Method and device for preparing Munyule ring based on Gemman-Man placement

Abstract

The invention discloses a method and a device for preparing a Maniyle ring based on a Gigabit-Maniyle placement technology. The method comprises the following steps: preprocessing the Maniyle ring and a Gigabit ring; preparing expanded pellets, and spraying heat-sensitive hydrogel on the surfaces of the expanded pellets; the surface modifier is used for modifying the heat-sensitive hydrogel, so that the expanded globules are not adhered to the muscular layer at the bottom of the uterus; and assembling the Mangyule ring, the Gamstone ring and the small expansion ball to form an integrated structure. The invention provides a method and a device for preparing a Maniyle ring based on Gemnant-Memnant placement, which are characterized in that the Maniyle ring and a Gemnant ring are cut off and pretreated, an expansion ball with a heat-sensitive hydrogel coating is prepared and modified to enhance the anti-blocking property, and finally the Maniyle ring, the Gemnant ring and the expansion ball are assembled into an integrated structure. According to the invention, integration of a Munyle ring fixing mechanism and a Gignette ring fixing mechanism is realized, the operation preparation process is simplified, the stability of the intrauterine device is improved, and the risk and trauma during taking out of the intrauterine device are reduced.

Description

Technical Field

[0001] The present invention relates to the technical field of contraception, and in particular to a preparation method and device of a Mirena ring based on the Gilead-Mann placement technique. Background Art

[0002] The Gilead-Mann placement procedure is a modified Mirena IUD placement procedure that combines the features and advantages of the Mirena IUD and the Gilead IUD, providing a new treatment option for female patients.

[0003] The Guinea Ring is a stentless, fixed intrauterine contraceptive device consisting of 6 small copper tubes connected in series on a polypropylene biological suture with a Guinea knot on the top. When placed, the Guinea knot is fixed in the myometrium of the fundus of the uterus, thereby achieving stable fixation of the device in the uterine cavity.

[0004] Mirena IUD is an intrauterine contraceptive system containing levonorgestrel, which is widely used for contraception and treatment of various gynecological diseases, such as menorrhagia, dysmenorrhea, endometriosis and adenomyosis.

[0005] According to the existing technology, the Mirena ring is T-shaped, with two horizontal arms as a bracket to support the position of the entire ring body in the uterine cavity. A cylindrical drug reservoir is provided on the longitudinal arm, which contains levonorgestrel. Levonorgestrel is a highly effective progestin that can be continuously and stably released into the uterine cavity, thereby exerting contraceptive and therapeutic effects.

[0006] Based on the respective advantages of the Generic Ring and the Mirena Ring, the Generic Ring placement technique combines the Mirena Ring with the Generic Ring and uses the Generic Ring's fixing device to enhance the stability of the Mirena Ring in the uterine cavity, thereby effectively solving the problem of Mirena Ring falling out in patients with large uterine cavities or abnormal uterine cavity morphology. However, the implementation of the Generic Ring placement technique still relies on manual operation by medical staff, which may have certain errors and risks, and requires medical staff to have rich experience and superb skills. In addition, since these two contraceptive devices are placed in the uterus for a long time, the risk of surgical removal is increased.

[0007] Therefore, it is necessary to improve the preparation method and device of Mirena ring based on the Gilman placement technique in the prior art to solve the above problems. Summary of the invention

[0008] The present invention overcomes the deficiencies of the prior art and provides a method and device for preparing a Mirena IUD based on the Gilman insertion technique, aiming to solve the problems of the prior art in which the surgical preparation of the device is complicated, the contraceptive device is unstable, and there is trauma during removal.

[0009] To achieve the above-mentioned purpose, the technical solution adopted by the present invention is: a Mirena ring device based on the Gilles-Mann placement technique, comprising: an expansion ball;

[0010] The expandable ball comprises: a ball core, a thermosensitive hydrogel sprayed on the ball core, and a surface modifier sprayed on the thermosensitive hydrogel, and the expandable ball can absorb water and expand at a phase change temperature;

[0011] The diameter of the ball core is 2-3 mm, the ball core is spherical, a groove is arranged at the bottom of the ball core, two hooks are arranged inside the groove, and the hooks are respectively connected to the tail wire of the Mirena ring and the wire of the Gini ring;

[0012] The Mirena ring and the expansion ball are placed in a hollow push tube. A hollow push rod is provided at the bottom of the Mirena ring. The tubular drug reservoir of the Mirena ring is a hollow structure. A push pin passes through the Mirena ring from the hollow push rod and is connected to the groove of the expansion ball.

