Antibacterial catheter and preparation method therefor, and external drainage device

Abstract

An antibacterial catheter and a preparation method therefor, and an external drainage device. The antibacterial catheter (1) comprises a catheter main body, wherein the materials of the catheter main body comprise silica gel. A solvent used during the preparation process of the antibacterial catheter (1) comprises hexafluoroisopropanol. The catheter main body is swelled by means of using the solvent, such that the antibacterial agent is dispersed inside the catheter main body. The catheter main body of the antibacterial catheter (1) is swollen by means of the solvent, and the solvent used contains hexafluoroisopropanol. Hexafluoroisopropanol has a good swelling effect on a catheter main body containing silica gel, and does not require the addition of an additional alkalizing agent, penetrant or drug solubilizer, or the use of subsequent treatments, such as heating or autoclaving. The external drainage device (4) can be connected to the antibacterial catheter (1). By means of the outer drainage device (4), it is convenient to adjust the height of a drainage drip bottle (300), and the accuracy and convenience of the reading of the drainage drip bottle (300) is improved; and it is convenient fix a liquid collection bag. In addition, the structure of the outer drainage device (4) is simple.

Description

Antibacterial catheter and method of making same and external drainage device TECHNICAL FIELD

[0001] The present disclosure relates to the technical field of medical devices, and in particular to an antibacterial catheter and method of making same and external drainage device. BACKGROUND

[0002] With the development of catheter diagnosis and treatment technology, the demand for medical catheters in the clinic is increasing, with an annual use of nearly ten million cases. As a component of the drainage or shunt system, the external ventricular drainage catheter is used in the drainage or shunt surgery of cerebrospinal fluid in patients with hydrocephalus. During the intervention of the human brain, bacteria are easily adhered to the surface of the catheter and quickly proliferate to form a bacterial biofilm, which can cause medical infection accidents and even lead to patient death in severe cases. Therefore, it is of great clinical application value and significance to prepare an external drainage catheter with antibacterial function.

[0003] Currently, the swelling loading method and the surface coating method are mainly used to prepare antibacterial functional external drainage catheters. For example, the invention patent application CN115154864A discloses an antibacterial and anti-adhesion super-smooth drainage catheter, which uses a surface coating method to coat poly pyrrolidone on the outer surface of the catheter groove drainage section. The poly pyrrolidone combines with water molecules to form a layer of hydrogel film coating, which can prevent the deposition of bacteria to a large extent, thereby playing an antibacterial role. However, the drainage catheter has the disadvantages of easy deposition of biological proteins on the surface of the coated catheter, which reduces the antibacterial effect, and the like when used for long-term implantation in the human body.

[0004] The commonly used solvents in the swelling loading method are dichloromethane, tetrahydrofuran, methanol, and chloroform, and the commonly used antibacterial agents are rifampicin, clindamycin hydrochloride, and minocycline, etc. However, the existing solvents have some shortcomings, such as poor light stability and high toxicity of chloroform, and poor swelling effect of methanol on the catheter body. Moreover, a single solvent cannot simultaneously dissolve multiple drugs, and it is even more difficult to achieve uniform loading of multiple drugs on the catheter. Even if multiple solvents are used in combination, it is usually necessary to add a penetrating agent, an alkalizing agent, or perform a heating treatment, otherwise it is difficult to achieve good loading effect of each drug.

[0005] In addition, the invention patent US10589003B2 discloses a method for coating or impregnating a non-organic surface with minocycline and rifampicin, using dichloromethane, tetrahydrofuran, chloroform, etc. as a solvent to dissolve rifampicin and minocycline, to prepare an antibacterial catheter loaded with antibiotics. However, the method needs to cure the coated or impregnated non-organic surface material at a temperature of at least about 40℃, and needs to heat dry the surface at a temperature of at least 50℃ for at least 12 hours, which has large energy consumption and a complicated preparation process.

[0006] Therefore, it is an urgent technical problem to develop an antibacterial catheter with high drug loading capacity, good antibacterial effect and simple preparation method.

[0007] In addition, the existing external drainage device usually includes a scale, a drainage drop bottle and a collection bag. The sliding groove and the sliding member are arranged on the scale, the drainage drop bottle is fixed on the sliding member, the drainage drop bottle is driven by the sliding member to slide up and down in the sliding groove, so that the height of the drainage drop bottle can be conveniently adjusted to control the drainage speed, and the intracranial pressure of the patient can be adjusted and monitored. In the existing cranial pressure monitoring and adjusting device, how to realize the sliding and fixing of the sliding member is a key problem. The existing sliding member usually has a complex structure, poor operation convenience and high manufacturing cost.

[0008] In addition, the drainage drop bottle of the external drainage device is usually aligned by naked eye observation during fixation. There are many accidental factors, the requirements for the operator are high, the use is not convenient, and the accuracy of the intracranial pressure reading is affected, thereby affecting the treatment effect.

[0009] Furthermore, the collection bag is used to collect cerebrospinal fluid, which can be used for cerebrospinal fluid property testing or can be used to judge whether the drainage is insufficient or excessive by the amount of cerebrospinal fluid collected in the collection bag within a period of time, and then the drainage speed can be accurately adjusted. The collection bag is usually fixed by hanging a rope on a bed frame or an infusion support, or the sliding member is extended outward to form a hanging bracket, and the collection bag is hung on the hanging bracket. The fixing mode of the collection bag on the bed frame or the infusion support needs to be re-opened when moving or replacing, and there is a risk of unstable binding and easy falling off. By the way of hanging on the hanging bracket formed by the extension of the sliding member, the sliding member slides, which drives the drainage drop bottle and the collection bag to slide up and down together, which is inconvenient to operate, and increases the manufacturing cost and difficulty of the sliding member part.

[0010] Therefore, it is of great significance for doctors and patients to develop an external drainage device which can conveniently adjust the height of the drainage drop bottle, improve the accuracy and convenience of the reading of the drainage drop bottle, and conveniently fix the collection bag. SUMMARY

[0011] In view of the technical problems existing in the prior art, the present disclosure first provides an antibacterial catheter. The antibacterial catheter of the present disclosure contains hexafluoroisopropanol in the solvent used in the preparation process. The hexafluoroisopropanol has good swelling effect on the silica gel catheter body, promotes the loading of the antibacterial agent to the catheter body, and is environmentally friendly, reducing the use of other higher toxicity solvents.

[0012] The solvent used in the preparation process of the antibacterial catheter contains hexafluoroisopropanol, can dissolve various antibacterial agents, is especially suitable for dissolving clindamycin hydrochloride and minocycline, can simultaneously serve as the solvent of the antibacterial agent and the swelling agent of the catheter body, makes the antibacterial agent solution have a higher concentration, and makes the catheter body have a higher drug loading after swelling, the drug loading is uniform, the drug is released for a long time, and the antibacterial effect is good.

[0013] Further, the disclosure also provides a preparation method of the antibacterial catheter, which is simple and easy to implement, raw materials are easy to obtain, and is suitable for mass production.

[0014] The preparation method of the disclosure dissolves drugs in groups, realizes sufficient dissolution of various drugs, shortens the preparation time, and reduces the mutual influence between drug solutions.

[0015] The disclosure also provides an external drainage device which is convenient to adjust the height of a drainage drop bottle, has a simple structure, is convenient to operate, and has low manufacturing cost.

[0016] In order to overcome or at least alleviate the deficiencies of the prior art, the technical scheme of the disclosure is:

[0017] The disclosure first provides an antibacterial catheter, the antibacterial catheter comprises a catheter body, the material of the catheter body comprises silica gel, and the solvent used in the preparation process of the antibacterial catheter comprises hexafluoroisopropanol, wherein,

[0018] The catheter body is swelled by using the solvent, and the antibacterial agent is dispersed in the catheter body.

[0019] The disclosure also provides a preparation method of the antibacterial catheter according to the disclosure, which is characterized in that,

[0020] The preparation method comprises swelling the catheter body in an antibacterial agent solution, and dispersing the antibacterial agent in the catheter body; wherein the antibacterial agent is dissolved in a solvent comprising hexafluoroisopropanol to obtain the antibacterial agent solution.

[0021] The disclosure also provides an external drainage device, which comprises a sliding structure, a scale plate and a drainage drop bottle, the drainage drop bottle is installed on the sliding structure, and the sliding structure is slidably connected with the scale plate.

[0022] The sliding structure comprises a first sliding member, a second sliding member and an adjusting member arranged on the front and back surfaces of the scale plate respectively, and the adjusting member is used for adjusting the distance between the first sliding member and the second sliding member; wherein,

[0023] The drainage drop bottle can be connected with the antibacterial catheter described above.

[0024] Compared with the prior art, the disclosure has the following beneficial effects:

[0025] The catheter body of the antibacterial catheter of the present disclosure is swelled via solvent, and the solvent used contains hexafluoroisopropanol, which has a good swelling effect on the silica gel-containing catheter body. Therefore, the present disclosure does not need to add additional alkalizing agents, penetrating agents or drug solubilizers, etc. when dispersing the antibacterial agent in the catheter body, nor does it need to use subsequent treatments such as heating or autoclaving.

