CN105854161B

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Publication number: CN105854161B
Application number: CN201610449980.2A
Authority: CN
Inventors: 吴丹; 汪世琼; 王玉东; 李柱南; 许颖; 陈忆; 林靖; 花琪; 邱骏; 高泳涛
Original assignee: International Peace Maternity & Child Health Hospital Of China Welfare Institute
Current assignee: International Peace Maternity & Child Health Hospital Of China Welfare Institute
Priority date: 2016-06-21
Filing date: 2016-06-21
Publication date: 2022-06-24
Anticipated expiration: 2036-06-21
Also published as: CN105854161A

Abstract

The invention relates to a cervical anti-adhesion dilating rod, which consists of a handle part, a cylindrical middle part, a bending part and a dilating part; the handle part is flat and slender, and the tail end of the handle part is provided with a notch; the middle part and the expansion part are provided with a groove and a bulge at the same side; the diameter of the expansion part adopts a progressive mode, and the diameter of the expansion part is gradually increased from the head end to the end connected with the bending part; the groove and the bulge are respectively positioned at the positions of 1cm and 5cm corresponding to the size scales; the surface of the expansion part is coated with a biodegradable anti-adhesion coating prepared from chitosan and sodium hyaluronate. The invention has the advantages that: the cervical anti-adhesion dilating rod has the advantages of simple structure, easy manufacture, lower cost and convenient use and operation, lightens the workload of medical personnel, and reduces the medical cost of patients. The cervical anti-adhesion dilating rod can effectively prevent cervical adhesion after LEEP operation, has good long-term curative effect, does not increase the adverse reaction of patients, and is worthy of clinical popularization and application.

Description

Cervical anti-adhesion dilating rod and preparation method and application thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to a cervical anti-adhesion dilating rod and a preparation method and application thereof.

Background

Chronic cervical diseases are common and frequently encountered diseases of gynecology, seriously affect the reproductive health of women, and particularly have higher morbidity of married women. Wherein, the drug treatment of the diseases of severe cervical erosion, cervical intraepithelial neoplasia, cervical polyp, condyloma acuminatum and the like is ineffective, and an operation or physical treatment is needed. LEEP generates 3.8MHz high frequency electric wave through the electrode tip, and after LEEP contacts with the body, the high frequency electric wave is absorbed by the impedance of the tissue to generate high heat instantly, so that the water in the cell forms steam wave to finish various surgical purposes such as cutting, hemostasis and the like. Therefore, the LEEP knife uses a small annular electrotome with low voltage and high current to resect cervical lesion tissues, can obtain the operation effect which cannot be achieved by the traditional electrotome, does not generate the phenomena of tissue pulling and carbonization, does not hurt adjacent tissues, can ensure the integrity of pathological tissues, and does not influence the pathological examination result. The LEEP operation is simple and easy to implement, can be performed in an outpatient clinic, does not influence future pregnancy, and is a safe and effective diagnosis and treatment method for cervical lesions.

Cervical canal stenosis and adhesion are one of the postoperative complications of LEEP, and are serious manifestations of cervical function impairment, and the incidence rate is reported in the literature to be 4% -16.8%. Clinically, patients with cervical canal adhesion can show uncomfortable symptoms such as unsmooth menstrual blood discharge, menstrual abdominal pain and the like. For menopausal patients, the subsequent effects of cervical tube adhesion cause difficulties in follow-up assessment of the cervix after surgery, increasing the probability of unsatisfactory cervical cytology and colposcopy during follow-up. The literature reports that the following points should be noted for the prevention of cervical canal adhesion after LEEP surgery: the vaginal and cervical infection is eliminated and treated before operation, the application of prophylactic antibiotics is carried out after operation, the operation range and depth are mastered, and the excessive burn to the cervical canal tissue is avoided; strictly obeying the conventional operation, the person who excessively bends the uterus corrects the uterus as much as possible, and the electrotomy range should be controlled between the internal and external orifices of the cervix during the operation, so as to prevent the cervical function from being damaged; long-time large-range electric coagulation hemostasis is avoided, particularly electric coagulation on cervical mucosa after the conization is avoided, and a point-to-point coagulation method is adopted as much as possible; when suture is performed for hemostasis, the dissected structure should be cleared, and the suture on the mucosa surface of the cervix is avoided as much as possible; it has also been suggested by scholars that menopausal patients, if not contraindicated, may help to prevent cervical stenosis and adhesions using hormone replacement therapy. However, in clinical practice, a significant proportion of patients undergoing LEEP surgery are pre-cancerous for menopausal patients, and thus a perioperative method of hormone replacement therapy is clearly inappropriate. Therefore, in addition to the above mentioned operational precautions in LEEP surgery and perioperative use of antibiotics to prevent infection, it is important to find an effective method to prevent fundamentally the occurrence of cervical canal adhesions after LEEP surgery in menopause. Statistics show that the incidence of cervical stenosis in postmenopausal patients is higher than that in premenopausal patients by 73% and 15%, respectively, and that the incidence of cervical stenosis and adhesions in postmenopausal patients is significantly higher than the reproductive age, possibly associated with decreased hormone levels in vivo, ascending intima of the cervical canal, and increased risk of this complication.

