CN110585570A

CN110585570A - Liquid-absorbing expansion self-adaptive and antibacterial dilating cervical dilator and preparation method thereof

Info

Publication number: CN110585570A
Application number: CN201910875976.6A
Authority: CN
Inventors: 罗滔
Original assignee: Beijing Zhongjie Ruikang Science And Technology Development Co Ltd
Current assignee: Beijing Zhongjie Ruikang Science And Technology Development Co Ltd
Priority date: 2019-09-17
Filing date: 2019-09-17
Publication date: 2019-12-20
Anticipated expiration: 2039-09-17
Also published as: CN110585570B

Abstract

The invention provides a liquid-absorbing expansion self-adaptive and antibacterial diastole cervical dilating rod and a preparation method thereof, relates to the technical field of medical instruments and material science, has the characteristics of high liquid absorption, quick expansion, bacteriostasis and good biocompatibility, can provide stable continuous supporting force and has tissue self-adaptive capacity; the cervical dilating rod comprises a rod body, an antibacterial agent and a cervical dilating drug; the rod body is made of a porous self-expanding composite material; the antibacterial agent is arranged on the surface of the rod body; the cervical-relaxing drug is arranged inside the rod body; the porous self-expanding composite material generates an expansion supporting force with the size of 2N-100N when absorbing liquid and self-expanding, and the expansion time for reaching the maximum volume of the porous self-expanding composite material under the condition of sufficient liquid is 100s-1200 s. The technical scheme provided by the invention is suitable for the cervical dilatation process caused by operation or other conditions.

Description

Liquid-absorbing expansion self-adaptive and antibacterial dilating cervical dilator and preparation method thereof

[ technical field ] A method for producing a semiconductor device

The invention relates to the technical field of medical instruments and material science, in particular to a liquid-absorbing self-expansion self-adaptive and antibacterial relaxation cervical dilating rod and a preparation method thereof.

[ background of the invention ]

The uterus has abundant innervation, mainly sympathetic and parasympathetic nerves and sensory nerves conducted toward the heart, with the most abundant cervical nerve endings. In the operation of taking out and placing intrauterine devices, artificial abortion and other various transcervical intrauterine operations, pain and abortion syndrome are frequently accompanied with adverse reactions. The pain is caused by the fact that when the cervix is dilated and the negative pressure suction is performed, certain pain substances are released by tissues and act on nerve endings; the artificial abortion syndrome is mainly caused by vagus nerve excitation and release of a large amount of acetylcholine caused by mechanical stimulation on cervix and uterus during uterus dilatation and uterus suction. Because the cervix and the uterus are excited by mechanical stimulation to cause vagus nerve excitation, and the mental stress of a patient is added, adverse reactions such as nausea, vomiting, pale complexion, cold sweat, blood pressure reduction and the like caused by cervical dilatation, traction and overhigh negative pressure attraction can not be resisted.

The cervical dilator is a medical operation instrument commonly used in gynecological operations in obstetrics and gynecology and family planning departments. On the one hand, induced abortion surgery or induced labor surgery performed to reduce certain complications caused by high-risk pregnancy and to reduce the mortality rate of childbirth requires effective softening and expansion of the connective tissue of the cervix; the rapid development of hysteroscope technology brings great convenience to the examination, diagnosis and treatment of gynecological diseases. One of the factors that hysteroscopy works smoothly depends on the degree of cervical dilatation. Clinical observation shows that the disposable cervical dilator can be used for slowly dilating the cervix, reducing the operation difficulty and reducing the occurrence of complications.

The traditional clinical cervical dilator is a dilating rod with different diameters made of metal or rigid plastic, dilates the cervix in a physical rigid dilation mode, and is mainly sequentially and gradually put into a cervical orifice to achieve the purpose of dilating the uterus according to different types of metal cervical dilators. The operation of medical staff is complicated, the patient suffers from physical and mental pains, and meanwhile, uterine damage, embryo damage, bleeding and other adverse reactions are easily caused by uterine cavity infection due to repeated replacement of instruments.