[0013] In a preferred embodiment of the present invention, the expansion ball is 1.5 cm away from the Mirena ring and the Genie ring.

[0014] The present invention provides a method for preparing a Mirena ring based on the Gilles-Mann placement technique:

[0015] S1, pre-treatment of Mirena and Genie rings;

[0016] S2, preparing expansion balls, and spraying thermosensitive hydrogel on the surface of the expansion balls;

[0017] S3, modifying the thermosensitive hydrogel by using a surface modifier so that the expanded balls do not adhere to the myometrium of the uterine fundus;

[0018] S4. Assemble the Mirena ring, the Genie ring and the expansion ball to form an integrated structure.

[0019] In a preferred embodiment of the present invention, in step S1, the horizontal arm of the Mirena ring is cut off, leaving only the tubular drug reservoir of the Mirena ring; and the sleeves of the second to sixth sections of the Genie ring are cut off.

[0020] In a preferred embodiment of the present invention, in step S2, the step of preparing the thermosensitive hydrogel comprises:

[0021] S21, dissolving N-isopropylacrylamide, a crosslinking agent and an initiator in pure water, and mixing them evenly to form a premix; wherein the mass ratio of N-isopropylacrylamide, the crosslinking agent and the initiator is 50-200:1-10:5-20; the crosslinking agent is N,N'-methylenebisacrylamide; and the initiator is ammonium persulfate;

[0022] S22, adding a pH adjusting solution to the premix to make a neutral solution; the concentration of the pH adjusting solution is 0.1-0.3%;

[0023] S23, heating the neutral solution to 50-75° C. in vacuum and maintaining for 2-4 hours to obtain a hydrogel and then cooling to room temperature;

[0024] S24, washing the hydrogel with pure water and then vacuum drying it.

[0025] In a preferred embodiment of the present invention, the phase transition temperature of the thermosensitive hydrogel is 36-37°C.

[0026] In a preferred embodiment of the present invention, in step S2, the step of spraying the thermosensitive hydrogel on the small balls comprises:

[0027] S25, re-dissolving the dried thermosensitive hydrogel in pure water; pre-heating the pure water to 2-4°C below the phase transition temperature of the hydrogel, slowly adding the dried hydrogel, and continuously stirring until it is completely dissolved;

[0028] S26, spraying the thermosensitive hydrogel solution evenly on the surface of the ball; the coating of the thermosensitive hydrogel is 0.5-1 mm;

[0029] S27. After spraying is completed, the thermosensitive hydrogel is solidified.

[0030] In a preferred embodiment of the present invention, in step S3, the surface modifier is one of polyethylene glycol and polyvinyl alcohol.

[0031] In a preferred embodiment of the present invention, the molecular weight of the surface modifier is 1000-4000 Da, and the dosage is 1-3 wt %.

[0032] In a preferred embodiment of the present invention, the surface modifier is evenly sprayed on the surface of the thermosensitive hydrogel, the modified film thickness is 1-3 μm, and dried at 20-25° C. for 1-2 hours to prepare a complete expanded ball.

[0033] The present invention solves the defects existing in the background technology and has the following beneficial effects:

[0034] (1) The present invention proposes a method and device for preparing a Mirena ring based on the Gilead-Mann placement technique, wherein the Mirena ring and the Genesis ring are cut off and pre-treated, an expandable ball with a thermosensitive hydrogel coating is prepared and modified to enhance its anti-adhesion property, and finally the Mirena ring, the Genesis ring and the expandable ball are assembled into an integrated structure, thereby realizing the integrated integration of the Mirena ring and the Genesis ring fixation mechanism, simplifying the surgical preparation process, improving the stability of the contraceptive device, and reducing the risk and trauma during removal.

[0035] (2) The present invention combines the preparation of thermosensitive hydrogel and surface modification in steps S2 and S3 to achieve intelligent expansion and anti-adhesion performance of the expandable spheres; in step S2, a thermosensitive hydrogel with a specific phase transition temperature is prepared and sprayed on the core surface of the spheres. When the expandable spheres contact the myometrium of the human uterus, the hydrogel expands due to the increase in temperature to the phase transition temperature, so that the spheres are firmly fixed in the holes of the myometrium of the uterus; in step S3, the thermosensitive hydrogel is modified by spraying a surface modifier to improve its anti-adhesion to the myometrium, ensuring that when the Mirena and Genie rings need to be removed, the expandable spheres can be smoothly separated from the myometrium of the uterus, reducing the risk of surgical trauma and postoperative complications; this combination enables the expandable spheres to have both the function of intelligent expansion and good anti-adhesion performance, providing a strong guarantee for the stable placement and subsequent removal of the contraceptive device.

