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

Abstract

The utility model relates to a medical anti-adhesion film wrapped silicon rubber stent for preventing adhesion and draining after a uterine cavity operation. The medical anti-adhesion film wrapped silicon rubber stent consists of a triangular silicon rubber stent frame (2) with a mould pressing flash film (1), a wrapped medical anti-adhesion film (3), an anti-adhesion composite stent (4), an assembling pull wire (7) and a connecting silicon 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 the anti-adhesion composite stent (4) 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 line (7), the anti-adhesion composite stent (4) is gently pushed into a 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 utility model relates to a kind of medical anti-adhesion membrane wrapping silicone rubber stents for preventing endometrial adhesion and re-adhesion in uterine cavity after gynecological uterine cavity operation or minimally invasive gynecological hysteroscopy is performed uterine cavity adhesion separation technique, belong to the technical field of medical devices. BACKGROUND

[0002] Intrauterine Adhesions (IUA) is due to various reasons, for example, multiple artificial abortion, especially painless artificial abortion, suction, curettage and other uterine cavity trauma surgery, resulting in endometrial basal layer damage in uterine cavity and / or cervical canal, uterine cavity muscle wall and / or cervical canal are adhered to each other, and thereby destroy the anatomical morphology of uterine cavity, cause endometrial fibrosis and scarring. Clinical manifestations are amenorrhea or reduced menstrual flow, periodic abdominal pain, abortion, infertility and placenta implantation in uterine wall after pregnancy, etc., seriously affect the physiological and reproductive function of women. It becomes a medical problem affecting 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 performed uterine cavity adhesion separation technique treatment (Trascervical Resection of Adhesion, TCRA), written by gynecological experts such as Duan Hua and Xia Anlan, published in Chinese Journal of Obstetrics and Gynecology, 2015, Vol. 50, No. 12, pages 881-887, "Chinese experts consensus on clinical diagnosis and treatment of intrauterine adhesions" and Guan Jing, editor-in-chief of "Minimally Invasive Gynecology", 2nd edition, Science Press, 2017, pages 417-430, have systematic description.

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

[0004] In the past decade, TCRA is the main method for the treatment of IUA or re-adhesion, and the effect is good for the treatment of mild IUA. 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%. The main reason is the intrauterine membrane damage or intrauterine infection caused by the operation of TCRA for moderate and severe IUA. How to improve the effect of TCRA and reduce the re-adhesion rate is the research direction of gynecologists and biomedical engineers. One of the directions is to use physical barrier isolation method, that is, to put a physical barrier isolation object with good tissue affinity between the newly separated intrauterine wall wounds after TCRA operation, and to use a large amount of estrogen to stimulate the growth of intrauterine membrane, prevent intrauterine membrane re-adhesion, promote intrauterine membrane repair and regeneration, and restore the normal anatomical shape and physiological function of the uterine cavity.

[0005] In the 1960s, gynecologists put the newly invented T-shaped, round-shaped and palace-shaped intrauterine device (IUD) into the intrauterine wall between the uterine cavity after operation, which played some physical barrier isolation effect. 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 postoperative repeated treatment rate was high. This is because the isolation area of IUD is too small, the configuration and material are not soft enough, and it is a foreign body, which may cause excessive inflammatory reaction. There are also risks of abnormal bleeding, intrauterine infection, impaction and uterine perforation, etc. It is very troublesome to take it out again.

[0006] In order to improve the shortcomings of IUD used for TCRA after operation to prevent intrauterine re-adhesion, Xu Dabao et al. published a modified palace-shaped IUD as a physical barrier isolation support in Chinese Utility Model CN-201189193y (2008) and CN-202537620U (2012). The elastic palace-shaped ring is used as the frame, and the nylon film is sewn in the middle. But so far there is no report on its clinical application.

[0007] After 1970s, gynecologists used the easily available silicone or natural rubber balloon catheter (Foley catheter) as a physical barrier to isolate the stent, put it into the uterine cavity after hysteroscopic surgery or TCRA, to prevent the occurrence of postoperative intrauterine adhesion or re-adhesion, and can drain the intrauterine bleeding and inflammatory exudate, reduce the chance of infection. Studies have found that the improvement rate of menstruation reaches 81.4-95.0%, and reduces the formation of re-adhesion. However, the shape of the balloon does not match the uterine cavity, and it is difficult to achieve complete isolation of the wound. When the balloon pressure is too high, it will excessively compress the endometrium, causing endometrial ischemic necrosis and affecting endometrial repair and regeneration. In addition, the Foley catheter needs to be connected to a drainage bag after being introduced from the vaginal orifice to the outside of the body, and it is adhered to the surface of the thigh, which hinders the patient's physical activity and is very uncomfortable. When moving, the catheter will be pulled, causing the balloon to move in the uterine cavity.

