Disinfection part, preparation process and preparation equipment

Abstract

The invention provides a disinfection part, a preparation process and preparation equipment, and relates to the technical field of medical instruments. The disinfection part comprises a cap body and a disinfection rod; the cap body is provided with a groove, and the side wall of the groove is provided with an internal thread used for being matched with a guide pipe. One end of the disinfection rod extends into the groove to be connected with the bottom wall of the groove, the other end of the disinfection rod is located outside the groove, and the disinfection rod extends into an inner cavity of the catheter; a first antibacterial coating is arranged on the outer surface of the disinfection rod. The disinfection part provided by the invention solves the technical problem of insufficient disinfection of the front end and the inner cavity part of the catheter in the prior art.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a disinfection piece, a preparation process and a preparation device. Background Art

[0002] Blood catheters play an important role in monitoring and infusion in emergency and major surgery, and in the care of critically ill patients due to their advantages of easy operation, minimal trauma, sufficient flow, and long retention time. They have become an indispensable medical method in clinical practice. Catheter-related bloodstream infection is one of the common complications during catheter placement and is also a common cause of nosocomial infection in intensive care units.

[0003] At present, the commonly used methods for disinfecting the surface of catheters include cotton swab disinfection, alcohol cotton pad wiping disinfection, or disinfection of connector disinfection caps containing disinfectants. Among them, cotton swab disinfection has the disadvantages of being time-consuming, the disinfectant is easily ineffective and wasteful if not properly stored, and the disinfection effect of cotton swabs on the sides and cross-sections of the connector is not ideal; alcohol cotton pad wiping disinfection has the problem of low compliance, which may lead to adverse consequences such as incomplete disinfection due to failure to thoroughly disinfect the dead corners of the connector, neglect of aseptic operation, and failure to ensure wiping and disinfection time; connector disinfection cap disinfection has the advantages of short disinfection time, good effect, convenient operation, and high nursing compliance; the disinfectant used inside the connector disinfection cap is generally an alcohol disinfectant such as 70% isopropyl alcohol or 75% ethanol aqueous solution. This type of disinfectant can effectively disinfect and sterilize the surface of the catheter connector, but this type of disinfection cap does not fully disinfect the front end of the catheter, and some bacteria and microorganisms are not completely killed and migrate to the distal end of the catheter and the implanted end of the human body, causing serious blood infection. Summary of the invention

[0004] The object of the present invention is to provide a disinfection part, a preparation process and a preparation device to alleviate the technical problem of insufficient disinfection of the front end and inner cavity of the catheter existing in the prior art.

[0005] In order to solve the above technical problems, the technical solution provided by the present invention is:

[0006] In a first aspect, the disinfection device provided by the present invention comprises a cap body and a disinfection rod;

[0007] The cap body is provided with a groove, and the side wall of the groove is provided with an internal thread for matching with the catheter;

[0008] One end of the disinfection rod extends into the groove and is connected to the bottom wall of the groove, and the other end is located outside the groove, and the disinfection rod is used to extend into the inner cavity of the catheter;

[0009] The outer surface of the disinfection rod is provided with a first antibacterial coating.

[0010] Furthermore, the inner wall of the groove is provided with a second antibacterial coating.

[0011] Furthermore, the coating amount per unit area of ​​the first antibacterial coating is the same as the coating amount per unit area of ​​the second antibacterial coating, and / or the material of the first antibacterial coating is the same as the material of the second antibacterial coating.

[0012] Furthermore, the coating amount of the entire disinfection component is set to 0.4-3.0 μg / mg.

[0013] Furthermore, the first antibacterial coating includes one or more of chlorhexidine base, chlorhexidine acetate, chlorhexidine gluconate, EDTA, silver sulfadiazine, taurolidine, gentamicin, etimicin, ceftriaxone, amoxicillin, tobramycin, rifampicin, minocycline, vancomycin, levofloxacin, amikacin, amphotericin B deoxycholate, ampicillin, azithromycin, caspofungin, ceftazidime, cefepime, ceftriaxone, ciprofloxacin, clindamycin, polymyxin, daptomycin, fluconazole, linezolid, moxifloxacin, metronidazole, voriconazole and itraconazole.

[0014] Furthermore, the cap body and the disinfection rod are integrally formed.

[0015] Furthermore, the disinfection rod comprises a first section and a second section, one end of the first section is connected to the bottom wall of the groove, and the other end is connected to the second section;

[0016] The cross-sectional area of ​​the first section is greater than the cross-sectional area of ​​the second section, and there is a tapered transition between the first section and the second section.

[0017] In a second aspect, the present invention provides a preparation process for preparing the disinfection element according to any one of the first aspects, comprising:

[0018] Loading: Screening and sorting the sterilized samples, and transferring the sterilized samples;

[0019] Dip coating: Use antibacterial liquid to flush the disinfected sample;

[0020] Drying: Continuously blow hot air on the sterilized parts;

[0021] Discharging: Blow cold air on the sterilized parts and move the sterilized parts.

[0022] Furthermore, when the antibacterial liquid is used to flush the disinfection component sample, the concentration of the antibacterial liquid is set to 0.5-8%, and the dipping time of a single disinfection component sample is set to 1-5s.

[0023] Furthermore, during the continuous hot air blowing on the disinfection parts, the temperature of the hot air is set to 90-150° C., and the hot air drying time of a single disinfection part is set to 10-40s.

[0024] In a third aspect, the present invention provides a preparation device for preparing the sterilized article as described in any one of the first aspects, comprising a feeding mechanism, a material moving mechanism, a clamping mechanism, a material soaking mechanism, a drying mechanism and a material discharging mechanism;

[0025] The outlet end of the feeding mechanism is arranged opposite to the material moving mechanism;

[0026] The material moving mechanism, the material soaking mechanism, the drying mechanism and the material discharging mechanism are arranged at intervals along the first direction;

[0027] The clamping mechanism is located above the material transfer mechanism and has a clamping claw; the clamping claw can move along the first direction to move the sterilization piece sample located in the material transfer mechanism to the material immersion mechanism and the drying mechanism.