[0036] (3) The present invention uses expansion balls as the key components of the present invention. The expansion function of the expansion balls implanted in the human body is achieved by spraying thermosensitive hydrogel and surface modifier in steps S3 and S4, so that the IUD can remain stable and applicable under special uterine cavity conditions, including uterine enlargement and loose cervical os. Compared with the prior art, the use of expansion balls not only improves the fixation effect of the IUD, but also reduces the risks of downward movement, falling off or perforation of the IUD caused by poor uterine cavity conditions, further improves the use effect of the IUD and patient satisfaction, and avoids the situation where it is difficult to remove the fixing parts during surgery and the need to expand the wound.

[0037] (4) In step S4 of the present invention, the Mirena IUD, the Generic IUD and the expansion ball are assembled into an integrated structure, which simplifies the number and complexity of surgical preparation instruments and enables the doctor to complete the placement and fixation of the contraceptive device more quickly during the operation, thereby shortening the operation time and improving the operation efficiency. Compared with the prior art, the design of this integrated structure reduces the number of operating steps and potential human errors during the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art are briefly introduced below. Obviously, the drawings described below are only some embodiments recorded in the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work.

[0039] Figure 1 is a flow chart of a preferred embodiment of the present invention;

[0040] Figure 2 is a three-dimensional structural diagram of a preferred embodiment of the present invention;

[0041] Figure 3 It is a structural diagram of an expanded ball of a preferred embodiment of the present invention;

[0042] In the figure: 1. push cylinder; 2. hollow push rod; 3. Mirena ring; 4. expansion ball; 5. thimble; 6. tail thread of Mirena ring; 7. thread of Guinea ring; 8. Guinea ring; 9. groove; 10. hook. DETAILED DESCRIPTION

[0043] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0044] In the following description, many specific details are set forth to facilitate a full understanding of the present invention, but the present invention may also be implemented in other ways different from those described herein. Therefore, the protection scope of the present invention is not limited to the specific embodiments disclosed below.

[0045] In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the scope of protection of the present application. In addition, the terms "first", "second", etc. are only used for descriptive purposes, and cannot be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, features defined as "first", "second", etc. may explicitly or implicitly include one or more of the features. In the description of the invention, unless otherwise specified, "multiple" means two or more.

[0046] In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "connected", and "connected" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood by specific circumstances.

[0047] Application Overview

[0048] Mirena, an intrauterine contraceptive system containing levonorgestrel, is not only effective for contraception, but can also be used to treat various gynecological diseases such as menorrhagia, dysmenorrhea and endometriosis. On the other hand, the Ginie ring, with its unique stentless design and stable fixation in the uterine cavity, provides new possibilities for the application of intrauterine contraceptive devices. The Ginie-Mann placement technique combines the advantages of these two intrauterine contraceptive devices to improve the stability and applicability of the Mirena ring under special uterine cavity conditions.

[0049] Although the Gilead placement technique enhances the stability of the Mirena IUD through the fixation mechanism of the Gilead knot, there are still some limitations in practical applications: the traditional Gilead placement technique is highly dependent on the experience and skills of medical staff, which can easily lead to deviations in the preparation process of the two, affecting the effectiveness of the contraceptive device; the long-term placement of these two types of contraceptive devices in the uterus increases the risk of surgical removal, especially the Gilead knot is embedded in the myometrium of the fundus of the uterus and adheres to it, increasing the difficulty and risk of surgical removal. When removing the Gilead knot, it is necessary to enlarge the incision, which will increase the surgical trauma, thereby increasing the risk of postoperative bleeding and infection, and the postoperative recovery time may be prolonged accordingly.

[0050] In view of the above-mentioned deficiencies in the prior art, the present invention proposes a method and device for preparing the Mirena ring based on the Gilead-Mann placement technique, aiming to achieve the integrated integration of the Mirena ring and the Gilead fixation mechanism, thereby simplifying the time for surgical preparation of instruments and reducing the risk of removing the contraceptive device.

