Method for fixing manyule under hysteroscope

By using a hysteroscopic method to fix the Mirena, and employing controlled tension knotting and pushing techniques, the risk of displacement and dislodgement of the Mirena in patients with adenomyosis has been eliminated. This method achieves stable fixation and simplifies the procedure, making it suitable for high-risk individuals and reducing surgical difficulty and cost.

CN120859620APending Publication Date: 2025-10-31XIAMEN MATERNAL & CHILD HEALTH HOSPITAL (XIAMEN EUGENICS & POSTNATAL CARE SERVICE CENT XIAMEN UNIV AFFILIATED WOMEN & CHILDRENS HOSPITAL XIAMEN LIN QIAOZHI WOMEN & CHILDRENS HOSPITAL)
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Patent Information

Application Number
CN202511056940.7
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-07-30
Publication Date
2025-10-31

AI Technical Summary

Technical Problem

Mirena carries risks of displacement, detachment, and decreased efficacy in patients with adenomyosis complicated by uterine enlargement and menorrhagia. Furthermore, hysteroscopic Mirena suture fixation is difficult to perform, has a long learning curve, and is challenging to promote clinically.

Method used

The Mirena fixation method under hysteroscopy involves suturing needle-lined sutures into the uterine cavity wall to form a controllable tension knot. The needle holder is then used to fix the Mirena at the intersection of the T arms. The tension is adjusted within the uterine cavity using a knot pusher, allowing the Mirena to suspend without tension. The sutures are then crossed, knotted, and the ends are cut off to achieve stable fixation.

Benefits of technology

It significantly reduces the risk of Mirena displacement and detachment, is simple and efficient to operate, reduces surgical trauma, is suitable for high-risk groups, expands the scope of application, and lowers the technical threshold and cost.

✦ Generated by Eureka AI based on patent content.

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Abstract

According to the technical scheme, the method comprises the following specific steps: S1, knotting two ends of a suture with a needle outside the uterus, and pulling the needle end of the suture with the needle to enable the knots to slide into the uterine cavity; s2, under a hysteroscope, a needle holder is used for accurately fixing the bartack to a T-arm intersection point of Munule, and tension is adjusted, so that the Munule is suspended without tension; s3, knotting two ends of the suture with the needle outside the uterus in a crossed manner, pushing a knot into the uterine cavity by using a knot pusher, and repeating knotting and knot pushing operations; s4, cutting off the thread tail of the suture with the needle under the direct view of the hysteroscope, and remaining for a certain length; the tension-controllable knot pushing device has the advantages that the tension-controllable knot is used for replacing traditional ligating and knotting actions, the tension in the knot pushing process can be accurately controlled through the tension-controllable knot, the accuracy and operability can be improved, rapidness and convenience are achieved, tension-free hanging of Munyule can be achieved, the cutting effect on the posterior wall muscle layer cannot be caused, and the labor intensity of workers is reduced. Postoperative local muscular layer necrosis is not caused, and Mangule shedding is not caused.
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Description

Technical Field

[0001] This invention relates to the field of therapeutic technology, specifically to a hysteroscopic method for fixing Mirena. Background Technology

[0002] Currently, intrauterine devices (IUDs) are widely used for long-term contraception in women. Among them, Mirena, containing levonorgestrel and featuring a unique longitudinal-arm intrauterine sustained-release system, can continuously and quantitatively release levonorgestrel (25 micrograms / day, with an effect lasting up to 5 years) within the uterine cavity, and is effective in treating menorrhagia and adenomyosis. However, in patients with adenomyosis, especially those with enlarged uterus and menorrhagia, Mirena carries risks such as displacement, expulsion, and decreased efficacy.

[0003] To reduce the risk of Mirena expulsion, hysteroscopic Mirena suture fixation has been used to effectively address the problem of easy expulsion. However, the surgical steps of this fixation procedure are difficult to master, have a long learning curve, and require a long operation time, making clinical promotion difficult. There is still a risk of expulsion after the operation, and there is currently no standardized operating procedure.

[0004] Therefore, it is necessary to invent a hysteroscopic method for fixing Mirena. Summary of the Invention

[0005] Therefore, the present invention provides a hysteroscopic method for fixing Mirena to solve the problems in the background art.

