CN-121971716-A - Degradable minimally invasive implantation device for preventing and treating intrauterine adhesion

CN121971716ACN 121971716 ACN121971716 ACN 121971716ACN-121971716-A

Abstract

The invention discloses a degradable minimally invasive implantation device for preventing and treating uterine cavity adhesion, which is characterized by comprising a spiral stent body, wherein the spiral stent body is made of a temperature responsive shape memory polymer (PLLA-TMC-GA). Solves the problem of poor treatment effect of the existing intrauterine adhesion.

Inventors

HU XULIN
YONG XIN
ZHU HUILI
QIAN ZHIYONG
WU HAOMING
CHEN YU

Assignees

成都大学附属医院(成都市创伤骨科研究所)

Dates

Publication Date: 20260505
Application Date: 20251212

Claims (9)

1. A degradable minimally invasive implantation device for preventing and treating intrauterine adhesion is characterized by comprising a spiral stent body, wherein the spiral stent body is made of a temperature responsive shape memory polymer (PLLA-TMC-GA).
2. The degradable minimally invasive implantation device for preventing and treating uterine adhesion according to claim 1, wherein the step of preparing the stent body in a spiral shape by using a temperature responsive shape memory polymer (PLLA-TMC-GA) comprises the steps of A, PLTG preparing the stent, B preparing liposome, C compounding the liposome and HAMA, and D, PLTG loading the stent with medicine.
3. The degradable minimally invasive implantation device for preventing and treating uterine cavity adhesion according to claim 2, wherein the preparation of the PLTG scaffold in the step A is specifically printing by using an EFL-BP6601 biological printer, and printing a scaffold primary structure in a spiral shape.
4. The degradable minimally invasive implantation device for preventing and treating uterine cavity adhesion according to claim 3, wherein the printing parameters are adjusted according to the uterine cavity shape of the patient to achieve the shape most suitable for the patient when printing PLTG the bracket, and the printing parameters specifically comprise barrel temperature, needle temperature and extrusion pressure.
5. The degradable minimally invasive implantation device for preventing and treating uterine adhesion according to claim 2, wherein the liposome prepared in the step B is prepared by a conventional thin film method, the prepared liposome comprises E2-liposome and Cur-liposome, wherein a lipid bilayer of the E2-liposome consists of lecithin and cholesterol in a mass ratio of 2:1, the E2-liposome is prepared by a rotary evaporator at 45 ℃, finally, the liposome is hydrated by PBS at 45 ℃ to obtain liposome, the particle size of the liposome is verified by a Dynamic Light Scattering (DLS) method, the lipid bilayer of the Cur-liposome consists of DOPE, DPPC and cholesterol in a mass ratio of 2:1:1, the E2-liposome is prepared by a rotary evaporator at 45 ℃, finally, the liposome is hydrated by PBS at 45 ℃ to obtain liposome, and the particle size of the liposome is verified by a Dynamic Light Scattering (DLS) method.
6. The degradable minimally invasive implantation device for preventing and treating uterine adhesion according to claim 2, wherein the step C of compounding the liposome and HAMA is characterized in that the liposome is purified by differential centrifugation, then the liposome (0.5%, w/v) and HAMA solution (5%, w/v) are magnetically stirred at 30 ℃, the stirring speed is 200rpm for 30 minutes until the liposome is completely dissolved in the HAMA solution to obtain the compounded liposome HAMA solution, and finally the compounded liposome HAMA solution is poured into a test tube for storage for later use.
7. The degradable minimally invasive implantation device for preventing and treating uterine adhesion according to claim 2, wherein the drug loading of PLTG stents in the step D comprises the steps of adding PLTG stents into Tris buffer (1.5 g/L for dopamine) with pH of 8.5, stirring for 12 hours at room temperature, washing the stents with deionized water after the reaction is completed, drying in a vacuum environment, and finally, uniformly coating the complexes of liposome and HAMA on the PLTG stents, and curing by ultraviolet light to obtain the final stent body with spiral morphology.
8. The degradable minimally invasive implantation device for preventing and curing uterine adhesion according to claim 1, characterized in that the stent body in a spiral shape is used by firstly controlling the temperature to change it into a straight shape, then being equipped with a low-temperature catheter to fix its form, and then implantation is achieved from the vaginal opening through the catheter.
9. The degradable minimally invasive implantation device for preventing and treating uterine adhesion according to claim 1, wherein the surface of the stent body is further coated with bioactive hydrogel.

