Suspension surgical method and device along the round ligament to the inguinal ligament in front of the anterior superior iliac spine for treating pelvic organ prolapse

Abstract

The present invention relates to a device for treating pelvic organ prolapse, including a mesh, a uterine prolapse surgical tool, and a vault prolapse surgical tool; the mesh is in a "cross" shape; the uterine prolapse surgical tool consists of a uterine prolapse surgical tool tray and a uterine prolapse surgical tool handle; the vault prolapse surgical tool consists of a vault prolapse surgical tool cone and a vault prolapse surgical tool handle. Its advantages are as follows: compared with the current "gold standard" transabdominal sacral colpopexy, the curative effect is the same, and it can more effectively solve anterior vaginal wall bulging. The anatomical difficulty is reduced, it is easy to master, there are no serious complications, and it is easy to promote.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and specifically, to a device for treating pelvic organ prolapse and a suspension surgical method along the round ligament to the inguinal ligament in front of the anterior superior iliac spine. Background Art

[0002] Female pelvic organ prolapse (POP) mainly refers to the pathological descent of the pelvic organs: the bladder, uterus, vagina, and rectum due to pelvic tissue degeneration, trauma, congenital dysplasia, or postpartum factors, resulting in the pathological descent of the uterus, vagina, and / or adjacent organs.

[0003] With the trend of the aging population in our country, the incidence of pelvic floor organ prolapse will gradually increase, and POP has become one of the common diseases among women. Approximately 40% present with varying degrees of pelvic floor organ prolapse symptoms and require surgical treatment. Currently, the common surgical methods clinically are mainly cervical or vaginal mesh sacral fixation, uterosacral ligament fixation, sacrospinous ligament fixation, and total pelvic floor reconstruction, etc., all of which were invented by foreign experts. The main treatment approach is to restore the normal anatomical structure through surgery, thereby restoring function and improving the quality of life of patients. Due to the diverse surgical methods for pelvic floor organ prolapse, the complex surgical procedures, high anatomical difficulty, postoperative recurrence, and complications such as rejection and erosion of synthetic mesh, all existing surgical methods have certain limitations.

[0004] In recent years, domestic pelvic floor experts have also conducted relevant research. For example, transvaginal surgeries: "Xiehe-style" and "Tong-style" total pelvic floor reconstruction have achieved great success. However, when placing a mesh through transvaginal surgery internationally, the complication rates such as mesh erosion, exposure, infection, and mesh contracture are as high as 10%. In particular, the impact on sexual life is the current focus of discussion. In 2011, the US FDA issued a second warning and imposed restrictions on the use of vaginal mesh implants for the treatment of POP. Therefore, transabdominal sacral fixation has become the current "gold standard" and has been widely favored by pelvic floor experts in recent years. However, its high anatomical difficulty and relatively serious complications have restricted the popularization of the surgery. Therefore, it is an urgent problem to find a simple and easy-to-master surgical method with fewer complications, a low recurrence rate, and low cost for the treatment of pelvic floor organ prolapse and standardize it.

[0005] Chinese Patent Document CN205054532U discloses an inguinal ligament suspension mesh for female pelvic organ prolapse, including a cervix and anterior vaginal wall suspension strap; inguinal ligament suspension arms, with two inguinal ligament suspension arms symmetrically arranged on one side of the cervix and anterior vaginal wall suspension strap; sacral ligament or posterior vaginal wall suspension arms, with two sacral ligament or posterior vaginal wall suspension arms symmetrically arranged at both ends of the cervix and anterior vaginal wall suspension strap. Chinese Patent Document CN205814481U discloses an auxiliary device for repairing female pelvic organ prolapse, including: a mutually cooperating suspension mesh, a fornix plate and a fornix cone. However, there is currently no report on the device for treating pelvic organ prolapse of the present invention and the suspension surgical method along the round ligament to the inguinal ligament in front of the anterior superior iliac spine. Summary of the Invention

[0006] The first object of the present invention is to provide a device for treating pelvic organ prolapse in view of the deficiencies in the prior art.

[0007] The second object of the present invention is to provide a suspension surgical method along the round ligament to the inguinal ligament in front of the anterior superior iliac spine.