[0008] Gynecologists and medical device manufacturers have continued to improve the shape of the Foley catheter to better fit the uterine cavity over the past decade. Cook Medical introduced a Cook balloon uterine stent called Cook balloon. It is a triangular balloon that mimics the shape of the uterine cavity, also known as a heart-shaped balloon catheter, made of silicone rubber. It increases the contact area of the balloon with the inner wall of the uterine cavity and reduces the pressure of the balloon on the inner wall of the uterine cavity. Its research data is 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 Lei, China modern drug application, 2016, vol. 10, No. 6, 82-83, reported that 134 cases of moderate and severe IUA were treated with TCRA and placed Cook balloon for 2-3 months, which proved that long-term placement was effective, the pressure was balanced, and bleeding was not easy. The cumulative pregnancy rate was 60.48%, and the live birth rate was 20.90%. But found that 15 cases of triangular balloon moved down or out, and also did not set up drainage tube. Because when the balloon is put into the uterine cavity, the triangular balloon needs to be rolled longitudinally to the smallest diameter of 9 mm, the cervix is dilated with a 10 mm cervical dilator, and the balloon tip is grasped with a toothless forceps and inserted from the cervical canal. Obviously, it is very difficult to put it in this way. There are many cases that 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 such biomedical gels into the uterine cavity after TCRA or injecting them into the uterine cavity after placing an IUD or a Foley catheter to increase the physical barrier isolation and lubrication and anti-inflammatory and antibacterial effects. The disadvantage of this treatment is that biomedical gels are high-viscosity fluid states, have a short residence time in the uterine cavity, and will slowly flow out of the uterine cavity. In recent years, some clinical studies have been published. For example: [1] Xiaosushu et al. Chinese Journal of Obstetrics and Gynecology, 2015, Vol. 50, No. 1, pp. 32-36. [2] Huang Yaming, Duanhua et al. Journal of Chongqing Medical University, 2017, Vol. 42, No. 4, pp. 445.

[0010] In the past decade, gynecologists and biomedical material experts have thought that a biomedical membrane with certain geometric shape, appropriate mechanical strength and contact with flesh, and excellent tissue affinity could be used as a physical barrier isolation membrane for TCRA postoperative anti-re-adhesion, wrapped on an IUD or a Foley catheter, and placed in the uterine cavity between the TCRA surgical wounds to prevent re-adhesion and promote endometrial repair and regeneration. Such clinical studies, especially those using human amniotic membrane as a medical anti-adhesion membrane, are expected to make a breakthrough. The research of Egyptian doctor Amer, MI. and Chinese doctor Duanhua et al. is noteworthy. The clinical research data are as follows: [1] Amer, MI. et al. J. Obstet. Gynecology Res., 2006, vol. 32, No. 6, pp. 559-566. [2] Amer, MI et al. J. of minimally Invasive Gynecology, 2010, vol. 17, No. 5, pp. 605-611. [3] Zhang Ran, Duanhua. Chinese Journal of Obstetrics and Gynecology, 2012, Vol. 47, No. 6, pp. 470-472. [4] Wang Yin, Duanhua. Chinese Journal of Obstetrics and Gynecology, 2016, Vol. 51, No. 1, pp. 27-30. The above clinical studies found that the IUD or the Foley catheter is not suitable in terms of geometric configuration and flesh texture for the human uterine cavity, and the isolation area is not large enough to smoothly spread the human amniotic membrane in the uterine cavity. Practical new type content

[0011] The purpose of the utility model is to prevent gynecological hysteroscopic surgery or minimally invasive gynecological hysteroscopic adhesion separation surgery from causing endometrial trauma in the uterine cavity, leading to endometrial adhesion or re-adhesion, and to wrap a medical anti-adhesion membrane on a silicone rubber support.