[0028] Furthermore, the feeding mechanism includes a driving member, a spiral feeding track and a screen falling track, the driving member is connected to the spiral feeding track and the screen falling track, and the outlet end of the spiral feeding track is connected to the screen falling track, and the outlet end of the screen falling track is arranged opposite to the material moving mechanism.

[0029] Furthermore, the dipping mechanism includes a liquid storage tank, a liquid supply pipeline, a liquid return pipeline, a dipping box and a pump body;

[0030] A dipping tube is installed in the dipping box, and a dipping column with an opening is provided on the top of the dipping tube, and the dipping column is used to support the disinfection piece sample;

[0031] One end of the upper liquid pipeline is connected to the liquid storage tank, and the other end is connected to the dip coating pipe;

[0032] One end of the liquid return pipeline is communicated with the dipping tank, and the other end is communicated with the liquid storage tank, and the pump body is communicated with the liquid storage tank.

[0033] Furthermore, the drying mechanism comprises a hot air blower and a placement piece, the bottom of the placement piece is connected to the hot air blower, and the top of the placement piece is provided with a first guide groove for placing the disinfection piece;

[0034] The extension direction of the first guide groove is arranged along the first direction.

[0035] Based on the above technical solutions, the technical effects that can be achieved by the present invention are analyzed as follows:

[0036] The disinfection piece provided by the present invention comprises a cap body and a disinfection rod; the cap body is provided with a groove, and the side wall of the groove is provided with an internal thread for cooperating with a catheter; one end of the disinfection rod extends into the groove and is connected to the bottom wall of the groove, and the other end is located outside the groove, and the disinfection rod is used to extend into the inner cavity of the catheter; the outer surface of the disinfection rod is provided with a first antibacterial coating.

[0037] In actual use, the first end of the catheter is inserted into the blood vessel, and the catheter will remain in the human body for a period of time; the disinfection rod of the disinfection piece is inserted into the second end of the catheter, and the cap body is threadedly connected to the second end of the catheter; there is liquid in the second end of the catheter, and after the disinfection piece is installed at the second end of the catheter, the first antibacterial coating of the disinfection rod can release antibacterial components in contact with the liquid, thereby achieving an antibacterial effect. The disinfection piece includes a cap body and a disinfection rod, the cap body is used to cooperate with the catheter, the disinfection rod is used to extend into the inner cavity of the catheter, and the first antibacterial coating on the outer surface of the disinfection piece can release antibacterial components to achieve an antibacterial effect, thereby achieving a disinfection effect on the front end and inner cavity of the catheter. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] In order to more clearly illustrate the specific implementation methods of the present invention or the technical solutions in the prior art, the drawings required for use in the specific implementation methods or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0039] Figure 1 A schematic diagram of the structure of the disinfection device provided in an embodiment of the present invention Figure 1 ;

[0040] Figure 2 A schematic diagram of the structure of the disinfection device provided in an embodiment of the present invention Figure 2 ;

[0041] Figure 3 A schematic diagram of the structure of the disinfection device provided in the embodiment of the present invention Figure 1 ;

[0042] Figure 4 A schematic diagram of the structure of the disinfection device provided in the embodiment of the present invention Figure 2 ;

[0043] Figure 5 A schematic diagram of the structure of a feeding mechanism in a preparation device for a sterilized item provided in an embodiment of the present invention;

[0044] Figure 6 A schematic diagram of the structure of a material transfer mechanism and a clamping mechanism in a sterilization preparation device provided in an embodiment of the present invention;

[0045] Figure 7A schematic diagram of the structure of the soaking mechanism in the preparation device for the disinfection part provided in the embodiment of the present invention Figure 1 ;

[0046] Figure 8 A schematic diagram of the structure of the soaking mechanism in the preparation device for the disinfection part provided in the embodiment of the present invention Figure 2 ;

[0047] Fig. 9 A schematic diagram of the structures of a drying mechanism and a discharging mechanism in a device for preparing disinfected parts provided in an embodiment of the present invention.

[0048] icon:

[0049] 110-cap body; 111-groove; 112-anti-slip protrusion; 120-disinfection rod; 121-first section; 122-second section;

[0050] 200-feeding mechanism; 210-spiral feeding track; 220-screening track;

[0051] 300-material moving mechanism; 310-placing slot; 320-first guide rail; 330-material moving block; 340-material moving motor; 350-sensor;

[0052] 400-gripping mechanism; 410-gripping claw; 420-second guide rail; 430-gripping block; 440-pick;

[0053] 500-dipping mechanism; 510-liquid storage tank; 520-upper liquid pipeline; 530-return liquid pipeline; 540-dipping box; 550-dipping tube; 560-dipping column; 570-pump body;

[0054] 600-drying mechanism; 610-hot air blower; 620-placing member; 630-first guide groove;

[0055] 700-discharging mechanism; 710-second guide groove; 720-linear vibrator; 730-air duct; 740-quantity sensor;

[0056] a-First direction. DETAILED DESCRIPTION

[0057] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings here can be arranged and designed in various different configurations.

[0058] Therefore, the following detailed description of the embodiments of the present invention provided in the accompanying drawings is not intended to limit the scope of the invention claimed for protection, but merely represents selected embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0059] It should be noted that similar reference numerals and letters denote similar items in the following drawings, and therefore, once an item is defined in one drawing, further definition and explanation thereof is not required in subsequent drawings.

[0060] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inside", "outside", etc. indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, or the positions or positional relationships in which the product of the invention is usually placed when in use. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific position, be constructed and operated in a specific position, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", "third", etc. are only used to distinguish the description, and cannot be understood as indicating or implying relative importance.