[0026] Further, when the catheter body is swelled using one or more other solvents mixed with hexafluoroisopropanol, the swelling degree of the catheter body can be adjusted and enhanced.

[0027] Further, hexafluoroisopropanol can dissolve a variety of antibacterial agents, and in particular, has good solubility for clindamycin hydrochloride and minocycline. Therefore, hexafluoroisopropanol can simultaneously serve as a solvent for the antibacterial agent and a swelling agent for the catheter body, so that the antibacterial catheter has good drug loading effect and sustained release effect.

[0028] Further, the antibacterial catheter of the present disclosure can load two or more antibacterial drugs, which can enhance the antibacterial synergy of the catheter, thereby improving the broad-spectrum antibacterial property of the catheter against a variety of microorganisms. The antibacterial catheter of the present disclosure has a high drug loading capacity for the loaded multiple drugs, and has good antibacterial effect.

[0029] Further, the preparation method of the antibacterial catheter of the present disclosure is simple and easy to implement, the raw materials are easy to obtain, and it is suitable for mass production.

[0030] Further, the external drainage device of the present disclosure is composed of three structures of the first sliding member, the second sliding member and the adjusting member to form a sliding structure, which has a simple structure and low manufacturing cost; the sliding and fixing of the sliding structure are realized by adjusting the distance between the first sliding member and the second sliding member through the adjusting member, which facilitates the disassembly and installation of medical staff. BRIEF DESCRIPTION OF DRAWINGS

[0031] Figure 1 shows the swelling effect diagram of the antibacterial catheter of Example 3;

[0032] Figure 2 shows the swelling effect diagram of the antibacterial catheter of Comparative Example 1;

[0033] Figure 3 is a drug release curve diagram of rifampicin in the antibacterial catheter of Example 3;

[0034] Figure 4 is a drug release curve diagram of clindamycin hydrochloride in the antibacterial catheter of Example 3;

[0035] Figure 5 shows a structural schematic diagram of the antibacterial catheter of the present disclosure; wherein the left diagram is a front view of the antibacterial catheter, and the right diagram is a rear view of the antibacterial catheter.

[0036] Figure 6 is an exploded view of the sliding structure of the external drainage device;

[0037] Fig. 7 is a perspective view of a sliding structure of the external drainage device;

[0038] Fig. 8 is a structural schematic view of the sliding structure combined with the scale plate from a first perspective;

[0039] Fig. 9 is a structural schematic view of the sliding structure combined with the scale plate from another perspective;

[0040] Fig. 10 is a front view of the scale plate of the external drainage device;

[0041] Fig. 11 is a back view of the scale plate of the external drainage device;

[0042] Fig. 12 is a structural schematic view of the sliding structure installed with the drainage drip bottle;

[0043] Fig. 13 is a structural schematic view of the external drainage device as a whole from a first perspective;

[0044] Fig. 14 is a structural schematic view of the external drainage device as a whole from another perspective;

[0045] Fig. 15 is a structural schematic view of a drainage kit comprising the antibacterial catheter and the external drainage device;

[0046] BRIEF DESCRIPTION OF THE DRAWINGS 100, sliding structure; 110, first sliding piece; 111, through hole; 112, first circular table; 113, clamping assembly; 1131, first elastic claw; 1132, second elastic claw; 114, positioning block; 115, scale indicating block; 120, second sliding piece; 121, screw hole; 122, second circular table; 130, adjusting piece; 131, operation part; 132, threaded part; 133, first supporting leg; 134, second supporting leg; 135, first bulging part; 136, second bulging part; 150, limiting structure; 200, scale plate; 230, second sliding groove; 240, first sliding groove; 250, hook-shaped part; 300, drainage drip bottle. 201, first plate part; 202, second plate part; 203, third plate part; 204, opening; 205, reinforcing rib; 206, hollow groove; 207, first scale mark; 208, second scale mark; 209, mounting part; 400, hanging part; 500, level; 600, clamp. 310, bottle body; 320, liquid inlet; 330, liquid outlet; 340, gas inlet; 350, positioning table; 351, first positioning plane; 352, second positioning plane; 360, liquid inlet mark line; 370, scale mark; 380, liquid inlet tube; 710, connecting plate. 1, antibacterial catheter; 2, connector; 3, drainage pipeline; 4, external drainage device; 5, drainage bag. DETAILED DESCRIPTION

[0047] Exemplary embodiments of the present disclosure are described below with reference to the accompanying drawings.

[0048] Various exemplary embodiments, features, and aspects of the present disclosure will be described in detail below. The word "exemplary" is used herein to mean "serving as an example, instance, or illustration." Any implementation described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other implementations.

[0049] The present disclosure will be further described with reference to the drawings. In the drawings, the same or similar components are designated by the same or similar reference numerals, and the size, the relative shapes and the like of components do not reflect the actual scale. In order to more clearly illustrate embodiments of the present disclosure, some components in the drawings can be omitted, exaggerated or simplified.

[0050] In the drawings of the present disclosure, the same or similar reference numerals are assigned to the same or similar components. In the description of the present disclosure, it should be understood that the orientation or positional relationship indicated by terms such as "upper", "lower", "left", "right", etc. are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present disclosure and simplifying the description, and do not indicate or imply that the device or element referred to must have a particular orientation, be constructed and operated in a particular orientation. Therefore, the terms describing the positional relationship in the drawings are only used for exemplary illustration, and cannot be understood as limiting the present patent. For those skilled in the art, the specific meanings of the above terms can be understood according to the specific circumstances.

[0051] Unless otherwise specified, the units used in the present specification are international standard units, and the numerical values and numerical value ranges appearing in the present disclosure should be understood to include the systematic errors that are inevitable in industrial production.

[0052] In the present specification, the meaning of "may" includes both the meaning of performing a certain process and the meaning of not performing a certain process.

[0053] In the present specification, "some specific / preferred embodiments", "other specific / preferred embodiments", "embodiments", and the like refer to specific elements (e.g., features, structures, properties, and / or characteristics) described in relation to the embodiments, which are included in at least one embodiment described herein, and can or can not be present in other embodiments. In addition, it should be understood that the elements can be combined in various embodiments in any suitable manner.

[0054] In the present specification, the numerical value range represented by "numerical value A - numerical value B" refers to a range including the end point numerical values A and B.

[0055] In the present specification, the meaning of "mass-volume concentration" is the ratio of the mass of a solute to the volume of a solvent.

[0056] In the present specification, the temperature of "room temperature" or "normal temperature" can be 15-30℃, for example: 20-25℃.

[0057] <First aspect>

[0058] The first aspect of the present disclosure provides an antibacterial catheter, which comprises a catheter body, the material of the catheter body comprises silica gel, and the solvent used in the preparation process of the antibacterial catheter comprises hexafluoroisopropanol, wherein,

[0059] The catheter body is swelled by using the solvent, and the antibacterial agent is dispersed inside the catheter body.

[0060] The antibacterial catheter of the present disclosure comprises a catheter body, which has an inlet (such as a drainage hole) and an outlet, and the inlet and the outlet are in communication through the catheter body to form a cavity structure. The material of the catheter body comprises silica gel.

[0061] Specifically, as shown in FIG. 5, the tip of the antibacterial catheter has an asymmetric drainage hole, and the maximum distance between two points on the profile line of the drainage hole passing through the center is the major axis, and the minimum distance between two points on the profile line of the drainage hole passing through the center is the minor axis.

[0062] Preferably, the antibacterial catheter has a first drainage hole and a second drainage hole. The major axis of the first drainage hole is greater than the major axis of the second drainage hole; and / or, the number of the first drainage hole is less than the number of the second drainage hole. More preferably, the major axis of the first drainage hole is 4.0mm-5.5mm, and the minor axis is 1.0mm-2.5mm; the major axis of the second drainage hole is 2.0mm-2.5mm, and the minor axis is 1.0mm-2.5mm.

[0063] The present disclosure can prevent large drainage blockage of the catheter by setting the first drainage hole; and can prevent the escape of the puncture needle during the puncture process by setting the second drainage hole, and the small hole is suitable for drainage after puncture.

[0064] In the present disclosure, the antibacterial catheter also has ring-printed scale lines that surround the antibacterial catheter axially in a whole circle, which facilitates the observation of the insertion depth of the catheter from different angles. Preferably, the distance between adjacent ring-printed scale lines is 1cm or 2cm, and the middle distance between adjacent ring-printed scale lines is marked with a dot scale. Further, at least one side is printed with numbers, which facilitates reading.

[0065] In the present disclosure, the solvent used in the preparation process of the antibacterial catheter comprises hexafluoroisopropanol. The inventors of the present disclosure found that hexafluoroisopropanol has good swelling effect on the catheter body. The antibacterial catheter of the present disclosure uses hexafluoroisopropanol as a solvent, which expands the use range of conventional solvents.

