A fixing structure for mirena

Abstract

This utility model discloses a fixation structure for Mirena, including a fixing harness with a connecting structure sleeved on the Mirena. The fixation structure includes an outer sheath tube inserted into the patient's uterus and a needle core inserted into the outer sheath tube. A puncture needle is fixed to the top of the needle core. A limiting structure is set inside the outer sheath tube. In use, the doctor can first insert the Mirena, which is pre-tied with the fixing harness, into the uterine cavity using medical instruments. After hysteroscopy confirms that the Mirena is in the correct position in the uterus, the outer sheath tube can be inserted into the uterine cavity via a bypass under the doctor's operation. The doctor can use the handle to push out the needle core, and then lock the front end of the needle core into the fixing knot at the front end of the fixing harness. The fixing knot and barbs at the front end of the fixing harness are then implanted into the myometrium in the center of the uterine fundus. The needle core is then removed. The operation is simpler, and the needle core is safer to operate under the limitation of the limiting structure.

Description

Technical Field

[0001] This utility model relates to the field of Mirena technology, specifically a fixing structure for Mirena. Background Technology

[0002] Adenomyosis is a condition caused by the invasion and growth of the endometrial lining (including glands and stroma) into the myometrium. The Chinese expert consensus on the diagnosis and treatment of adenomyosis indicates that the main clinical symptoms include menorrhagia (even leading to severe anemia), severe dysmenorrhea, and infertility, which seriously affect the patient's physical and mental health. It commonly affects women of remaining age, with an incidence rate of 7%-23%. Drug treatment is only temporarily effective, with symptoms recurring after discontinuation, requiring long-term use. Treatment options include: 1. Nonsteroidal anti-inflammatory drugs (NSAIDs); 2. Oral contraceptives; 3. Oral progestins; 4. Gonadotropin-releasing hormone agonists (GnRH-a); 5. Levonorgestrel-releasing intrauterine system (LNG-IUS); 6. Traditional Chinese medicine; and 7. Other medications that can reduce bleeding. Clinical applications have shown that LNG-IUS is effective for dysmenorrhea caused by adenomyosis, chronic pelvic pain, and menorrhagia. It has been recommended by multiple guidelines and recognized by patients. Its efficacy is superior to combined oral contraceptives and it can be used as the first-line treatment for patients with menorrhagia due to adenomyosis.

[0003] Endometrial hyperplasia is defined as endometrial hyperplasia exceeding the normal range of hyperplasia. It is divided into endometrial hyperplasia without atypical features and atypical endometrial hyperplasia, and is a common gynecological condition, most frequently seen in women of reproductive age. Progestins are the first-line treatment for endometrial hyperplasia without atypical features. Compared with expectant observation, progestin therapy has a higher remission rate and can reduce the risk of progression to malignancy and hysterectomy. The Chinese guidelines for the management of endometrial hyperplasia indicate that compared with oral progestins, LNG-IUS has a higher remission rate, lower recurrence rate, and fewer adverse events in endometrial hyperplasia without atypical features, making it the first-line progestin treatment option. For patients with atypical endometrial hyperplasia who have strong fertility requirements, are under 45 years of age, or cannot tolerate surgery, LNG-IUS treatment has a higher complete remission rate and lower recurrence rate compared to oral progestins, and can be used alone or in combination with GnRH-a. It also improves patient adherence and follow-up.

[0004] However, most Mirena IUDs currently used in China are inserted by securing them to the sides of the uterine wall. Since the uteruses of the two types of patients mentioned above are often large, this can easily lead to IUD dislodgement, unsatisfactory treatment results, or even endometrial malignancy, ultimately requiring hysterectomy. This consumes a significant amount of time, energy, and money, causing serious harm to the patient's physical and mental health. Furthermore, the current suture technique is difficult to operate; although it can secure the Mirena IUD, it requires sophisticated surgical instruments and is technically challenging. Therefore, we propose a fixation structure for Mirena IUDs to address this problem. Utility Model Content

[0005] The purpose of this invention is to provide a fixing structure for Mirena to solve the problems mentioned in the background art.