[0061] In addition, the terms "horizontal", "vertical", "overhanging" and the like do not mean that the components are required to be absolutely horizontal or overhanging, but can be slightly tilted. For example, "horizontal" only means that its direction is more horizontal than "vertical", and does not mean that the structure must be completely horizontal, but can be slightly tilted.

[0062] In the description of the present invention, it is also necessary to explain that, unless otherwise clearly specified and limited, the terms "set", "install", "connect", and "connect" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0063] Some embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. In the absence of conflict, the following embodiments and features in the embodiments can be combined with each other.

[0064] Embodiment 1

[0065] Blood catheters play an important role in emergency treatment, monitoring and infusion during major surgery, and care of critically ill patients due to their advantages of easy operation, minimal trauma, sufficient flow, and long retention time. They have become an indispensable medical method in clinical practice. Catheter-related bloodstream infections (CRBSI) are one of the common complications during catheter placement and are also a common cause of nosocomial infections in intensive care units.

[0066] Generally, for patients with short-term catheterization (<10 days), the most common source of infection is skin microorganisms along the outer surface of the catheter. Currently, the commonly used methods for disinfecting the catheter surface include cotton swab disinfection, 75% alcohol cotton pad wiping disinfection, or connector disinfection caps containing disinfectants inside. Traditional cotton swab disinfection is time-consuming, the disinfectant is easily ineffective and wasteful if not properly stored, and the cotton swab has poor disinfection effect on the side and cross-section of the connector. It is gradually fading out of clinical use. The alcohol cotton pad wiping method is a time-consuming manual disinfection process with low compliance, especially for nursing staff with heavy workload and long working hours. They may fail to thoroughly disinfect the dead corners of the connector, ignore aseptic operation, and fail to ensure the wiping disinfection time, resulting in adverse consequences such as incomplete disinfection. The connector disinfection cap containing disinfectants inside has the advantages of shorter disinfection time, good disinfection effect, convenient operation, high nursing compliance, and sustainable disinfection, and is increasingly used in clinical use.

[0067] At present, the disinfectant used inside the connector disinfection cap is generally an alcohol disinfectant such as 70% isopropyl alcohol or 75% ethanol aqueous solution, which can effectively disinfect and sterilize the surface of the catheter connector. However, this type of disinfection cap does not fully disinfect the front end of the catheter, and some bacteria and microorganisms are not completely killed and migrate to the distal end of the catheter and the implanted end of the human body, causing serious blood infection.

[0068] In view of this, see Figure 1 and Figure 2 The disinfection piece provided by the embodiment of the present invention includes a cap body 110 and a disinfection rod 120; the cap body 110 is provided with a groove 111, and the side wall of the groove 111 is provided with an internal thread for cooperating with a catheter; one end of the disinfection rod 120 extends into the groove 111 and is connected to the bottom wall of the groove 111, and the other end is located outside the groove 111, and the disinfection rod 120 is used to extend into the inner cavity of the catheter; the outer surface of the disinfection rod 120 is provided with a first antibacterial coating. In actual use, the first end of the catheter is inserted into the blood vessel, and the catheter will remain in the human body for a period of time; the disinfection rod 120 of the disinfection piece is inserted into the second end of the catheter, and the cap body 110 is threadedly connected to the second end of the catheter; there is liquid in the second end of the catheter, and after the disinfection piece is installed at the second end of the catheter, the first antibacterial coating of the disinfection rod 120 can release antibacterial components in contact with the liquid, thereby achieving an antibacterial effect.

[0069] Specifically, the catheter is configured in a Y shape, wherein the end of one long tube is a first end inserted into the blood vessel, and the ends of the other two short tubes are second ends, each of which is equipped with two disinfection components.

[0070] The disinfection piece includes a cap body 110 and a disinfection rod 120. The cap body 110 is used to cooperate with the catheter, and the disinfection rod 120 is used to extend into the inner cavity of the catheter. The first antibacterial coating on the outer surface of the disinfection piece can release antibacterial components to achieve an antibacterial effect and achieve disinfection of the front end and inner cavity of the catheter.

[0071] The structure and shape of the disinfection piece are described in detail below:

[0072] In an optional solution of the embodiment of the present invention, the inner wall of the groove 111 is provided with a second antibacterial coating.

[0073] Specifically, the axis of the disinfection rod 120 is colinear with the axis of the groove 111 , so that the disinfection rod 120 is located in the middle of the cap body 110 .

[0074] A second antibacterial coating is provided on the inner thread of the cap body 110 to enhance the antibacterial effect of the disinfection device.

[0075] In an optional solution of the embodiment of the present invention, the coating amount per unit area of ​​the first antibacterial coating is the same as the coating amount per unit area of ​​the second antibacterial coating, and / or the material of the first antibacterial coating is the same as the material of the second antibacterial coating.

[0076] Specifically, in this embodiment, the coating amount per unit area of ​​the first antibacterial coating is equal to the coating amount per unit area of ​​the second antibacterial coating, and the material of the first antibacterial coating is the same as the material of the second antibacterial coating, so that the coating is formed at one time, and there is no need to coat the cap body 110 and the disinfection rod 120 separately, thereby improving efficiency.

[0077] In an optional solution of the embodiment of the present invention, the coating amount of the entire disinfection component is set to 0.4-3.0 μg / mg.

[0078] Specifically, the overall coating amount of the disinfection piece refers to the ratio of all antimicrobial dosages on the disinfection piece to the overall weight of the disinfection piece.

[0079] The overall coating amount of the disinfection part is set to 0.4-3.0 μg / mg, which is beneficial to improving the antibacterial effect.

[0080] In an optional scheme of an embodiment of the present invention, the first antibacterial coating includes one or more of chlorhexidine base, chlorhexidine acetate, chlorhexidine gluconate, EDTA, silver sulfadiazine, taurolidine, gentamicin, etimicin, ceftriaxone, amoxicillin, tobramycin, rifampicin, minocycline, vancomycin, levofloxacin, amikacin, amphotericin B deoxycholate, ampicillin, azithromycin, caspofungin, ceftazidime, cefepime, ceftriaxone, ciprofloxacin, clindamycin, polymyxin, daptomycin, fluconazole, linezolid, moxifloxacin, metronidazole, voriconazole and itraconazole.