[0066] Hexafluoroisopropanol can dissolve a variety of antibacterial agents and has a good swelling effect on the catheter body. Therefore, the present disclosure does not need to add additional alkalinizing agents, penetrating agents or drug solubilizers (such as NaOH) and the like when dispersing the antibacterial agent in the catheter body, nor does it need to use subsequent treatments such as heating or high-pressure sterilization.

[0067] In the present disclosure, hexafluoroisopropanol can be used as a solvent for a variety of antibacterial agents, which can dissolve the antibacterial agents while penetrating and "swelling" the entire catheter body, causing the internal channels of the catheter body to open, and the antibacterial agents can enter these channels, achieving uniform dispersion of the antibacterial agents in the catheter body. Therefore, hexafluoroisopropanol can also enable the drug-containing drainage catheter of the present disclosure to achieve good loading and release effects of a variety of antibacterial agents.

[0068] In the present disclosure, the catheter body is swelled by using the solvent, and the antibacterial agent is penetrated inside the catheter body. Specifically, the preparation process of the antibacterial catheter includes dissolving the antibacterial agent using the solvent to obtain an antibacterial agent solution, and swelling the catheter body using the antibacterial agent solution, so that the antibacterial agent is dispersed inside the catheter body. Further, the antibacterial catheter of the present disclosure can simultaneously load two or more antibacterial drugs, which can enhance the antibacterial synergy of the catheter, thereby improving the broad-spectrum antibacterial property of the catheter against a variety of microorganisms. The antibacterial catheter of the present disclosure also has a high drug loading capacity and good antibacterial effect.

[0069] In some specific embodiments, the antibacterial agent includes clindamycin hydrochloride and / or minocycline. Among them, minocycline is a tetracycline antibiotic with a wide antibacterial spectrum, which can effectively resist a variety of bacteria, including gram-positive and gram-negative bacteria. Clindamycin hydrochloride mainly plays a role by inhibiting the synthesis of bacterial proteins, and has good antibacterial effect on gram-positive bacteria (such as Staphylococcus aureus, Streptococcus, etc.) and some anaerobic bacteria.

[0070] When the antibacterial agent includes clindamycin hydrochloride and / or minocycline, the preparation process of the antibacterial catheter includes dissolving the clindamycin hydrochloride and / or the minocycline in the solvent to obtain the antibacterial agent solution, and then immersing the catheter body in the antibacterial agent solution, so that the antibacterial agent is dispersed inside the catheter body.

[0071] In some specific embodiments, the solvent used in the preparation process of the antibacterial catheter also includes dichloromethane and / or tetrahydrofuran. The inventors of the present disclosure found that using dichloromethane and / or tetrahydrofuran together with hexafluoroisopropanol for mixing and use in the catheter body can adjust and enhance the swelling degree of the catheter body, further increasing the drug loading capacity.

[0072] In some specific embodiments, the antibacterial agent comprises rifampicin and clindamycin hydrochloride, or the antibacterial agent comprises rifampicin and minocycline. The present disclosure can produce a synergistic effect by using the combination of rifampicin and clindamycin hydrochloride or rifampicin and minocycline, and can more effectively inhibit or kill bacteria. Rifampicin is a rifamycin antibiotic, which also has a broad-spectrum antibacterial effect, especially on Mycobacterium tuberculosis and other difficult-to-treat bacteria.

[0073] In some specific embodiments, the drug loading amount of rifampicin is 0.040 wt% or more, for example, 0.040 wt%-0.1 wt%, based on the total mass of the antibacterial catheter; and the drug loading amount of clindamycin hydrochloride or minocycline is 0.10 wt% or more, for example, 0.10 wt%-0.2 wt%. The antibacterial catheter of the present disclosure can simultaneously load two or more antibacterial drugs, which can enhance the antibacterial synergy of the catheter and thus improve the broad-spectrum antibacterial property of the catheter against various microorganisms.

[0074] The antibacterial catheter of the present disclosure has a long drug release time and excellent antibacterial effect. Specifically, the drug release time of the antibacterial catheter is greater than 14 days; and the in vitro antibacterial rate of the antibacterial catheter within 7 days is greater than 95%.

[0075] The antibacterial catheter of the present disclosure is suitable for preparing various medical implants, including but not limited to drainage catheters, vascular catheters, dialysis catheters, long-term tunnel central venous catheters, peripheral venous catheters, short-term central venous catheters, arterial catheters, Swan-Ganz pulmonary artery catheters, urinary catheters, long-term urinary devices, tissue-bound urinary devices, penile prostheses, vascular grafts, vascular catheter ports, wound drainage tubes, hydrocephalus shunts, peritoneal dialysis catheters, pacemaker capsules, artificial urinary sphincters, small or temporary joint replacements, urinary dilators, or heart valves, etc., and is particularly suitable for drainage catheters, especially external cerebrospinal fluid drainage catheters.

[0076] The first aspect of the present disclosure also provides a preparation method of the antibacterial catheter according to the first aspect of the present disclosure, which comprises immersing a catheter body in an antibacterial agent solution to disperse the antibacterial agent inside the catheter body; wherein the antibacterial agent is dissolved in a solvent comprising hexafluoroisopropanol to obtain the antibacterial agent solution.

[0077] The present disclosure can use a solvent to penetrate and "swell" the entire catheter body of the catheter body, so as to open the internal channels of the catheter body. At the same time, the antibacterial agent can enter these channels, achieving uniform dispersion of the antibacterial agent in the catheter body.

[0078] The preparation method of the antibacterial catheter of the present disclosure is simple, and during the swelling and impregnation of the catheter body, no additional alkalinizing agent, penetrating agent or drug solubilizer (such as NaOH) is needed, and no subsequent treatment such as heating or high-pressure sterilization is needed, and after natural evaporation of the solvent, drying can achieve high loading and long-acting antibacterial effect of various drugs on the catheter body.

[0079] In some specific embodiments, the antibacterial agent includes clindamycin hydrochloride and / or minocycline, and the preparation method of the antibacterial catheter includes dissolving the clindamycin hydrochloride and / or the minocycline in the solvent including hexafluoroisopropanol to obtain the antibacterial agent solution, and then impregnating the catheter body in the antibacterial agent solution to disperse the antibacterial agent inside the catheter body.

[0080] In some specific embodiments, the solvent used in the preparation process of the antibacterial catheter further includes dichloromethane and / or tetrahydrofuran; and the antibacterial agent includes rifampicin and clindamycin hydrochloride, or rifampicin and minocycline. When the solvent and the antibacterial agent combination of the present embodiments are used, both rifampicin and clindamycin hydrochloride, or rifampicin and minocycline, can have good loading effect.

[0081] In some specific embodiments, in order to shorten the preparation time of the antibacterial agent mixed solution, reduce the risk of drug degradation and crystallization, improve the drug loading performance of the antibacterial catheter, and thus improve the antibacterial effect of the catheter, the preparation method includes the following steps:

[0082] dissolving a first antibacterial agent in a first solvent to obtain a first antibacterial agent solution; wherein the first antibacterial agent includes rifampicin, and the first solvent includes dichloromethane and / or tetrahydrofuran;

[0083] dissolving a second antibacterial agent in a second solvent to obtain a second antibacterial agent solution; wherein the second antibacterial agent includes clindamycin hydrochloride and / or minocycline, and the second solvent includes hexafluoroisopropanol;

[0084] mixing the first antibacterial agent solution and the second antibacterial agent solution uniformly to obtain the antibacterial agent mixed solution;

[0085] immersing the catheter body in the antibacterial agent mixed solution, and then taking out the catheter body to remove the first solvent and the second solvent, thereby obtaining the antibacterial catheter.

[0086] The present disclosure can quickly achieve complete dissolution of the first antibacterial agent and the second antibacterial agent by dissolving the first antibacterial agent and the second antibacterial agent in the first solvent and the second solvent respectively and then mixing them, shorten the preparation time of the first antibacterial agent and the second antibacterial agent mixed solution, reduce the risk of drug degradation and crystallization, and thus improve the drug loading effect and drug release effect of the catheter.

[0087] In some specific embodiments, in the antibacterial agent mixed solution, the mass-volume concentration of the first antibacterial agent can be 0.002 g / mL-2 g / mL, preferably 0.01 g / mL-1.0 g / mL, and the mass-volume concentration of the second antibacterial agent can be 0.002 g / mL-2 g / mL, preferably 0.01 g / mL-1.0 g / mL, relative to the total volume of the first solvent and the second solvent.

[0088] Further, in the present disclosure, the volume ratio of the first solvent to the second solvent can be 1:(0.05-30), preferably 1:(0.1-10).

[0089] Further, the present disclosure obtains the antibacterial catheter by placing the catheter body in the antibacterial agent mixed solution for impregnation, removing the first solvent and the second solvent. The present disclosure does not make special limitations on the time for impregnation, which can be specifically 0.5 h-1 h. Specifically, the catheter body is impregnated in the antibacterial agent mixed solution, sealed and protected from light, and taken out after impregnation at room temperature for 0.5 h-1 h.

[0090] Further, the present disclosure does not make special limitations on the method for removing the solvent, which can generally be by volatilizing the solvent under natural conditions, for example, volatilizing the solvent in a fume hood at room temperature.