[0051] Exemplary Methods

[0052] like Figure 1 As shown, a method for preparing Mirena ring based on Gilead-Mann placement technique comprises the steps of:

[0053] S1, pre-treatment of Mirena and Genie rings;

[0054] S2, preparing expansion balls, and spraying thermosensitive hydrogel on the surface of the expansion balls;

[0055] S3, modifying the thermosensitive hydrogel by using a surface modifier so that the expanded balls do not adhere to the myometrium of the uterine fundus;

[0056] S4. Assemble the Mirena ring, the Genie ring and the expansion ball to form an integrated structure.

[0057] The entire application process is carried out in a sterile environment to avoid cross infection.

[0058] Mirena IUD, also known as the levonorgestrel-releasing intrauterine system, not only has contraceptive effects, but can also treat abnormal uterine bleeding, dysmenorrhea, endometriosis and adenomyosis; however, among the above-mentioned gynecological diseases, some women also have symptoms of uterine enlargement, loose cervical os and severe cervical tearing, which leads to the fact that when using Mirena IUD alone, it is impossible to fix it in the uterus only by the support of the cross arm of the Mirena IUD, and the Mirena IUD is prone to moving down and falling off. To avoid this situation, the existing technology requires the use of drugs that promote uterine shrinkage as premedication when placing the Mirena IUD. However, premedication may have the possibility of adverse reactions. Therefore, the combination of Mirena IUD and Genesis IUD is chosen, and the Genesis IUD plays a role of fixing the whole.

[0059] In step S1, the horizontal arm of the Mirena ring is cut off, and only the tubular drug reservoir of the Mirena ring is retained; the sleeves of the second to sixth sections of the Genie ring are cut off;

[0060] Dip sterile gauze in 0.9% saline or distilled water, wipe the surface and cut edges of the Mirena and Genie rings, remove dust and impurities on the surface, and ensure that there are no burrs on the cut edges; soak sterile gauze in 3% hydrogen peroxide solution, and apply it to the surface of the Mirena and Genie rings for 1-2 minutes; rinse the Mirena and Genie rings with 0.9% saline or distilled water, and wipe the surface dry.

[0061] The prior art often uses the tail wire of the Mirena ring and the knot of the Guinea ring to fix together to form a Guinea knot, and then fix the Guinea knot in the hole opened in the myometrium of the fundus of the uterus. However, the material of the Guinea knot is medical-grade polypropylene thread. Since it is manually knotted by medical staff, pores are easily generated. After being embedded in the myometrium of the fundus of the uterus for a long time, the myometrium of the fundus of the uterus is easy to grow into the pores after recovery, causing the Guinea knot to adhere to the myometrium of the fundus of the uterus. This adhesion will increase the difficulty of removing the Guinea knot, resulting in the need to expand the incision, increasing the risk of surgical trauma and postoperative complications.

[0062] To this end, the present application proposes to prepare an expandable ball to replace the Guinea knot to fix the Mirena ring and the Guinea ring; when this expandable ball needs to contact the myometrium of the fundus of the uterus, it will expand and be fixed in the hole opened in the myometrium of the fundus of the uterus to avoid slipping.

[0063] The expanded sphere includes a sphere core and a modified thermosensitive hydrogel;

[0064] In step S2, the ball core, as a carrier of the thermosensitive hydrogel, needs to have good mechanical strength so as to maintain its shape during expansion and to be well combined with the thermosensitive hydrogel; the material of the ball core is one of medical grade silicone or polyurethane; the diameter of the ball core is 2-3 mm, the ball core is spherical, a groove is provided at the bottom, and two hooks are provided inside the groove, which are respectively connected to the tail wire of the Mirena ring and the wire of the Gini ring; the design of the groove facilitates the insertion of the thimble to accurately push the ball into the hole in the myometrium of the bottom of the uterus;

[0065] In step S2, the steps of preparing the thermosensitive hydrogel include:

[0066] S21, dissolving N-isopropylacrylamide, a crosslinking agent and an initiator in pure water, and mixing them evenly to form a premix; wherein the mass ratio of N-isopropylacrylamide, the crosslinking agent and the initiator is 50-200:1-10:5-20; the crosslinking agent may be N,N'-methylenebisacrylamide; and the initiator may be ammonium persulfate;

[0067] S22, adding a pH adjusting solution to the premix to make a neutral solution; the concentration of the pH adjusting solution is 0.1-0.3%;

[0068] S23, heating the neutral solution to 50-75° C. in vacuum and maintaining for 2-4 hours to obtain a hydrogel and then cooling to room temperature;

[0069] S24, washing the hydrogel with pure water and then vacuum drying;