[0006] To achieve the above objectives, the present invention provides the following technical solution: a hysteroscopic method for fixing Mirena, wherein Mirena has been inserted into the uterine cavity, and a suture with a needle is sutured on the inner wall of the uterine cavity corresponding to the left and right positions of the T-arm of Mirena (one suture needle has already been sewn inside the uterine cavity), and both ends of the suture with the needle are outside the uterus. The specific steps are as follows:

[0007] S1. Tie a knot at both ends of the suture outside the uterus, and pull the needle end of the suture to make the knot slide into the uterine cavity.

[0008] S2. Under hysteroscopy, use a needle holder to precisely fix the knot at the intersection of the T arms of the Mirena and adjust the tension so that the Mirena is suspended without tension.

[0009] S3. Withdraw the hysteroscope, tie the two ends of the suture with needle across the outside of the uterus, use a knot pusher to push the knot into the uterine cavity, and repeat the knot tying and knot pushing operation once more.

[0010] S4. Under hysteroscopy, ensure that the Mirena is stably fixed in the uterine cavity. Under direct hysteroscopic visualization, cut off the suture tail with needle and thread, leaving a certain length.

[0011] Preferably, the specific steps of tying the knot in step S1 are as follows:

[0012] Step 1: Initial posture, let the needle-carrying thread A and the other end B hang down naturally. Hold thread A and thread B in each hand, leaving a rope section for operation on thread A and thread B. Hold thread B over thread A, and pinch the intersection of the threads with your fingers to secure it.

[0013] Step 2: Bend into a loop. Bend the B line, which is draped to the left, to the right from behind the A line to make the first small loop (similar to the letter "O"). At this time, the opening of the small loop is facing to the left.

[0014] Step 3: Repeat step 2 with the B line wrapped back to the right, making a second small loop (similar to the letter "O"). Wrap the B line clockwise to the front and pass it through the first small loop between the first and second small loops, then pass it down to form a knot.

[0015] Step 4: Tighten and shape, pull the upper and lower ends of lines A and B to gradually flatten and tighten the knot, adjust the tightness, and form a loop.

[0016] Preferably, in step 3, the second small loop is located above the first small loop, and the B line is rotated and wrapped around the AB lines.

[0017] Preferably, the suture used in step S1 is 2-OPX-82 non-absorbable suture, and the suture needle with needle thread is a curved round suture needle.

[0018] Preferably, the remaining length in step S4 is 1 cm.

[0019] The beneficial effects of this invention are:

[0020] 1. This invention replaces the traditional ligation and knotting action with a controllable tension loop. The controllable tension loop can precisely control the tension during the knot pushing process. This not only improves speed, accuracy and operability, but also achieves tension-free suspension of the Mirena. It will not cause a cutting effect on the posterior wall muscle layer due to the suture being too tight, leading to postoperative local muscle layer necrosis and Mirena fall off.

[0021] 2. Significantly reduces the risk of displacement and expulsion: Through innovative knot fixation and push-knot techniques, Mirena is stably fixed in the uterine cavity, effectively reducing the possibility of displacement and expulsion;

[0022] 3. Highly efficient and convenient operation: The operation time is short and the trauma is minimal, which reduces the patient's pain and surgical risks. At the same time, the simplified operation steps shorten the learning curve and facilitate clinical promotion.

[0023] 4. Wide range of applications: It can be safely used in high-risk groups such as those with adenomyosis, enlarged uterine cavity, and menorrhagia, thus expanding the clinical application range of Mirena.

[0024] 5. Low equipment requirements: No additional special equipment is required, and it can be performed on a conventional hysteroscopic operating platform, which lowers the threshold and cost of technology application. Attached Figure Description

[0025] To more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings in the following description are merely exemplary, and those skilled in the art can derive other embodiments based on the provided drawings without creative effort.

[0026] The structures, proportions, sizes, etc. illustrated in this specification are only for the purpose of assisting those skilled in the art in understanding and reading the content disclosed herein, and are not intended to limit the conditions under which the present invention can be implemented. Therefore, they have no substantial technical significance. Any modifications to the structure, changes in the proportions, or adjustments to the size, without affecting the effects and objectives that the present invention can produce, should still fall within the scope of the technical content disclosed in the present invention.

[0027] Figure 1 A schematic diagram of knotting provided by the present invention Figure 1 ;

[0028] Figure 2 A schematic diagram of knotting provided by the present invention Figure 2 ;

[0029] Figure 3 A schematic diagram of knotting provided by the present invention Figure 3 ;

[0030] Figure 4 A schematic diagram of knotting provided by the present invention Figure 4 ;

[0031] Figure 5 A schematic diagram of knotting provided by the present invention Figure 5 ;

[0032] Figure 6 Schematic diagram of knotting provided by the present invention Figure 1 ;

[0033] Figure 7 Schematic diagram of knotting provided by the present invention Figure 2 . Detailed Implementation

[0034] The preferred embodiments of the present invention will be described below with reference to the accompanying drawings. It should be understood that the preferred embodiments described herein are for illustration and explanation only and are not intended to limit the present invention.

