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CN-121971699-A - Absorbable patch for myometrium repair and preparation method thereof

CN121971699ACN 121971699 ACN121971699 ACN 121971699ACN-121971699-A

Abstract

The application relates to the field of medical implant materials, and particularly discloses an absorbable patch for myometrium repair and a preparation method thereof. The absorbable patch for the myometrium repair is prepared by mixing 2-9.5 parts of poly (L-lactide-caprolactone) and 0.5-8 parts of biomedical materials, wherein the molecular weight of the poly (L-lactide-caprolactone) is 5-30 ten thousand, and the preparation method comprises the steps of mixing biomedical material stock solution and poly (L-lactide-caprolactone) stock solution, performing electrostatic spinning, freeze drying or tape casting treatment, and drying to remove organic solvents to obtain the absorbable patch for the myometrium repair. The absorbable patch provided by the application can be completely degraded in vivo, has a similar extracellular matrix structure, can provide muscle cell repair for the damaged part of the myometrium, avoids scar tissues formed by fibrosis, and reduces the risk brought by secondary operation required by uterine scar diverticulum.

Inventors

  • ZHANG HUIMIN
  • PEI XIN
  • XIANG JIALING
  • LI CHEN

Assignees

  • 上海典范医疗科技有限公司

Dates

Publication Date
20260505
Application Date
20260407

Claims (8)

  1. 1. An absorbable patch for repairing the myometrium is characterized by comprising the following components in parts by weight: 2-9.5 parts of poly (L-lactide-caprolactone); 0.5-8 parts of biomedical material; The poly (L-lactide-caprolactone) is prepared by copolymerization of L-lactide and caprolactone, and the mole percentage of the L-lactide to the caprolactone is 10:90-95:5; The molecular weight of the poly (L-lactide-caprolactone) is 5-30 ten thousand; the biomedical material comprises one or more of fibrinogen, gelatin, collagen, chitosan, silk fibroin, zeolite and porcine small intestine submucosa.
  2. 2. The absorbable patch for the repair of the myometrium of claim 1, consisting of the following components in parts by weight: 5-8 parts of poly (L-lactide-caprolactone); 2-5 parts of biomedical material.
  3. 3. The absorbable patch for myometrial repair of claim 1, wherein the poly (L-lactide-caprolactone) is made by copolymerization of L-lactide with caprolactone in a mole percent of 40-60; the molecular weight of the poly (L-lactide-caprolactone) is 25 ten thousand; the biomedical material is formed by mixing collagen and chitosan.
  4. 4. The absorbable patch for the repair of the uterine fibroid of claim 1, wherein the absorbable patch for the repair of the uterine myoid has a thickness of 0.2-2.0 mm and a porosity of 55-85%.
  5. 5. The method for preparing the absorbable patch for the myometrial repair of any one of claims 1 to 4, characterized by comprising the following steps: (1) Mixing the biomedical material with a first organic solvent to obtain a biomedical material stock solution with the concentration of 50-200 mg/ml; Mixing poly (L-lactide-caprolactone) with a second organic solvent to obtain poly (L-lactide-caprolactone) stock solution with mass fraction of 5-20%; (2) Mixing biomedical material stock solution and poly (L-lactide-caprolactone) stock solution, performing electrostatic spinning, freeze drying or tape casting treatment, and drying to remove organic solvent to obtain the absorbable patch for myometrium repair.
  6. 6. The method for preparing an absorbable patch for uterine myometrium repair according to claim 5, wherein in the step (1), the volume ratio of the biomedical material stock solution to the poly (L-lactide-caprolactone) stock solution is (2-5): 5-8.
  7. 7. The method of preparing an absorbable patch for use in the repair of the myometrium of claim 5, wherein in step (1), the first organic solvent comprises one or more of hexafluoroisopropanol, acetic acid, trifluoroethanol, and formic acid.
  8. 8. The method of preparing an absorbable patch for use in myometrial repair of claim 5, wherein in step (1), the second organic solvent comprises one or more of hexafluoroisopropanol, trifluoroethanol, tetrahydrofuran, and chloroform.