[0012] The technical scheme adopted by the utility model discloses the following: the medical anti-adhesion film wrapped silicon rubber support is a triangular silicon rubber support frame with a molded flash film in the center, and the two surfaces are wrapped with medical anti-adhesion film, becoming an anti-adhesion film composite support, the triangular configuration and mechanical characteristics thereof are adapted to the anatomical form of the uterine cavity, and a larger area perfectly isolates the two uterine cavity membranes of the surgical trauma.The surface of the medical anti-adhesion film has good tissue affinity with the two uterine cavity membranes of the surgical trauma.The medical anti-adhesion film wrapped silicon rubber support also has a special and ingenious mechanical structure and mechanical behavior, and is provided with an auxiliary surgical use tool accessory and a drainage tube.The medical anti-adhesion film wrapped silicon rubber support can be easily and gently inserted into the uterine cavity from the cervical orifice in an elongated strip shape, and automatically retracts to the triangular configuration after release, and is not easy to move, thereby playing the role of uterine cavity trauma isolation.The bleeding and inflammatory exudate of the uterine cavity trauma can be drained to the outside of the cervical orifice through the drainage tube, and then automatically flows out of the body through the vagina and is absorbed by a sanitary towel.The entire support and drainage tube can be easily and gently taken out of the body by the doctor after treatment.

[0013] The utility model discloses the following: the triangular silicon rubber support frame with a molded flash film in the center is made of medical grade silicon rubber with good biocompatibility and soft mechanical properties, and the two surfaces of the support frame are wrapped with medical anti-adhesion film with good tissue affinity, becoming a support wrapped with anti-adhesion film.The support has special and ingenious mechanical properties, can be elongated into an elongated strip shape, and automatically retracts to the triangular configuration after release, and can be smoothly spread between the uterine cavity membranes of the uterine cavity surgery or TCRA surgery trauma after being inserted into the uterine cavity, thereby playing the role of perfect physical barrier isolation.The surface of the medical anti-adhesion film with good tissue affinity contacts the uterine cavity membranes of the surgical trauma, thereby being beneficial to the repair and regeneration of the uterine cavity membranes.The medical anti-adhesion film is made of natural biological medical material, and can be made of human placental amniotic membrane, collagen membrane, sodium hyaluronate membrane, chitosan membrane or natural silk fabric.These natural biological medical materials have been widely used in artificial skin, wound dressing, artificial cornea, tissue growth guide film, tissue engineering support, joint lubrication and facial cosmetic surgery, and are safe, effective and easy to obtain.The soft plastic push rod with a groove at the end, the pull wire and the silicon rubber drainage tube are accessories of the composite anti-adhesion support, and are convenient for the surgeon to use and dispose of the new medical device.

[0014] The utility model discloses the following: the triangular silicon rubber support frame with a molded flash film in the center is made of medical grade silicon rubber with good biocompatibility and soft mechanical properties, and the two surfaces of the support frame are wrapped with medical anti-adhesion film with good tissue affinity, becoming a support wrapped with anti-adhesion film.The support has special and ingenious mechanical properties, can be elongated into an elongated strip shape, and automatically retracts to the triangular configuration after release, and can be smoothly spread between the uterine cavity membranes of the uterine cavity surgery or TCRA surgery trauma after being inserted into the uterine cavity, thereby playing the role of perfect physical barrier isolation.The surface of the medical anti-adhesion film with good tissue affinity contacts the uterine cavity membranes of the surgical trauma, thereby being beneficial to the repair and regeneration of the uterine cavity membranes.The medical anti-adhesion film is made of natural biological medical material, and can be made of human placental amniotic membrane, collagen membrane, sodium hyaluronate membrane, chitosan membrane or natural silk fabric.These natural biological medical materials have been widely used in artificial skin, wound dressing, artificial cornea, tissue growth guide film, tissue engineering support, joint lubrication and facial cosmetic surgery, and are safe, effective and easy to obtain.The soft plastic push rod with a groove at the end, the pull wire and the silicon rubber drainage tube are accessories of the composite anti-adhesion support, and are convenient for the surgeon to use and dispose of the new medical device. BRIEF DESCRIPTION OF DRAWINGS

[0015] ATTACHMENT Figure 1The composition of the medical anti-adhesion membrane wrapped silicon rubber stent for preventing postoperative adhesion and drainage.

[0016] Figure: 1. Molding flash film. 2. Triangular silicon rubber stent frame.

[0017] 3. Medical anti-adhesion film. 4. Anti-adhesion composite stent.

[0018] 5. Round hole. 6. Soft plastic push rod.

[0019] 7. Pull wire. 8. Silicon rubber drainage tube.

[0020] Figure Figure 2 The medical anti-adhesion membrane wrapped silicon rubber stent is longitudinally lengthened and transversely folded into an elongated strip.