[0081] Specifically, the first antibacterial coating and the second antibacterial coating both include one or more of chlorhexidine base, chlorhexidine acetate, chlorhexidine gluconate, EDTA, silver sulfadiazine, taurolidine, gentamicin, etimicin, ceftriaxone, amoxicillin, tobramycin, rifampicin, minocycline, vancomycin, levofloxacin, amikacin, amphotericin B deoxycholate, ampicillin, azithromycin, caspofungin, ceftazidime, cefepime, ceftriaxone, ciprofloxacin, clindamycin, polymyxin, daptomycin, fluconazole, linezolid, moxifloxacin, metronidazole, voriconazole and itraconazole. The first antibacterial coating and the second antibacterial coating can release antibacterial components to achieve antibacterial effects.

[0082] In an optional solution of the embodiment of the present invention, the cap body 110 and the disinfection rod 120 are integrally formed.

[0083] Specifically, a mold is used to form a disinfection member having a cap body 110 and a disinfection rod 120. Preferably, see Figure 1 The outer wall of the cap body 110 is provided with anti-slip protrusions 112 .

[0084] The cap body 110 and the disinfection rod 120 are integrally formed, which improves the connection strength between the two, reduces the risk of falling off, and ensures the safety of clinical use; in addition, it can achieve disposable coating, reduce working hours and reduce costs.

[0085] In the optional solution of the embodiment of the present invention, see Figure 2 The disinfection rod 120 includes a first section 121 and a second section 122. One end of the first section 121 is connected to the bottom wall of the groove 111, and the other end is connected to the second section 122. The cross-sectional area of ​​the first section 121 is larger than the cross-sectional area of ​​the second section 122, and there is a conical transition between the first section 121 and the second section 122.

[0086] Specifically, the cross-sections of the first section 121 and the second section 122 are both set to be circular, and the diameter of the first section 121 is larger than the diameter of the second section 122. The tapered transition between the first section 121 and the second section 122 means that the outer wall diameter of the connection between the first section 121 and the second section 122 gradually decreases from one end close to the first section 121 to one end close to the second section 122.

[0087] The diameter of the first section 121 is greater than that of the second section 122. When the disinfection rod 120 is inserted into the inner cavity of the catheter, the first section 121 can play a role of disinfection and sealing at the same time, preventing the liquid in the catheter from leaking out of the disinfection element.

[0088] Embodiment 2

[0089] The preparation process for preparing the disinfection part described in Example 1 provided in an embodiment of the present invention includes loading: screening and regularizing the disinfection part samples, and transferring the disinfection part samples; dipping: flushing the disinfection part samples with antibacterial liquid; drying: continuously blowing hot air on the disinfection part; discharging: blowing cold air on the disinfection part, and moving the disinfection part.

[0090] Specifically, in this article, the disinfection piece sample refers to the disinfection piece that is not coated with an antibacterial coating; the disinfection piece refers to the finished disinfection piece that is coated with an antibacterial coating.

[0091] The loading steps are as follows: add the cleaned and dried disinfection sample to the material bin of the upper feeding mechanism 200, start the equipment, and the loading mechanism 200 sends the disinfection sample to the material transfer mechanism 300 in a specific posture. After the disinfection sample fills the placement slot 310 of the material transfer mechanism 300, the clamping claw 410 of the clamping mechanism 400 clamps the disinfection sample to the immersion mechanism 500.

[0092] The dipping steps are as follows: an antibacterial solution (such as chlorhexidine acetate solution) with a concentration of 0.5 to 8% is placed in the liquid storage tank 510 of the dipping mechanism 500, and after the disinfection piece sample is placed on the dipping column 560 of the dipping mechanism 500, the pump body 570 is started, and the antibacterial liquid continuously flushes the disinfection piece sample. The dipping time of a single disinfection piece sample is 1 to 5 seconds.

[0093] The concentration of the antibacterial liquid is set to 0.5-8%. If the concentration of the antibacterial liquid is too low, the coating amount will decrease, resulting in poor sterilization effect; if the concentration of the antibacterial liquid is too high, the antibacterial coating formed will easily fall off, and the uniformity of the coating cannot be controlled. The dipping time of a single disinfection sample is set to 1-5s. If the dipping time is too short, the coating amount will be insufficient; if the dipping time is too long, the production efficiency will be affected, and there will be no obvious effect on the increase in the coating amount.

[0094] Drying: After dipping, the clamping mechanism 400 places the disinfected piece in the first guide groove 630 of the drying mechanism 600, and the hot air blower 610 provides hot air at 90 to 150°C and blows continuously until the subsequent disinfected piece pushed by the paddle 440 of the clamping mechanism 400 pushes the earlier disinfected piece into the discharging mechanism 700; the duration of hot air drying of a single disinfected piece is 10 to 40 seconds.

[0095] The hot air temperature is set to 90-150℃. If the temperature is too low, it will not dry in a short time, and the drying time needs to be extended, affecting production efficiency. If the temperature is too high, it will damage the sterilized parts, such as melting the sterilized parts or peeling off the coating. The hot air drying time of a single sterilized part is set to 10-40s. If the time is too short, it cannot be fully dried; if the time is too long, it will affect production efficiency.

[0096] Discharging: In the discharging mechanism 700, the sterilized parts are continuously dried by cold air until they are driven by the linear vibrator 720 and sent to the discharging area.

