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CN-122005159-A - Safe support for preventing uterine cavity adhesion and application method thereof

CN122005159ACN 122005159 ACN122005159 ACN 122005159ACN-122005159-A

Abstract

The invention belongs to the technical field of medical treatment, and particularly relates to a safe support for preventing intrauterine adhesion and a use method thereof. The support consists of hydrogel and sterilization water for injection, wherein the hydrogel is of a hollow spiral inverted pear-shaped structure, the hydrogel is expanded to be balanced to form the support after meeting the sterilization water for injection, the shape of the support is matched with the uterine cavity and is completely attached to the inner wall of the uterine cavity, and the dosage of the sterilization water for injection is calculated according to the formula V=min (L/L, W/W1, T/T) ×v. The invention is based on the physiological structure and physiological movement of uterus, and the cervical orifice is expanded by absorbing water so as to prop up the inner wall of the uterus, and the support is broken into small particles by the physiological pressure generated by the peristaltic motion of the endometrium and discharged out of the body together with menstrual blood, so that the invention realizes the effects of effectively preventing adhesion in the uterine cavity, avoiding the risk of uterine infection and overlarge pressure, avoiding the influence of individual size of the uterus and the menstrual cycle of the uterus, and improving the safety of the uterus.

Inventors

  • HUANG YAZHE
  • ZHANG SHUAI
  • ZHUANG YAN

Assignees

  • 南阳市中心医院

Dates

Publication Date
20260512
Application Date
20260410

Claims (10)

  1. 1. A safe support for preventing intrauterine adhesion is characterized by comprising hydrogel and sterile water for injection, wherein the hydrogel is of a hollowed spiral inverted pear-shaped structure, the outer maximum size of the hydrogel is l=2-3 mm, the top width W1=1-2 mm, the bottom width W2=0.1-0.5 mm and the thickness t=0.5-1 mm, the volume is V, the hydrogel is prepared from non-degradable materials or degradable materials with degradation period of more than 1 month, the hydrogel expands to be balanced after being sterilized with the water for injection to form the support, the size of the support is 7-9 cm, the width of the support is 4-5 cm and the thickness of the support is 2-3 cm, the shape of the support is matched with the intrauterine cavity and is completely attached to the inner wall of the intrauterine cavity, the top and the bottom of the support are respectively abutted to the top and the bottom of the uterus, the use amount of the sterile water for injection is calculated according to the formula V=min (L/L, W/W1, T/T) x V, L is the actual length of the uterus of a patient measured by ultrasound, and T is the actual top width of the uterus of the patient measured by ultrasound, and T is the actual thickness of the patient measured by ultrasound.
  2. 2. The safe intrauterine adhesion-preventing stent according to claim 1, wherein the pressure of the stent on endometrium is not more than 10mmHg, the maximum equilibrium expansion multiple of the hydrogel after the hydrogel is contacted with water is 100-1000 times, the compressive strength of the hydrogel after the hydrogel is expanded is 16 mmHg-26 mmHg, and the time required for the hydrogel to reach equilibrium after the hydrogel is contacted with water is not more than 4 hours.
  3. 3. The safe intrauterine adhesion preventing stent according to claim 2, wherein the pressure of the stent on endometrium is 3-5 mmhg, the maximum equilibrium expansion multiple of hydrogel after the hydrogel is contacted with water is 200-500 times, the compressive strength of the hydrogel after the hydrogel is expanded is 16 mmhg-20 mmhg, and the time required for the hydrogel to reach equilibrium after the hydrogel is contacted with water is 1-3 h.
  4. 4. The safe intrauterine adhesion-preventing stent according to claim 1, wherein the spiral pitch of the stent is uniformly arranged, or the bottom is dense and the top is loose, and the spiral diameter of the stent is uniformly arranged, or the bottom is thick and the top is thin.
  5. 5. A safe intrauterine adhesion-preventing stent according to claim 1, wherein the head end of the stent has a spherical configuration.
  6. 6. The safe intrauterine adhesion-preventing stent according to claim 1, wherein one or more than two of an endometrial spacer substance, an endometrial regeneration medicine and an antibiotic medicine are added into the hydrogel.
  7. 7. The safe intrauterine adhesion-preventing stent according to claim 6, wherein the endometrial spacer is one or more of hyaluronic acid, chitosan and polylactic acid, the endometrial regeneration medicine is an oestrogen, and the antibiotic medicine is penicillin.
  8. 8. A safe, intrauterine adhesion-preventing stent according to claim 7, wherein the additive component of the hydrogel gradually exudes from the stent over time for sustained administration and is released in large amounts upon disruption of the stent factor uterine physiological peristalsis for potent administration.
  9. 9. A method of using the safe intrauterine adhesion-preventing stent of any one of claims 1-8, comprising the steps of: (1) Measuring the actual length L, the actual top width W and the actual thickness T of the uterus of a uterine cavity adhesion patient by ultrasonic waves; (2) Soaking hydrogel in sterilized injectable water for 1min, taking out, placing into uterus of patient, and positioning the top of hydrogel at the top of uterus; (3) The amount of sterilized water for injection was calculated according to the formula v=min (L/L, W/W1, T/T) ×v and injected into the uterus of the patient; (4) Adjusting the patient to a recumbent position; (5) After injection of sterilization injection water for 10-30 min, judging the placement condition of the stent by ultrasound, and adjusting the stent which starts to expand according to the ultrasound result; (6) After injection of the sterilized water for injection for 4 hours, the patient can get out of the bed to resume activities; (7) When the first menstruation of the patient comes or the uterus is contracted, the bracket is crushed by the physiological peristaltic pressure of the uterus and is discharged out of the body along with the menstrual blood.
  10. 10. A method of using a safe intrauterine adhesion-preventing stent according to claim 9, wherein in step (2), the hydrogel is placed in the uterus of the patient using a delivery system or surgical instrument forceps.