In the practical clinical work, the inventor finds that cervical tube adhesion can be effectively prevented by using the dilating rod to perform cervical dilatation, confirms the outstanding effect of cervical tube adhesion prevention by using the dilating rod to perform cervical dilatation after LEEP operation through research on cervical tube adhesion after LEEP operation and clinical analysis of related influence factors and effectiveness analysis of preventive measures, finds out an economic and effective prevention method to reduce the incidence of cervical tube adhesion after LEEP operation of menopausal patients, and has wide application prospect for diagnosis and treatment of cervical diseases. However, the existing cervical dilating rods are generally rods made of metal or rigid plastic with different diameters, and are commonly used for induced abortion surgery or induced labor surgery implemented for reducing certain complications caused by high-risk pregnancy and reducing the mortality rate of perinatal infants to effectively soften and dilate the cervical connective tissue; and also as a gynecological minimally invasive diagnosis and treatment technology, cervical dilatation is performed for smooth hysteroscopic operation.

Chitosan is also called chitosan and is obtained by deacetylation of chitin widely existing in the nature, and has a chemical name of polyglucosamine (1-4) -2-amino-B-D glucose. The chitosan has good film forming property, and in a proper solvent, the chitosan is polymerizedThe sugar molecules can be cross-linked into hydrogen bonds, the film forming property is good, and the viscosity of the chitosan solution enables the chitosan solution to be easily formed into a film. The special molecular structure and physicochemical properties of the chitosan enable the chitosan to have good biocompatibility (the chemical property and the biological property are similar to the tissues of human bodies), biodegradability (the chitosan can be decomposed by chitinase, lysozyme, amylase and lipase in the human bodies to generate glucosamine existing in the human bodies so as to be absorbed by the human bodies, and the antibacterial and anti-inflammatory effects of histocyte components are formed (because the molecules contain unsaturated cationic groups, the chitosan has strong adsorption effect on harmful substances with negative charges and has wide bacteriostatic action, such as escherichia coli, staphylococcus aureus, candida albicans and the like), DIAN connectivity, adhesion (mainly adhesion to osteoblasts and fibroblasts), anticoagulation (obvious DIAN and agglutination effects on erythrocytes), immunity enhancement, wound healing promotion and other capabilities, is widely applied to various medical care materials such as heat engineering organs, wound dressings, hemostatic materials, bone repair materials, immune preparations and the like. Although chitosan has excellent antibacterial and antibacterial properties, chitosan has certain defects when used alone, mainly has poor heat resistance and short duration of drug effect. Hyaluronic acid (HA for short) with molecular formula (C)₁₄H₂₁NO₁₁) n is the same as the formula (I). The commercial hyaluronic acid is generally in the form of sodium salt, is a white fibrous or powdery solid, has strong hygroscopicity, and is soluble in water and insoluble in organic solvents. HA solutions are highly viscoelastic, with molecules highly hydrated in solution, and viscosity rising exponentially with concentration. When the HA chains are wound together, the chains interact with each other to form a spiral coil, and the spiral coil HAs certain mechanical strength. Animal experiments and clinical application show that sodium hyaluronate can prevent and relieve adhesion after local surgery, however, the effect of single use of sodium hyaluronate is not ideal, and sodium hyaluronate must be combined with other measures to improve the comprehensive effect.