In order to realize the slow expansion of the cervix, relieve the pain of patients and reduce the operation difficulty and the occurrence of complications, people utilize the water absorption expansion characteristic of medical polymer materials with good biocompatibility to prepare the slow expansion type disposable cervix expansion rod with self-expansion performance. The medical expansion high-molecular expansion rod comprises a seaweed rod, an artificial polyethylene ethanol integrated sponge rod, gelatin and the like, and the medical expansion high-molecular expansion rod absorbs the moisture of cervical secretions to expand after being placed into the medical expansion high-molecular expansion rod. However, these medical swelling polymer materials have disadvantages in practical use, such as a strength drop of an alginate or gelatin swelling rod after absorbing body fluid at the cervix, and a fracture and breakage phenomenon may occur at the time of taking out. Meanwhile, because some pathogenic bacteria exist in the female cervix, the existing medical swelling macromolecule imbibition swelling material lacks the antibacterial and anti-inflammatory effects, and is easy to cause the infection of the endocervix or cause some complications. Most importantly, most of the currently marketed medical swelling polymer dilating rods have low strength, are difficult to provide a supporting force for slowly dilating the uterus and continuously supporting the uterine wall when in use, and are slow in dilating process, so that the medical swelling polymer dilating rods are not beneficial to use in obstetrical surgery and outpatient cervical examination surgery.

Accordingly, there is a need to address the deficiencies of the prior art by providing a liquid-imbibition expansion-adaptive and antibacterial-relaxation cervical dilating rod and a method of making the same that address or mitigate one or more of the problems set forth above.

[ summary of the invention ]

In view of the above, the invention provides a liquid-absorbing expansion self-adaptive and antibacterial relaxation cervical dilating rod and a preparation method thereof, which have the characteristics of high liquid absorption, quick expansion, bacteriostasis and good biocompatibility, can provide stable and continuous supporting force and have tissue self-adaptive capacity.

In one aspect, the invention provides a liquid-absorbing expansion self-adaptive and antibacterial dilating cervical dilating rod, which is characterized by comprising a rod body, an antibacterial agent and a cervical dilating drug; the rod body is of a porous network structure; the material is self-expanding composite material; the antibacterial agent is compounded on the rod body in an in-situ grafting manner; the cervical-dilating drug is disposed in the porous network structure of the rod.

The above aspects and any possible implementations further provide an implementation in which the self-expanding composite material, upon imbibition self-expansion, produces an expansion holding force of a magnitude of 2N to 100N, and an expansion time to its maximum volume under liquid-sufficient conditions is 100s to 1200 s.

The above aspects and any possible implementation further provide an implementation in which the rod has a porosity of 60% to 90%, a pressure of 500KPa to 2MPa, a water absorption of 500% to 1500%, an expansion ratio of 1500% to 3000%, and an elongation of 100% to 500% when expanded.

There is further provided in accordance with any one of the above aspects and possible implementations, a material of the rod includes a polyhydroxy polymer, a polysaccharide, and a nanofiber crystal.

In another aspect, the present invention provides a method for preparing a cervical dilating rod, the method comprising the steps of:

s1, placing the polyhydroxy polymer, the polysaccharide and the nanofiber crystal in a container, heating until the polyhydroxy polymer, the polysaccharide and the nanofiber crystal are completely and uniformly mixed to obtain a mixed solution;

s2, placing the mixed solution in a closed reaction container, adding supercritical gas and stirring until bubbles with uniform sizes are generated;

s3, adding a cross-linking agent and stirring to enable the mixed solution and the cross-linking agent to generate dynamic cross-linking reaction;

s4, placing the crosslinked solution in a mould for preforming to prepare a rod body of the porous self-expansion composite material;

s5, sterilizing the rod body, and compounding the rod body with an antibacterial agent;

s6, injecting a cervical dilating drug into the rod body to obtain the cervical dilating rod.

The above aspects and any possible implementations further provide an implementation where the polysaccharide is one or more of chitosan, alginate, aminopolysaccharide, dextran, and hyaluronic acid.

The above aspects and any possible implementations further provide an implementation in which the polyhydroxy polymer is a polyhydroxy polymer obtained by polymerizing a monomer having both a carbon-carbon double bond and an alcoholic hydroxyl group.

The above aspect and any possible implementation further provides an implementation in which the supercritical gas is supercritical CO₂Or supercritical nitrogen.

The aspects and any possible implementations described above, further provide an implementation where the cross-linking agent is an aldehyde solution, genipin, or a complex cross-linking agent; the composite crosslinking agent is specifically a composite of 1- (3-dimethylaminopropyl) -3-ethylcarbodiimide hydrochloride and N-hydroxysuccinimide.