Description

Degradable minimally invasive implantation device for preventing and treating intrauterine adhesion Technical Field The invention relates to the field of surgical instruments, in particular to a degradable minimally invasive implantation device for preventing and treating intrauterine adhesion. Background Intrauterine adhesions (IUA) are often caused by damage to the endometrium during surgery, especially in pregnancy related procedures such as curettage, abortion and the like. Uterine adhesion is one of the main causes of female infertility, and it remains a significant clinical challenge due to the high recurrence rate and limited therapeutic effect. Existing therapeutic strategies mainly include drug therapy and physical barrier methods, but these methods face many limitations in clinical application, especially significant drawbacks in terms of regenerative effects, therapeutic persistence and uterine morphology adaptation. 1. Drug therapy, which is mostly dependent on estrogens, aims to promote regeneration and repair of endometrium. However, in patients with severe adhesion, the wound surface of the uterine cavity is scarred in a large area, residual endometrium is few, the effect of the medicine is limited, and effective repair and regeneration are difficult to realize; 2. Physical barriers, such as balloons, are currently used clinically, and mainly rely on mechanical action to prevent adhesion. However, such barrier materials often suffer from the following drawbacks: Cannot be degraded, and many physical barrier materials cannot be degraded in vivo, and may cause local reactions or secondary infections during use. The method is not suitable for uterine morphological changes, and rigid barriers such as a balloon and the like cannot be adapted according to the uterine morphological changes, so that the treatment effect is not durable. The procedure is complicated, the placement of the physical barrier often requires expansion of the cervical orifice, resulting in trauma and affecting the recovery process, increasing patient pain and treatment risk. Therefore, there are still many disadvantages to the treatment of intrauterine adhesions, and there is a need for an innovative treatment that can both prevent re-adhesion of the wound surface and promote regeneration and repair of the intima. Disclosure of Invention The invention aims to provide a degradable minimally invasive implantation device for preventing and treating intrauterine adhesion, which solves the problem of poor treatment effect of the existing intrauterine adhesion. In order to solve the technical problems, the invention adopts the following technical scheme: A degradable minimally invasive implantation device for preventing and treating intrauterine adhesion is characterized by comprising a spiral stent body, wherein the spiral stent body is made of a temperature responsive shape memory polymer (PLLA-TMC-GA). The support is made of temperature responsive shape memory polymer (PLLA-TMC-GA), so that the support can be conveyed in a compact form through a catheter at low temperature, the trauma and recovery period caused by traditional operation are avoided, the support body can recover a predefined spiral configuration at physiological temperature, the support can be stably positioned in a uterine cavity, after the spiral configuration is recovered, the support has the mechanical property of a spring like a spring due to the structure of the support, the myometrium of the uterus can be contracted, the mechanical property of the spring can adapt to the contraction to provide necessary structural support for the uterine cavity, and the support has good adaptability and can play a role of continuous support. As a further preferred aspect of the invention, the step of preparing the stent body in a spiral form by using a temperature responsive shape memory polymer (PLLA-TMC-GA) comprises the steps of A, PLTG preparing the stent, B preparing the liposome, C compounding the liposome and HAMA, and D, PLTG loading the stent with the drug. As a further preferred aspect of the present invention, the preparation of the PLTG scaffold in the step A is specifically performed by using an EFL-BP6601 biological printer to print out a scaffold primary structure in a spiral form. As a further preferred aspect of the invention, printing parameters, including barrel temperature, needle temperature and extrusion pressure, are adjusted to achieve the most appropriate morphology for the patient according to the morphology of the uterine cavity of the patient when printing PLTG stents. As a further preferred aspect of the present invention, the liposome in step B is prepared by a conventional thin film method, the prepared liposome comprises E2-liposome and Cur-liposome, wherein the lipid bilayer of the E2-liposome is composed of lecithin and cholesterol in a mass ratio of 2:1, the E2-liposome membrane is prepared by a rotary evaporator at 45 ℃, finally, the lipo