Chinese patent document 2014106210944 discloses a cervical canal hole anti-adhesion device and its application; the cervical canal hole anti-adhesion device comprises a T-shaped bracket part and a tail fiber: the T-shaped support part comprises a transverse arm and a longitudinal arm, the transverse arm is made of a material capable of elastically bending and deforming, the longitudinal arm is vertically connected to the middle of the transverse arm, a through hole is formed in one end, far away from the transverse arm, of the longitudinal arm, and a tail fiber penetrates through the through hole and is fixed; the cervical canal hole anti-adhesion device is placed in the uterus of a patient before the residual uterine body and vagina are sutured in the cervicitis resection, the tail silk and the T-shaped bracket can prevent the endometrium and the cervical canal hole from being adhered after operation, and the tail silk can be pulled after the operation, so that the anti-adhesion device can be conveniently taken out of the patient without anesthesia; the device can prevent the occurrence of narrow adhesion of cervical canal holes after the cervicitis removal, can effectively reduce postoperative complications and improve the postoperative life quality of patients. Chinese patent document 2015101219824 discloses a material for preventing intrauterine adhesion, which is temperature-sensitive gel; the temperature-sensitive gel consists of a gel main body, a tissue affinity agent, a humectant, a gelation temperature regulator and pure water, wherein the gel main body is one or two of poloxamer 407, polylactic acid/glycolic acid/polyethylene glycol copolymer, poly (N-isopropylacrylamide), chitosan, beta-sodium glycerophosphate, polyethylene glycol monomethyl ether- (sebacic acid-D, L-lactic acid) polyester anhydride-polyethylene glycol monomethyl ether triblock copolymer, cellulose and derivatives thereof and polyethylene glycol/polycaprolactone block copolymer, the tissue affinity agent is hyaluronic acid or sodium hyaluronate, the humectant is glycerol or sodium alginate, and the gelation temperature regulator is poloxamer 188 or polyethylene glycol. At present, no expansion rod specially used for preventing the adhesion of the cervical canal exists. Based on the urgent need of preventing the cervical canal adhesion and reducing the incidence rate of the cervical canal adhesion, the urgent need is to develop a cervical anti-adhesion dilating rod.

Disclosure of Invention

The invention aims to provide a cervical anti-adhesion dilating rod aiming at the defects in the prior art.

In order to achieve the purpose, the invention adopts the technical scheme that:

an anti-adhesion cervical dilation rod is formed by sequentially and smoothly connecting a handle part, a cylindrical middle part engraved with size scales, a bending part and a dilation part, wherein the handle part is coaxial with the middle part, and the bending part and the axis of the middle part form an included angle of 5-20 degrees; the handle part is in a flat, slender and rod shape with a smooth outer surface, the tail end of the handle part is provided with a notch, and the notch, the bending part and the expansion part are positioned on the same side; the same side of the middle part and the expansion part is provided with a groove and a bulge, and the size scales are positioned on the other side of the middle part; the length of the expansion part is 2-4 cm; the diameter of the expansion part adopts a progressive mode, the diameter of the expansion part is gradually increased from the head end to the end connected with the bending part, and the maximum diameter is 5-8 mm;

the length of the bending part is 2cm, and the width of the bending part is 5-8 mm; the diameter of the middle part is 5-8 mm; the groove and the bulge are respectively positioned at the positions of 1cm and 5cm corresponding to the size scales; the surface of the expansion part is coated with a biodegradable anti-adhesion coating prepared from chitosan and sodium hyaluronate, and the mass ratio of the chitosan to the sodium hyaluronate is 2: 2-10.

Further, the mass ratio of the chitosan to the sodium hyaluronate is 2: 7.

Furthermore, the top end of the expansion part is a semi-spherical head part, and the diameter of the expansion part is 3-4 mm.

