horizontally synchronously to drive the medical device to be tested on the surface to perform a translational movement, and cooperate with the sponge strip 13 that is continuously rolled and moved to ensure that the sponge strip 13 can fully contact and wipe the surface area of the medical device to be tested over a large area, and this process does not require the hands to continuously contact the medical device to be tested and the sponge strip 13.
[0036] The basic principles and main features of the present invention and the advantages of the present invention are shown and described above. For those skilled in the art, it is obvious that the present invention is not limited to the details of the above exemplary embodiments, and the present invention can be implemented in other specific forms without departing from the spirit or basic characteristics of the present invention.
[0037] In addition, it should be understood that although the present specification is described according to implementation modes, not every implementation mode contains only one independent technical solution. This description of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment may also be appropriately combined to form other implementation modes that can be understood by those skilled in the art.
Claims
1. A sterility testing device for medical devices, comprising a testing device body, characterized in that: The detection device body comprises an elution tank (1), a culture box (3), a sampling assembly (8) and a sponge strip (13); brackets (2) are welded on both sides of the elution tank (1); a winding box (4) and a reeling box (5) are welded on the top of the bracket (2); two ends of the sponge strip (13) are respectively wound inside the winding box (4) and the reeling box (5); the bottom of the elution tank (1) is in an open state, and the culture box (3) is inserted inside the elution tank (1); the top of the elution tank (1) is screwed with a sampling box (7) The sampling box (7) is internally inserted with a sampling assembly (8), the sampling assembly (8) is used to place and support the medical device to be tested, and the sponge strip (13) passes through the top of the medical device to be tested inside the sampling box (7), the elution tank (1) is internally installed with an extrusion assembly (9) and an oscillation mechanism (12), the sponge strip (13) passes through the inside of the extrusion assembly (9), and the oscillation mechanism (12) rests on one side of the sponge strip (13), and the inside of the culture box (3) is injected with an eluent (10).
2. A sterility testing device for medical devices according to claim 1, characterized in that: The top of the elution tank (1) is provided with a through-port (23), the top of the through-port (23) is provided with a guide rod (24), one side of the sampling box (7) is provided with a through-port (14), the front end of the sampling box (7) is provided with a push port (26), and the side of the elution tank (1) is provided with a locking bolt (20).
3. A sterility testing device for medical devices according to claim 2, characterized in that: A locking groove (19) is provided on the side of the culture box (3), and the locking bolt (20) passes through the surface of the elution tank (1) and is embedded in the interior of the locking groove (19). A connecting hole (25) is provided on the bottom of the sampling box (7), and the interior of the sampling box (7) is connected to the interior of the elution tank (1) through the connecting hole (25).
4. A sterility testing device for medical devices according to claim 3, characterized in that: The unwinding box (4) and the rewinding box (5) are both columnar structures as a whole, the sponge strip (13) passes through the surface of the unwinding box (4) and the rewinding box (5) respectively, the inner walls of the unwinding box (4) and the rewinding box (5) are both screwed with ultraviolet lamp tubes (11), and the sponge strip (13) passes around the top of the guide rod (24).
5. A sterility testing device for medical devices according to claim 2, characterized in that: The outer side of the reel box (5) is screwed with a transmission compartment (6), one end of the outer side of the transmission compartment (6) is screwed with a motor (27), the output end of the motor (27) is plugged with a drive shaft (28), the surface of the drive shaft (28) is wound with a sponge strip (13), and one side of the sponge strip (13) is attached with a sterile film (31).
6. A sterility testing device for medical devices according to claim 5, characterized in that: The surface of the driving shaft (28) is key-connected with a driving gear (29), and a toothed belt (30) is sleeved on the side of the driving gear (29). The oscillating mechanism (12) comprises a cam (22) and a driven gear (21). Both ends of the cam (22) are embedded in the inner wall of the elution tank (1) through bearings. One end of the outer side of the cam (22) is connected with the driven gear (21), and the other end of the driven gear (21) passes through the inner side of the toothed belt (30). The cam (22) vibrates the surface of the sterile film (31) by rotating.
7. A sterility testing device for medical devices according to claim 6, characterized in that: The extrusion assembly (9) comprises an extrusion wheel (38) and a lower hanging plate (39). The number of the extrusion wheels (38) is two, and a gap is provided between the two extrusion wheels (38). The sponge strip (13) passes through the middle of the two extrusion wheels (38). A fixing rod (40) is integrally formed on the top of the lower hanging plate (39).
8. A sterility testing device for medical devices according to claim 2, characterized in that: The sampling assembly (8) comprises a spring rod (16), a rotating plate (17) and a sliding plate (18); the bottom of the sampling box (7) is integrally formed with a convex plate (15); the bottom of the spring rod (16) is inserted into the inner side of the convex plate (15); and the top of the spring rod (16) is welded with a lifting plate (32).
9. A sterility testing device for medical devices according to claim 8, characterized in that: A rotating shaft (34) is inserted at the rear end of the rotating plate (17), a sliding groove (33) is provided at the top end of the rotating plate (17), and the bottom of the rotating plate (17) is pressed against the surface of the lifting plate (32).
10. A sterility testing device for medical devices according to claim 9, characterized in that: Both ends of the rotating shaft (34) are embedded in the inner wall of the sampling box (7), the bottom of the sliding plate (18) is integrally formed with a slider (35), the slider (35) is embedded in the interior of the slide groove (33), a partition (36) is welded on the top of the sliding plate (18), a pull rod (37) is inserted on the outer side of the partition (36), and the surface of the sliding plate (18) is used to place the medical device to be tested.
Citation Information
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