The above aspects and any possible implementations further provide an implementation in which the antibacterial agent is one or more of a quaternary ammonium salt antibacterial agent, an organic antibacterial agent, and a silver-based antibacterial agent.

The above aspects and any possible implementations further provide an implementation in which the cervical-relaxing drug is misoprostol or carboprost methyl ester.

Compared with the prior art, the invention can obtain the following technical effects: the invention has the advantages of good elasticity and water swelling property, good biocompatibility, high dry state wetting rate, bacteriostasis, good tissue adaptability and the like, can be used as a disposable cervical dilating rod, can slowly dilate the cervix, reduces the operation difficulty and the pain of a patient in the operation process, reduces complications, and has wide application prospect and remarkable social and economic benefits.

Of course, it is not necessary for any one product in which the invention is practiced to achieve all of the above-described technical effects simultaneously.

[ description of the drawings ]

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art to obtain other drawings based on these drawings without creative efforts.

Fig. 1 is a graph of the swelling force generated by the self-swelling of five cervical dilating rods according to an embodiment of the present invention as a function of time;

fig. 2 is a flowchart of a method for preparing a cervical dilating rod according to an embodiment of the present invention.

[ detailed description ] embodiments

For better understanding of the technical solutions of the present invention, the following detailed descriptions of the embodiments of the present invention are provided with reference to the accompanying drawings.

It should be understood that the described embodiments are only some embodiments of the invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

The terminology used in the embodiments of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used in the examples of the present invention and the appended claims, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

The invention provides a self-expanding porous composite material which has the advantages of few raw material types, simple preparation process, low production cost, imbibition, self-expansion, bacteriostasis, good biocompatibility and tissue adaptivity. Wherein the higher porosity and open cell structure gives the material high liquid absorption and fast swelling capacity; by changing the proportion of the nano-fiber crystals in the composite material, the expansion supporting force and the imbibition expansion time of the material can be regulated and controlled; the natural polysaccharide carbohydrate can improve the surface smoothness of the material and clear the exudate.

The cervical dilating rod is prepared from polyhydroxy polymer, polysaccharide and nanocrystalline cellulose through supercritical pore-forming and dynamic cross-linking reaction. The disposable cervical dilating rod with different expansion supporting force, different imbibition expansion time and different imbibition self-expansion multiplying power can be obtained by regulating the content ratio and the crosslinking state of the polyhydroxy polymer, the polysaccharide and the nanofiber crystal. Meanwhile, the cervical dilating rod adopts a supercritical pore-forming process, so that the porosity is high and the pore diameter is uniformly distributed.

The preparation method of the cervical dilating rod with imbibition self-expansion self-adaption and antibacterial relaxation performance is shown in figure 2, and comprises the following steps:

step one, preparing a mixed solution:

placing the polyhydroxy polymer, the polysaccharide and the nanofiber crystal in a high-temperature pressure cooker, heating until the polyhydroxy polymer, the polysaccharide and the nanofiber crystal are completely and uniformly mixed to prepare a mixed solution; the mass ratio of the polyhydroxy polymer, the polysaccharide and the nanofiber crystal is 1 (0.1-1) to 0.1-1.5, the expansion speed and the expansion force of the cervical dilator can be influenced when the ratio is adjusted, and the ratio of the raw materials can be adjusted according to actual needs;

the parameters of the high-temperature pressure cooker are 110-;

wherein, the polysaccharide can be one or more of quaternized chitosan, alginate, aminopolysaccharide and hyaluronic acid, and can also be other polysaccharides capable of realizing the content of the invention;

the polyhydroxy polymer is obtained by polymerizing a monomer simultaneously having carbon-carbon double bonds and alcoholic hydroxyl groups by methods such as copolymerization, homopolymerization and the like;

step two, supercritical pore-forming reaction:

placing the prepared mixed solution in a closed reaction container, slowly introducing supercritical gas into the closed reaction container, slowly stirring the liquid at a stirring speed of less than 300r/min until the bubbles in the solution are dense and the bubbles in the upper part and the lower part are uniform and stable to obtain a foaming solution; the supercritical gas may be supercritical CO₂Or nitrogen; the specific supercritical parameters are as follows: supercritical CO₂Foaming conditions, critical temperature 31.1 ℃, and critical pressure 7.37 MPa; supercritical N₂Foaming conditions, wherein the critical temperature is-147 ℃, and the critical pressure is 3.39 MPa; foaming is by heating of homogeneous supercritical gas/polymer systemsInduced by chemical instability; the foaming number is far greater than that of the common chemical foaming;

