Sterility testing equipment for medical devices

Abstract

The present invention provides a sterility detection device for medical devices, which relates to the field of microbial testing technology, including an elution tank, a culture box, a sampling assembly and a sponge strip, wherein brackets are welded on both sides of the elution tank, and a winding box and a reeling box are welded on the top of the bracket, and 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, and the top of the elution tank is screwed with a sampling box. The present invention rolls up the sponge strip for smear sampling through the reeling box and the unwinding box on the top, and cooperates with the sampling assembly to quickly bring the surface of the medical device to be tested into contact with the sponge strip in a large range. The whole process does not require manual contact with the sponge strip and the medical device, thereby reducing the probability of external contamination, and the sampling range is larger. It can also quickly perform multiple sampling processes, thereby improving the efficiency of fully mixing the smear sampling area on the sponge strip with the eluent.

Description

Technical Field

[0001] The present 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 use, thereby reducing the risk of infection for patients. Sterility testing uses scientific methods to ensure that medical devices remain sterile throughout the entire process of production, packaging, transportation, and use. Effective sterility testing can also verify that medical devices have undergone effective sterilization and check for the presence of viable bacteria or whether the viable bacteria count is below a specific standard. This helps ensure that medical devices do not cause infection during clinical use, thereby improving patient safety and treatment outcomes.

[0003] The detection method in the existing technology 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. 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 existing technology, the purpose of the present invention is to provide a sterility testing equipment for medical devices to solve the problems raised in the above 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 entire 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, and 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, and the interior of the sampling box is inserted with a sampling assembly, 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 interior of the elution tank is installed with an extrusion assembly and an oscillation mechanism, the sponge strip passes through the interior of the extrusion assembly, and the oscillation mechanism is against one side of the sponge strip, and the interior of the culture box is injected with eluent.

[0006] Furthermore, a through-port is provided on the top of the elution tank, a guide rod is installed on the top of the through-port, a through-port is provided on 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 on 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 lamps are screwed on the inner walls of the unwinding box and the rewinding box, and the sponge strips go around the top of the guide rod.

[0009] Furthermore, a transmission compartment is screwed to the outside of the reel box, a motor is screwed to one end of the outside of the transmission compartment, 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. The outer end 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 the top of the spring rod is welded with a lifting plate.

[0013] Furthermore, a rotating shaft is inserted into the rear end of the rotating plate, a sliding groove is provided at the top end of the rotating plate, and the bottom of the rotating plate is pressed against 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 used for smear sampling through the reel-in box and reel-out box on the top. Together with the sampling assembly, the surface of the medical device to be tested can be quickly brought into contact with the sponge strips over a large area. The entire process does not require manual contact with the sponge strips and the medical device, reducing the probability of external contamination. The sampling range can be expanded by scraping 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 does 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 sterility testing sampling processes can be completed in a short time.

[0018] 3. This sterility testing equipment for medical devices uses a motor to control the reeling of the sponge strip inside the reeling box, and can also drive the vibration component to move through the transmission compartment. With the help of the vibration component, a vibration effect can be provided 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 This is a schematic structural diagram of the appearance of a sterility testing 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 Enlarged view of area A in the middle;

[0022] Figure 4 This 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 oscillation mechanism portion 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. UV 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. drive 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 easier to understand, the present invention is further described below in conjunction with specific implementation methods.

[0028] See also Figures 1 to 7The present invention provides the following technical solutions: A sterility testing device for medical devices, comprising a testing device body, the testing 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, 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 open, 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, the interior of the sampling box 7 is 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 in the sampling box 7, the interior of the elution tank 1 is installed with an extrusion assembly 9 and an oscillation mechanism 12, the sponge strip 13 passes through the interior of the extrusion assembly 9, and the oscillation mechanism 12 rests on one side of the sponge strip 13, and the interior of the culture box 3 is injected with 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 pushing 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 interior of the sampling box 7, the culture box 3 injected with the eluent 10 is inserted from the bottom into the interior of 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 rotation of the motor 27 drives the sponge strip 13 inside the winding box 4 to be pulled, and the sponge strip 13 is pulled out from the interior of 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 back and forth, 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 inside of the eluent 10. The wiped sponge strip 13 part is squeezed and shaken by the extrusion component 9 and the vibration 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 sterile.

