Medical anti-mucosa coated silicone rubber stent for preventing adhesion and drainage after uterine cavity operation

Abstract

The invention discloses a medical anti-mucosa coated silicone rubber stent for preventing adhesion and drainage after a uterine cavity operation, and belongs to the technical field of medical apparatuses and instruments. The invention relates to an anti-adhesion composite stent which is composed of a triangular silicone rubber stent frame (2) with a mould pressing flash film (1), a coated medical anti-adhesion film (3), an assembly stay wire (7) and a connecting silicone rubber drainage tube (8). The device is used for preventing endometrial adhesion and draining after the uterine cavity operation. The configuration and the flexible mechanical property of the anti-adhesion composite stent (4) are matched with the anatomical form of the uterine cavity, and a perfect physical barrier isolation effect is achieved. The surface of the medical anti-adhesion membrane (3) has good affinity with the inner membrane of an operative wound, so that the repair and regeneration of the inner membrane of the wound can be promoted. A surgeon can longitudinally lengthen and transversely fold the anti-adhesion composite stent (4) into a slender strip shape by means of the soft plastic push rod (6) and the pull wire (7), the anti-adhesion composite stent (4) is gently pushed into the uterine cavity, and the anti-adhesion composite stent (4) automatically retracts to restore a triangular structure after being released and is smoothly spread in the uterine cavity. And after treatment, the uterine cavity is gently pulled out.

Description

Technical Field

[0001] The invention relates to a medical anti-adhesion film coated silicone rubber stent for preventing and draining endometrial adhesion and re-adhesion after gynecological uterine cavity surgery or minimally invasive gynecological hysteroscopy for uterine cavity adhesion separation, and belongs to the technical field of medical devices. Background Art

[0002] Intrauterine Adhesions (IUA) are caused by various reasons, such as multiple artificial abortions, especially painless artificial abortions, vacuum extraction, curettage and other intrauterine trauma surgeries, which lead to damage to the basal layer of the uterine cavity and (or) the endocervical canal, adhesions between the uterine cavity muscle wall and (or) the endocervical canal, thereby destroying the anatomical morphology of the uterine cavity, causing endometrial fibrosis and scar formation. Clinical manifestations include amenorrhea or decreased menstrual volume, cyclical abdominal pain, miscarriage, infertility, and placenta implantation in the uterine wall after pregnancy, which seriously affect women's physiological and reproductive functions. It has become a medical problem that affects society, marriage and family. In 1948, American doctor Asherman, JD described this gynecological disease and defined it as Asherman syndrome. Regarding the occurrence of IUA or re-adhesion, minimally invasive gynecological hysteroscopy is used to perform Trascervical Resection of Adhesion (TCRA). The Chinese Medical Association's Obstetrics and Gynecology Branch, written by gynecological experts such as Duan Hua and Xia Enlan, was published in the Chinese Journal of Obstetrics and Gynecology, 2015, Volume 50, Issue 12, Pages 881-887, "Chinese Expert Consensus on Clinical Diagnosis and Treatment of Intrauterine Adhesions" and "Minimally Invasive Gynecology" edited by Guan Chen, 2nd edition, Science Press, 2017, Pages 417-430, which systematically describes it.

[0003] In the past two decades, there have been many advances in the treatment of IUA. The main method is to use gynecological surgical instruments to separate the adhesions of the uterine cavity wall, and to administer estrogen drugs to promote the repair and regeneration of the endometrium and restore the anatomical morphology and physiological function of the uterine cavity.

[0004] In the past decade, TCRA has been the main method for treating IUA or re-adhesion, and the treatment effect for mild IUA is relatively good. However, for moderate and severe IUA, the re-adhesion rate after TCRA is as high as 62.5%, and the pregnancy success rate is only 22.5-33.3%. This is mainly because the TCRA operation for moderate and severe IUA causes endometrial damage or intrauterine infection. How to improve the efficacy of TCRA and reduce the re-adhesion rate is a collaborative research direction for gynecologists and biomedical engineering. One direction is to use a physical barrier isolation method, that is, after the TCRA operation, a physical barrier isolator with good tissue affinity is placed between the newly separated uterine cavity wall wounds, and a large amount of estrogen is used to stimulate the growth of the endometrium, prevent endometrial re-adhesion, promote endometrial repair and regeneration, and restore the normal anatomical morphology and physiological function of the uterine cavity.