Furthermore, the surfaces of the head part and the expansion part are provided with medicine storage grooves which are round or rectangular, and the medicine storage grooves are spirally arranged.

Furthermore, the top end of the expansion part is a curved surface body protruding outwards, and the diameter of the curved surface body is larger than that of the expansion part.

Furthermore, the joint of the expansion part and the bending part is provided with an anti-suction end, and the surfaces of the curved surface body, the expansion part and the anti-suction end are provided with medicine storage grooves.

Further, the material of the anti-adhesion expansion rod is selected from one or more of metal, ceramic and carbon.

The preparation method of the biological anti-adhesion coating comprises the following steps:

(1) weighing raw materials in proportion, dissolving chitosan in 2% acetic acid solution to prepare solution with chitosan concentration of 6-8g/L, and sterilizing with high pressure steam for later use;

(2) adding sodium hyaluronate into deionized water to obtain sodium hyaluronate solution with concentration of 0.01-20.0 mg/ml;

(3) adding the sodium hyaluronate solution prepared in thestep 2 into the chitosan solution in thestep 1 at 50-80 ℃, and uniformly mixing;

(4) and (3) immersing the expansion part of the expansion rod into the mixed solution obtained in the step (3), taking out after immersing for 10min, draining, and forming the biodegradable anti-adhesion coating on the surface of the expansion part.

Further, the concentration of the chitosan is 7 g/L.

Further, the concentration of the sodium hyaluronate is 10 mg/ml.

The invention has the advantages that:

1. the cervical anti-adhesion dilating rod has the advantages of simple structure, easy manufacture, lower cost and convenient use and operation, lightens the workload of medical care personnel, and reduces the medical cost of patients.

2. The cervical anti-adhesion dilating rod can effectively prevent cervical adhesion after LEEP operation, has good long-term curative effect, does not increase the adverse reaction of patients, and is worthy of clinical popularization and application.

Drawings

Fig. 1 is a schematic structural view of the cervical anti-adhesion dilating rod.

Fig. 2 is a schematic structural diagram (I) of an improved cervical anti-adhesion dilating rod.

Fig. 3 is a schematic diagram (II) of an improved structure of the cervical anti-adhesion dilating rod.

Fig. 4 is a schematic structural diagram (III) of the cervical anti-adhesion dilating rod of the invention.

Detailed Description

The invention will be further illustrated with reference to specific embodiments. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Furthermore, it should be understood that various changes and modifications can be made by those skilled in the art after reading the disclosure of the present invention, and equivalents fall within the scope of the appended claims. The reference numerals and components referred to in the drawings are as follows:

1. a handle portion;

2. dimension calibration;

3. a middle part;

4. a bending section;

5. an expansion section;

6. a notch;

7. a groove;

8. a protrusion;

9. an anti-adhesion coating;

10. a head portion;

11. a medicine storage groove;

12. a curved surface body;

13. suction-proof end

EXAMPLE 1 cervical anti-adhesion dilating rod of the present invention

Referring to fig. 1, fig. 1 is a schematic structural view of the cervical anti-adhesion dilating rod of the present invention.

The cervical anti-adhesion dilating rod is formed by sequentially and smoothly connecting ahandle part 1, a cylindricalmiddle part 3 carved withsize scales 2, a bendingpart 4 and a dilatingpart 5, wherein thehandle part 1 is coaxial with themiddle part 3, and an included angle of 5-20 degrees is formed between the bendingpart 4 and the axis of themiddle part 3; thehandle part 1 is flat, slender and rod-shaped with a smooth outer surface, anotch 6 is arranged at the tail end of thehandle part 1, and thenotch 6, the bendingpart 4 and theexpansion part 5 are positioned at the same side of thehandle part 1; the surface of themiddle part 3 is provided with agroove 7 and abulge 8 on the same side as theexpansion part 5, and thesize scale 2 is positioned on the other side of the surface of the middle part 3 (or on the side surfaces of the groove and the bulge); the length of theexpansion part 5 is 2-4cm, preferably 3cm, the top end of theexpansion part 5 is ahemispherical head 10, and the diameter of the head is 3-4mm, preferably 4 mm;