[0006] To achieve the above objectives, this utility model provides the following technical solution: a fixing structure for Mirena, including Mirena, and further comprising:

[0007] The connection structure includes a fixing harness sleeved on the Mirena to define the position of the Mirena;

[0008] The fixing structure includes an outer sheath body inserted into the patient's uterus and a needle core inserted into the outer sheath body. A puncture needle is fixed to the top of the needle core, and the puncture needle is connected to the fixing wire bundle.

[0009] A limiting structure, located inside the outer sheath, is used to limit the length by which the tip of the needle extends out of the outer sheath.

[0010] Preferably, the puncture needle has an "asymmetrical V" shape, and the two arms of the puncture needle are of different lengths, with the longer arm being 2mm long and the shorter arm being 1mm long.

[0011] Preferably, the fixing wire harness is made of 2-0 polypropylene non-absorbable wire. The front end of the fixing wire harness is made into a fixing knot and has a 2mm long barb. The fixing knot is sleeved between the two arms of the puncture needle. The tail end of the fixing wire harness is made into an adjustable collar. The length between the fixing knot and the adjustable collar is 1.3cm, and the adjustable collar made into the tail end of the fixing wire harness is sleeved on the outside of Mirena.

[0012] Preferably, the limiting structure includes a limiting tube and a limiting protrusion. The limiting tube is fixed to the outside of the needle core and slides through the inside of the outer sheath tube. The limiting protrusion is fixed to the top inner wall of the outer sheath tube and can contact the limiting tube. The vertical distance between the limiting tube and the limiting protrusion is 0.8 cm.

[0013] Preferably, the outer sheath is a hollow plastic tube with a total length of 20cm and an inner diameter of 2mm.

[0014] Preferably, the end of the needle core away from the puncture needle tip is fixed with a handle, and the handle is made of hard plastic.

[0015] Compared with the prior art, the beneficial effects of this utility model are:

[0016] 1. When using this utility model, the doctor can first insert the Mirena, which is pre-tied with a fixed wire harness, into the uterine cavity using medical equipment. After hysteroscopic examination confirms that the Mirena is in the correct position in the uterus, the external sheath can be inserted into the patient's uterine cavity via a bypass method under the doctor's operation. Subsequently, the doctor can use the handle to push out the needle core and lock the "asymmetrical V" of the needle core into the fixing knot at the front end of the fixed wire harness. Under direct hysteroscopic visualization, the fixing knot and barbs at the front end of the fixed wire harness are implanted into the myometrium in the center of the uterine fundus. The needle core is then pulled out, and if there is no obvious bleeding, the entire device is withdrawn under hysteroscopic monitoring. The tail string of the Mirena is then cut off near the cervix. The operation is simpler, and the needle core is safer to operate under the constraints of the limited structure.

[0017] 2. The puncture needle of this utility model can hold the fixation knot and puncture into the myometrium at the bottom of the uterus. The asymmetrical V-shaped structure of the needle tip makes puncture easier. After the barbs of the fixation knot enter the myometrium, they are tightly attached to the puncture site, thereby fixing the Mirena. The Mirena is more firmly fixed, avoiding the secondary injury to the patient caused by the Mirena falling off. Attached Figure Description

[0018] Figure 1 This is a schematic diagram showing the operation of the overall structure of this utility model after the Mirena is attached;

[0019] Figure 2 This is a schematic diagram of the outer sheath of this utility model;

[0020] Figure 3 This is a schematic diagram of the connection structure of this utility model;

[0021] Figure 4 This is a schematic diagram of the needle core of this utility model.

[0022] In the diagram: 1. Mirena; 2. Needle core; 3. Puncture needle; 4. Limiting tube; 5. Outer sheath; 6. Limiting protrusion; 7. Fixing harness; 8. Handle. Detailed Implementation

[0023] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention.