[0091] Further, the preparation method of the present disclosure further comprises the step of post-treating the antibacterial catheter; preferably, the post-treatment comprises cleaning and then drying the antibacterial catheter. For drying, in order to not damage the function of the antibacterial catheter, the present disclosure can be preferably air-dried at room temperature.

[0092] <Second aspect>

[0093] The second aspect of the present disclosure provides an external drainage device, which comprises a sliding structure 100, a scale plate 200 and a drainage drip bottle 300, as shown in FIG. 13 and FIG. 14. The drainage drip bottle 300 of the drainage device can be connected to the antibacterial catheter of the first aspect.

[0094] The drainage drip bottle 300 is installed on the sliding structure 100, the sliding structure 100 is slidingly connected with the scale plate 200, and the height adjustment of the drainage drip bottle 300 relative to the scale plate 200 is achieved by up-down sliding between the sliding structure 100 and the scale plate 200; the sliding structure 100 comprises a first sliding member 110, a second sliding member 120 and an adjusting member 130 for adjusting the distance between the first sliding member 110 and the second sliding member 120, which are respectively arranged on the front and back surfaces of the scale plate 200, as shown in FIG. 6-7.

[0095] In some specific embodiments, the first sliding member 110 and the second sliding member 120 are both in sliding connection with the scale plate 200, and the adjustment of the distance between the first sliding member 110 and the second sliding member 120 by the adjusting member 130 realizes the sliding and fixing of the sliding structure 100, so as to realize the adjustment of the height of the drainage drop bottle 300 and the fixing of the drainage drop bottle 300.

[0096] In some specific embodiments, the adjusting member 130 comprises an operation part 131 and a threaded part 132 which are connected and arranged, the first sliding member 110 is provided with a through hole 111, the second sliding member 120 is provided with a threaded hole 121, and the threaded part 132 is in threaded connection with the threaded hole 121 through the through hole 111, so as to change the distance between the first sliding member 110 and the second sliding member 120, and further realize the sliding and fixing of the sliding structure 100. In the present disclosure, the second sliding member 120 can be manually limited during the adjustment operation, or a limiting structure 150 can be arranged to limit the rotation of the second sliding member 120, which is not specifically limited in the present disclosure. In order to facilitate the rotation operation, the operation part 131 of the present disclosure is an operation knob provided with a plurality of convex parts in the circumferential direction.

[0097] In order to prevent the second sliding member 120 from being separated from the adjusting member in the slidable state, in some specific embodiments, the adjusting member 130 further comprises a first leg 133 and a second leg 134 which are symmetrically arranged, and a first bulging part 135 and a second bulging part 136 which are symmetrically arranged, the first leg 133 is arranged between the threaded part 132 and the first bulging part 135, the second leg 134 is arranged between the threaded part 132 and the second bulging part 136, there is a gap between the first leg 133 and the second leg 134, the diameters of the first leg 133 and the second leg 134 are smaller than the diameters of the through hole 111 and the threaded hole 121, and the diameters of the first bulging part 135 and the second bulging part 136 are larger than the diameters of the through hole 111 and the threaded hole 121, as shown in FIG. 6. The pressing of the first leg 133 and the second leg 134 makes the first leg 133 and the second leg 134 close to each other, so as to realize the quick installation of the adjusting member 130, and due to the arrangement of the first bulging part 135 and the second bulging part 136, even if the adjusting member 130 is loosened, the second sliding member 120 will not fall off.

[0098] The external drainage device of the present disclosure can realize the adjustment of the distance between the first sliding member 110 and the second sliding member 120 by rotating the adjusting member 130, so as to realize the sliding and fixing of the sliding structure 100, which is simple and convenient to operate; the structure arrangement of the adjusting member 130 can realize the quick installation of the adjusting member 130, and even if the adjusting member 130 is loosened, the second sliding member 120 will not fall off, which effectively guarantees the structural stability of the whole device.

[0099] In some specific embodiments, the scale board 200 is provided with a first sliding groove 240 and a second sliding groove 230 arranged in parallel, the first sliding member 110 is in sliding connection with the first sliding groove 240, and the second sliding member 120 is in sliding connection with the second sliding groove 230, as shown in FIGS. 8 and 9. In this way, the stable sliding of the sliding structure 100 can be ensured through the design of two sliding positions.

[0100] The first sliding groove 240 is in communication with the second sliding groove 230, and the width of the second sliding groove 230 is greater than the width of the first sliding groove 240. The first sliding groove 240 is located in front of the second sliding groove 230, the first sliding member 110 is connected with the infusion drip bottle 300 and bears a relatively heavy weight, and the front-narrow-and-back-wide slot design helps to improve the stability of the sliding of the sliding structure 100 relative to the scale board 200.

[0101] In addition, the first sliding member 110 includes a connecting plate 710 and a limiting structure 150 in abutment with the second sliding member 120 to limit the rotation of the second sliding member 120, the limiting structure 150 is arranged on the connecting plate 710, and the limiting structure 150 is in sliding connection with the first sliding groove 240. In addition to being used as a sliding component of the first sliding member 110 and being in sliding connection with the first sliding groove 240, the limiting structure 150 can prevent the second sliding member 120 from rotating together with the rotation of the adjusting member 130 when the relative distance between the first sliding member 110 and the second sliding member 120 is adjusted.

[0102] To ensure the structural strength of the through hole 111 and the threaded hole 121 and to avoid the adverse effects of the abrasion of the adjusting member 130 on the structural strength of the first sliding member 110 and / or the second sliding member 120 during the rotation operation, a first circular table 112 is machined on the side of the first sliding member 110 close to the operation part 131, and a second circular table 122 is machined on both opposite sides of the second sliding member 120.

[0103] The sliding structure 100 further includes a clamping assembly 113 for clamping the infusion drip bottle 300 and a positioning block 114 arranged above the clamping assembly 113, the clamping assembly 113 and the positioning block 114 are both arranged on the first sliding member 110, and the top surface of the infusion drip bottle 300 is in abutment with the lower surface of the positioning block 114. The positioning block 114 limits the height of the infusion drip bottle 300, which helps to simplify the reading operation and reduce the reading error, as shown in FIG. 7.

[0104] In some embodiments, the clamping assembly 113 includes a first elastic claw 1131 and a second elastic claw 1132 arranged symmetrically, and a clamping space for clamping the infusion drip bottle 300 is formed between the first elastic claw 1131 and the second elastic claw 1132.

[0105] In some specific embodiments, the drainage drip bottle 300 comprises a bottle body 310 and a positioning platform 350 arranged on the outer periphery of the bottle body 310, the positioning platform 350 is in abutment with the clamping assembly 113, and the lower surface of the positioning platform 350 is in the same plane as the upper surface of the clamping assembly 113, determining the lowermost mounting position of the drainage drip bottle 300 relative to the clamping assembly 113, and no further downward relative displacement occurs. The top surface of the drainage drip bottle 300 is in contact with the lower surface of the positioning block 114, achieving positioning of the drainage drip bottle 300 in two directions, up and down, and being more accurate.

[0106] In order to achieve simultaneous positioning of the upper and lower surfaces of the positioning platform 350 to maintain the accuracy and stability of the positioning of the drainage drip bottle 300, in some specific embodiments, the positioning platform 350 is in abutment with the positioning block 114, and the upper surface of the positioning platform 350 is in the same plane as the lower surface of the positioning block 114. The upper surface of the positioning platform 350 and the top surface of the drainage drip bottle 300 are in abutment with the lower surface of the positioning block 114, which can increase the contact area between them and improve the stability of the positioning of the drainage drip bottle.

[0107] The upper surface of the positioning platform 350 is a first positioning plane 351, and the lower surface of the positioning platform 350 is a second positioning plane 352. The arrangement of the first and second positioning planes 351 and 352 limits the movement of the drainage drip bottle 300 in two opposite directions, effectively and accurately positioning the position of the drainage drip bottle 300, which helps to accurately read the intracranial pressure reading, as shown in FIGS. 12-14.

[0108] At this time, the upper surface of the positioning platform 350, the lower surface of the positioning block 114, the top surface of the drainage drip bottle 300, and the first positioning plane 351 are all in the same plane.

[0109] Alternatively, when the drainage drip bottle 300 is fixedly mounted, the lower surface of the positioning block 114 can also be in contact with a parallel plane of the first positioning plane 351 for positioning, and the upper surface of the clamping assembly 113 can also be in contact with a parallel plane of the second positioning plane 352 for positioning. With such an arrangement, the movement of the drainage drip bottle 300 in the upward and downward directions is limited, as well as the rotation of the drainage drip bottle 300 backward (the drainage drip bottle 300 is in front and the scale plate 200 is behind). In addition to the clamping action of the clamping assembly 113, the movement of the drainage drip bottle 300 is limited from three directions, effectively ensuring the accuracy of the positioning of the drainage drip bottle 300 and the stability of the positioning position after positioning.