[0005] In the 1960s, gynecologists placed the newly invented T-shaped, round, and uterine-shaped intrauterine devices (IUDs) between the inner walls of the uterine cavity after uterine surgery to act as a physical barrier. A 4-year follow-up study found that the overall menstrual improvement rate of patients was 62.7%, but the total pregnancy rate was only 22.5%, and the rate of repeated treatment after surgery was high. This is because the isolation area of ​​the IUD is too small, the configuration and material are not soft enough, and it is a foreign body that may cause excessive inflammatory response. There are also risks of abnormal bleeding, uterine cavity infection, incarceration, and uterine perforation, and it is very troublesome to remove it.

[0006] In order to improve the shortcomings of IUD in preventing intrauterine adhesions after TCRA surgery, Xu Dabao et al. published a modified uterine IUD as a physical barrier isolation stent in Chinese utility model CN-201189193y (2008) and CN-202537620U (2012). An elastic uterine ring was used as the frame, and a nylon film was sewn in the middle. However, there has been no report on its clinical application so far.

[0007] Since the 1970s, gynecologists have used readily available silicone rubber or natural latex balloon catheters (Foley catheters) as physical barrier isolation stents, placed in the uterine cavity after intrauterine surgery or TCRA, to prevent postoperative adhesion or re-adhesion of the uterine cavity wall, and to drain intrauterine bleeding and inflammatory exudates, reducing the chance of infection. Studies have found that the menstrual improvement rate reached 81.4-95.0%, reducing the formation of re-adhesion. However, the shape of the balloon is not compatible with the uterine cavity, and it is difficult to completely isolate the wound surface. When the balloon pressure is too high, it will over-compress the endometrium, causing endometrial ischemia and necrosis, affecting endometrial repair and regeneration. In addition, after the Foley catheter is led out of the vaginal opening to the outside of the body, it needs to be connected to a drainage fluid collection bag, and it needs to be adhered to the surface of the thigh, which hinders the patient's physical activities and is also very uncomfortable. During activities, the catheter will be pulled, causing the balloon to move in the uterine cavity.

[0008] In the past decade, gynecologists and medical device manufacturers have continued to improve the shortcomings of the Foley catheter's shape that is not compatible with the uterine cavity configuration. Cook Medical has launched a Cook balloon intrauterine stent called the Cook balloon. It is a triangular balloon made of silicone rubber that simulates the uterine cavity configuration, also known as a heart-shaped balloon connection catheter. The contact area between the balloon and the inner wall of the uterine cavity is increased, and the pressure of the balloon on the inner wall of the uterine cavity is reduced. Its research data was published in the following four papers. [1] March, CM, et al, Reproductive Biomedical Online, 2011, vol. 23, 63-76, reported 1240 clinical cases with a pregnancy rate of 61.6%. [2] Myers, MD. et al, Fertility and sterility, 2012, vol. 97, No. 1, 160-164, [3] Xiaona lin, et al, European J. of obstertics &. Gynecology and Reproductive Biology, 2013, vol. 170, 512-516, [4] Zhu Leilei, Chinese Modern Drug Application, 2016, vol. 10, No. 6, pp. 82-83, reported that 134 cases of moderate and severe IUA were treated with TCRA and placed Cook balloon for 2-3 months. The results showed that long-term placement was effective, the pressure was relatively balanced, and bleeding was not easy. The cumulative pregnancy rate was 60.48%, and the live birth rate was 20.90%. However, 15 cases were found to have the triangular balloon moving downward or dislodged, and no drainage tube was set. Because when the balloon is inserted into the uterine cavity, the triangular balloon needs to be rolled longitudinally to a minimum diameter of 9 mm, the cervix needs to be dilated with a No. 10 cervical dilator, the top of the balloon needs to be grasped with toothless forceps, and inserted from the cervical canal. Obviously, this insertion operation is difficult. In many cases, it cannot be inserted.