[0008] To achieve the above first object, the technical solution adopted by the present invention is: a device for treating pelvic organ prolapse, the device includes a mesh, a uterine prolapse surgical tool, and a fornix prolapse surgical tool; the mesh is in a "cross" shape, the mesh has 2 long mesh arms and 2 short mesh arms, the directions of the 2 long mesh arms are the same, the directions of the 2 short mesh arms are the same, the long mesh arm and the short mesh arm are vertically intersecting, the length of the long mesh arm is 12 - 14 cm, the width is 1.5 - 2.5 cm, the length of the short mesh arm is 3 - 12 cm, the width is 2.5 - 4 cm; the uterine prolapse surgical tool consists of a uterine prolapse surgical tool plate and a uterine prolapse surgical tool handle, the uterine prolapse surgical tool plate consists of a front-end plate and a rear-end plate, an angle α is formed between the front-end plate and the rear-end plate, α = 30°, the length of the front-end plate is 5 cm, the length of the rear-end plate is 7 cm, the widths of the front-end plate and the rear-end plate are 4 - 5 cm, the rear-end plate of the uterine prolapse surgical tool plate is connected to the uterine prolapse surgical tool handle, an angle β is formed between the rear-end plate of the uterine prolapse surgical tool plate and the uterine prolapse surgical tool handle, β = 15°, the length of the uterine prolapse surgical tool handle is 25 cm, the width is 1 cm; the fornix prolapse surgical tool consists of a fornix prolapse surgical tool cone and a fornix prolapse surgical tool handle, the length of the fornix prolapse surgical tool cone is 10 - 12 cm, the fornix prolapse surgical tool cone is connected to the fornix prolapse surgical tool handle, the length of the fornix prolapse surgical tool handle is 25 cm, the width is 1 cm.

[0009] The mesh is a synthetic mesh or a biological mesh.

[0010] The middle part of the handle of the uterine prolapse surgical tool has a uterine prolapse surgical tool ring, and the middle part of the handle of the vault prolapse surgical tool has a vault prolapse surgical tool ring.

[0011] The widths of the front end plate and the rear end plate of the uterine prolapse surgical tool tray are 4 cm.

[0012] The widths of the front end plate and the rear end plate of the uterine prolapse surgical tool tray are 4.5 cm.

[0013] The widths of the front end plate and the rear end plate of the uterine prolapse surgical tool tray are 5 cm.

[0014] The top cross-section of the vault prolapse surgical tool cone is an ellipse with a minor axis length of 0.8 cm and a major axis length of 4 cm, gradually obliquely extending for 5 cm, so that the cross-section becomes an ellipse with a minor axis length of 2 cm and a major axis length of 4 cm and extends parallelly for 7 cm.

[0015] The top cross-section of the vault prolapse surgical tool cone is an ellipse with a minor axis length of 0.8 cm and a major axis length of 5 cm, gradually obliquely extending for 5 cm, so that the cross-section becomes an ellipse with a minor axis length of 2 cm and a major axis length of 5 cm and extends parallelly for 7 cm.

[0016] To achieve the above second object, the technical solution adopted by the present invention is: a surgical method for treating pelvic organ prolapse, the surgical method includes removing the uterus and vault prolapse without uterus, and the steps are as follows: using the vault prolapse surgical tool, opening the vesicouterine peritoneal reflection in the abdominal cavity, separating the prevesical space and the rectovaginal septum, intermittently suturing the cross center of the mesh to the vaginal apex or the vault end with non-absorbable sutures, and then respectively suturing the short arms of the mesh to the anterior and posterior walls of the vagina, paying attention not to penetrate the mucous membranes of the anterior and posterior walls of the vagina during the suture process; if the prolapse with the uterus retained, cutting the short arms of the mesh from the middle into two "T" shapes, and respectively winding the short arms of the mesh around the parametrium and suturing them to the anterior and posterior walls of the vagina and the isthmus of the uterus, pressing the area 1-2 cm in front of the anterior superior iliac spine outside the abdominal cavity to locate the inguinal ligament area, so as to determine the suspension points on the inguinal ligament; opening the inguinal side abdominal wall peritoneum to fully expose the inguinal ligament and fascia; pulling the long arm of the mesh outside the side abdominal wall peritoneum along the direction of the round ligament to the outside of the femoral canal entrance, and then reaching the inguinal ligament suspension point along the extraperitoneal channel, after measuring the vaginal length through the vagina, suturing the long arm of the mesh to the inguinal ligament with non-absorbable sutures.