[0097] The performance of the disinfection parts produced using this preparation process is described below:

[0098] Table 1 Surface disinfectant content of samples from the same batch

[0099]

[0100] Table 2 Absorbance of surface disinfectants of different batches of samples

[0101]

[0102] Among them, the absorbance reflects the amount of coating on the surface of the disinfected part;

[0103] Table 1 shows a batch of samples obtained after dipping for 3 seconds and drying at a drying temperature of 100°C for 10 seconds. Ten samples prepared in the same batch were randomly selected, immersed in ethanol solution, diluted a certain multiple, and then tested for absorbance at 258nm by UV-visible spectrophotometer. It can be seen from Table 1 that the absorbance of the surface disinfectant of the disinfected parts produced in the same batch is between 0.6 and 0.75, which is converted to a coating density of 0.74 to 0.93 μg / mg, and the coefficient of variation is less than 10%.

[0104] Samples were randomly selected from the samples prepared in different batches, immersed in ethanol solution, diluted a certain number of times, and then tested by UV-visible spectrophotometer at 258 nm. As shown in Table 2, the absorbance of the surface disinfectant of the disinfected parts produced in the same batch was between 0.70 and 0.81, which was converted into a coating density of 0.87 to 1.01 μg / mg.

[0105] It can be seen that the disinfected parts prepared by this preparation process can meet the product requirements.

[0106] Embodiment 3

[0107] The preparation device for preparing the disinfection element in Example 1 provided in the embodiment of the present invention is shown in FIG. Figure 3 and Figure 4 , including a feeding mechanism 200, a material moving mechanism 300, a clamping mechanism 400, a soaking mechanism 500, a drying mechanism 600 and a discharging mechanism 700; the outlet end of the feeding mechanism 200 is arranged opposite to the material moving mechanism 300; the material moving mechanism 300, the soaking mechanism 500, the drying mechanism 600 and the discharging mechanism 700 are arranged at intervals along a first direction a; the clamping mechanism 400 is located above the material moving mechanism 300 and has a clamping claw 410; the clamping claw 410 can move along the first direction a to move the disinfection piece sample located in the material moving mechanism 300 to the soaking mechanism 500 and the drying mechanism 600.

[0108] Specifically, see Figure 6 The material transfer mechanism 300 is provided with a plurality of placement slots 310 for placing the sterilized sample delivered from the feeding mechanism 200. Furthermore, the number of the placement slots 310 is consistent with the number of the clamping claws 410 of the clamping mechanism 400.

[0109] The loading mechanism 200 is used to send the disinfection piece samples to the material transfer mechanism 300 in a fixed posture; the material transfer mechanism 300 is used to receive the disinfection piece samples from the loading mechanism 200; the clamping mechanism 400 is used to clamp the disinfection piece samples in the placement groove 310 of the material transfer mechanism 300, and send these samples to the dipping mechanism 500 or the drying mechanism 600, etc.; the dipping mechanism 500 sprays the antibacterial liquid onto the surface of the disinfection piece sample through a circulating pump, and the excess liquid flows back into the liquid storage tank 510 to enter the next cycle; the drying mechanism 600 is used to quickly dry the disinfection piece dipped in the antibacterial liquid; the discharging mechanism 700 is used to send the dried disinfection piece to the finished product area through vibration.

[0110] The structure of the preparation equipment is described in detail below:

[0111] In the optional solution of the embodiment of the present invention, see Figure 5 The feeding mechanism 200 includes a driving member (not shown in the figure), a spiral feeding track 210 and a screen falling track 220. The driving member is connected to the spiral feeding track 210 and the screen falling track 220, and the outlet end of the spiral feeding track 210 is connected to the screen falling track 220. The outlet end of the screen falling track 220 is arranged opposite to the material moving mechanism 300.

[0112] Specifically, the driving member is configured as a vibration motor. The spiral feeding track 210 refers to a track that spirally rises in the vertical direction. One end of the sieve drop track 220 is connected to the spiral feeding track 210, and the other end is opposite to the material transfer mechanism 300. The shape of the track matches the shape of the disinfection sample, so that the posture of the disinfection sample can be adjusted so that the cap body 110 is above the disinfection rod 120; the disinfection rod 120 of the disinfection sample entering the material transfer mechanism 300 faces downward, which is convenient for the clamping claw 410 of the clamping mechanism 400 to clamp the disinfection sample and to match the disinfection sample with the dipping column 560 in the dipping mechanism 500.

[0113] The directional frequency force generated by the vibration motor causes the sterilized samples in the hopper of the feeding mechanism 200 to rise along the spiral feeding track 210, and the posture of the sterilized samples is adjusted through the screening track 220, and the sterilized samples that are not adjusted are screened out, and finally the sterilized samples are sent to the material transfer mechanism 300 in a specific posture.

[0114] In an optional scheme of an embodiment of the present invention, the material moving mechanism 300 is opposite to the loading mechanism 200, and the material moving mechanism 300 includes a first guide rail 320 extending along a first direction a, and a material moving block 330 slidably matched with the first guide rail 320; the material moving block 330 is provided with a plurality of placement grooves 310.

[0115] Specifically, see Figure 6 , a plurality of placement slots 310 are arranged at intervals along the first direction a, and the number of the placement slots 310 is equal to the number of the clamping jaws 410. Furthermore, one side wall of the material moving block 330 is slidably matched with the first guide rail 320, and the other side wall is provided with a plurality of placement slots 310. The material moving mechanism 300 also includes a material moving motor 340, which is transmission-connected with the material moving block 330 to drive the material moving block 330 to move along the first direction a; the material moving block 330 stops at a fixed position on the first guide rail 320, that is, each placement slot 310 stops after being aligned with the discharge port of the feeding mechanism 200, so that the sterilized sample coming out of the discharge port of the feeding mechanism 200 can smoothly enter the placement slot 310. Preferably, a sensor 350 is installed next to the discharge port of the loading mechanism 200 and the material moving mechanism 300, and the sensor 350 is facing the placement slot 310 in front of the discharge port. When the sterilized sample enters the placement slot 310, the sensor 350 can recognize the entry signal and move the material moving block 330 by a distance unit through instructions, so that the next placement slot 310 is aligned with the discharge port.