[0035] This invention provides a hysteroscopic method for fixing a Mirena nipple. The Mirena nipple is inserted into the uterine cavity. A suture with a needle is sutured along the uterine wall at the left and right positions corresponding to the T-arm of the Mirena nipple, with both ends of the suture outside the uterus. Specifically, the suture is inserted under direct hysteroscopic visualization. A suture needle is inserted into the posterior endometrium below the left side of the Mirena nipple T-arm, passes around the longitudinal arm of the Mirena nipple, and exits from the posterior endometrium below the right side of the T-arm, so that both ends of the suture with the needle are located on either side of the longitudinal arm of the Mirena nipple. The suture with the needle is then pulled out of the uterus. The specific steps are as follows:

[0036] S1. Tie a knot at both ends of the suture outside the uterus, and pull the needle end of the suture to make the knot slide into the uterine cavity.

[0037] S2. Under hysteroscopy, a needle holder is used to precisely fix the knot at the intersection of the T arms of the Mirena and adjust the tension so that the Mirena is suspended without tension, which can avoid cutting the posterior wall myometrium.

[0038] S3. Withdraw the hysteroscope, tie the two ends of the suture with needle across the outside of the uterus, use a knot pusher to push the knot into the uterine cavity, and repeat the knot tying and knot pushing operation once more.

[0039] S4. Under hysteroscopy, ensure that the Mirena is stably fixed in the uterine cavity. Under direct hysteroscopic visualization, cut off the suture tail with needle and thread, leaving a length of 1cm.

[0040] In practical use, the specific operating procedure for tying the loop in step S1 can be found in the instruction manual appendix. Figure 1-5 The following is a diagram illustrating the actual process of tying a loop knot. The specific steps are explained below:

[0041] Step 1: Initial attitude (refer to the instruction manual) Figure 1 Let the needle-attached thread A and thread B hang down naturally. Hold thread A and thread B in each hand, leaving a rope section for operation on thread A and thread B. Hold thread B and drape it over thread A, while pinching the intersection of the threads with your fingers to secure it.

[0042] Step 2: Bend into a ring (refer to the instruction manual). Figure 2 ), bend the B line that is draped to the left to the right after the A line, and make the first small loop (similar to the letter "O"). At this time, the opening of the small loop is facing the left.

[0043] Step 3: (Refer to the attached instruction manual) Figure 3-4 Repeat step 2 with line B wrapped back to the right, making a second small loop (similar to the letter "O"). The second small loop is above the first small loop. Wrap line B clockwise to the front and pass it between the first and second small loops. Then, bring line B down to form a knot.

[0044] Step 4: Tighten and shape (refer to the instruction manual) Figure 5 Slowly pull the upper and lower ends of lines A and B to gradually flatten and tighten the knot, making the knot stable. Adjust the tightness to finally form a loop with a tight and moderate structure.

[0045] To better secure the Mirena, the sutures used in step S1 are 2-0PX-82 non-absorbable sutures. For ease of suturing, the suture needle is a curved round needle.

[0046] The process of using this invention is as follows: Select conventional hysteroscopic instruments or matching customized suture needles. The suture needles can be round suture needles to facilitate operation in the uterine cavity. Carry 2-0PX-82 non-absorbable sutures or other suitable non-absorbable sutures. The strength and flexibility of the sutures must meet the requirements of the surgery.

[0047] When it is necessary to fix the Mirena, the patient is anesthetized. After anesthesia, a hysteroscopy is performed to observe the condition inside the uterine cavity, determine the degree of adenomyosis, the size and shape of the uterine cavity, and then determine the position of the Mirena in the uterine cavity. If it is the first placement, the Mirena must be correctly placed into the uterine cavity. If it is a repositioning, the Mirena that has been moved down must be adjusted to the central bottom position of the uterine body.