the diameter of theexpansion part 5 adopts a progressive mode, the diameter of the expansion part gradually increases from the head end to the end connected with the bendingpart 4, and the maximum diameter is 5-8 mm;

the length of the bendingpart 4 is 2cm, and the width is 5-8 mm; the diameter of themiddle part 3 is 5-8 mm; thegroove 7 and thebulge 8 are respectively positioned at the positions of 1cm and 5cm corresponding to thesize scale 2;

the surface of theexpansion part 5 is coated with a biodegradableanti-adhesion coating 9 prepared from chitosan and sodium hyaluronate, and the mass ratio of the chitosan to the sodium hyaluronate is 2: 2-10. Preferably, the mass ratio of the chitosan to the sodium hyaluronate is 2: 7. The sodium hyaluronate has the effects of promoting wound healing, lubricating, relieving pain and having good anti-adhesion effect; the chitosan has the functions of reducing cell growth and preventing tissue adhesion, and also has certain antibacterial and anti-inflammatory effects; the anti-adhesion material is convenient to obtain, the manufacturing cost of the cervical anti-adhesion dilating rod is reduced, and the medical cost of a patient is reduced. The material of the anti-adhesion dilating rod is selected from one or more of metal, ceramic, high polymer material, silica gel and carbon, and the anti-adhesion dilating rod can also be a cervical dilating rod made of any shape and material in the prior art.

In this embodiment, agroove 7 and aprotrusion 8 are provided on the same side of the surface of themiddle portion 3 as theexpansion portion 5, and thesize scale 2 is located on the other side of the surface of themiddle portion 3; thegroove 7 and thebulge 8 are respectively positioned at the positions of 1cm and 6cm corresponding to thesize scale 2; recess and arch are the yardstick mark of feeling, and this design can make things convenient for medical personnel to know the degree of depth that the expansion stick head end got into the cervical canal when operating, according to expansion stick middle part size scale during the use, the suggestion gets into the scale of uterine cavity, avoids the uterus damage, and the expansion portion reachs including the neck position, accomplishes the cervical dilatation.

In this embodiment, the diameter of theexpansion part 5 is gradually increased from the head end to the end connected to the bendingpart 4, and the maximum diameter is 5-8 mm. The cervical dilator used in clinic is mostly composed of more than ten, and the cervical orifice is enlarged by entering the cervical dilator one by one during operation, so that repeated operation is susceptible to infection, the operation time is long, and physical and mental injuries and pains are brought to women who are subjected to the operation. The progressive dilation design of the invention can dilate cervix at one time, avoid damaging uterus, shorten operation time and reduce the chance of increasing infection due to frequent operation, and meanwhile, the bending part of the rod body is beneficial to adapting to the angle of the cervix and reducing treatment risk.

In the present embodiment, thehandle portion 1 is a rod shape having a flat, slender shape and a smooth outer surface, the end of thehandle portion 1 is provided with anotch 6, and thenotch 6, the bendingportion 4 and the expandingportion 5 are located on the same side of thehandle portion 1. The design of flat slender handle is favorable to using the operation, and the crooked direction of bendingportion 4 is discerned according to the breach when the terminal breach of handle portion is convenient for medical personnel to use, avoids the dilating rod to get into behind the cervix doctor forget the orientation of bendingportion 4.

The cervical anti-adhesion dilating rod is applied to preventing postoperative cervical canal adhesion, and the anti-adhesion coating is arranged on the rod body of the dilating rod, so that the dilating rod has an anti-adhesion effect, the cervical canal adhesion can be effectively prevented through the dilating rod, the incidence rate of the postoperative cervical canal adhesion is effectively reduced, and an effective instrument is provided for preventing the cervical canal adhesion after LEEP (cervical extension EP) in the menopause; meanwhile, the utility model has the advantages of simple structure, convenient use, economy, effectiveness and the like.

Example 2 improvement of the invention

This example is a modification of example 1, and the structure of the cervical anti-adhesion dilating rod is substantially the same as that of example 1, and the modification is as follows.

