Transvaginal midurethral pubovaginal sling linear suspension system for treatment of stress urinary incontinence

Abstract

The application belongs to the field of intelligent medical treatment and particularly relates to a system for treating SUI through transvaginal urethral middle segment pubic paravaginal ligament linear suspension. The system comprises: a positioning and dissection processing unit (101) for incising the mucosa of the anterior vaginal wall along the longitudinal line of the anterior vaginal wall to a set depth reaching the urethral transverse groove; a separation and exposure processing unit (102) for separating the bladder from the vaginal wall, then separating the left / right side space of the bladder to obtain the free left / right side urethral middle segment paravaginal fascia and expose the left / right side pubic ramus lateral ligament; and a suspension processing unit (103) for respectively lifting the left / right side urethral middle segment paravaginal fascia to the left / right side pubic ramus lateral ligament obliquely above and suturing and fixing. The application linearly sutures and suspends the urethral middle segment paravaginal fascia tissue in a reverse V shape on the pubic paravaginal ligament, and the sutures on the left and right sides do not cross at the urethral midline, which not only anatomically recovers the urethra and bladder angle with autologous tissue, avoids the risk of mesh erosion and exposure, but also reduces the incidence of postoperative urethral obstruction and urinary retention.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of intelligent medical treatment, and more particularly to a system and device for treating SUI through transvaginal mid-urethral pubo-rectal ligament linear suspension. BACKGROUND

[0002] Stress urinary incontinence (SUI), also known as tension urinary incontinence, is characterized by involuntary urine leakage under increased abdominal pressure, often accompanied by urinary urgency and frequency, which seriously affects the quality of life of patients. SUI can be classified as mild, moderate and severe according to the main clinical symptoms. Urinary incontinence during coughing and sneezing is considered mild, urinary leakage during daily activities such as running, jumping and fast walking is considered moderate, and urinary incontinence during light activities or when changing body position is considered severe.

[0003] Currently, there are various but not unified methods for treating SUI, which can be generally classified into conservative treatment and surgical treatment. Non-surgical treatment is suitable for mild patients, including lifestyle intervention, pelvic floor muscle training, pelvic floor electrical stimulation therapy, drug treatment, and uterine descent treatment. Moderate and severe SUI patients need surgical treatment. Surgery is the main and most effective method for treating moderate and severe SUI, and the purpose of surgery is to change the anatomical structure of the pelvic floor and increase the urinary control ability of the bladder neck and urethra to prevent urinary incontinence. Currently, the surgical methods commonly used in clinical practice include transpubic urethral fixation and suspension (Burch), tension-free vaginal tape (TVT), outside-in transobturator tape (TOT), inside-out tension-free vaginal tape-obturator (TVT-O), tension-free transvaginal mid-urethral tape (TVT-S), single-incision adjustable tape (Ajust), and the like. Although these methods for treating SUI have achieved certain results, there is still no unified surgical treatment for SUI.

[0004] Damage to the pelvic floor muscles leading to decreased pelvic floor support, damage to surrounding tissues supporting the urethra, and lesions of the urethral sphincter itself are the main causes of scrotal urethritis (SUI). Currently, the "hammock" surgical approach is widely used in clinical practice. TVT and TVT-O have become common surgical methods due to their minimal invasiveness, high cure rate, and short operation time. However, TVT is prone to bladder damage during surgery, requiring cystoscopy to rule out bladder injury. TVT-O has a higher incidence of postoperative groin pain and is also more expensive. Further research is needed on novel sling techniques, including multi-center, large-sample, randomized controlled trials based on evidence-based medicine, to find safe and effective individualized treatment methods and minimize surgical complications. The paper "Application of Urethral Folding Combined with Mid-Urethral Pubic Ligament Suspension in the Treatment of Stress Urinary Incontinence" published by Zhou Li et al. discloses a guided urethral folding combined with mid-urethral pubic suspension without a "hammock." After urethral folding, the posterior urethral ligament is supported by mattress sutures. Then, the periosteum at the lower edge of the pubic bone near one side of the pubic symphysis is sutured with non-absorbable sutures, and the periosteal suture is sutured to the mid-urethral tissue. After suspension, the vaginal mucosa is sutured with absorbable sutures. However, this procedure, combining transvaginal urethral folding and mid-urethral pubic suspension, is cumbersome, has a high intraoperative risk, and is not easily promoted in primary care settings. Furthermore, the surgical method described in this article is for patients without pelvic inflammatory disease (POP), and its efficacy in patients with stress urinary incontinence and POP is unknown. Therefore, there is an urgent clinical need, especially in primary care settings, for a simple and effective surgical system that does not require mesh for treating female POP combined with stress urinary incontinence using mid-urethral parapubic ligament linear suspension. Summary of the Invention

[0005] In view of the above problems, the present invention provides a system for treating SUI by transvaginal mid-urethral parapubic ligament linear suspension, which utilizes the suspension of the mid-urethra to the parapubic ligament to achieve treatment of SUI combined with POP.

[0006] This application (first aspect) discloses a system for treating SUI via transvaginal mid-urethral parapubic ligament linear suspension, comprising:

[0007] Positioning and anatomical processing unit 101: used to longitudinally cut the anterior vaginal wall mucosa along the midline of the anterior vaginal wall, reaching a set depth below the transverse urethral groove, and to separate the bladder from the vaginal wall;

[0008] Separation and exposure processing unit 102: used to locate the left and right bladder spaces, separate the left and right bladder spaces, and expose the left / right mid-urethral parafascia and the left / right descending pubic ramus lateral ligament;

[0009] Suspension unit 103: used to lift the para-fascia of the middle segment of the left / right urethra to the left / right lateral ligament of the descending pubis obliquely above the urethra and suture it in place.