[0110] In some specific embodiments, the positioning platform 350 is an ear-shaped structure for fixing the liquid inlet tube 380, and the ear-shaped structure is arranged on the outer periphery of the bottle body 310.

[0111] In some specific embodiments, the positioning platform 350 is a ring structure surrounding the outer periphery of the bottle body 310, which can be a complete annular structure or a partial arc ring structure. When the positioning platform 350 is designed as a complete arc structure, the ring structure can be a cover body detachably connected to the bottle body 310, and the diameter of the cover body is greater than that of the bottle body 310, so that a positioning step is formed at the connection between the cover body and the bottle body 310. In this way, the positioning of the drainage drip bottle 300 can be realized by using the bottle cap itself, without the need for a separate positioning platform 350, which is low in manufacturing cost and difficulty.

[0112] In some embodiments, the bottle body 310 of the drainage drip bottle 300 is provided with a liquid inlet 320 and a liquid outlet 330 at both ends, and a gas inlet 340 is arranged beside the liquid inlet 320. The outer periphery of the liquid inlet 320 and the gas inlet 340 abuts against the side surface of the positioning block 114.

[0113] In some embodiments, the front surface of the scale plate 200 is provided with scale marks, and one side or both sides of the first sliding member 110 are provided with scale indicating blocks 115. The scale indicating blocks 115 are located on the front surface of the scale plate 200, and the scale indicating blocks 115 cooperate with the scale marks to read the intracranial pressure.

[0114] In some specific embodiments, at least one side of the connecting plate 710 is provided with a scale indicating block 115 arranged in a triangular shape, and the drainage drip bottle 300 is circumferentially provided with a liquid inlet mark line 360. When the drainage drip bottle 300 is positioned in abutment with the positioning block 114, the tip of the scale indicating block 115 is located at the cross section where the liquid inlet mark line 360 is located.

[0115] Specifically, the liquid inlet mark line 360 is provided below with scale marks 370, which are volume marks. The liquid inlet mark line 360 is specifically a double-headed arrow, and the plane where the double-headed arrow is located is perpendicular to the axis of the drainage drip bottle 300. When the liquid flow rate of the liquid inlet 320 of the drainage drip bottle 300 approaches 0, the reading corresponding to the liquid inlet mark line 360 is the intracranial pressure of the patient at this time; the scale marks 370 are used to read the volume of the liquid in the drainage drip bottle 300.

[0116] The existing cranial pressure monitoring and adjusting device only relies on naked eyes to judge the alignment position of the liquid inlet mark line 360 and the scale line to read the number, which is easy to produce errors, leading to inaccurate reading and time-consuming and laborious reading judgment. In order to conveniently read the intracranial pressure value, the connecting plate 710 of the present disclosure is provided with a triangular scale indicating block 115 on at least one side, and when the drainage drip bottle 300 is positioned and fixed, the tip of the scale indicating block 115 is located at the cross section where the liquid inlet mark line 360 is located. When the drainage drip bottle 300 is fixed and positioned by the clamping assembly 113, the liquid inlet mark line 360 is exactly in the same horizontal plane as the tip of the scale indicating block 115, so that the current intracranial pressure value of the patient can be directly read by the pointing of the tip of the scale indicating block 115.

[0117] In order to conveniently and stably hang the collecting bag, the present disclosure is provided with a hook-shaped part 250 at the bottom of the scale plate 200 for hanging the collecting bag. The present disclosure uses the hook-shaped part 250 to hang the collecting bag, which is easy to operate and stable, and can effectively prevent the collecting bag from falling off the hook-shaped part 250. When in use, the collecting bag is hung on the hook-shaped part 250, i.e. the bottom of the scale plate 200, and will not move with the sliding of the drainage drip bottle 300, which is easy to operate and has low manufacturing cost and difficulty. In some specific embodiments, the hook-shaped part 250 is integrally formed at the bottom of the scale plate 200. That is, the hook-shaped part 250 is formed on the scale plate 200, which can be formed by injection molding.

[0118] The scale plate 200 comprises a first plate part 201, a second plate part 202 and a third plate part 203 arranged from top to bottom, the first plate part 201 is provided with a hanging part 400 for hanging and fixing the scale plate 200, the surface of the second plate part 202 is provided with scale marks, the hook-shaped part 250 is arranged on the third plate part 203, and the second plate part 202 is provided with an opening 204 in the direction from the first plate part 201 to the third plate part 203. The thickness of the first plate part 201 and the thickness of the third plate part 203 are both less than the thickness of the second plate part 202.

[0119] In order to further reduce the material cost and the weight of the entire scale while ensuring the mechanical strength of the entire scale, the present disclosure is provided with a plurality of reinforcing ribs 205 on the back of the second plate part 202, and the adjacent reinforcing ribs 205 form a hollow groove 206, as shown in FIG. 11.

[0120] In order to adapt to the use habits of different users, in some specific embodiments, the scale marks include first scale marks 207 and second scale marks 208, which are respectively arranged on both sides of the opening 204. The first scale marks 207 include mercury column scale lines and mercury column digital marks arranged on the side of the mercury column scale lines away from the opening 204, and the second scale marks 208 include water column scale lines and water column digital marks arranged on the side of the water column scale lines away from the opening 204. The combined marking mode of the scale lines and the digital marks simplifies the reading operation.

[0121] In the present disclosure, the scale plate 200 is suspended and fixed by the suspension part 400 to realize the fixation of the whole external drainage device.

[0122] In some specific embodiments, the external drainage device further includes a level 500 and a mounting part 209 for mounting the level 500, and the whole device is kept horizontal by the level 500 to facilitate observation, as shown in FIG. 10.

[0123] In addition, in some specific embodiments, a detachable clamp 600 is arranged on the back of the scale plate 200. The detachable connection can adopt bolt and screw hole connection, and the screw hole is arranged on the scale plate 200 but does not penetrate through the scale plate 200, so as to avoid affecting the reading of the scale marks when the screw hole is opened to the plane where the first scale marks 207 and the second scale marks 208 are located. The whole device can be fixed on a bedside support by the clamp 600, so as to simplify the operation process and ensure the operation stability.

[0124] <Third aspect>

[0125] The third aspect of the present disclosure provides an external drainage kit. As shown in FIG. 15, the external drainage kit includes an antibacterial catheter 1, a connector 2, a drainage pipeline 3, an external drainage device 4 and a drainage bag 5. The antibacterial catheter 1 is the antibacterial catheter of the first aspect, and the external drainage device 4 is the external drainage device of the second aspect.

[0126] Embodiments

[0127] The embodiments of the present disclosure will be described in detail below with reference to the embodiments, but those skilled in the art will understand that the following embodiments are only used to illustrate the present disclosure and should not be regarded as limiting the scope of the present disclosure. The specific conditions not mentioned in the embodiments are carried out according to the conventional conditions or the conditions recommended by the manufacturer. The reagents or instruments used are not marked with the manufacturer, which are all conventional products that can be obtained by market purchase.

[0128] Embodiment 1

[0129] S1: Preparation of antibacterial agent solution

[0130] (1) Clindamycin hydrochloride 1.5 g was weighed and dissolved in 1.5 mL of hexafluoroisopropanol, stirred and dissolved to prepare a Clindamycin hydrochloride antiseptic solution with a mass-volume concentration of 1.0 g / mL.

[0131] S2: Preparation of an antibacterial catheter

[0132] A 1 cm long silica gel catheter was immersed in the above-mentioned antiseptic solution, sealed and protected from light, and after immersion at room temperature for 1 h, the silica gel catheter was removed and the excess solvent was volatilized under a fume hood to obtain an antibacterial catheter. The antibacterial catheter was then washed and finally left to dry at room temperature to obtain a clean antibacterial catheter product.

[0133] Example 2

[0134] S1: Preparation of an antiseptic solution

[0135] (1) Rifampicin 0.5 g was weighed and dissolved in 0.5 mL of hexafluoroisopropanol, stirred and dissolved to prepare a rifampicin antiseptic solution with a mass-volume concentration of 1.0 g / mL.

[0136] (2) Clindamycin hydrochloride 1.0 g was weighed and dissolved in 1.0 mL of hexafluoroisopropanol, stirred and dissolved to prepare a Clindamycin hydrochloride antiseptic solution with a mass-volume concentration of 1.0 g / mL.

[0137] (3) The rifampicin antiseptic solution and the Clindamycin hydrochloride antiseptic solution were mixed uniformly to prepare an antiseptic mixed solution; in the antiseptic mixed solution, the mass-volume concentration of rifampicin was 0.33 g / mL and the mass-volume concentration of Clindamycin hydrochloride was 0.67 g / mL, relative to the total volume of hexafluoroisopropanol.

[0138] S2: Preparation of an antibacterial catheter

[0139] A 1 cm long silica gel catheter was immersed in the above-mentioned antiseptic mixed solution, sealed and protected from light, and after immersion at room temperature for 1 h, the silica gel catheter was removed and the excess solvent was volatilized under a fume hood to obtain an antibacterial catheter. The antibacterial catheter was then washed and finally left to dry at room temperature to obtain a clean antibacterial catheter product.