step three, dynamic crosslinking reaction:

stirring by using a high-speed stirrer after bubbles with uniform sizes are formed in the solution, increasing the stirring speed to 1500r/min-2000r/min, simultaneously adding a cross-linking agent, adding the cross-linking agent into the stirred solution by using a liquid transfer device or a dropper, stirring for 6-10 minutes, and carrying out dynamic cross-linking reaction on the mixed solution and the cross-linking agent in the stirring process; continuously measuring the viscosity of the mixed solution by using a viscometer, and stopping stirring when the viscosity of the mixed solution is more than 1000 cP;

the cross-linking agent is aldehyde solution or genipin or composite cross-linking agent, and the composite cross-linking agent is a composite of 1- (3-dimethylaminopropyl) -3-ethylcarbodiimide hydrochloride (EDC) and N-hydroxysuccinimide (NHS);

step four, performing the composite material:

placing the crosslinked solution (also called pre-polymerization solution) in a mold, placing the mold in a vacuum drying oven at 60 ℃, and dehydrating, drying and pre-molding the material in the mold for 4-6 hours; cleaning the preformed sample, specifically: placing the preformed material in a rotary compression cleaner filled with deionized water for cleaning five times, and cleaning the crosslinking agent or the residual chemical reagent;

the expansion rod is in a thin cylindrical shape with a smooth surface, and the sample can be bent, so that the expansion rod is convenient for cervical operation; the sample has no cavity inside and is of a three-dimensional porous network structure;

step five, sterilization and antibacterial agent compounding:

drying, sterilizing and deeply cleaning the cleaned material;

and (3) drying: the ultra-low temperature freeze drying is adopted, so that the structure and the performance of the material are not changed; then carrying out sterilization treatment;

and (3) sterilization: a two-step sterilization method is adopted, firstly, ultraviolet irradiation is used for sterilization, and the sterilization mainly acts on bacteria on the surface and inside of a sample; the second step is cobalt 60 radiation sterilization, which mainly acts on bacteria remained in the material and on the surface, wherein the cobalt 60 radiation sterilization is carried out twice, the first radiation intensity is 15k, and the second radiation intensity is 25 k;

deep cleaning: in an aseptic environment, putting the material into a rotary compression cleaner filled with deionized water, and continuously compressing and rotationally cleaning the material for three times; then taking out the material, putting the material into an ultrasonic cleaning machine filled with deionized water, and carrying out ultrasonic cleaning once for 1 hour; finally, the material is placed in a container filled with deionized water and placed in a constant temperature oscillator for oscillation for 24 hours, so that the deep cleaning of the material is realized;

compounding the deeply cleaned sample with an antibacterial agent; compounding the material with the antibacterial agent by adopting an in-situ grafting method, wherein chemical groups in polyhydroxy polymer, polysaccharide and cellulose in the material react with corresponding groups of different antibacterial agents under different experimental conditions and under the action of different catalysts (usually acid), so that the in-situ grafting of the antibacterial agent on the material is realized; compared with the common method for soaking or smearing the composite antibacterial agent, the in-situ grafting method enables the antibacterial agent to exist in the material more stably, and meanwhile, the effect of continuous and long-term antibacterial can be realized in the antibacterial process;

the antibacterial agent is one or more of quaternary ammonium salt antibacterial agent, organic antibacterial agent and silver antibacterial agent;

step six, compounding of cervical vasodilating medicines:

injecting a cervical diastole drug into the three-dimensional porous network structure inside the sample by using an injector; the cervical dilating medicine is misoprostol or carboprost methyl ester;

the sample can release the medicine in the three-dimensional network structure to the external environment in the process of absorbing body fluid and expanding;

step seven, shaping of the cervical dilating rod:

the material is shaped, cut into the same size by a cutter, then the surface of the material is polished on a polishing machine, and the polished material is molded by compression and extrusion, thus finally obtaining the cervical dilating rod with imbibition self-expansion self-adaption and antibacterial diastole performance.