[0017] The advantages of the present invention are as follows:

[0018] 1. Compared with the current "gold standard" transabdominal sacral colpopexy, the curative effect is the same, and it can more effectively solve anterior vaginal wall bulge.

[0019] 2. The anatomical difficulty is reduced, it is easy to master, and there are no serious complications.

[0020] 3. The surgical method of the present invention is easy to promote. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Attached Figure 1 is a schematic structural view of the mesh.

[0022] Attached Figure 2 is a top view of the uterine prolapse surgical tool.

[0023] Attached Figure 3 is a side view of the uterine prolapse surgical tool.

[0024] Attached Figure 4 is a top view of the vault prolapse surgical tool.

[0025] Attached Figure 5 is a side view of the vault prolapse surgical tool. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0026] The following detailed description of the specific embodiments provided by the present invention will be given in conjunction with the embodiments.

[0027] The reference numerals and components involved in the drawings are as follows:

[0028] 1. Mesh

[0029] 11. Long arm of the mesh

[0030] 12. Short arm of the mesh

[0031] 2. Uterine prolapse surgical tool

[0032] 21. Pallet of the uterine prolapse surgical tool

[0033] 22. Handle of the uterine prolapse surgical tool

[0034] 23. Ring of the uterine prolapse surgical tool

[0035] 3. Vault prolapse surgical tool

[0036] 31. Cone of the vault prolapse surgical tool

[0037] 32. Handle of the vault prolapse surgical tool

[0038] 33. Ring of the vault prolapse surgical tool

[0039] POP is one of the common and frequently-occurring diseases in elderly women, seriously affecting the quality of life of patients. The recurrence rate of total vaginal hysterectomy and anterior and posterior vaginal wall repair is 40-60%. Surgery based on patches can provide sufficient support for pelvic floor tissues and better restore the anatomical structure of pelvic organs. However, in transvaginal pelvic floor reconstruction surgery, complications such as mesh erosion, exposure, infection, and mesh contracture rate are as high as 10%, and the rate of affecting sexual life is 13%. Currently, transabdominal sacral colpopexy and its modified procedures are recognized as the standard procedures for treating moderate to severe POP. However, this surgery requires high anatomical requirements for surgeons, has a relatively large operation difficulty, the surgical implementation process is complex, and although the complications are few, they are very serious, making it difficult to be widely carried out. The inventor first proposed a surgical method with the bilateral inguinal ligaments as the suspension area to repair the prolapsed pelvic organs.

[0040] Through female cadaver dissection and animal experiments, the inventor found the specific anatomical location of the inguinal ligament suspension points, and confirmed that this surgical method can effectively treat uterine prolapse, vaginal vault prolapse, and simultaneous anterior and posterior vaginal wall prolapse (bulging). The successful implementation of this surgery is expected to establish a new pelvic floor reconstruction surgical method, provide a safer surgical option for clinicians to treat pelvic organ prolapse, and can be widely promoted and applied at home and abroad.

[0041] A device for treating pelvic organ prolapse, the device includes a mesh 1, a uterine prolapse surgical tool 2, and a vaginal vault prolapse surgical tool 3.

[0042] Example 1 Mesh

[0043] Please refer to the appendix Figure 1 , the appendix Figure 1 is the structural schematic diagram of the mesh.

[0044] A mesh 1, the mesh 1 can be a synthetic mesh or a biological mesh, the mesh 1 is in a "cross" shape, and the mesh 1 has 2 mesh long arms 11 and 2 mesh short arms 12. The 2 mesh long arms 11 are in the same plane and have the same direction, the 2 mesh short arms 12 are in the same plane and have the same direction, and the mesh long arms 11 and the mesh short arms 12 are perpendicular to each other. The length of the mesh long arm 11 is 12-14 cm, the width is 1.5-2.5 cm, the length of the mesh short arm 12 is 3-12 cm, and the width is 2.5-4 cm.

[0045] Example 2 Uterine prolapse surgical tool

[0046] Please refer to the appendix Figure 2 , the appendix Figure 3 , the appendix Figure 2 is the top view of the uterine prolapse surgical tool, and the appendix Figure 3 is the side view of the uterine prolapse surgical tool.