Description

Safe support for preventing uterine cavity adhesion and application method thereof Technical Field The invention belongs to the technical field of medical treatment, and particularly relates to a safe support for preventing intrauterine adhesion and a use method thereof. Background Under normal physiological conditions, the endometrium is in an intact state, its basal layer is structurally intact and functions normally. Although the anterior and posterior walls of the uterine cavity are in contact with each other, they do not adhere. Even if the endometrium is subjected to minor trauma, the endometrium has a periodical shedding function, so that the endometrium can rapidly regenerate and repair the wound surface, and adhesion cannot be caused. However, common diseases such as uterine cavity operation, inflammation and the like can cause the damage of the basal lamina of the endometrium, and the thinning or the defect of the endometrium can be caused, so that granulation tissues, collagen deposition and the like are formed due to inflammatory exudation, cell proliferation and the like in the wound repair process, and uterine cavity adhesion is gradually developed. The intrauterine adhesion (intrauterine adhesions, IUA) is also called Asherman syndrome, and is mostly caused by the intrauterine operations such as induced abortion, uterine curettage and the like or inflammation to cause the injury of the basal lamina of endometrium, and the partial or total occlusion of the uterine cavity is caused, and the clinical manifestations of the intrauterine adhesion are the characteristics of reduced menstrual flow, amenorrhea, infertility and the like. In the assisted reproduction technique, the problem of endometrial adhesion affects the success rate of in vitro fertilization-embryo transfer. Although there are many methods and means at present, there is still a lack of methods for completely avoiding the adhesion, which are absolutely effective, and there is also a lack of a unified therapeutic standard. At present, common treatment methods are methods of medicines, instruments and the like: The method of the medicine is to inject medicine such as hyaluronic acid, chitosan, estrogen, polylactic acid gel, etc. into uterine cavity, and to realize the treatment by the medicine. If the medicine is solid, it is difficult to cover the inner wall of the uterine cavity completely, thereby affecting the anti-adhesion effect. If the medicine is in a liquid state, thrombus is easy to form, the residence time of the medicine in the uterine cavity is short, and the long-term effect is poor. If the drug is in a gel state, the drug may be highly swelled and show obvious deformation, which is unfavorable for the tensionless repair of soft tissues. The method of the instrument mainly realizes mechanical barrier for isolation, such as a balloon stent, a contraceptive device, a double-cavity catheter, an anti-adhesion membrane and the like. Although the balloon uterine stent can effectively play roles of compression hemostasis and mechanical barrier, the balloon uterine stent has the adverse effects of affecting endomembrane repair and the like caused by endomembrane ischemia if the pressure is high, and is easy to fall off and lose effect if the pressure is low. Even though the specially designed Cook uterine balloon has short retention time and poor effect, new adhesion formation cannot be prevented, and thus postoperative re-adhesion is caused. However, long residence times are prone to inflammation and risk of infection. At the same time, friction caused by uterine contractions can cause mechanical damaging aseptic inflammation or result in uterine balloon incarceration. The anti-adhesion film can form a layer of continuous gelatinous protective film on the surface of uterine cavity tissue, can form an effective barrier in a long time, but becomes astringent when meeting water, is difficult to pass through a uterine cavity tube, and is difficult to be automatically unfolded in the uterine cavity, so that a naked leakage area which is not covered by the anti-adhesion film locally appears. The patent of publication No. CN102120059A proposes a medicine film-carrying bracket for preventing and treating intrauterine adhesion, which adopts a basket woven by nickel-titanium alloy wires with shape memory property as a support to attach a film material coated with a slow-release medicine carrying layer to the wall of the uterine cavity so as to achieve the purpose of preventing and treating intrauterine adhesion. But it is recovered after treatment and may be damaged by mechanical separation, which is disadvantageous for endometrial repair. The patent of publication No. CN103417272A proposes a drug-distribution type uterine stent, which takes a balloon as a supporting function and extrudes a liquid or gel-like drug with small holes in the stent to the endometrium so as to realize the synergistic effect of the drug and the stent. However,