[0140] Example 3

[0141] S1: Preparation of an antiseptic solution

[0142] (1) Rifampicin 0.008 g was weighed and dissolved in 0.5 mL of dichloromethane, stirred and dissolved to prepare a rifampicin antiseptic solution with a mass-volume concentration of 0.016 g / mL.

[0143] (2) Weigh 0.012 g of clindamycin hydrochloride, dissolve it in 1.0 mL of hexafluoroisopropanol, stir to dissolve, and prepare a clindamycin hydrochloride antibacterial agent solution with a mass-volume concentration of 0.012 g / mL.

[0144] (3) Mix rifampicin antibacterial agent solution and clindamycin hydrochloride antibacterial agent solution evenly to prepare antibacterial agent mixed solution; wherein, relative to the total volume of dichloromethane and hexafluoroisopropanol, the mass-volume concentration of rifampicin is 0.0053 g / mL, the mass-volume concentration of clindamycin hydrochloride is 0.0080 g / mL, and the volume ratio of dichloromethane to hexafluoroisopropanol is 1:2.

[0145] S2: Preparation of antibacterial catheters:

[0146] A 1cm long silicone tubing was immersed in the above-mentioned antibacterial agent mixture solution, sealed and protected from light, and immersed at room temperature for 1 hour. The silicone tubing was then removed and excess solvent was evaporated under a fume hood to obtain the antibacterial tubing. The antibacterial tubing was then cleaned and finally air-dried at room temperature to obtain a clean antibacterial tubing product.

[0147] Example 4

[0148] S1: Preparation of antibacterial agent solution:

[0149] (1) Weigh 0.008 g of rifampicin, dissolve it in 0.5 mL of tetrahydrofuran, stir to dissolve, and prepare a rifampicin antibacterial agent solution with a mass-volume concentration of 0.016 g / mL.

[0150] (2) Weigh 0.012 g of clindamycin hydrochloride, dissolve it in 1.0 mL of hexafluoroisopropanol, stir to dissolve, and prepare a clindamycin hydrochloride antibacterial agent solution with a mass-volume concentration of 0.012 g / mL.

[0151] (3) Mix rifampicin antibacterial agent solution and clindamycin hydrochloride antibacterial agent solution evenly to prepare antibacterial agent mixed solution; wherein, relative to the total volume of tetrahydrofuran and hexafluoroisopropanol, the mass-volume concentration of rifampicin is 0.0053 g / mL, the mass-volume concentration of clindamycin hydrochloride is 0.0080 g / mL, and the volume ratio of tetrahydrofuran to hexafluoroisopropanol is 1:2.

[0152] S2: Preparation of antibacterial catheters:

[0153] A 1cm long silicone tubing was immersed in the above-mentioned antibacterial agent mixture solution, sealed and protected from light, and immersed at room temperature for 1 hour. The silicone tubing was then removed and excess solvent was evaporated under a fume hood to obtain the antibacterial tubing. The antibacterial tubing was then cleaned and finally air-dried at room temperature to obtain a clean antibacterial tubing product.

[0154] Example 5

[0155] S1: Preparation of an antibacterial agent solution

[0156] (1) 0.008 g of rifampicin was weighed and dissolved in 0.8 mL of dichloromethane, and stirred to dissolve, to prepare a rifampicin antibacterial agent solution having a mass-volume concentration of 0.01 g / mL.

[0157] (2) 0.012 g of clindamycin hydrochloride was weighed and dissolved in 0.7 mL of hexafluoroisopropanol, and stirred to dissolve, to prepare a clindamycin hydrochloride antibacterial agent solution having a mass-volume concentration of 0.017 g / mL.

[0158] (3) The rifampicin antibacterial agent solution and the clindamycin hydrochloride antibacterial agent solution were mixed uniformly to prepare an antibacterial agent mixture solution; in the antibacterial agent mixture solution, the mass-volume concentration of rifampicin was 0.0053 g / mL and the mass-volume concentration of clindamycin hydrochloride was 0.0080 g / mL, relative to the total volume of dichloromethane and hexafluoroisopropanol; the volume ratio of dichloromethane to hexafluoroisopropanol was 1:0.875.

[0159] S2: Preparation of an antibacterial catheter

[0160] A 1 cm long silica gel catheter was immersed in the above antibacterial agent mixture solution, sealed and protected from light, and after immersion for 1 h at room temperature, the silica gel catheter was removed and excess solvent was volatilized under a fume hood to obtain an antibacterial catheter. The antibacterial catheter was then washed and finally left to dry at room temperature to obtain a clean antibacterial catheter product.

[0161] Example 6

[0162] S1: Preparation of an antibacterial agent solution

[0163] (1) 0.012 g of rifampicin was weighed and dissolved in 0.5 mL of tetrahydrofuran, and stirred to dissolve, to prepare a rifampicin antibacterial agent solution having a mass-volume concentration of 0.024 g / mL.

[0164] (2) 0.016 g of clindamycin hydrochloride was weighed and dissolved in 1.0 mL of hexafluoroisopropanol, and stirred to dissolve, to prepare a clindamycin hydrochloride antibacterial agent solution having a mass-volume concentration of 0.016 g / mL.

[0165] (3) The rifampicin antibacterial agent solution and the clindamycin hydrochloride antibacterial agent solution were mixed uniformly to prepare an antibacterial agent mixture solution; in the antibacterial agent mixture solution, the mass-volume concentration of rifampicin was 0.008 g / mL and the mass-volume concentration of clindamycin hydrochloride was 0.0107 g / mL, relative to the total volume of tetrahydrofuran and hexafluoroisopropanol; the volume ratio of tetrahydrofuran to hexafluoroisopropanol was 1:2.

[0166] S2: Preparation of the antibacterial catheter

[0167] A 1 cm long silica gel catheter was immersed in the above antibacterial agent mixed solution, sealed and protected from light, and after immersion at room temperature for 1 h, the silica gel catheter was taken out and the excess solvent was volatilized under a fume hood to obtain an antibacterial catheter. Then the antibacterial catheter was cleaned and finally placed at room temperature to dry, to obtain a clean antibacterial catheter product.

[0168] Example 7

[0169] S1: Preparation of the antibacterial agent solution

[0170] (1) 0.008 g of rifampicin was weighed and dissolved in 0.5 mL of dichloromethane, stirred and dissolved to prepare a rifampicin antibacterial agent solution with a mass-volume concentration of 0.016 g / mL.

[0171] (2) 0.012 g of minocycline was weighed and dissolved in 1.0 mL of hexafluoroisopropanol, stirred and dissolved to prepare a minocycline antibacterial agent solution with a mass-volume concentration of 0.012 g / mL.

[0172] (3) The rifampicin antibacterial agent solution and the minocycline antibacterial agent solution were mixed uniformly to prepare an antibacterial agent mixed solution; in the antibacterial agent mixed solution, the mass-volume concentration of rifampicin was 0.0053 g / mL and the mass-volume concentration of minocycline was 0.0080 g / mL, relative to the total volume of dichloromethane and hexafluoroisopropanol; the volume ratio of dichloromethane to hexafluoroisopropanol was 1:2.

[0173] S2: Preparation of the antibacterial catheter

[0174] A 1 cm long silica gel catheter was immersed in the above antibacterial agent mixed solution, sealed and protected from light, and after immersion at room temperature for 1 h, the silica gel catheter was taken out and the excess solvent was volatilized under a fume hood to obtain an antibacterial catheter. Then the antibacterial catheter was cleaned and finally placed at room temperature to dry, to obtain a clean antibacterial catheter product.

[0175] Example 8

[0176] S1: Preparation of the antibacterial agent solution

[0177] (1) 0.008 g of rifampicin was weighed and dissolved in 0.5 mL of tetrahydrofuran, stirred and dissolved to prepare a rifampicin antibacterial agent solution with a mass-volume concentration of 0.016 g / mL.

[0178] (2) 0.012 g of minocycline was weighed and dissolved in 1.0 mL of hexafluoroisopropanol, stirred and dissolved to prepare a minocycline antibacterial agent solution with a mass-volume concentration of 0.012 g / mL.

[0179] (3) mixing the rifampicin antibacterial agent solution and the minocycline antibacterial agent solution to prepare an antibacterial agent mixed solution; wherein in the antibacterial agent mixed solution, the mass-volume concentration of rifampicin is 0.0053 g / mL, and the mass-volume concentration of minocycline is 0.0080 g / mL, relative to the total volume of tetrahydrofuran and hexafluoroisopropanol; the volume ratio of tetrahydrofuran to hexafluoroisopropanol is 1:2.

[0180] S2: Preparation of an antibacterial catheter

[0181] A 1-cm-long silica gel catheter is immersed in the antibacterial agent mixed solution, sealed and protected from light, and after immersion at room temperature for 1 h, the silica gel catheter is taken out and the excess solvent is volatilized under a fume hood to obtain an antibacterial catheter. The antibacterial catheter is then cleaned, and finally left to air dry at room temperature to obtain a clean antibacterial catheter product.