[0047] A uterine prolapse surgical tool 2, said uterine prolapse surgical tool 2 is composed of a uterine prolapse surgical tool tray 21, a uterine prolapse surgical tool handle 22, and a uterine prolapse surgical tool ring 23. The uterine prolapse surgical tool tray 21 is composed of a front tray and a rear tray. There is an included angle α between the front tray and the rear tray, α = 30°, the length of the front tray is 5 cm, and the length of the rear tray is 7 cm. The rear tray of the uterine prolapse surgical tool tray 21 is connected to the uterine prolapse surgical tool handle 22, and there is an included angle β between the rear tray of the uterine prolapse surgical tool tray 21 and the uterine prolapse surgical tool handle 22, β = 15°. The length of the uterine prolapse surgical tool handle 22 is 25 cm, and the width is 1 cm. A uterine prolapse surgical tool ring 23 is provided in the middle of the uterine prolapse surgical tool handle 22.

[0048] The uterine prolapse surgical tool 2 has three models:

[0049] Small size: The widths of the front tray and the rear tray of the uterine prolapse surgical tool tray 21 are 4 cm.

[0050] Medium size: The widths of the front tray and the rear tray of the uterine prolapse surgical tool tray 21 are 4.5 cm.

[0051] Large size: The widths of the front tray and the rear tray of the uterine prolapse surgical tool tray 21 are 5 cm.

[0052] Example 3 Vault prolapse surgical tool

[0053] Please refer to Appendix Figure 4 、Appendix Figure 5 Appendix Figure 4 is the top view of the vault prolapse surgical tool, Appendix Figure 5 is the side view of the vault prolapse surgical tool.

[0054] A vault prolapse surgical tool 3, said vault prolapse surgical tool 3 is composed of a vault prolapse surgical tool cone 31, a vault prolapse surgical tool handle 32, and a vault prolapse surgical tool ring 33. The vault prolapse surgical tool cone 31 is connected to the vault prolapse surgical tool handle 32. The length of the vault prolapse surgical tool cone 31 is 10 - 12 cm, the length of the vault prolapse surgical tool handle 32 is 25 cm, and the width is 1 cm. A vault prolapse surgical tool ring 33 is provided in the middle of the vault prolapse surgical tool handle 32.

[0055] The vault prolapse surgical tool 3 has two models:

[0056] Small size: The top cross-section of the vault prolapse surgical tool cone 31 is an ellipse with a short diameter of 0.8 cm and a long diameter of 4 cm, gradually obliquely extending for 5 cm, making the cross-section an ellipse with a short diameter of 2 cm and a long diameter of 4 cm and extending parallelly for 7 cm.

[0057] Medium size: The top cross-section of the vault prolapse surgical tool cone 31 is an ellipse with a short diameter of 0.8 cm and a long diameter of 5 cm, gradually obliquely extending for 5 cm, making the cross-section an ellipse with a short diameter of 2 cm and a long diameter of 5 cm and extending parallelly for 7 cm.

[0058] Surgical method of Example 4

[0059] There are two surgical methods: 1. Resect the uterus or perform inguinal ligament suspension for vault prolapse in patients who have had their uterus removed. 2. Inguinal ligament suspension while preserving the uterus.

[0060] 1. Open the vesicouterine peritoneal reflection, and separate the prevesical space and rectovaginal space. For patients with a uterus, first resect the uterus, and then adjust the length of the mesh according to the degree of anterior and posterior vaginal wall prolapse. Intermittently suture the middle of the cross part of the mesh to the vaginal vault end with non-absorbable sutures, and then suture the short arms of the mesh to the anterior and posterior vaginal walls respectively. During the suture process, pay attention not to penetrate the mucous membranes of the anterior and posterior vaginal walls. If the vault prolapse is accompanied by II - III degree anterior and posterior vaginal wall prolapse, the short arms of the mesh extend to the lower parts of the anterior and posterior vaginal walls; if the anterior vaginal wall prolapse is of degree IV, the short arms of the mesh extend to the level of the vaginal transverse groove (urethrovesical junction); if the posterior vaginal wall prolapse is of degree IV, the short arms of the mesh extend to 2 cm above the perineal body and are sutured and fixed above the levator ani muscle.