[0048] Next, under real-time hysteroscopic guidance, the suture needle is inserted as vertically as possible into the posterior endometrium on the lower left side of the Mirena T-arm. The needle tip penetrates the endometrial layer, travels along a pre-set path, bypasses the Mirena longitudinal arm, and exits from the posterior endometrium on the lower right side of the T-arm. The needle insertion and exit positions are ensured to be accurate and located at corresponding positions on both sides of the T-arm to guarantee that the knot can be stably fixed at the intersection of the T-arm and the longitudinal arm. Then, the A and B lines exiting the uterus are knotted to form a knot. The A line is gently pulled, allowing the knot to slide slowly upwards along the A line and smoothly enter the uterine cavity. The position of the knot within the uterine cavity is observed through hysteroscopy, and the needle holder is used to precisely adjust it to the intersection of the Mirena T-arms. Then, by pulling the A and B lines, the tension of the knot is adjusted to ensure the Mirena is in a tension-free suspension state. During the adjustment process, the condition of the posterior myometrium is closely monitored to ensure that the knot does not exert cutting force on the myometrium and avoid postoperative myometrial necrosis.

[0049] The hysteroscope was withdrawn, and the sutures were re-tied outside the uterus, as shown in the attached document. Figure 6-7As shown, a secure knot is formed. Using a knot pusher, the knot is slowly and evenly pushed into the uterine cavity. The hysteroscope is then inserted again to check if the knot is in the correct position and if the tightness is appropriate. If the position or tightness is not ideal, it can be adjusted appropriately. To enhance the fixation effect, the above knot pushing operation is repeated once, that is, a total of 2 knot pushing fixation operations are performed. Under hysteroscopy, the excess suture tail is cut off, leaving about 1 cm of suture tail length. Finally, the uterine cavity is thoroughly examined again through hysteroscopy to confirm that the Mirena is fixed stably, there are no signs of displacement, the knot position is correct, and there is no abnormal bleeding in the uterine cavity, and the operation is ended.

[0050] The above description is merely a preferred embodiment of the present invention. Any person skilled in the art can modify the present invention or modify it into an equivalent technical solution using the technical solutions described above. Therefore, any simple modifications or equivalent substitutions made based on the technical solutions of the present invention fall within the scope of protection claimed by the present invention.

Claims

1. A hysteroscopic method for fixing a Mirena, wherein the Mirena has been inserted into the uterine cavity, and a suture with needles is sutured along the inner wall of the uterine cavity at the left and right positions corresponding to the T-arm of the Mirena, with both ends of the suture extending outside the uterus, characterized in that... The specific steps are as follows: S1. Tie a knot at both ends of the suture outside the uterus, and pull the needle end of the suture to make the knot slide into the uterine cavity. S2. Under hysteroscopy, use a needle holder to precisely fix the knot at the intersection of the T arms of the Mirena and adjust the tension so that the Mirena is suspended without tension. S3. Withdraw the hysteroscope, tie the two ends of the suture with needle across the outside of the uterus, use a knot pusher to push the knot into the uterine cavity, and repeat the knot tying and knot pushing operation once more. S4. Under hysteroscopy, ensure that the Mirena is stably fixed in the uterine cavity. Under direct hysteroscopic visualization, cut off the suture tail with needle and thread, leaving a certain length.

2. The method for hysteroscopic fixation of Mirena according to claim 1, characterized in that: The specific steps for tying the loop in step S1 are as follows: Step 1: Initial posture, let the needle-carrying thread A and the other end B hang down naturally, hold thread A and thread B in each hand respectively, and leave a rope section for operation on thread A and thread B. Hold thread B over thread A, and pinch the intersection of the threads with your fingers to fix it. Step 2: Bend into a loop. Bend the B line, which is draped to the left, to the right from behind the A line to make the first small loop (similar to the letter "O"). At this time, the opening of the small loop is facing to the left. Step 3: Repeat step 2 with the B line wrapped back to the right, and make a second small loop (similar to the letter "O"). Wrap the B line clockwise to the front and pass it through the first small loop between the first and second small loops, then pass it down to form a knot. Step 4: Tighten and shape, pull the upper and lower ends of lines A and B to gradually flatten and tighten the knot, adjust the tightness, and form a loop.

3. The method for hysteroscopic fixation of Mirena according to claim 2, characterized in that: In step 3, the second small loop is located above the first small loop, and it is formed by rotating and wrapping line B around lines A and B.

4. The method for hysteroscopic fixation of Mirena according to claim 1, characterized in that: The suture used in step S1 is 2-OPX-82 non-absorbable suture, and the suture needle with the needle is a curved round suture needle.

5. The method for hysteroscopic fixation of Mirena according to claim 1, characterized in that: The remaining length in step S4 is 1 cm.