[0070] In order to make the myometrium at the bottom of the human uterus expand when in contact, the phase transition temperature of the thermosensitive hydrogel is 36-37°C;

[0071] In step S2, the step of spraying the thermosensitive hydrogel on the small balls includes:

[0072] S25, re-dissolving the dried thermosensitive hydrogel in pure water; pre-heating the pure water to 2-4°C below the phase transition temperature of the hydrogel, slowly adding the dried hydrogel, and continuously stirring until it is completely dissolved;

[0073] S26, spraying the thermosensitive hydrogel solution evenly on the surface of the ball core; the coating of the thermosensitive hydrogel is 0.5-1 mm;

[0074] S27. After spraying, solidify the core of the ball; place it at 20-25 degrees Celsius to solidify for 5-8 hours.

[0075] In order to prevent the expansion balls from adhering to the myometrium of the uterine fundus, thereby ensuring that the expansion balls can be smoothly detached from the myometrium of the uterine fundus when the Mirena and Genie rings need to be removed, thereby reducing the risk of surgical trauma and postoperative complications; the thermosensitive hydrogel needs to be surface modified to improve the anti-adhesion property of the thermosensitive hydrogel to the myometrium.

[0076] In step S3, the surface modifier is one of polyethylene glycol and polyvinyl alcohol for modification spraying;

[0077] Polyethylene glycol has good biocompatibility and hydrophilicity, which can improve the wettability and lubricity of hydrogels; polyvinyl alcohol has good film-forming properties and biocompatibility, which can form a protective film to reduce adhesion;

[0078] Specifically, the molecular weight of the surface modifier is 1000-4000Da, and the amount used is 1-3wt%;

[0079] A modified film with a thickness of 1-3 μm is uniformly sprayed on the surface of the thermosensitive hydrogel, and then dried at 20-25°C for 1-2 hours to prepare a complete expanded ball, which can achieve both expansion and anti-adhesion to the uterine myometrium.

[0080] In step S4, the expansion ball hook is fixedly connected to the tail thread of the Mirena ring and the line of the Genie ring, the material of the tail thread of the Mirena ring and the line of the Genie ring is medical grade polypropylene, and the three constitute a contraceptive component, wherein the expansion ball is 1.5 cm away from the Mirena ring and the Genie ring;

[0081] A hollow push tube needs to be prepared, in which the Mirena ring and the expansion ball are placed. A hollow push rod is provided at the bottom of the Mirena ring. The tubular drug reservoir of the Mirena ring is a hollow structure, and a push pin passes through the Mirena ring through the hollow push rod and is connected to the groove of the expansion ball.

[0082] When it is necessary to remove the ball, you can choose to remove it blindly, and directly pull the tail thread to pull out the ball. Because the hydrogel film on its surface has been modified, the adhesion with the myometrium of the bottom of the uterus has been reduced. Compared with the Gini knot of the existing technology, the wound has been relatively reduced; and the blind removal method is relatively simple, does not require complex equipment support, and reduces medical costs;

[0083] You can also choose to locate the position of the expansion ball with a probe under hysteroscopy, inject cold saline into the expansion ball to reduce its volume and remove it. Once the expansion ball shrinks, it is removed from the hole in the myometrium at the bottom of the uterus. This method further reduces the incision, but the medical cost increases. It is suitable for patients with other uterine lesions.

[0084] After removing the ball, use micro scissors to cut the connection point between the Mirena ring tail wire and the Genie ring line, and pull out the Mirena ring and Genie ring in turn, ensuring a smooth operation to avoid sudden pulling that may cause tissue damage.

[0085] Embodiment 1

[0086] A method for preparing a Mirena ring based on the Gilead-Mann placement technique comprises the following steps:

[0087] S1, pre-treatment of Mirena and Genie rings;

[0088] Cut off the horizontal arm of the Mirena ring and keep the cylindrical drug reservoir; cut off the sleeves of the second to sixth sections of the Genesis ring; use sterile gauze dipped in 0.9% saline to clean the surface and cut edges of the Mirena and Genesis rings to ensure that there are no burrs; soak sterile gauze with 3% hydrogen peroxide solution and apply it to the surface of the Mirena and Genesis rings for 2 minutes; rinse again with 0.9% saline and wipe the surface dry;

[0089] S2, preparing expansion balls, and spraying thermosensitive hydrogel on the surface of the expansion balls;