[0182] Comparative Example 1

[0183] S1: Preparation of an antibacterial agent solution

[0184] Rifampicin 0.008 g and clindamycin hydrochloride 0.012 g are weighed into 1.5 mL of dichloromethane, stirred and dissolved to prepare an antibacterial agent mixed solution; wherein in the antibacterial agent mixed solution, the mass-volume concentration of rifampicin is 0.0053 g / mL relative to the volume of dichloromethane, and clindamycin hydrochloride forms a precipitate.

[0185] S2: Preparation of an antibacterial catheter

[0186] A 1-cm-long silica gel catheter is immersed in the antibacterial agent mixed solution from which the precipitate is removed, sealed and protected from light, and after immersion at room temperature for 1 h, the silica gel catheter is taken out and the excess solvent is volatilized under a fume hood to obtain an antibacterial catheter. The antibacterial catheter is then cleaned, and finally left to air dry at room temperature to obtain a clean antibacterial catheter.

[0187] Comparative Example 2

[0188] S1: Preparation of an antibacterial agent solution

[0189] Rifampicin 0.008 g and clindamycin hydrochloride 0.012 g are weighed into 1.5 mL of tetrahydrofuran, stirred and dissolved to prepare an antibacterial agent mixed solution; wherein in the antibacterial agent mixed solution, the mass-volume concentration of rifampicin is 0.0053 g / mL relative to the volume of solvent, and clindamycin hydrochloride forms a precipitate.

[0190] S2: Preparation of an antibacterial catheter

[0191] The 1 cm long silicone catheter was immersed in the anti-microbial mixed solution from which the precipitate was removed, sealed and kept away from light, and then taken out after being immersed at room temperature for 1 h. The excess solvent was volatilized under a fume hood to obtain the anti-microbial catheter. The anti-microbial catheter was then cleaned and finally left to dry at room temperature to obtain the clean anti-microbial catheter.

[0192] Comparative Example 3

[0193] S1: Preparation of an anti-microbial solution

[0194] Rifampicin 0.008 g and clindamycin hydrochloride 0.012 g were weighed into 1.5 mL of methanol, stirred and dissolved to prepare an anti-microbial mixed solution. In the anti-microbial mixed solution, the mass-volume concentration of rifampicin was 0.0053 g / mL and the mass-volume concentration of clindamycin hydrochloride was 0.008 g / mL relative to the volume of the solvent.

[0195] S2: Preparation of an anti-microbial catheter

[0196] The 1 cm long silicone catheter was immersed in the anti-microbial mixed solution from which the precipitate was removed, sealed and kept away from light, and then taken out after being immersed at room temperature for 1 h. The excess solvent was volatilized under a fume hood to obtain the anti-microbial catheter. The anti-microbial catheter was then cleaned and finally left to dry at room temperature to obtain the clean anti-microbial catheter.

[0197] Comparative Example 4

[0198] S1: Preparation of an anti-microbial solution

[0199] (1) Rifampicin 0.008 g was weighed and dissolved in 0.5 mL of acetonitrile to prepare a rifampicin anti-microbial solution with a mass-volume concentration of 0.016 g / mL.

[0200] (2) Clindamycin hydrochloride 0.012 g was weighed and added to 1.0 mL of methanol, stirred and dissolved to prepare a clindamycin hydrochloride anti-microbial solution with a mass-volume concentration of 0.008 g / mL.

[0201] (3) The rifampicin anti-microbial solution was mixed uniformly with the precipitate-removed clindamycin hydrochloride anti-microbial solution to prepare an anti-microbial mixed solution. In the anti-microbial mixed solution, the mass-volume concentration of rifampicin was 0.0053 g / mL and the mass-volume concentration of clindamycin hydrochloride was 0.008 g / mL relative to the total volume of methanol and acetonitrile.

[0202] S2: Preparation of an anti-microbial catheter

[0203] The 1 cm long silicone catheter was immersed in the above antibacterial agent mixed solution, sealed and protected from light, and after immersion at room temperature for 1 h, the silicone catheter was taken out and the excess solvent was volatilized under a fume hood to obtain an antibacterial catheter. Then the antibacterial catheter was cleaned and finally placed at room temperature to dry to obtain a clean antibacterial catheter product.

[0204] Performance test

[0205] 1. Swelling performance test

[0206] The volume swelling degree was used to evaluate the swelling performance of the antibacterial catheters of Examples 1-8 and Comparative Examples 1-4 during preparation. The silicone catheter of a certain length was cut and immersed in the corresponding solvent of Examples 1-8 and Comparative Examples 1-4 for a certain time, and after swelling equilibrium, the volume swelling degree was calculated. The volume swelling degree was calculated as follows: (volume of the antibacterial catheter after swelling equilibrium - volume of the antibacterial catheter before swelling) / volume of the antibacterial catheter before swelling * 100%, and the results are shown in Table 1.

[0207] Table 1 Volume swelling of antibacterial catheters during preparation

[0208] As can be seen from Table 1, compared with Comparative Example 3 and Comparative Example 4, the antibacterial catheter of the present disclosure has a higher volume swelling degree after swelling equilibrium, and hexafluoroisopropanol has a good swelling effect on the catheter body, which is beneficial to loading more antibacterial agent solution in the antibacterial catheter.

[0209] 2. Drug loading

[0210] The antibacterial catheters of Examples 1-8 and Comparative Examples 1-4 of a certain length were cut and immersed in chloroform for a certain time, the drug particles were obtained by thoroughly volatilizing the chloroform, the drug was dissolved, the drug concentration was determined using a liquid chromatograph, and the content of each drug in the antibacterial catheter (i.e. drug loading) was calculated. The calculation formula of drug loading is: drug loading = (mass of single drug / mass of drug-loaded silicone catheter) * 100%. The results are shown in Table 2 and Table 3 below. Table 2 is the drug loading of the antibacterial catheters of Examples 1-8, and Table 3 is the drug loading of the antibacterial catheters of Comparative Examples 1-4.

[0211] Table 2 Drug loading of each drug in the antibacterial catheters of Examples 1-8

[0212] Table 3 Drug loading of each drug in the antibacterial catheters of Comparative Examples 1-4

[0213] From Table 2 and Table 3, it can be seen that the drug loading amount of rifampicin in Examples 1-8 is higher than that in Comparative Examples 1-4. Also, from Table 2 and Table 3, it can be seen that in Examples 3-8, the drug loading amount of rifampicin can reach more than 0.04wt%, and the drug loading amount of clindamycin hydrochloride or minocycline can reach more than 0.10wt%. In Example 2, the drug loading amount of rifampicin can reach more than 0.03wt%, and the drug loading amount of clindamycin hydrochloride can reach more than 0.05wt%. In Example 1, the drug loading amount of clindamycin hydrochloride can reach more than 0.05wt%.

[0214] However, in Comparative Examples 1-2, although the swelling degree of the antibacterial catheter of Comparative Example 1 and Comparative Example 2 is high, since clindamycin hydrochloride is not dissolved, the drug loading amount of clindamycin hydrochloride cannot be detected. In Comparative Example 3, the swelling degree of the catheter by methanol is low, and even if a certain amount of clindamycin hydrochloride can be dissolved, the drug loading amount of rifampicin and clindamycin hydrochloride is extremely small. In Comparative Example 4, the conventional composite solvent hardly swells the antibacterial catheter, and hardly allows the antibacterial agent mixed solution to penetrate into the inside of the catheter, so the drug loading amount of rifampicin and clindamycin hydrochloride cannot be detected. It can be seen that the solvent including hexafluoroisopropanol used in the present disclosure can better swell the catheter, and has good solubility to the antibacterial agent, so that the antibacterial catheter has better drug loading effect.

[0215] In addition, from the apparent color depth of Figure 1 and Figure 2, it can be seen that the drug loading amount of the antibacterial catheter of Example 3 is much higher than that of the antibacterial catheter of Comparative Example 1.

[0216] 3. Antibacterial activity

[0217] Cut a certain length of the antibacterial catheter prepared in Example 3, and place it in a certain concentration of Staphylococcus aureus suspension, and then incubate it at 37°C. The Staphylococcus aureus suspension is used as a blank control group. Every 1 day, take out the drainage tube, immerse it in a new prepared Staphylococcus aureus suspension test tube, and at the same time, replace the new bacteria suspension tube of the blank control group. Take 3 samples at 1 day and 7 days of incubation, take the bacteria suspension at the end of incubation, dilute it, and use the spread plate method to count the number of bacteria colonies. Compared with the blank control group, calculate the antibacterial rate. The calculation formula of the antibacterial rate is: antibacterial rate = (bacteria colony number of the blank control group - bacteria colony number of the sample group) / bacteria colony number of the blank control group x 100%. The results are shown in Table 4.

[0218] Table 4 In vitro antibacterial rate of the antibacterial catheter of Example 3

[0219] As can be seen from Table 4, the silica gel conduit in the present disclosure is swelled by a solvent including hexafluoroisopropanol, at least two kinds of antibacterial drugs are loaded, a high drug loading of multiple antibacterial agents can be achieved in a short time, and the prepared antibacterial conduit has a low concentration sustained release and a long-acting antibacterial effect, so as to enhance the antibacterial synergy of the conduit and improve the broad-spectrum antibacterial property of the conduit to multiple microorganisms.