[0009] In the past decade, biomedical material experts have invented and developed several biomedical gels that have anti-adhesion and lubricating effects on human tissues. For example, sodium hyaluronate gel and carboxymethyl chitosan gel have been used for joint lubrication, ophthalmology and facial plastic surgery. Gynecologists have thought of injecting this type of biomedical gel into the uterine cavity after TCRA surgery, or injecting it into the uterine cavity after inserting an IUD and Foley catheter to increase the physical barrier isolation and lubrication and anti-inflammatory and antibacterial effects. The disadvantage of this therapy is that the biomedical gel is in a high-viscosity fluid state and does not stay in the uterine cavity for a long time, and will slowly drain out of the uterine cavity. Some clinical studies on this type of therapy have been published in recent years. For example: [1] Xiao Songshu et al., Chinese Journal of Obstetrics and Gynecology, 2015, Vol. 50, No. 1, pp. 32-36. [2] Huang Yanming, Duan Hua et al., Journal of Chongqing Medical University, 2017, Vol. 42, No. 4, p. 445.

[0010] Over the past decade, gynecologists and biomedical material experts have wondered whether a biomedical membrane with a certain geometric shape, appropriate mechanical strength, and good contact feel, as well as excellent tissue affinity, could be used as a physical barrier membrane to prevent re-adhesion after TCRA surgery. The membrane could be wrapped on a tangible mechanical support such as an IUD or Foley catheter and placed between the wound surfaces of the uterine cavity after TCRA surgery to prevent re-adhesion and promote endometrial repair and regeneration. This type of clinical research, especially the use of human placental amniotic membrane as a medical anti-adhesion membrane, is expected to make a breakthrough. The research of Egyptian doctor Amer, MI, et al. and Chinese doctor Duan Hua, et al. has attracted attention. Clinical research data include: [1] Amer, MI. et al., J. Obstet. Gynecology Res., 2006, vol. 32, No. 6, 559-566. [2] Amer, MI et al, J. of minimally invasive Gynecology, 2010, vol. 17, No. 5, 605-611. [3] Zhang Ran, Duan Hua, Chinese Journal of Obstetrics and Gynecology, 2012, vol. 47, No. 6, pp. 470-472. [4] Wang Yin, Duan Hua, Chinese Journal of Obstetrics and Gynecology, 2016, vol. 51, No. 1, pp. 27-30. The above clinical studies have found that the geometric configuration and texture of IUD or Foley catheter are not sufficiently compatible with the configuration of human uterine cavity, and the isolation area is not large enough, making it difficult to smoothly spread the human placental amniotic membrane in the uterine cavity. Summary of the invention

[0011] The purpose of the present invention is to innovate a medical anti-adhesion membrane coated silicone rubber stent for preventing endometrial trauma caused by gynecological intrauterine surgery or minimally invasive gynecological hysteroscopic intrauterine adhesion separation surgery for the treatment of TCRA, resulting in endometrial adhesion or re-adhesion.

[0012] The technical solution adopted to achieve the purpose of the present invention is as follows: the silicone rubber stent coated with medical anti-adhesion film is a triangular silicone rubber stent frame with a molded flash film in the center of the stent, and is coated with medical anti-adhesion film on both sides to form an anti-adhesion film composite stent, whose triangular configuration and mechanical properties are compatible with the anatomical morphology of the uterine cavity, and has a large area to perfectly isolate the two sides of the uterine cavity endometrium of the surgical trauma. The surface of the medical anti-adhesion film has good tissue affinity with the two sides of the uterine cavity endometrium of the surgical trauma. The silicone rubber stent coated with medical anti-adhesion film also has a special and ingenious mechanical structure and mechanical behavior, and is provided with auxiliary surgical tool accessories and drainage tubes. It is convenient for the surgeon to longitudinally stretch the medical anti-adhesion film coated silicone rubber stent and transversely fold it into a slender strip, gently put it into the uterine cavity from the cervical opening, and automatically retract and restore it to a triangular configuration after release, spread out, and not easy to move, so as to play a role in isolating the uterine cavity wound surface. At the same time, the bleeding and inflammatory secretions from the uterine cavity wound can be drained from the drainage tube to the outside of the cervix, and then automatically flow out of the vagina to the outside of the body, and be absorbed and removed by the sanitary napkin. After the treatment, the doctor can easily and gently remove the entire stent and drainage tube from the body.