[0024] Please see Figure 1-4 This utility model provides a fixing structure for Mirena, including Mirena (1), and further including:

[0025] The fixing structure includes an outer sheath 5 inserted into the patient's uterus and a needle core 2 inserted into the outer sheath 5. A puncture needle 3 is fixed to the top of the needle core 2, and the puncture needle 3 is connected to the fixing wire bundle 7. The connection structure includes the fixing wire bundle 7 sleeved on the Mirena 1 to limit the position of the Mirena 1. The fixing wire bundle 7 is made of 2-0 polypropylene non-absorbable thread. The front end of the fixing wire bundle 7 is made into a fixing knot and has a 2mm long barb. The tail end of the fixing wire bundle 7 is made into an adjustable loop. The length between the fixing knot and the adjustable loop is 1.3cm. The adjustable loop made into the tail end of the fixing wire bundle 7 is sleeved on the top of the hormone storage tube of the Mirena 1. The adjustable loop can be used to bind the cross arm of the Mirena 1 to the connection position of the hormone storage tube. At the same time, the adjustable loop can also be adjusted, which makes it convenient for doctors to adjust the position of the Mirena 1 in the patient's uterine cavity.

[0026] The puncture needle 3 has an "asymmetrical V" shape, and its two arms are of different lengths, with the longer arm being 2mm long and the shorter arm being 1mm long. The fixing knot at the top of the fixing harness 7 is connected between the two arms of the puncture needle 3. This type of puncture needle 3 can hold the fixing knot and puncture into the myometrium at the bottom of the uterus. The asymmetrical V-shaped structure of the needle tip makes puncture easier. After the barbs of the fixing knot enter the myometrium, they are tightly attached to the puncture site, thereby achieving fixation of Mirena 1. Mirena 1 is more firmly fixed, avoiding secondary injury to the patient caused by Mirena 1 falling off.

[0027] A limiting structure, located inside the outer sheath 5, limits the length of the needle core 2 extending beyond the outer sheath 5. The limiting structure includes a limiting tube 4 and a limiting protrusion 6. The limiting tube 4 is fixed to the outside of the needle core 2 and slides through the inside of the outer sheath 5. The limiting protrusion 6 is fixed to the inner top wall of the outer sheath 5 and can contact the limiting tube 4. The vertical distance between the limiting tube 4 and the limiting protrusion 6 is 0.8 cm. The limiting protrusion 6 limits the limiting tube 4, ensuring that the needle core 2 can only extend 0.8 cm beyond the outer sheath, thus controlling the maximum puncture depth of the needle core 2 into the patient's uterine myometrium. The outer sheath 5 is a 20 cm long, 2 mm inner diameter hollow plastic tube. A handle 8 is fixed to the end of the needle core 2 furthest from the puncture needle tip 3, and the handle 8 is made of [material missing]. Made of rigid plastic, the device allows the doctor to insert the Mirena 1, pre-tied with a fixing harness 7, into the uterine cavity using medical instruments. After hysteroscopic examination confirms the Mirena 1 is in the correct position, the external sheath 5, under the doctor's guidance, carries the needle core 2 into the uterine cavity via a bypass approach. Subsequently, the doctor can use the handle 8 to push the needle core 2 out approximately 0.8 cm, securing the asymmetrical V-shaped tip of the needle core 2 into the fixing knot at the front of the fixing harness 7. Under direct hysteroscopic visualization, the fixing knot and barbs at the front of the fixing harness 7 are implanted into the myometrium at the center of the uterine fundus. The needle core 2 is then removed, and if no significant bleeding is observed, the entire device is withdrawn under hysteroscopic monitoring. The tail string of the Mirena 1 is cut approximately 1 cm from the cervix, and the hysteroscope is then withdrawn. Because these patients have a larger uterine cavity and a thicker myometrium, this device is relatively safe to use.