[0090] Medical grade silica gel was selected as the core material of the ball, with a diameter of 2.5 mm, and made into a spherical shape. A groove was designed at the bottom, and two hooks were set in the groove to connect the tail wire of the Mirena ring and the line of the Genie ring; N-isopropylacrylamide, N,N'-methylenebisacrylamide and ammonium persulfate were dissolved in pure water at a mass ratio of 100:5:10, and mixed evenly to form a premix; a 0.2% sodium hydroxide solution was added to neutrality; the premix was vacuum heated to 60°C and maintained for 3 hours to obtain a hydrogel and then cooled to room temperature; the hydrogel was washed with pure water and vacuum dried;

[0091] The dried hydrogel was redissolved in purified water preheated to 34°C and stirred continuously until completely dissolved;

[0092] The thermosensitive hydrogel solution was uniformly sprayed on the surface of the ball core, with a coating thickness of 0.7 mm; the sprayed ball core was placed at 22°C for curing for 6 hours;

[0093] S3, modifying the thermosensitive hydrogel by using a surface modifier so that the expanded balls do not adhere to the myometrium of the uterine fundus;

[0094] Polyethylene glycol was selected as a surface modifier with a molecular weight of 2000Da and a dosage of 2wt%; a layer of polyethylene glycol modified film with a thickness of 2μm was uniformly sprayed on the surface of the thermosensitive hydrogel; and the mixture was dried at 22°C for 1.5 hours to prepare anti-adhesion expanded spheres;

[0095] S4. Assemble the Mirena ring, the Genie ring and the expansion ball to form an integrated structure.

[0096] Embodiment 2

[0097] A method for preparing a Mirena ring based on the Gilman placement technique, the same points as those in Example 1 are not repeated here, and the difference between this embodiment and Example 1 is that;

[0098] The thickness of the thermosensitive hydrogel coating is 0.5 mm;

[0099] Embodiment 3

[0100] A method for preparing a Mirena ring based on the Gilman placement technique, the same points as those in Example 1 are not repeated here, and the difference between this embodiment and Example 1 is that;

[0101] The thickness of the thermosensitive hydrogel coating is 1 mm;

[0102] Embodiment 4

[0103] A method for preparing a Mirena ring based on the Gilman placement technique, the same points as those in Example 1 are not repeated here, and the difference between this embodiment and Example 1 is that;

[0104] The premix was heated under vacuum at 55°C;

[0105] Embodiment 4

[0106] A method for preparing a Mirena ring based on the Gilead-Mann placement technique, the same points as those in Example 2 are not repeated here, and the difference between this embodiment and Example 2 is that;

[0107] The premix was heated under vacuum at 55°C;

[0108] Embodiment 6

[0109] A method for preparing a Mirena ring based on the Gilead-Mann placement technique, the same points as those in Example 3 are not repeated here, and the difference between this embodiment and Example 3 is that;

[0110] The premix was heated under vacuum at 55°C;

[0111] Embodiment 7

[0112] A method for preparing a Mirena ring based on the Gilman placement technique, the same points as those in Example 1 are not repeated here, and the difference between this embodiment and Example 1 is that;

[0113] The premix was heated under vacuum at 65°C;

[0114] Embodiment 8

[0115] A method for preparing a Mirena ring based on the Gilead-Mann placement technique, the same points as those in Example 2 are not repeated here, and the difference between this embodiment and Example 2 is that;

[0116] The premix was heated under vacuum at 65°C;

[0117] Embodiment 9

[0118] A method for preparing a Mirena ring based on the Gilead-Mann placement technique, the same points as those in Example 3 are not repeated here, and the difference between this embodiment and Example 3 is that;

[0119] The premix was heated under vacuum at 65°C;

[0120] Embodiment 10

[0121] A method for preparing a Mirena ring based on the Gilman placement technique, the same points as those in Example 1 are not repeated here, and the difference between this embodiment and Example 1 is that;

[0122] The thickness of the polyethylene glycol-modified membrane was 1 μm;

[0123] Embodiment 11

[0124] A method for preparing a Mirena ring based on the Gilman placement technique, the same points as those in Example 1 are not repeated here, and the difference between this embodiment and Example 1 is that;

[0125] The thickness of the polyethylene glycol-modified membrane was 3 μm;

[0126] Comparative Example 1

[0127] A method for preparing a Mirena ring based on the Gilead-Mann placement technique, the same points as those in Example 1 are not repeated here, and the difference between this comparative example and Example 1 is that;

[0128] Do not spray thermosensitive hydrogels and polyethylene glycol;

[0129] Comparative Example 1

[0130] A method for preparing a Mirena ring based on the Gilead-Mann placement technique, the same points as those in Example 1 are not repeated here, and the difference between this comparative example and Example 1 is that;

[0131] Do not spray thermosensitive hydrogels and polyethylene glycol;

[0132] Comparative Example 2

[0133] A method for preparing a Mirena ring based on the Gilead-Mann placement technique, the same points as those in Example 1 are not repeated here, and the difference between this comparative example and Example 1 is that;

[0134] Do not spray polyethylene glycol.