[0013] The invention has the advantages that a triangular silicone rubber stent frame with a molded flash film in the center is made of a medical grade silicone rubber with excellent biocompatibility and pliable mechanical properties, and a medical anti-adhesion membrane with excellent tissue affinity is coated on both sides of the stent frame to form a composite anti-adhesion composite stent. The composite stent has a special and ingenious mechanical property of being able to be stretched into a slender strip and automatically shrinking to restore the triangular configuration after release. After being placed in the uterine cavity and released, it can be smoothly spread between the endometrium of uterine cavity surgery or TCRA surgical trauma, and is compatible with the anatomical morphology of the uterine cavity with a large contact area, playing a perfect physical barrier isolation effect. At the same time, the surface of the medical anti-adhesion membrane with excellent tissue affinity contacts the endometrium of surgical trauma, which is conducive to the repair and regeneration of the endometrium. The selected medical anti-adhesion membrane is made of natural biomedical materials. Human placental amniotic membrane, collagen membrane, sodium hyaluronate membrane, chitosan membrane or natural silk woven sheet can be selected. These natural biomedical materials have been widely used in artificial skin, wound dressings, artificial corneas, tissue growth guide membranes, tissue engineering scaffolds, joint lubrication, facial plastic surgery, etc. They are safe, effective and readily available. The accessories of the composite anti-adhesion scaffold of the present invention, the soft plastic push rod with a groove at the end, the pull wire and the silicone rubber drainage tube, are convenient for surgeons to use and handle this new medical device.

[0014] The purpose of the present invention is to provide a new medical device for preventing endometrial adhesion or re-adhesion caused by endometrial trauma after gynecological intrauterine surgery or TCRA surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Attached Figure 1. Schematic diagram of the composition of a medical anti-adhesive membrane-coated silicone rubber stent for preventing adhesion and drainage after intrauterine surgery. In the figure: 1. Molded flash film. 2. Triangular silicone rubber bracket frame. 3. Medical anti-adhesion film. 4. Anti-adhesion composite stent. 5. Round hole. 6. Soft plastic push rod. 7. Pull wire. 8. Silicone rubber drainage tube.

[0016] Attached Figure 2 .Schematic diagram of a medical anti-adhesive film-coated silicone rubber stent being longitudinally stretched and transversely folded into a thin strip.

[0017] Attached Figure 3 .The medical anti-adhesive film-coated silicone rubber stent is automatically retracted and restored to a triangular configuration after being released into the uterine cavity. DETAILED DESCRIPTION

[0018] The preferred embodiment of the present invention: Figure 1 The invention discloses a method for manufacturing a triangular silicone rubber stent frame (2) by using a new medical grade silicone rubber material with low hardness and high elasticity and excellent biocompatibility and mechanical flexibility. The mold is designed and manufactured according to the shape and structure of the triangular silicone rubber stent frame (2). The triangular silicone rubber stent frame (2) with a triangular configuration and a molded flash film (1) with a thickness of 0.01-0.05 mm is manufactured by a hot molding vulcanization process. Then two pieces of medical anti-adhesion films (3) softened by soaking in sterile physiological saline are coated on both sides of the triangular silicone rubber stent frame (2) with the molded flash film (1). The anti-adhesion composite stent (4) is fixed by suturing with surgical sutures at points A, B, C, D, E, and F. A circular hole (5) with a diameter of 5 mm is punched at the G point of the anti-adhesion composite stent (4). Two soft pull wires (7) are attached to the ring at the H point. A section of medical silicone rubber tube with a diameter of 4 mm is selected as the silicone rubber drainage tube (8). At its mid-section, it is tied and connected with the lead-out end of the pull wire (7).