[0116] The placement groove 310 is used to place the disinfection sample output from the discharge port of the loading mechanism 200, and when the disinfection sample is placed in the placement groove 310, the cap body 110 is located at the top of the placement groove 310, so that the clamping claw 410 of the clamping mechanism 400 can smoothly clamp the disinfection sample; in addition, the material transfer motor 340 can drive the material transfer block 330 to move, so that multiple disinfection samples are output to multiple placement grooves 310 in sequence.

[0117] In an optional scheme of an embodiment of the present invention, the clamping mechanism 400 is located above the material moving mechanism 300, and the clamping mechanism 400 includes a second guide rail 420 extending along the first direction a, and a clamping block 430 slidably matched with the second guide rail 420; the clamping block 430 is provided with a plurality of clamping claws 410 arranged at intervals along the first direction a.

[0118] Specifically, see Figure 3 and Figure 6 , the second guide rail 420 is parallel to the first guide rail 320, and the length of the second guide rail 420 is greater than the length of the first guide rail 320. The number of the clamping jaws 410 is equal to the number of the placement slots 310, and the spacing between two adjacent clamping jaws 410 is equal to the spacing between two adjacent placement slots 310. The clamping mechanism 400 also includes a first cylinder and a second cylinder. The first cylinder is installed on the back of the clamping block 430 and is connected to the clamping jaw 410 to control the opening and closing of the clamping jaw 410; the second cylinder is slidably matched with the second guide rail 420, and the movable end of the second cylinder is connected to the clamping block 430 to drive the lifting and lowering of the clamping block 430, so that the clamping mechanism 400 can be lowered to clamp the sterilizing sample, and then rise to avoid the placement slot 310 after clamping the sterilizing sample, and then move along the first direction a to the next process and then lowered to achieve placement at the position corresponding to the next process. Preferably, a serrated protrusion is provided on the inner side of the clamping jaw 410 to stably clamp the cap body 110 of the disinfection piece sample.

[0119] The clamping mechanism 400 realizes the clamping and transportation of the sterilized sample.

[0120] In the optional solution of the embodiment of the present invention, see Figure 7 and Figure 8 The dipping mechanism 500 includes a liquid storage tank 510, an upper liquid pipeline 520, a return liquid pipeline 530, a dipping box 540 and a pump body 570; a dipping tube 550 is installed in the dipping box 540, and a dipping column 560 with an opening is provided on the top of the dipping tube 550, and the dipping column 560 is used to support the disinfection piece sample; one end of the upper liquid pipeline 520 is connected to the liquid storage tank 510, and the other end is connected to the dipping tube 550; one end of the return liquid pipeline 530 is connected to the dipping box 540, and the other end is connected to the liquid storage tank 510, and the pump body 570 is connected to the liquid storage tank 510.

[0121] Specifically, the dipping mechanism 500 is arranged beside the material transfer mechanism 300, the liquid storage tank 510 contains antimicrobial liquid, and the upper liquid pipeline 520 and the return liquid pipeline 530 are both connected to the liquid storage tank 510. The pump body 570 is configured as a circulation pump for realizing the circulation of the antimicrobial liquid in the liquid storage tank 510. The upper liquid pipeline 520 is connected to the dipping tube 550 of the dipping box 540, and the circulation pump is used to provide power to allow the antimicrobial liquid to enter the dipping tube 550 through the upper liquid pipeline 520; the return liquid pipeline 530 is connected to the bottom of the dipping box 540 to recover the antimicrobial liquid into the liquid storage tank 510. Furthermore, the dipping box 540 is configured as a funnel shape, that is, the cross-sectional area of ​​the top opening is large and the cross-sectional area of ​​the bottom is small, so that the excess antimicrobial liquid can be fully recovered by the return liquid pipeline 530. A dipping tube 550 is provided on the top of the dipping box 540, and the dipping tube 550 extends along the first direction a; the upper liquid pipeline 520 is connected to the dipping tube 550, and the antibacterial liquid is sent into the dipping tube 550. The top of the dipping tube 550 protrudes to form a plurality of dipping columns 560 with openings on the top, wherein the number and interval of the dipping columns 560 match the number and interval of the clamping jaws 410, and the clamping jaws 410 place the disinfection rod 120 of the disinfection piece sample in the opening of the dipping column 560.

[0122] During the dipping process, the antimicrobial liquid transported by the upper liquid pipeline 520 continuously flows into the dipping tube 550 and into the dipping column 560, and the antimicrobial agent continuously flushes the inner wall of the disinfection rod 120 and the cap body 110 of the disinfected sample, and the overflowing antimicrobial liquid is recovered into the liquid storage tank 510 through the bottom return liquid pipeline 530.

[0123] In the optional solution of the embodiment of the present invention, see Fig. 9 The drying mechanism 600 includes a hot air blower 610 and a placement piece 620. The bottom of the placement piece 620 is connected to the hot air blower 610, and the top is provided with a first guide groove 630 for placing the disinfection piece; the extension direction of the first guide groove 630 is set along the first direction a.

[0124] Specifically, the drying mechanism 600 is located next to the dipping mechanism 500, the top of the placement member 620 is connected to the environment, and the disinfected pieces after dipping are transported to the first guide groove 630 by the clamping jaws 410 and dried by hot air. Furthermore, the clamping mechanism 400 also includes a paddle 440, which is located on the side of the clamping mechanism 400 close to the drying mechanism 600 and below the clamping jaws 410. When the clamping mechanism 400 moves from the dipping mechanism 500 to clamp the next wave of sample pieces that have completed dipping, the paddle 440 will push the disinfected pieces on the first guide groove 630 of the drying mechanism 600 toward the direction of the discharging mechanism 700 to prevent the previous wave of disinfected pieces from affecting the placement of the next wave of disinfected pieces.

[0125] The first guide groove 630 of the drying mechanism 600 is long and narrow, so the drying time of the sterilized object is longer than the dipping time, ensuring that the sterilized object is fully dried.