[0028] Working principle: First, the front end of the fixed wire harness 7 is made into a fixed knot and has a 2mm long barb. The tail end of the fixed wire harness 7 is made into an adjustable collar. The length between the fixed knot and the adjustable collar is 1.3cm. The adjustable collar made at the tail end of the fixed wire harness 7 is placed on the top of the hormone storage tube of Mirena 1. The adjustable collar can be used to bind the cross arm of Mirena 1 to the connection position of the hormone storage tube.

[0029] During use, the doctor can first insert the Mirena 1, which is pre-tied with a fixing harness 7, into the uterine cavity using medical equipment. After hysteroscopic examination confirms that the position of the Mirena 1 in the uterus is normal, the outer sheath 5 can be inserted into the patient's uterine cavity via a bypass method under the doctor's operation. Subsequently, the doctor can use the handle 8 to operate the needle core 2 to push the needle core 2 out of the outer sheath by about 0.8cm, and then use the "asymmetrical V" at the front end of the needle core 2 to lock it into the fixing knot at the front end of the fixing harness 7. Under direct hysteroscopic visualization, the fixing knot at the front end of the fixing harness 7 and the barbs are implanted into the myometrium in the center of the uterine fundus. The needle core 2 is then pulled out, and if there is no obvious bleeding, the entire device is withdrawn under hysteroscopic monitoring. The tail string of the Mirena 1 is cut off about 1cm from the cervix, and the hysteroscope is withdrawn. Because these patients have a larger uterine cavity and a thicker myometrium at the fundus, this device is relatively safe to use and easier to operate. The needle core 2 is safer under the constraints of the limited structure.

[0030] Furthermore, this type of puncture needle 3 can hold the fixation knot and puncture into the myometrium at the bottom of the uterus. The asymmetrical V-shaped structure of the needle tip makes puncture easier. After the barbs of the fixation knot enter the myometrium, they are tightly attached to the puncture site, thereby achieving fixation of Mirena 1. The fixation of Mirena 1 is more secure, avoiding the secondary injury to the patient caused by the fall off of Mirena 1.

[0031] Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or make equivalent substitutions for some of the technical features. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A fixing structure for Mirena, comprising Mirena (1), characterized in that: The connection structure includes a fixing harness (7) sleeved on the Mirena (1) for defining the position of the Mirena (1); The fixing structure includes an outer sheath (5) inserted inside the patient's uterus and a needle core (2) inserted inside the outer sheath (5). A puncture needle (3) is fixed at the top of the needle core (2), and the puncture needle (3) is connected to the fixing wire bundle (7). A limiting structure is provided inside the outer sheath (5) to limit the length of the needle core (2) extending from the top of the needle core (2) into the outer sheath (5); The puncture needle (3) is in the shape of an "asymmetrical V" and the two arms of the puncture needle (3) are one long and one short, with the long arm being 2mm long and the short arm being 1mm long. The fixing wire harness (7) is made of 2-0 polypropylene non-absorbable wire. The front end of the fixing wire harness (7) is made into a fixing knot and has a barb with a length of 2mm. The fixing knot is sleeved between the two arms of the puncture needle (3). The tail end of the fixing wire harness (7) is made into an adjustable collar. The length between the fixing knot and the adjustable collar is 1.3cm. The adjustable collar made at the tail end of the fixing wire harness (7) is sleeved on the outside of the Mirena (1).

2. The fixing structure for Mirena according to claim 1, characterized in that: The limiting structure includes a limiting tube (4) and a limiting protrusion (6). The limiting tube (4) is fixed outside the needle core (2) and slides through the inside of the outer sheath tube (5). The limiting protrusion (6) is fixed on the top inner wall of the outer sheath tube (5) and can contact the limiting tube (4). The vertical distance between the limiting tube (4) and the limiting protrusion (6) is 0.8 cm.

3. The fixing structure for Mirena according to claim 1, characterized in that: The outer sheath tube (5) is a hollow plastic tube with a total length of 20cm and an inner diameter of 2mm.

4. The fixing structure for Mirena according to claim 1, characterized in that: The needle core (2) is fixed with a handle (8) at the end away from the puncture needle (3), and the handle (8) is made of hard plastic.

Images