[0220] 4, sustained release time

[0221] The antibacterial conduit of Example 3 is cut to a certain length, immersed in a PBS solution, and placed in a shaking bed at 37°C for continuous release. The drug solution is taken at different time points, the drug concentration is determined using a liquid chromatograph, and the drug release concentration-time curve is plotted.

[0222] The release curves of rifampicin and clindamycin hydrochloride in the antibacterial conduit prepared in Example 3 are shown in Figures 3 and 4. It can be seen that rifampicin and clindamycin hydrochloride in the antibacterial conduit can achieve low concentration and slow release for up to 350h, which can prevent bacteria from colonizing on the surface of the antibacterial conduit. And as can be seen from the in vitro antibacterial rate results in Table 4, under the condition of replacing the new bacterial solution every day, the antibacterial rate of the antibacterial conduit can still maintain more than 95% after 7 days.

[0223] It should be noted that although the technical solutions of the present disclosure are introduced by specific examples, those skilled in the art can understand that the present disclosure should not be limited thereto.

[0224] The above has described various embodiments of the present disclosure, and the above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and changes are obvious to those skilled in the art without departing from the scope and spirit of the described embodiments. The choice of terms used herein is intended to best explain the principles, practical applications, or technical improvements in the market of the embodiments, or to enable other ordinary skilled persons in the art to understand the embodiments disclosed herein.

Claims

1. An antibacterial catheter, characterized in that, The antibacterial catheter comprises a catheter body, a material of the catheter body comprises silica gel, a solvent used in a preparation process of the antibacterial catheter comprises hexafluoroisopropanol, wherein The catheter body is swelled by using the solvent, and the antibacterial agent is dispersed inside the catheter body.

2. The antimicrobial catheter of claim 1, wherein, The preparation process of the antibacterial catheter comprises dissolving the antibacterial agent in the solvent to obtain an antibacterial agent solution, and swelling the catheter body by using the antibacterial agent solution, so that the antibacterial agent is dispersed inside the catheter body.

3. The antibacterial catheter according to claim 1 or 2, characterized in that, The antibacterial agent comprises clindamycin hydrochloride and / or minocycline.

4. The antimicrobial catheter of any of claims 1-3, wherein, The solvent further comprises dichloromethane and / or tetrahydrofuran, the antibacterial agent comprises rifampicin and clindamycin hydrochloride, or rifampicin and minocycline; Preferably, a drug loading amount of the rifampicin is greater than or equal to 0.040 wt%, and a drug loading amount of the clindamycin hydrochloride or minocycline is greater than or equal to 0.10 wt%, based on a total mass of the antibacterial catheter being 100%.

5. The antimicrobial catheter of any of claims 1-4, wherein, The antibacterial catheter has a drug release time greater than 14 days, an in-vitro antibacterial rate of the antibacterial catheter within 7 days is greater than 95%, and / or The antibacterial catheter is a drainage catheter, preferably a drainage catheter for cerebrospinal fluid drainage.

6. The antimicrobial catheter of any of claims 1-5, wherein, The antibacterial catheter has asymmetric drainage holes on both sides of a tip of the antibacterial catheter; Preferably, the antibacterial catheter has first drainage holes and second drainage holes, a long diameter of the first drainage holes is greater than a long diameter of the second drainage holes, wherein the long diameter is a maximum distance between two points on a profile line of the drainage holes passing through a center of the profile line, and a short diameter is a minimum distance between the two points on the profile line of the drainage holes passing through the center of the profile line; and / or a number of the first drainage holes is less than a number of the second drainage holes; More preferably, the long diameter of the first drainage holes is 4.0 mm-5.5 mm, and the short diameter is 1.0 mm-2.5 mm; the long diameter of the second drainage holes is 2.0 mm-2.5 mm, and the short diameter is 1.0 mm-2.5 mm.

7. A preparation method of the antibacterial catheter according to any one of claims 1-6, wherein The preparation method comprises swelling a catheter body in an antibacterial agent solution to disperse the antibacterial agent inside the catheter body; wherein the antibacterial agent is dissolved in a solvent comprising hexafluoroisopropanol to obtain the antibacterial agent solution.

8. The preparation method according to claim 7, characterized in that, The antibacterial agent comprises clindamycin hydrochloride and / or minocycline, and the preparation method of the antibacterial catheter comprises dissolving the clindamycin hydrochloride and / or the minocycline in the solvent to obtain the antibacterial agent solution, and then immersing the catheter body in the antibacterial agent solution to disperse the antibacterial agent inside the catheter body.

9. The production method according to claim 8, characterized by, The solvent used in the preparation process of the antibacterial catheter further comprises dichloromethane and / or tetrahydrofuran; The antibacterial agent comprises rifampicin and clindamycin hydrochloride, or rifampicin and minocycline; and The preparation method comprises the following steps: dissolving a first antibacterial agent in a first solvent to obtain a first antibacterial agent solution; wherein the first antibacterial agent comprises rifampicin, and the first solvent comprises dichloromethane and / or tetrahydrofuran; dissolving a second antibacterial agent in a second solvent to obtain a second antibacterial agent solution; wherein the second antibacterial agent comprises clindamycin hydrochloride and / or minocycline, and the second solvent comprises hexafluoroisopropanol; mixing the first antibacterial agent solution and the second antibacterial agent solution uniformly to obtain the antibacterial agent mixed solution; immersing the catheter body in the antibacterial agent mixed solution, taking out the catheter body, and removing the first solvent and the second solvent to obtain an antibacterial catheter.

10. The method of claim 9, wherein, In the antibacterial agent mixed solution, the mass-volume concentration of the first antibacterial agent is 0.002 g / mL-2 g / mL, preferably 0.01 g / mL-1.0 g / mL, and the mass-volume concentration of the second antibacterial agent is 0.002 g / mL-2 g / mL, preferably 0.01 g / mL-1.0 g / mL, relative to the total volume of the first solvent and the second solvent; and / or, The volume ratio of the first solvent to the second solvent is 1:(0.05-30), preferably 1:(0.1-10).

11. An external drainage device, characterized by The sliding structure, the scale plate, and the drainage drip bottle are provided, the drainage drip bottle is installed on the sliding structure, and the sliding structure is slidably connected with the scale plate. The sliding structure comprises a first sliding member, a second sliding member, and an adjusting member for adjusting the distance between the first sliding member and the second sliding member, which are arranged on the front and back surfaces of the scale plate, respectively. The drainage drip bottle can be connected with the antibacterial catheter according to any one of claims 1-10.

12. The external drainage device of claim 11, wherein, The adjusting member comprises an operating part and a threaded part which are connected, the first sliding member is provided with a through hole, the second sliding member is provided with a threaded hole, and the threaded part is threadedly connected with the threaded hole through the through hole.

13. The external drainage device of claim 12, wherein, The adjusting member further comprises a first leg and a second leg which are symmetrically arranged, and a first bulging part and a second bulging part which are symmetrically arranged, the first leg is arranged between the threaded part and the first bulging part, the second leg is arranged between the threaded part and the second bulging part, the diameters of the first leg and the second leg are smaller than the diameters of the through hole and the threaded hole, and the diameters of the first bulging part and the second bulging part are larger than the diameters of the through hole and the threaded hole.

14. The external drainage device of claim 11, wherein, The front and back surfaces of the scale plate are respectively provided with a first sliding groove and a second sliding groove which are arranged in parallel, the first sliding member is slidably connected with the first sliding groove, and the second sliding member is slidably connected with the second sliding groove; the first sliding groove and the second sliding groove are communicatively arranged, and the width of the second sliding groove is greater than the width of the first sliding groove. Preferably, the first sliding member comprises a connecting plate and a limiting structure which abuts against the second sliding member to limit the rotation of the second sliding member, the limiting structure is arranged on the connecting plate, and the limiting structure is slidably connected with the first sliding groove.

15. The external drainage device of claim 11, wherein, The sliding structure further comprises a clamping assembly for clamping the drainage drip bottle and a positioning block arranged above the clamping assembly, the clamping assembly and the positioning block are arranged on the first sliding member, and the top surface of the drainage drip bottle abuts against the lower surface of the positioning block.

16. The external drainage device of claim 15, wherein, The drainage drip bottle comprises a bottle body and a positioning table arranged on the outer periphery of the bottle body, the positioning table abuts against the clamping assembly, and the lower surface of the positioning table and the upper surface of the clamping assembly are located in the same plane.

17. The external drainage device of claim 15, wherein, The front surface of the scale plate is provided with scale marks, at least one side of the first sliding member is provided with a scale indicating block in triangular shape, and the drainage drip bottle is circumferentially provided with a liquid inlet mark line.

18. The external drainage device according to any one of claims 11 to 17, characterized in that The bottom of the scale plate is provided with a hook-shaped part for hanging a liquid collecting bag.

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