[0030] In this embodiment, the top of the elution tank 1 is provided with an opening 23, the top of which is mounted a guide rod 24. A side opening 14 is provided with the sampling box 7, and a push port 26 is provided at the front end of the sampling box 7. A locking bolt 20 extends from the side of the elution tank 1. A locking groove 19 is provided on the side of the incubator 3. The locking bolt 20 penetrates the surface of the elution tank 1 and then engages within the locking groove 19. A connecting hole 25 is provided at 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. The unwinding box 4 and the rewinding box 5 are both cylindrical in structure. The sponge strip 13 extends through the surfaces of the unwinding box 4 and the rewinding box 5, respectively. Ultraviolet lamps 11 are screwed onto the inner walls of both the unwinding box 4 and the rewinding box 5. The sponge strip 13 passes over the top of the guide rod 24. Multiple sampling processes can be carried out 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 sterility 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 across 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 inside of 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. After the internal extrusion component 9 is sterilized by ultraviolet light irradiation, 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 compartment 6, and 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 inserted with a drive shaft 28. 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 inside the toothed belt 30. The cam 22 vibrates the surface of the sterile film 31 after rotation. The extrusion assembly 9 includes two extrusion wheels 38, with a gap between them, and a lower hanging plate 39. The sponge strip 13 passes between the two extrusion wheels 38, and a fixing rod 40 is integrally formed on the top of the lower hanging plate 39. While the motor 27 controls the reeling of the sponge strip 13 within the reeling box 5, it also drives the vibration assembly through the transmission chamber 6. The vibration assembly provides a vibration effect from the top of the sponge strip 13, improving the efficiency of mixing the rubbed sampling area on the sponge strip 13 with the eluent 10, thereby improving the accuracy of the final sterility test.

[0033] Specifically, after starting the motor 27, the drive 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, cooperated 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 passed through the connecting hole 25 into the inside of the elution tank 1, and immersed in the eluent 10 in the culture box 3 at an inclined angle, and the eluent 10 and the sponge strip 13 were rinsed, contacted and mixed until they passed through the inside of the two squeezing wheels 38, and then with the help of the squeezing effect provided by the squeezing 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 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 this 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 protruding plate 15. The bottom of the spring rod 16 is inserted into the inner side of the protruding plate 15, and a lifting plate 32 is welded to the top of the spring rod 16. A rotating shaft 34 is inserted into the rear end of the rotating plate 17. A sliding groove 33 is formed at the top of the rotating plate 17, and the bottom of the rotating plate 17 presses 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 slider 35, which is embedded in the interior of the sliding groove 33. A partition 36 is welded to the top of the sliding plate 18, and a pull rod 37 is inserted into the outer side of the partition 36. 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 reeling box 5 and the unwinding box 4. With the help of the sampling component 8, the surface of the medical device to be tested can be quickly brought 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 pushing port 26, and apply downward pressure to compress the spring rod 16 and tilt the sliding plate 18 slightly downward. At this time, the medical device to be tested is placed on the surface of the sliding plate 18 and the sliding plate 18 is pushed back into the interior of the sampling box 7. After releasing the pull rod 37, the spring rod 16 is used to push upward, and the rotating plate 17 and the sliding plate 18 can be pushed 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, the pull rod 37 is pulled horizontally synchronously to drive the medical device to be tested on the surface to perform a translational movement, and the sponge strip 13 that is continuously rolled and moved can 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, main features and advantages of the present invention are shown and described above. It is obvious to those skilled in the art that the present invention is not limited to the details of the above exemplary embodiments, and that the present invention can be implemented in other specific forms without departing from the spirit or basic features of the present invention.

[0037] In addition, it should be understood that although this specification is described in terms of implementation methods, not every implementation method contains only one independent technical solution. This narrative method 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 can also be appropriately combined to form other implementation methods 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). The two sides of the elution tank (1) are welded with a bracket (2), the top of the bracket (2) is welded with a winding box (4) and a rewinding box (5), the two ends of the sponge strip (13) are respectively wound inside the winding box (4) and the rewinding box (5), the bottom of the elution tank (1) is in an open state, and the inner side of the elution tank (1) is plugged with a culture box (3), the top of the elution tank (1) is screwed with a sampling box (7), the interior of the sampling box (7) is plugged 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) is inside the sampling box (7) from the medical device to be tested. The top of the medical device passes through, the interior of the elution tank (1) is equipped with an extrusion assembly (9) and an oscillation mechanism (12), the sponge strip (13) passes through the interior of the extrusion assembly (9), and the oscillation mechanism (12) is pressed against one side of the sponge strip (13), and the interior of the culture box (3) is injected with an eluent (10); 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 a locking bolt (20) is provided on the side of the elution tank (1); the outer side of the reeling box (5) is screwed with a transmission bin (6), and the transmission bin ( 6) is screwed to an outer end of a motor (27), an output end of the motor (27) is inserted with a drive shaft (28), a sponge strip (13) is wound on the surface of the drive shaft (28), a sterile film (31) is attached to one side of the sponge strip (13), a surface key of the drive shaft (28) is connected to a driving gear (29), a side sleeve of the driving gear (29) is provided with a toothed belt (30), 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, an outer end of the cam (22) is connected to a 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) by 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 provided 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); 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), and the top of the spring rod (16) is welded with a lifting plate (32).

2. A sterility testing device for medical devices according to claim 1, 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).

3. A sterility testing device for medical devices according to claim 2, 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 surfaces of the unwinding box (4) and the rewinding box (5) respectively. Ultraviolet lamp tubes (11) are screwed onto the inner walls of the unwinding box (4) and the rewinding box (5). The sponge strip (13) passes around the top of the guide rod (24).

4. The sterility testing device for medical devices according to claim 1, characterized in that: A rotating shaft (34) is inserted into 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).

5. The sterility testing device for medical devices according to claim 4, 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), 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), and the surface of the sliding plate (18) is used to place the medical device to be tested.

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