[0135] Experimental Example 1

[0136] This experiment selected Examples 1 to 9 and Comparative Example 1 to test the expansion performance and anti-adhesion performance of the expanded balls;

[0137] The expansion rate of the expansion ball at 37°C is tested by measuring the change in diameter of the ball after it has been immersed in simulated body fluid or saline for a certain period of time. The expansion performance directly affects whether the ball can be effectively fixed in the holes in the myometrium of the uterine fundus, thereby ensuring the stable placement of the Mirena and Genie rings.

[0138] To evaluate the degree of adhesion between the expanded balls and the myometrium of the uterine fundus or the simulated uterine environment, the expanded balls are placed in a culture medium that simulates the uterine environment, and the degree of adhesion and ease of separation are observed and recorded. The adhesion area ratio and separation force can be used for evaluation. The quality of anti-adhesion performance is crucial to reducing postoperative adhesions and improving patient comfort.

[0139] Table 1 Expansion performance and anti-adhesion performance of the expanded balls of Examples 1 to 9 and Comparative Example 1

[0140]

[0141]

[0142] In Examples 1 to 9, the expansion rate is affected by the thickness of the thermosensitive hydrogel coating and the vacuum heating temperature of the premix. When the coating thickness is 0.7 mm, the expansion rate is relatively high and stable, while when the coating is too thin or too thick, the expansion rate decreases slightly. A moderate coating thickness can provide better hydrogel distribution and expansion effects; when the vacuum heating temperature of the premix is ​​60°C, the expansion rate is also relatively high and stable. When the temperature is too low or too high, the expansion rate decreases. An appropriate heating temperature helps to form a more uniform and stable hydrogel structure, while too high or too low will make the hydrogel structure unstable.

[0143] Experimental Example 1

[0144] This experiment selected Example 1, Example 10, Example 11 and Comparative Example 2 to test the expansion performance and anti-adhesion performance of the expanded balls;

[0145] Table 1 Expansion performance and anti-adhesion performance of the expanded balls of Examples 1, 10, 11 and Comparative Example 2

[0146]

[0147]

[0148] The expansion rate of Example 1 is 85%, the expansion rate of Example 10 is 87%, and the expansion rate of Example 11 is 82%. This shows that the thickness of the polyethylene glycol modified membrane has a certain effect on the expansion rate, but the effect is not particularly significant. The expansion rate of Example 10 is the highest because the thinner modified membrane has less restriction on the expansion of the hydrogel; the expansion rate of Comparative Example 2 reaches 90%, indicating that the expansion performance of the expanded ball is the best without the modified membrane because there is no additional layer to limit the expansion.

[0149] The adhesion area ratio of Example 1 is 6%, Example 10 is 8%, and Example 11 is 5%. The thickness of the modified membrane is effective in reducing the adhesion area, especially Example 11, which has the lowest adhesion area ratio, indicating that the thicker modified membrane can more effectively prevent the attachment of cells or tissues; the separation force of Example 1 is 0.7N, Example 10 is 0.9N, and Example 11 is 0.6N, indicating that the thickness of the modified membrane also has a positive effect on reducing the separation force. The separation force of Example 11 is the smallest, which means that it is easiest to separate from the myometrium of the fundus of the uterus.

[0150] In summary, the polyethylene glycol modified membrane not only helps to reduce the adhesion of the expansion ball to the myometrium of the uterine fundus, but also reduces the force required for separation, thereby reducing the harm to the patient during removal. At the same time, although the presence of the modified membrane may slightly reduce the expansion rate of the expansion ball, this sacrifice is worthwhile because it brings better anti-adhesion performance and higher safety. In Example 1, the combination of a thermosensitive hydrogel coating thickness of 0.7 mm and a polyethylene glycol modified membrane thickness of 2 μm exhibited good expansion performance and anti-adhesion performance.