Referring to fig. 2, as a modified version of the present invention, the top end of theexpansion portion 5 is ahead portion 10 with a semi-spherical shape, and the diameter of the head portion is 4 mm; the surfaces of thehead part 10 and theexpansion part 5 are provided withmedicine storage grooves 11 which are circular or rectangular, and themedicine storage grooves 11 are spirally arranged. Themedicine storage groove 11 has the functions of: (1) the medicine carrying area on the surface of the expansion rod is increased, so that the expansion rod obtains larger medicine carrying amount, and a large amount of medicine is stored in themedicine storage groove 11 and can be released quickly; (2) the adsorption effect of the drug and the surface of the expansion rod is increased, and the drug is prevented from falling off in the expansion process.

Referring to fig. 3, as a modified version of the present invention, the top end of theexpansion portion 5 is acurved body 12 protruding outward, and the diameter of thecurved body 12 is larger than that of theexpansion portion 5. Preferably, thecurved body 12 has a diameter of 5-9mm and a height of 12 mm. The surface of thecurved body 12 is provided with amedicine storage groove 11 which is round or rectangular. Thecurved body 12 functions as: the curved surface can be well matched with the cervical orifice, and because the diameter of thecurved surface body 12 is larger than that of theexpansion part 5, when the expansion rod is inserted into the cervical canal, theexpansion part 5 with smaller diameter is not contacted with the cervical canal, and the cervical tissue and the vaginal tissue are not injured in the treatment process.

Referring to fig. 4, as a modified version of the present invention, ananti-suction end 13 is disposed at the connection position of theexpansion portion 5 and the bendingportion 4, the diameter of theanti-suction end 13 is 9-20mm, preferably 15-20mm, and thecurved surface 12, theexpansion portion 5, and the surface of theanti-suction end 13 are disposed with adrug storage groove 11. The function of theanti-suction end 13 is as follows: (1) the expansion rod is prevented from being sucked into the uterus when in use, so that the treatment risk is reduced; (2) the cross section of thesuction end 13 is crescent, and compared with a structure without thesuction end 13, the anti-adhesion coating on the surface of thesuction end 13 can be well matched with the cervical orifice, can effectively act on the cervical orifice and improve the adhesion prevention effect.

Example 3 preparation of a biological anti-adhesion coating

(1) weighing raw materials according to the mass ratio of chitosan to sodium hyaluronate of 2:7, dissolving chitosan in 2% acetic acid solution to prepare solution with the concentration of chitosan of 7g/L, and sterilizing for later use by high-pressure steam;

(2) adding sodium hyaluronate into deionized water to obtain 10mg/ml sodium hyaluronate solution;

(4) the expanding part of the expanding rod of the embodiment 1-2 is immersed in the mixed solution of thestep 3, taken out after 10min of immersion, drained and formed with the biodegradable anti-adhesion coating on the surface of the expanding part.

Example 4 clinical experiment of cervical adhesion prevention and treatment rod for cervical adhesion prevention after LEEP surgery

1 data and method

1.1 general data

The patients with menopausal cervical pathological changes, including 140 patients with cervical erosion, cervical polyp, cervical hypertrophy and cervical condyloma, treated by gynecological outpatient cervical LEEP are selected, and the age is 45-55 years. Patients were randomly divided into treatment group, control group one, control group two, and control group three. Four groups of patients had no significant difference (P >0.05) in terms of age, disease course and the like by statistical treatment and were comparable.

1.2 methods

1.2.1 surgical methods

Performing conventional vaginal secretion examination before operation to remove vaginitis; making cytological examination of cervical scraping, colposcopy, and cervical biopsy if necessary, determining pathological change property, and eliminating cervical cancer; blood routine and blood coagulation function examination is carried out, and blood coagulation abnormality is eliminated. And performing operation 3-7 days after the menstruation is clear, taking a lithotomy position by a patient, spreading a towel by conventional disinfection, marking the range of a transition area by Lugol liquid after exposing the cervix, and selecting different types of annular electrodes according to the nature and range of pathological changes to excise pathological change tissues. In principle, clicking 0.5cm away from the outer edge of the iodine non-staining range, slowly moving the electrode from left to right or from top to bottom to cut the tissue, and cutting off the lesion tissue in the whole transitional area. For oversized tissue, the cuts are made in separate steps. The cutting depth is case specific.