[0126] In the optional solution of the embodiment of the present invention, see Fig. 9 , the discharging mechanism 700 is located next to the drying mechanism 600 ; the discharging mechanism 700 includes a second guide groove 710 and a linear vibrator 720 , the second guide groove 710 is located at the top of the linear vibrator 720 , and the second guide groove 710 is connected to the first guide groove 630 .

[0127] Specifically, the second guide groove 710 extends along the first direction a. Furthermore, an air duct 730 is connected below the second guide groove 710, and the air duct 730 introduces cold air into the second guide groove 710. After drying by the drying mechanism 600, the antibacterial coating is dried by air cooling, which helps to form the antibacterial coating on the surface of the disinfection piece more quickly and stably. Preferably, a quantity sensor 740 is provided above the second guide groove 710, and the quantity sensor 740 can monitor the number of disinfection pieces in the discharging mechanism 700, and can issue a command to stop the operation of the device when the number of disinfection pieces is sufficient.

[0128] The sterilizing element in the drying unit is pushed by the paddle 440 to enter the second guide groove 710 until the material is discharged.

[0129] The advantages of the preparation equipment are described in detail below:

[0130] (1) The preparation device can form an antibacterial coating at one time without the need to dip the cap body 110 and the disinfection rod 120 separately;

[0131] (2) The surface content of disinfected parts coated with antimicrobial agents in the same batch of the preparation equipment is uniform, and the difference between batches is small;

[0132] (3) The equipment can be applied to coating various types of antimicrobial agents;

[0133] (4) Loading, coating, drying and finished product collection are integrated and can be performed according to preset parameters without manpower, greatly improving production efficiency;

[0134] (5) The feeding mechanism 200 automatically sorts the materials without manual placement, thus improving production efficiency;

[0135] (6) The antimicrobial coating is achieved by spraying the antimicrobial agent through a circulation pump, avoiding manual leaching, and the coating is easily reflowed and can be reused;

[0136] (7) The combination of hot and cold air drying can not only quickly dry the surface coating, but also reduce the impact of high temperature on the material;

[0137] (8) The sensor 350 indicates whether the sterilization sample has entered the placement slot 310 normally, without manual inspection, thus improving efficiency;

[0138] (9) The dried sterilized parts are automatically transported to the finished product area through level vibration.

[0139] Example

[0140] Through three factors and three levels (L9,3 3 ), the orthogonal table is shown in Table 3, which further confirms the effectiveness of the process parameters. The experimental investigation indicator is the individual difference of the chlorhexidine acetate content on the surface of the disinfected piece. After the orthogonal experiment, the chlorhexidine acetate content in the disinfected piece is tested by UV-visible absorption spectrum, and the results are verified by mean processing and variance analysis.

[0141] Table 3. Orthogonal experiment L9(33) factor level table

[0142]

[0143] The test environment requirements are as follows:

[0144] Ambient temperature Relative humidity Atmospheric pressure 5～40℃ 10-93RH% 101.3kPa

[0145] The materials, instruments and reagents required for the experiment are as follows: (1) Materials and instruments: volumetric flask, electronic balance, disinfection sample, preparation equipment; (2) Reagents: 95% anhydrous ethanol, chlorhexidine acetate.

[0146] The experimental steps are as follows:

[0147] S1. Preparation of chlorhexidine acetate solution, including:

[0148] (1) Weigh 35 g of chlorhexidine acetate;

[0149] (2) Add about 900 ml of 95% anhydrous ethanol and stir to dissolve;

[0150] (3) Use a volumetric flask to make up to 1000 mL.

[0151] S2. Preparation of disinfection component coating, including:

[0152] (1) adding the prepared chlorhexidine acetate solution to the liquid storage tank 510 and turning on the preparation equipment;

[0153] (2) placing the sterilized sample on the vibrating plate of the loading mechanism 200 and starting the device;

[0154] (3) Set the parameters of drying temperature, dipping time and drying time in sequence according to Table 4;

[0155] (4) Disinfect the coating of the parts and collect the samples separately.

[0156] Table 4 Experimental plan

[0157]

[0158]

[0159] S3. Determination of coating content, including:

[0160] (1) Precisely prepare chlorhexidine acetate standard solutions with concentrations of 2.5, 5.0, 6.25, 7.5, 10.0, and 12.5 μg / mL, and measure the absorbance values ​​at 258 nm;

[0161] (2) According to the experimental plan in S2, 9 sterilized parts with different process parameters were prepared. Ten parts were randomly selected from each process, 5 mL of ethanol solution was added to each part, and the sterilized parts were added to the parts. The parts were shaken on a shaker for 30 min before being taken out.

[0162] (3) Take 300 μL of the solution in (2), add 2700 μL of ethanol, and test the absorbance under UV light;

[0163] (4) Based on the standard curve in (1) and the result in (3), multiply by the dilution factor to calculate the coating amount on the surface of the disinfection cap.

[0164] Under different processes, the content of chlorhexidine acetate on the surface of disinfected parts is as follows:

[0165] Table 5 The amount of chlorhexidine acetate attached under the process conditions of 90-1-10

[0166]

[0167] Table 6 Chlorhexidine acetate adhesion under 90-2-20 process conditions

[0168]

[0169]

[0170] Table 7 Chlorhexidine acetate adhesion under 90-5-50 process conditions

[0171]

[0172] Table 8 The amount of chlorhexidine acetate attached under the process conditions of 115-1-20

[0173]

[0174] Table 9: Chlorhexidine acetate adhesion under 115-2-20 process conditions

[0175]

[0176]

[0177] Table 10 The amount of chlorhexidine acetate attached under the process conditions of 115-5-10

[0178]

[0179] Table 11 Chlorhexidine acetate adhesion under 150-1-10 process conditions

[0180]

[0181] Table 12 The amount of chlorhexidine acetate attached under the process conditions of 150-2-10

[0182]

[0183]

[0184] Table 13 The amount of chlorhexidine acetate attached under the process conditions of 150-5-20

[0185]

[0186] Table 14 Summary of experimental data under different process conditions

[0187]

[0188] Notes: a :Substitute the absorbance into the standard curve to infer the concentration; b : Measured concentration multiplied by the dilution factor; c : The coating amount of each group of experimental samples is summed and averaged: AVE = ΣSi / N; d : CV = STDEV.S / AVE*100%.