Example 1:

and (3) placing the polyvinyl alcohol, the hyaluronic acid and the nanofiber crystal in a high-temperature pressure cooker, heating until the polyvinyl alcohol, the hyaluronic acid and the nanofiber crystal are completely and uniformly mixed, and preparing a mixed solution. Placing the mixed liquid in a closed reaction container, slowly introducing supercritical carbon dioxide gas into the container, and slowly stirring the liquid. After bubbles with uniform sizes are formed in the solution, the stirring speed is increased, an aldehyde solution (the aldehyde solution is specifically a mixed aqueous solution of formaldehyde and glutaraldehyde, the ratio of the formaldehyde solution to the glutaraldehyde is 1: 1: 1) is added, and the mixed solution and the aldehyde solution undergo dynamic crosslinking reaction in the stirring process. And (3) placing the crosslinked solution in a mold for molding, and cleaning a molded sample. The material is cleaned and dried, and then sterilized by cobalt 60 irradiation. And soaking the cleaned and sterilized sample in 100ml of nano-silver solution with the mass fraction of 0.1mol/L, taking out the sample after the sample is completely immersed in the solution for 12 hours, and processing and forming to obtain the finished cervical dilating rod with imbibition self-expansion self-adaption and antibacterial diastole performance.

Example 2:

and (3) placing the polyethylene glycol, the chitosan and the nanofiber crystal in a high-temperature high-pressure cooker, heating until the polyethylene glycol, the chitosan and the nanofiber crystal are completely and uniformly mixed, and preparing a mixed solution. Placing the mixed liquid in a closed reaction container, slowly introducing supercritical nitrogen into the reaction container, and slowly stirring the liquid. After bubbles with uniform sizes are formed in the solution, the stirring speed is increased, and simultaneously, the composite cross-linking agent 1- (3-dimethylaminopropyl) -3-ethylcarbodiimide hydrochloride (EDC) and N-hydroxysuccinimide (NHS) are added, and the mixed solution and the composite cross-linking agent are subjected to dynamic cross-linking reaction in the stirring process. And (3) placing the crosslinked solution in a mold for molding, and cleaning a molded sample. The material is washed, dried and sterilized with ethylene oxide steam. And processing and molding the cleaned and sterilized sample to obtain the finished cervical dilating rod with imbibition self-expansion self-adaption and antibacterial relaxation performance.

Example 3:

and (3) putting the polylactic acid, the glucan and the nanofiber crystal into a high-temperature pressure cooker, heating until the polylactic acid, the glucan and the nanofiber crystal are completely and uniformly mixed, and preparing a mixed solution. Placing the mixed liquid in a closed reaction container, slowly introducing supercritical carbon dioxide gas into the container, and slowly stirring the liquid. After bubbles with uniform sizes are formed in the solution, the stirring speed is increased, meanwhile, genipin is added, and the mixed solution and genipin undergo dynamic crosslinking reaction in the stirring process. And (3) placing the crosslinked solution in a mold for molding, and cleaning a molded sample. The material is cleaned, dried and sterilized by electron irradiation. Compounding the cleaned and sterilized sample with quaternary ammonium salt antiseptic, drying and forming to obtain the cervical dilating rod product with imbibition self-expansion self-adaption and antibiosis relaxation performance.

Example 4:

and (3) heating the polyester, the sodium alginate and the nano-fiber crystal in a high-temperature high-pressure cooker until the polyester, the sodium alginate and the nano-fiber crystal are completely and uniformly mixed to prepare a mixed solution. Placing the mixed liquid in a closed reaction container, slowly introducing supercritical carbon dioxide gas into the container, and slowly stirring the liquid. After bubbles with uniform sizes are formed in the solution, the stirring speed is increased, meanwhile, genipin is added, and the mixed solution and genipin undergo dynamic crosslinking reaction in the stirring process. And (3) placing the crosslinked solution in a mold for molding, and cleaning a molded sample. Cleaning the material, drying, and sterilizing by ultraviolet irradiation. And compounding the cleaned and sterilized sample with the organic antibacterial sol, drying, and processing and forming to obtain the finished cervical dilating rod product with imbibition self-expansion self-adaption and antibacterial relaxation performances.

When in use, the cervical dilating rod of the invention is selected to be used according to practical application for gynecologic and obstetrical operations and hysteroscopy, and the dilating rod with proper imbibition and expansion time and expansion supporting force is selected.