1.2.2 post-operative treatment

Treatment groups: using the cervical anti-adhesion dilating rod described in example 1, a biological anti-adhesion coating was prepared as in example 5. Respectively extending into cervix at 3 rd, 7 th and 12 th weeks after the operation is finished, and keeping for 0.5-3 minutes.

Control group one: the same body structure as the cervical anti-adhesion dilating rod of example 1 was used, and the anti-adhesion coating was prepared from chitosan by the following method:

(1) dissolving chitosan in 2% acetic acid solution to prepare solution with chitosan concentration of 7g/L, and sterilizing with high pressure steam for later use;

(2) stirring and mixing the chitosan solution uniformly at 50-80 ℃;

(4) and (3) immersing the expansion part of the expansion rod into the solution in the step (2), taking out after immersing for 10min, draining, and forming the biodegradable anti-adhesion coating on the surface of the expansion part.

The application method is the same as that of the treatment group.

Control group two: the body structure of the cervical anti-adhesion dilating rod is the same as that of the cervical anti-adhesion dilating rod in example 1, and the anti-adhesion coating is prepared from sodium hyaluronate gel according to a conventional method. The application method is the same as that of the treatment group.

Control group three: using the cervical anti-adhesion dilating rod of example 1, a biological anti-adhesion coating was prepared by the following method:

(1) weighing raw materials according to the mass ratio of chitosan to sodium hyaluronate of 5:2, dissolving chitosan in 2% acetic acid solution to prepare solution with chitosan concentration of 7g/L, and sterilizing with high pressure steam for later use;

The application method is the same as that of the treatment group.

2 results

After treatment, all patients are reexamined every month to observe the cervical morphology and the menstrual condition, and no adverse reaction occurs. Table 1 shows that four groups of patients treated with LEEP for cervical adhesion in the 1 st month after operation have no cervical adhesion after operation, and 8, 7 and 1 patients treated with LEEP for cervical adhesion in the control group respectively. The incidence of postoperative adhesion of patients in the first control group and the second control group is obviously higher than that of patients in the treatment group, P is less than 0.05, and the statistical significance is achieved.

TABLE 1 four groups ofpatients 1 month cervical adhesions (%)

Group of	Number of examples	Cervical adhesions	No adhesion
				Treatment group	58	0(0％)	58
Control group one	48	8(16.7)*	40
				Control group two	46	7(15.2)*	39
Control group III	48	1(2.0)	47

Note: p <0.05 compared to treatment group.

Table 2 shows that there is no cervical adhesion after LEEP operation in the treated group inmonth 3, while there are 10, 9 and 8 cervical adhesions in the control group. The third control group can effectively reduce cervical adhesion after LEEP operation, but the recent effect is obvious, and the long-term curative effect is poor. The incidence of postoperative adhesion of patients in the control group is obviously higher than that of patients in the treatment group, P is less than 0.05, and the statistical significance is achieved.

TABLE 2 four groups ofpatients 3 months cervical adhesions (%)

Common causes of cervical adhesions are infection, surgical trauma and induced abortion. It is mainly manifested as periodic abdominal pain, amenorrhea and infertility due to menstrual blood blockage and menstrual abdominal pain. There are many factors that affect cervical canal adhesion. The literature reports that the following points should be noted for the prevention of cervical canal adhesion after LEEP surgery: the vaginal and cervical infection is eliminated and treated before operation, the application of prophylactic antibiotics is carried out after operation, the operation range and depth are mastered, and the excessive burn to the cervical canal tissue is avoided; strictly obeying conventional operation, correcting the excessively bent uterus as much as possible, and controlling the electrotomy range between the inner and outer mouths of the cervix during operation to prevent the function of the cervix from being damaged; long-time large-range electric coagulation hemostasis is avoided, particularly electric coagulation on cervical mucosa after the conization is avoided, and a point-to-point coagulation method is adopted as much as possible; when suture is performed for hemostasis, the dissected structure should be cleared, and the suture on the mucosa surface of the cervix is avoided as much as possible; it has also been suggested by scholars that menopausal patients, if not contraindicated, may help to prevent cervical stenosis and adhesions using hormone replacement therapy. However, in the actual clinical work, cervical adhesions still remain in some patients after LEEP operation, and the incidence of cervical stenosis in postmenopausal patients is much higher than that in premenopausal patients. The results show that the cervical anti-adhesion dilating rod can effectively prevent cervical adhesion after LEEP operation, has good long-term curative effect, does not increase the adverse reaction of patients, and is worthy of clinical popularization and application.