[0021] Figure Figure 3 After the medical anti-adhesion membrane wrapped silicon rubber stent is released into the uterine cavity, it automatically retracts and restores to a triangular configuration. DETAILED DESCRIPTION

[0022] Preferred embodiment of the utility model: according to the design of the attached Figure 1 , adopt the low hardness, high elasticity medical grade silicon rubber new material with excellent biocompatibility and mechanical compliance, and the mold is manufactured according to the shape structure design of the triangular silicon rubber stent frame (2). The triangular silicon rubber stent frame (2) with triangular configuration is manufactured by hot molding vulcanization process, and the thickness of the molding flash film (1) in the middle is still 0.01-0.05 millimeters. Then two pieces of medical anti-adhesion film (3) soaked in sterile physiological saline and softened are wrapped on both sides of the triangular silicon rubber stent frame (2) with molding flash film (1). The anti-adhesion composite stent (4) is formed by suturing and fixing at A, B, C, D, E, F points with surgical suture. A round hole (5) with a diameter of 5 millimeters is punched at the G point position of the anti-adhesion composite stent (4). Two soft pull wires (7) are sleeved on the ring bolt at the H point position.

[0023] The surgeon inserts the anti-adhesion composite stent (4) and drainage tube (8) into the uterine cavity of the patient after performing uterine cavity surgery or TCRA surgery according to the method shown in the attached Figure 2 and the attached Figure 3 , a soft plastic push rod (6) with a concave groove at the end can be used to hold the position of the round hole (5) and pull the pull wire (7) at the same time, and the anti-adhesion composite stent (4) is longitudinally lengthened and transversely folded into an elongated strip according to the attached Figure 2 . Then it is pushed into the top of the uterine cavity through the cervical canal from the cervical orifice, and automatically retracts and restores to a triangular shape after release, smoothly spreading between the inner walls of the uterine cavity, becoming the attached Figure 3The upper open end of the drainage tube (8) is located at the lower corner of the anti-adhesion composite stent (4). The lower outlet end is located outside the cervical orifice. The free end of the pull wire (7) is also located outside the cervical orifice. In this way, the silicone drainage tube (8) can smoothly drain the bleeding and inflammatory secretions of the hysteroscopic surgical wound outside the cervical orifice and into the vagina, which is absorbed and removed by sanitary napkins. After the completion of the hysteroscopic or TCRA surgical treatment, the entire anti-adhesion composite stent (4) and silicone drainage tube (8) need to be removed, and the doctor can easily and gently pull the pull wire (7) outward.

Claims

1. A medical anti-adhesion film-coated silicone stent for preventing postoperative adhesion and drainage in uterine cavity surgery, characterized by comprising a silicone stent coated with a medical anti-adhesion film on the surface thereof. Its main body is composed of a triangular type of silicone rubber support frame (2) with a die flash film (1), a medical anti-adhesion film (3), an anti-adhesion composite support (4), a pull wire (7), and a silicone rubber drainage tube (8).

2. The medical anti-adhesion membrane-encased silicone rubber stent for prevention of postoperative adhesion and drainage of uterine cavity according to claim 1, characterized in that, The triangular type of silicone rubber support frame (2) is provided with a die flash film (1) in the center, and the thickness is 0.01-0.05 mm.

3. The medical anti-adhesion membrane-encased silicone rubber stent for prevention of postoperative adhesion and drainage of uterine cavity according to claim 1, characterized in that, The medical anti-adhesion film (3) is selected from one of human placental amniotic membrane, bone collagen membrane, sodium hyaluronate membrane, chitosan membrane, and natural silk fabric.

4. The medical anti-adhesion membrane-encased silicone rubber stent for prevention of postoperative adhesion and drainage of uterine cavity according to claim 1, characterized in that, The silicone rubber drainage tube (8) is connected to the lower corner of the triangular type of silicone rubber support frame (2) through the pull wire (7), the upper opening end of the silicone rubber drainage tube (8) is located at the lower corner of the triangular type of silicone rubber support frame (2), and the lower outlet end of the silicone rubber drainage tube (8) is located outside the cervical port after being placed in the uterine cavity.

5. The medical anti-adhesion membrane-encased silicone rubber stent for prevention of post-hysteroscopic adhesion and drainage according to claim 1, wherein, The anti-adhesion composite support (4) is also provided with a soft plastic push rod (6) with a groove at the front end and a pull wire (7), so that the surgeon can longitudinally lengthen and transversely fold the anti-adhesion composite support (4) into an elongated strip, gently push it into the uterine cavity, automatically retract and restore after release, smoothly spread in the uterine cavity and not easily move, and also facilitate the surgeon to pull the pull wire (7) to take out the anti-adhesion composite support (4) and the silicone rubber drainage tube (8) out of the body when necessary.

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