The application method of the cervical dilating rod comprises the following steps:

(1) during insertion, vulva and vagina are disinfected regularly;

(2) placing a vaginal speculum to expose cervix;

(3) disinfecting the uterine neck and the vaginal fornix;

(4) the invention is inserted manually or using forceps or the like;

(5) slowly pulling out after 1-10 hours.

The material for dilating cervix in gynecology, obstetrics and hysteroscopy needs to have an important characteristic of self-expansion by absorbing body fluid, i.e., self-imbibition expansion upon contact with fluid. The required time for the expansion of the cervical dilating rod to reach the maximum volume is 100s-1200s, and the continuous and stable expansion supporting force effect can be generated on the surrounding environment in the self-expansion process, so that the slow uterine dilating effect is achieved, and the strength reduction of the dilating rod after imbibition expansion is prevented from breaking. In the process of preparing the cervical dilating rod, the expansion supporting force can be regulated and controlled by changing the proportion of the nano-fiber crystals in the matrix of the dilating rod material, and the generated expansion force ranges from 2N to 100N. The cervical dilating rod can bear static tension of 15N-30N after imbibing and expanding and can last for 15s-60 s.

The material of the cervical dilating rod has a three-dimensional reticular open pore structure, the porosity is between 60 and 90 percent, the pressure generated during expansion is between 500KPa and 2MPa, the water absorption is between 500 and 1500 percent, the expansion ratio is between 1500 and 3000 percent, and the extensibility is between 100 and 500 percent.

FIG. 1 is a graph of the force of expansion versus time for five samples provided herein. The component ratios and preparation parameters of the five samples are shown in table 1. According to different operation requirements, the expansion rods with different expansion speeds and forces can be selected and used.

TABLE 1 sample component ratios and preparation Process parameters

The cervical dilating rod of the present invention has advantages including:

1. the cervix uteri dilation rod generates continuous and controllable dilation supporting force by self-dilation after imbibing liquid, meanwhile, the time required for the dilation to reach the maximum volume is controllable, and materials with proper dilation supporting force and dilation time can be selected according to specific application;

2. the cervical dilating rod obtained by the invention has the advantages of rebound resilience close to 100 percent, high strength and modulus, no debris falling, overcoming the problems of brittle fracture falling, poor tissue fluid or blood absorption effect and low strength of the existing alginic acid and gelatin materials in the operation process, and rapidly absorbing the tissue fluid flowing out of a wound and rapidly expanding in the operation process to achieve the purpose of dilating the cervix;

3. the cervical dilating rod obtained by the invention has simple and convenient operation: the cervix uteri can be dilated to the size required by the operation at one time without changing the uterine dilating rod for multiple times from small to large to dilate the cervix uteri; the surface is smooth, the sponge body with high elasticity is quickly expanded after imbibing, the required part is filled according to the shape of the filling part, and uniform support and compression are provided; after imbibing, the texture is soft, the damage to the mucous membrane of the cervical canal and the cervical wall is small, the placement and the taking out are easy, and the perforation of the uterus does not occur;

4. the cervical dilating rod obtained by the invention has excellent biocompatibility, smooth surface and tissue fitting property, can effectively reduce the operation difficulty and the pain of patients in the operation process, dilates the cervix progressively, has light pain in dilating the uterus, and is particularly suitable for women who are pregnant initially, have abnormal uterus positions, scar uterus and fear tension;

5. when in use, the obtained cervical dilating rod can rapidly absorb body fluid to self-expand, and release cervical dilating drugs from the inside in the expanding process, so that the cervical dilation is accelerated;

6. the cervical dilation rod obtained by the invention is compounded by the antibacterial agent, has better antibacterial ability, has good antibacterial effect on various bacteria, has antibacterial and anti-inflammatory effects in cervical dilation operation, and can reduce the occurrence of complications; meanwhile, the invention is used as a disposable material, so that one person can use the material one by one, and cross infection is avoided;

7. the preparation process is simple, the process is mature, the production efficiency is high, and the production period of the product is short; the adopted raw materials have low cost and are easy to synthesize; the production energy consumption is reduced, and the production emission is reduced; the operation cost is reduced, and the economic burden of the patient is lightened; the operation is simple, safe, the price is cheap, easy for the patient to accept, can replace the existing cervical dilator, have good social and economic benefits, have value to popularize.