Description

Absorbable patch for myometrium repair and preparation method thereof Technical Field The application relates to the technical field of medical implant materials, in particular to an absorbable patch for repairing myometrium and a preparation method thereof. Background The uterus is a core organ of female reproductive system, is positioned in the center of the pelvis, takes the shape of an inverted pear, the inner layer is endometrium, the middle layer is myometrium, the outer layer is serosa, and the main functions include menstrual cycle formation, embryo implantation and fetal development. The normal myometrium is mainly composed of a large amount of smooth muscle tissues and a small amount of collagen fibers, and healing of a uterine incision part after a caesarean section and a partial uterine operation is mainly granulation tissue hyperplasia, fibrosis repair and the like. Usually, the regeneration capability of smooth muscle cells is poor, local muscle cells are damaged after uterine trauma, and the damaged myometrium is not completely regenerated and repaired, and scar tissues with poor elastic strength and poor contraction function can be formed only through fiber proliferation, so that uterine scar diverticulum is easy to form. However, fibrotic scars are poorly nourished, have poor contractility, have reduced elasticity, and increase the risk of poor implantation, uterine rupture. At present, the medical treatment such as stem cell treatment and the like for myometrium repair is still in the experimental research stage, and most of clinical methods for treating hysteromy diverticulum caused by myometrium damage are surgical treatment, including hysteroscopic diverticulum electrotomy, transvaginal hysteromy diverticulectomy suture, and celioscope Gong Banhen diverticulum excision repair. Although the hysteroscope diverticulum electrotomy has short operation time, no wound on the abdomen and simple and convenient operation, the improvement effect on abnormal uterine bleeding after the operation is poor, the operation is easy to recur, and the residual muscle layer is likely to be thinner, so that the hysteroscope diverticulum electrotomy is not suitable for women with fertility requirements. Diverticulectomy suturing, which is a vaginal or laparoscopic hysterectomy, repairs diverticuli by resecting scar tissue and re-suturing the tissue of the lower uterine segment, with uncertainty in the post-operative incision healing process that may lead to diverticulum re-formation if not healed. It follows that surgical treatment does not completely repair the myometrium and secondary surgery is prone to other problems. Poor repair of damaged organs can lead to abnormalities in the extracellular matrix (ECM), which in turn affect tissue architecture. Such abnormalities can cause cell imbalance, cause persistent fibrosis, impair organ function, and may cause other diseases. Thus, there is a need for a medical material that addresses the problem of myometrial damage. Disclosure of Invention In order to promote the repair of the myometrium, the application provides an absorbable patch for the repair of the myometrium and a preparation method thereof, and the absorbable patch can be used for the repair of the myometrium after caesarean section or other uterine opening operations. In a first aspect, the present application provides an absorbable patch for myometrial repair, comprising the following technical scheme: an absorbable patch for repairing the myometrium comprises the following components in parts by weight: 2-9.5 parts of poly (L-lactide-caprolactone); 0.5-8 parts of biomedical material; The poly (L-lactide-caprolactone) is prepared by copolymerization of L-lactide and caprolactone, and the mole percentage of the L-lactide to the caprolactone is 10:90-95:5; The molecular weight of the poly (L-lactide-caprolactone) is 5-30 ten thousand; the biomedical material comprises one or more of fibrinogen, gelatin, collagen, chitosan, silk fibroin, zeolite and porcine small intestine submucosa. By adopting the technical scheme, on one hand, the biomedical materials of the types can be quickly combined or captured after contacting blood at the myometrium, so that various growth factors such as Vascular Endothelial Growth Factor (VEGF), basic fibroblast growth factor (bFGF/FGF-2), platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-beta) and the like are released, regeneration of uterine smooth muscle cells is promoted, and scar tissues formed at the myometrium due to fibrosis are effectively improved. On the other hand, the poly (L-lactide-caprolactone) prepared by copolymerization reaction of L-lactide and caprolactone in a specific proportion has the molecular weight of 5-30 ten thousand, the poly (L-lactide-caprolactone) has high tensile strength, is suitable for suturing tissues at the myometrium, has long supporting time and effective tension of 3-6 months, has good biocompatibility, h