[0019] Surgeon's press Figure 2 and attached Figure 3 The schematic method is to place an anti-adhesion composite stent (4) and a drainage tube (8) into the uterine cavity of a patient undergoing uterine surgery or TCRA surgery. A soft plastic push rod (6) with a groove at the end can be used to clamp the position of the round hole (5), and at the same time, the pull wire (7) can be pulled to press the attached Figure 2 The anti-adhesion composite stent (4) is stretched longitudinally and folded transversely into a long and thin strip. Then it is pushed from the cervical opening through the cervical canal to the top of the uterine cavity. After being released, it automatically shrinks and recovers to a triangular shape, and smoothly spreads between the inner walls of the uterine cavity to form an adhesion. Figure 3state. The upper open end of the drainage tube (8) is located at the lower corner of the anti-adhesion composite stent (4). Its lower outlet end is located outside the cervical os. The free end of the pull wire (7) is also located outside the cervical os. In this way, the silicone rubber drainage tube (8) can smoothly drain the bleeding and inflammatory secretions from the uterine cavity surgical wound to the outside of the cervical os and the vagina, and be absorbed and removed by the sanitary napkin. After the uterine cavity surgery or TCRA surgical treatment is completed, when the entire anti-adhesion composite stent (4) and the silicone rubber drainage tube (8) need to be removed, the doctor can easily and gently pull the pull wire (7) outwards.

Claims

1. A medical anti-adhesive film-coated silicone rubber stent for preventing adhesion and drainage after intrauterine surgery, characterized in that: The main body is composed of a triangular silicone rubber stent frame (2) with a molded flash film (1), coated with a medical anti-adhesion film (3), forming an anti-adhesion composite stent (4), assembled with a pull wire (7), and connected with a silicone rubber drainage tube (8).

2. The medical anti-adhesive film-coated silicone rubber stent for preventing adhesion and drainage after intrauterine surgery according to claim 1, characterized in that: The center of the triangular silicone rubber support frame (2) is provided with a molded flash film (1) with a thickness of 0.01 to 0.05 mm.

3. The medical anti-adhesive film-coated silicone rubber stent for preventing adhesion and drainage after intrauterine surgery according to claim 1, characterized in that: The medical anti-adhesion membrane (3) is selected from one of human placental amniotic membrane, collagen membrane, sodium hyaluronate membrane, chitosan membrane or natural silk woven sheet.

4. The medical anti-adhesive film-coated silicone rubber stent for preventing adhesion and drainage after intrauterine surgery according to claim 1, characterized in that: The silicone rubber drainage tube (8) is connected to the lower corner of the triangular silicone rubber support frame (2) through a pull wire (7); the upper opening end of the silicone rubber drainage tube (8) is located at the lower corner of the triangular silicone rubber support frame (2); and the lower outlet end of the silicone rubber drainage tube (8) is located outside the cervical os after being inserted into the uterine cavity.

5. The medical anti-adhesive film-coated silicone rubber stent for preventing adhesion and drainage after intrauterine surgery according to claim 1, characterized in that: The anti-adhesion composite stent (4) is also provided with a soft plastic push rod (6) and a pull wire (7) with a groove at the front end, so that when the surgeon inserts the anti-adhesion composite stent (4), the stent is longitudinally stretched and transversely folded into a thin strip, and gently pushed into the uterine cavity. After release, it automatically retracts and recovers, and is smoothly spread in the uterine cavity without being easily moved. It is also convenient for the surgeon to pull the pull wire (7) to remove the anti-adhesion composite stent (4) and the silicone rubber drainage tube (8) from the body when it is necessary.

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