[0151] The above is based on the ideal embodiment of the present invention. Through the above description, relevant personnel can make various changes and modifications without departing from the technical concept of the present invention. The technical scope of the present invention is not limited to the content in the specification, and the technical scope must be determined according to the scope of the claims.

Claims

1. A device for placing a Mirena ring based on the Gilles-Mann technique, comprising: The expansion ball is characterized by: The expandable ball comprises: a ball core, a thermosensitive hydrogel sprayed on the ball core, and a surface modifier sprayed on the thermosensitive hydrogel, and the expandable ball can absorb water and expand at a phase change temperature; The diameter of the ball core is 2-3 mm, the ball core is spherical, a groove is arranged at the bottom of the ball core, two hooks are arranged inside the groove, and the hooks are respectively connected to the tail wire of the Mirena ring and the wire of the Gini ring; The Mirena ring and the expansion ball are placed in a hollow push tube. A hollow push rod is provided at the bottom of the Mirena ring. The tubular drug reservoir of the Mirena ring is a hollow structure. A push pin passes through the Mirena ring from the hollow push rod and is connected to the groove of the expansion ball.

2. The device of Mirena IUD based on Gilles-Mann placement technique according to claim 1, characterized in that: The expansion ball is 1.5cm away from the Mirena ring and the Genie ring.

3. A method for preparing a Mirena ring based on Gilead-Mann placement technique, a device based on a Mirena ring based on Gilead-Mann placement technique according to any one of claims 1 to 2, characterized in that: S1, pre-treatment of Mirena and Genie rings; S2, preparing expansion balls, and spraying thermosensitive hydrogel on the surface of the expansion balls; S3, modifying the thermosensitive hydrogel by using a surface modifier so that the expanded balls do not adhere to the myometrium of the uterine fundus; S4. Assemble the Mirena ring, the Genie ring and the expansion ball to form an integrated structure.

4. The method for preparing the Mirena ring based on the Gilman placement technique according to claim 3, characterized in that: In step S1, the horizontal arm of the Mirena ring is cut off, and only the tubular drug reservoir of the Mirena ring is retained; and the tubular sleeves of the second to sixth sections of the Genie ring are cut off.

5. The method for preparing the Mirena ring based on the Gilead-Mann placement technique according to claim 3, characterized in that: In step S2, the steps of preparing the thermosensitive hydrogel include: S21, dissolving N-isopropylacrylamide, a crosslinking agent and an initiator in pure water, and mixing them evenly to form a premix; wherein the mass ratio of N-isopropylacrylamide, the crosslinking agent and the initiator is 50-200:1-10:5-20; the crosslinking agent is N,N'-methylenebisacrylamide; and the initiator is ammonium persulfate; S22, adding a pH adjusting solution to the premix to make a neutral solution; the concentration of the pH adjusting solution is 0.1-0.3%; S23, heating the neutral solution to 50-75° C. in vacuum and maintaining for 2-4 hours to obtain a hydrogel and then cooling to room temperature; S24, washing the hydrogel with pure water and then vacuum drying it.

6. The method for preparing the Mirena ring based on the Gilman placement technique according to claim 3, characterized in that: The phase transition temperature of the thermosensitive hydrogel is 36-37°C.

7. The method for preparing the Mirena ring based on the Gilead-Mann placement technique according to claim 3, characterized in that: In step S2, the step of spraying the thermosensitive hydrogel on the small balls includes: S25, re-dissolving the dried thermosensitive hydrogel in pure water; pre-heating the pure water to 2-4°C below the phase transition temperature of the hydrogel, slowly adding the dried hydrogel, and continuously stirring until it is completely dissolved; S26, spraying the thermosensitive hydrogel solution evenly on the surface of the ball; the coating of the thermosensitive hydrogel is 0.5-1 mm; S27. After spraying is completed, the thermosensitive hydrogel is solidified.

8. The method for preparing the Mirena ring based on the Gilead-Mann placement technique according to claim 3, characterized in that: In step S3, the surface modifier is one of polyethylene glycol and polyvinyl alcohol.

9. The method for preparing Mirena ring based on Gilead-Mann placement technique according to claim 1, characterized in that: The molecular weight of the surface modifier is 1000-4000Da, and the dosage is 1-3wt%.

10. The method for preparing the Mirena ring based on the Gilead-Mann placement technique according to claim 3, Features: The surface modifier is evenly sprayed on the surface of the thermosensitive hydrogel, and the thickness of the modified film is 1-3μm. Dry at 20-25°C for 1-2 hours to prepare a complete expanded ball.

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