The above description is only a preferred embodiment of the present invention, and it should be noted that, for those skilled in the art, several modifications and additions can be made without departing from the method of the present invention, and these modifications and additions should also be regarded as the protection scope of the present invention.

Claims

1. The anti-adhesion cervical dilation rod is formed by sequentially and smoothly connecting a handle part (1), a cylindrical middle part (3) carved with size scales (2), a bending part (4) and a dilation part (5), and is characterized in that the handle part (1) is coaxial with the middle part (3), and the bending part (4) and the axis of the middle part (3) form an included angle of 5-20 degrees; the handle part (1) is in a flat, slender and rod shape with a smooth outer surface, a notch (6) is formed in the tail end of the handle part (1), and the notch (6), the bending part (4) and the expansion part (5) are located on the same side; a groove (7) and a protrusion (8) are arranged on the same side of the middle part (3) and the expansion part (5), and the size scales (2) are positioned on the other side of the middle part (3); the length of the expansion part (5) is 2-4 cm; the diameter of the expansion part (5) adopts a progressive mode, the diameter of the expansion part is gradually increased from the head end to the end connected with the bending part (4), and the maximum diameter is 5-8 mm; the length of the bending part (4) is 2cm, and the width of the bending part is 5-8 mm; the diameter of the middle part (3) is 5-8 mm; the groove (7) and the bulge (8) are respectively positioned at the positions of 1cm and 5cm corresponding to the size scale (2); the surface of the expansion part (5) is coated with a biodegradable anti-adhesion coating (9) prepared from chitosan and sodium hyaluronate, and the mass ratio of the chitosan to the sodium hyaluronate is 2: 2-10; the preparation method of the biodegradable anti-adhesion coating comprises the following steps:

(3) adding the sodium hyaluronate solution prepared in the step 2 into the chitosan solution in the step 1 at 50-80 ℃, and uniformly mixing;

(4) and (4) immersing the expansion part of the expansion rod into the mixed solution obtained in the step (3), taking out after 10min of immersion, draining, and forming the biodegradable anti-adhesion coating on the surface of the expansion part.

2. The cervical anti-adhesion dilating rod of claim 1, wherein the mass ratio of the chitosan to the sodium hyaluronate is 2: 7.

3. The cervical adhesion-preventing dilating rod according to claim 1, wherein the top end of the dilating portion (5) is a semi-spherical head (10) with a diameter of 3-4 mm.

4. The cervical anti-adhesion dilating rod according to claim 3, wherein the surfaces of the head portion (10) and the dilating portion (5) are provided with medicine storage grooves (11) which are circular or rectangular in shape, and the medicine storage grooves (11) are arranged spirally.

5. The cervical anti-adhesion dilating rod according to claim 1, wherein the top end of the dilating portion (5) is an outwardly convex curved body (12), and the diameter of the curved body (12) is larger than that of the dilating portion (5).

6. The cervical anti-adhesion dilating rod according to claim 5, wherein an anti-suction end (13) is provided at the joint of the dilating portion (5) and the bending portion (4), and a medicine storage groove (11) is provided on the surface of the curved body (12), the dilating portion (5) and the anti-suction end (13).

7. The cervical anti-adhesion dilating rod of claim 1, wherein the anti-adhesion dilating rod is made of one or more materials selected from the group consisting of metal, ceramic and carbon.

8. The cervical anti-adhesion dilating rod of claim 1, wherein the chitosan is present at a concentration of 7 g/L.

9. The cervical anti-adhesion dilating rod of claim 1, wherein the sodium hyaluronate is present in a concentration of 10 mg/ml.