[0061] 2. For patients with the uterus preserved, cut the short arms of the mesh in the middle to form two "T" shapes, and respectively wrap the short arms of the mesh around the parametrium and suture them to the anterior and posterior vaginal walls and the isthmus of the uterus. Press 1 - 2 cm in front of the anterior superior iliac spine outside the abdominal cavity to locate the inguinal ligament area, so as to determine the suspension points on the inguinal ligament. Open the inguinal side abdominal wall peritoneum to fully expose the inguinal ligament and fascia. Pull the long arm of the mesh out of the side abdominal wall peritoneum along the direction of the round ligament to the femoral canal, and then reach the inguinal ligament suspension point (on the inguinal ligament 1.5 - 3 cm in front of the anterior superior iliac spine) along the extraperitoneal space. Suture the long arm of the mesh to the inguinal ligament with non-absorbable sutures for about 2 - 3 stitches. Do the same on the contralateral side. During the whole surgical operation process, keep the anterior and posterior vaginal walls and the vaginal apex clearly exposed.

[0062] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the method of the present invention, several improvements and supplements can still be made, and these improvements and supplements should also be regarded as the protection scope of the present invention.

Claims

1. A device for treating pelvic organ prolapse, characterized in that, the device includes a mesh, a uterine prolapse surgical tool, and a vault prolapse surgical tool; the mesh is in a "cross" shape, the mesh has 2 long mesh arms and 2 short mesh arms, the directions of the 2 long mesh arms are the same, the directions of the 2 short mesh arms are the same, the long mesh arm and the short mesh arm are perpendicularly intersected, the length of the long mesh arm is 12 - 14 cm, the width is 1.5 - 2.5 cm, the length of the short mesh arm is 3 - 12 cm, the width is 2.5 - 4 cm; the 2 short mesh arms are respectively sutured to the anterior and posterior vaginal walls, and the 2 long mesh arms are sutured to the inguinal ligament 1.5 - 3 cm in front of the anterior superior iliac spine; the uterine prolapse surgical tool consists of a uterine prolapse surgical tool tray and a uterine prolapse surgical tool handle, the uterine prolapse surgical tool tray consists of a front tray and a rear tray, an angle α is formed between the front tray and the rear tray, α = 30°, the length of the front tray is 5 cm, the length of the rear tray is 7 cm, the width of the front tray and the rear tray is 4 - 5 cm, the rear tray of the uterine prolapse surgical tool tray is connected to the uterine prolapse surgical tool handle, an angle β is formed between the rear tray of the uterine prolapse surgical tool tray and the uterine prolapse surgical tool handle, β = 15°, the length of the uterine prolapse surgical tool handle is 25 cm, the width is 1 cm; the vault prolapse surgical tool consists of a vault prolapse surgical tool cone and a vault prolapse surgical tool handle, the length of the vault prolapse surgical tool cone is 10 - 12 cm, the vault prolapse surgical tool cone is connected to the vault prolapse surgical tool handle, the length of the vault prolapse surgical tool handle is 25 cm, the width is 1 cm.

2. The device according to claim 1, characterized in that, the mesh is a synthetic mesh or a biological mesh.

3. The device according to claim 1, characterized in that, a uterine prolapse surgical tool ring is provided in the middle of the uterine prolapse surgical tool handle, and a vault prolapse surgical tool ring is provided in the middle of the vault prolapse surgical tool handle.

4. The device according to claim 1, characterized in that, the width of the front tray and the rear tray of the uterine prolapse surgical tool tray is 4 cm.

5. The device according to claim 1, characterized in that, the width of the front tray and the rear tray of the uterine prolapse surgical tool tray is 4.5 cm.

6. The device according to claim 1, characterized in that, the width of the front tray and the rear tray of the uterine prolapse surgical tool tray is 5 cm.

7. The device according to claim 1, characterized in that, the cross-section at the top of the vault prolapse surgical tool cone is an ellipse with a short diameter of 0.8 cm and a long diameter of 4 cm, gradually obliquely extending 5 cm, so that the cross-section becomes an ellipse with a short diameter of 2 cm and a long diameter of 4 cm and extends parallelly for 7 cm.

8. The device according to claim 1, characterized in that, The top cross-section of the cone of the vault prolapse surgical tool is an ellipse with a short diameter of 0.8 cm and a long diameter of 5 cm, gradually obliquely extending for 5 cm, making the cross-section an ellipse with a short diameter of 2 cm and a long diameter of 5 cm and extending parallelly for 7 cm.

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