The liquid-absorbing expansion self-adaptive and antibacterial relaxation cervical dilating rod and the preparation method thereof provided by the embodiment of the application are described in detail above. The above description of the embodiments is only for the purpose of helping to understand the method of the present application and its core ideas; meanwhile, for a person skilled in the art, according to the idea of the present application, there may be variations in the specific embodiments and the application scope, and in summary, the content of the present specification should not be construed as a limitation to the present application.

As used in the specification and claims, certain terms are used to refer to particular components. As one skilled in the art will appreciate, manufacturers may refer to a component by different names. This specification and claims do not intend to distinguish between components that differ in name but not function. In the following description and in the claims, the terms "include" and "comprise" are used in an open-ended fashion, and thus should be interpreted to mean "include, but not limited to. "substantially" means within an acceptable error range, and a person skilled in the art can solve the technical problem within a certain error range to substantially achieve the technical effect. The description which follows is a preferred embodiment of the present application, but is made for the purpose of illustrating the general principles of the application and not for the purpose of limiting the scope of the application. The protection scope of the present application shall be subject to the definitions of the appended claims.

It is also noted that the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a good or system that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such good or system. Without further limitation, an element defined by the phrase "comprising an … …" does not exclude the presence of other like elements in a commodity or system that includes the element.

It should be understood that the term "and/or" as used herein is merely one type of association that describes an associated object, meaning that three relationships may exist, e.g., a and/or B may mean: a exists alone, A and B exist simultaneously, and B exists alone. In addition, the character "/" herein generally indicates that the former and latter related objects are in an "or" relationship.

The foregoing description shows and describes several preferred embodiments of the present application, but as aforementioned, it is to be understood that the application is not limited to the forms disclosed herein, but is not to be construed as excluding other embodiments and is capable of use in various other combinations, modifications, and environments and is capable of changes within the scope of the application as described herein, commensurate with the above teachings, or the skill or knowledge of the relevant art. And that modifications and variations may be effected by those skilled in the art without departing from the spirit and scope of the application, which is to be protected by the claims appended hereto.

Claims

1. The liquid-absorbing expansion self-adaptive and antibacterial dilating cervical dilating rod is characterized by comprising a rod body, an antibacterial agent and a cervical dilating drug; the rod body is of a porous network structure; the antibacterial agent is compounded on the rod body in an in-situ grafting manner; the cervical-dilating drug is disposed in the porous network structure of the rod.

2. The liquid-imbibing expansion self-adaptive and antibacterial dilating cervical dilation bar according to claim 1, wherein the bar body generates an expansion supporting force of 2N-100N when absorbing liquid and expanding automatically, and the generated pressure is 500KPa-2 MPa; the expansion time to reach its maximum volume under liquid-sufficient conditions is 100s-1200 s.

3. The liquid-absorbing expansion adaptive and antibacterial relaxing cervical dilating rod according to claim 1 or 2, wherein the rod body has a porosity of 60% to 90%, a water absorption of 500% to 1500%, an expansion ratio of 1500% to 3000%, and an elongation of 100% to 500%.

4. The liquid-imbibing expansion self-adaptive and antibacterial dilating cervical dilating rod according to claim 1 or 2, wherein the rod body is made of a material including polyhydroxy polymer, polysaccharide and nanofiber crystal.

5. A method for preparing the cervical dilating rod of any one of claims 1 to 4, comprising the steps of:

6. The method for preparing a cervical dilating rod according to claim 5, wherein the polysaccharide is one or more of chitosan, alginate, aminopolysaccharide, dextran and hyaluronic acid.

7. The method for preparing a cervical dilating rod according to claim 5, wherein the polyhydroxyl polymer is a polyhydroxyl polymer obtained by polymerizing a monomer having both a carbon-carbon double bond and an alcoholic hydroxyl group.

8. The method for preparing a cervical dilating rod according to claim 5, wherein the crosslinking agent is an aldehyde solution, genipin, or a complex crosslinking agent; the composite crosslinking agent is specifically a composite of 1- (3-dimethylaminopropyl) -3-ethylcarbodiimide hydrochloride and N-hydroxysuccinimide.

9. The method for preparing a cervical dilating rod according to claim 5, wherein the antibacterial agent is one or more of a quaternary ammonium salt antibacterial agent, an organic antibacterial agent, and a silver-based antibacterial agent.

10. The method for preparing a cervical dilating rod according to claim 5, wherein the cervical dilating drug is misoprostol or carboprost methyl ester.