[0189] According to the experimental results, under the above-mentioned process conditions, the coefficient of variation of the coating amount of the disinfected parts produced is as high as 27.44%. Compared with the average coefficient of variation of the coating amount of the disinfected parts produced by manual dipping, which is about 45%, the product yield has been greatly improved.

[0190] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A disinfection device, characterized in that: include: A cap body (110) and a disinfection rod (120); The cap body (110) is provided with a groove (111), and the side wall of the groove (111) is provided with an internal thread for matching with a catheter; One end of the disinfection rod (120) extends into the groove (111) and is connected to the bottom wall of the groove (111), and the other end is located outside the groove (111), and the disinfection rod (120) is used to extend into the inner cavity of the catheter; The outer surface of the disinfection rod (120) is provided with a first antibacterial coating.

2. The disinfection element according to claim 1, characterized in that: The inner wall of the groove (111) is provided with a second antibacterial coating.

3. The disinfection element according to claim 2, characterized in that: The coating amount per unit area of ​​the first antibacterial coating is the same as the coating amount per unit area of ​​the second antibacterial coating, and / or the material of the first antibacterial coating is the same as the material of the second antibacterial coating.

4. The disinfection element according to claim 2, characterized in that: The coating amount of the entire disinfection component is set to 0.4-3.0 μg / mg.

5. The disinfection device according to claim 1, characterized in that: The first antimicrobial coating comprises one or more of chlorhexidine base, chlorhexidine acetate, chlorhexidine gluconate, EDTA, silver sulfadiazine, taurolidine, gentamicin, etimicin, ceftriaxone, amoxicillin, tobramycin, rifampicin, minocycline, vancomycin, levofloxacin, amikacin, amphotericin B deoxycholate, ampicillin, azithromycin, caspofungin, ceftazidime, cefepime, ceftriaxone, ciprofloxacin, clindamycin, polymyxin, daptomycin, fluconazole, linezolid, moxifloxacin, metronidazole, voriconazole and itraconazole.

6. The disinfection device according to claim 1, characterized in that: The cap body (110) and the disinfection rod (120) are integrally formed.

7. The disinfection device according to claim 1, characterized in that: The disinfection rod (120) comprises a first section (121) and a second section (122), wherein one end of the first section (121) is connected to the bottom wall of the groove (111), and the other end is connected to the second section (122); The cross-sectional area of ​​the first section (121) is greater than the cross-sectional area of ​​the second section (122), and there is a tapered transition between the first section (121) and the second section (122).

8. A process for preparing the disinfection article according to any one of claims 1 to 7, characterized in that: include: Loading: Screening and sorting the sterilized samples, and transferring the sterilized samples; Dip coating: Use antibacterial liquid to flush the disinfected sample; Drying: Continuously blow hot air on the sterilized parts; Discharging: Blow cold air on the sterilized parts and move the sterilized parts.

9. The preparation process according to claim 8, characterized in that: When the antibacterial liquid is used to flush the disinfection piece sample, the concentration of the antibacterial liquid is set to 0.5-8%, and the dipping time of a single disinfection piece sample is set to 1-5s.

10. The preparation process according to claim 8, characterized in that: During the continuous hot air blowing on the sterilized parts, the temperature of the hot air is set to 90-150° C., and the hot air drying time of a single sterilized part is set to 10-40 seconds.

11. A preparation device for preparing the sterilized article according to any one of claims 1 to 7, characterized in that: include: A material loading mechanism (200), a material moving mechanism (300), a clamping mechanism (400), a material soaking mechanism (500), a drying mechanism (600) and a material discharging mechanism (700); The outlet end of the feeding mechanism (200) is arranged opposite to the material moving mechanism (300); The material moving mechanism (300), the material soaking mechanism (500), the drying mechanism (600) and the material discharging mechanism (700) are arranged at intervals along the first direction (a); The clamping mechanism (400) is located above the material transfer mechanism (300) and has a clamping claw (410); the clamping claw (410) can move along the first direction (a) to move the sterilized piece sample located in the material transfer mechanism (300) to the material soaking mechanism (500) and the drying mechanism (600).

12. The preparation device according to claim 11, characterized in that: The feeding mechanism (200) comprises a driving member, a spiral feeding track (210) and a screen drop track (220); the driving member is connected to the spiral feeding track (210) and the screen drop track (220); the outlet end of the spiral feeding track (210) is connected to the screen drop track (220); the outlet end of the screen drop track (220) is arranged opposite to the material moving mechanism (300).

13. The preparation device according to claim 11, characterized in that: The dipping mechanism (500) comprises a liquid storage tank (510), a liquid supply pipeline (520), a liquid return pipeline (530), a dipping box (540) and a pump body (570); A dipping tube (550) is installed in the dipping box (540), and a dipping column (560) having an opening is provided on the top of the dipping tube (550), and the dipping column (560) is used to support the disinfection part sample; One end of the upper liquid pipeline (520) is in communication with the liquid storage tank (510), and the other end is in communication with the dipping tube (550); One end of the liquid return pipeline (530) is in communication with the dipping tank (540), and the other end is in communication with the liquid storage tank (510); the pump body (570) is in communication with the liquid storage tank (510).

14. The preparation device according to claim 11, characterized in that: The drying mechanism (600) comprises a hot air blower (610) and a placement piece (620); the bottom of the placement piece (620) is connected to the hot air blower (610), and the top is provided with a first guide groove (630) for placing the disinfection piece; The extension direction of the first guide groove (630) is arranged along the first direction (a).

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