[0010] Further, the suture fixation in the urethral interruption suspension processing unit 103 is inverted "eight" suture, specifically: the left / right side urethral middle segment parietal fascia is pulled up to the left / right side pubic ramus lateral ligament obliquely above the urethra, so that the left and right pulled fascia forms an inverted "eight" suture fixation;

[0011] Optionally, the two sides of the suture fixation are not crossed at the urethral midline, and a gap with a set width is provided between the two sides at the urethral midline.

[0012] Further, the angle between the pulled fascia and the horizontal line of the urethra is 10°-30°;

[0013] Optionally, the angle between the pulled fascia and the horizontal line of the urethra is 25°;

[0014] Optionally, the left / right side urethral middle segment parietal fascia is pulled up to the left / right side pubic ramus lateral ligament obliquely above the urethra in the cross-sectional direction of the human body for suture fixation; optionally, a No. 7 silk thread is used for the suture fixation.

[0015] Further, the suture fixation lines in the suspension processing unit 103 are not crossed at the urethral midline, and a gap with a set width is provided between the two sides at the urethral midline;

[0016] Optionally, the set width is 0.3-1 cm;

[0017] Optionally, the set width is 0.5 cm.

[0018] Further, the set depth is 0.2-0.5 cm;

[0019] Optionally, the set depth is 0.3 cm.

[0020] Further, the system further comprises a hemostatic suture processing unit 104: for suturing the vaginal anterior wall mucosa along the vaginal anterior wall midline.

[0021] Further, the hemostatic suture is specifically: first, the first pass uses continuous suture hemostasis, and the excess vaginal wall tissue is trimmed after suture; then the second pass uses continuous lock suture to suture the autologous tissue along the urethra.

[0022] The second aspect of the present application discloses a device for treating SUI by transvaginal urethral middle segment pubic paravaginal ligament linear suspension, the device comprising: a single or multiple processors, and a memory; the memory is used to store single or multiple computer program instructions; when the single or multiple computer programs are executed by the single or multiple processors, the following steps are implemented:

[0023] S101: positioning the vaginal anterior wall midline, longitudinally incising the vaginal anterior wall mucosa at the vaginal anterior wall midline, reaching a set distance below the urethral transverse groove, and separating the bladder and the vaginal wall;

[0024] S102: Separate the bladder from the vaginal wall, and then separate the left / right side gap of the bladder to obtain the free left / right side urethral middle segment para-fascia, and expose the left / right side pubic ramus lateral ligament;

[0025] S103: The left / right side urethral middle segment para-fascia is respectively lifted to the left / right side pubic ramus lateral ligament above the urethral oblique to be sutured and fixed.

[0026] Further, when the single or multiple computer programs are executed by the single or multiple processors, the following steps are implemented:

[0027] S101: Position the anterior vaginal wall midline, and make a longitudinal incision on the anterior vaginal wall mucosa at the anterior vaginal wall midline to a certain distance below the urethral transverse groove;

[0028] S102: Separate the bladder from the vaginal wall, and then separate the left / right side gap of the bladder to obtain the free left / right side urethral middle segment para-fascia, and expose the left / right side pubic ramus lateral ligament;

[0029] S103: The left / right side urethral middle segment para-fascia is respectively lifted to the left / right side pubic ramus lateral ligament above the urethral oblique to be sutured and fixed.

[0030] S104: Suture the anterior vaginal wall mucosa along the anterior vaginal wall midline.

[0031] Further, the device comprises a positioning member, a dissection member, a separation member, and a suturing member;

[0032] Optionally, the positioning and dissection member comprises a microscope;

[0033] The dissection member comprises tissue scissors, microscissors, dissecting scissors, an electrotome, a No. 10 blade, a fine-toothed forceps, a mosquito forceps, a curved hemostatic forceps, a curved blood vessel forceps,

[0034] The separation member comprises a No. 10 knife handle and a vaginal compression plate

[0035] The suturing member comprises a No. 7 silk thread, a gynecological suture needle, an extracranial suture needle, a needle holder, and a 2-0 absorbable surgical suture.

[0036] The present application has the following beneficial effects:

[0037] (1) The present application utilizes human tissues to achieve suspension, without mesh, and there is no risk of mesh exposure and erosion;

[0038] (2) The application will be inverted "8" linear suture suspension fixed in the pubic ligament, lifting the urethra, help group urine control, short surgical path, low risk of bladder injury, nerve injury, postoperative pain, complications, etc.

[0039] (3) The application of inverted "8" linear suture line does not cross the urethral midline, which can effectively avoid the occurrence of urethral obstruction, and the urethral midline autologous tissue reinforcement uses human autologous tissue repair, and the postoperative recovery effect is good, and the risk of postoperative sequelae is lower.

[0040] (4) The suture reinforcement method of the application avoids the excessive trimming of the vaginal tissue, which leads to postoperative vaginal stenosis and affects sexual life; through bilateral suture hemostasis, it is complete. BRIEF DESCRIPTION OF DRAWINGS

[0041] In order to make the technical solutions in the embodiments of the present application clearer, the following will briefly introduce the drawings needed to be used in the embodiment description. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can also be obtained according to these drawings without creative labor for those skilled in the art.

[0042] Figure 1 is a system flowchart provided by the first aspect of the embodiment of the present application;

[0043] Figure 2 is a schematic diagram of a conventional urethral mid-segment pubic suspension provided by the embodiment of the present application, which is fixed to the subpubic margin periosteum near the pubic symphysis by simulating a hammock;

[0044] Figure 3 is a suture position diagram of a suspension processing unit provided by the embodiment of the present application;

[0045] Figure 4 is a schematic diagram of a positioning dissection and exposure processing process provided by the embodiment of the present application;

[0046] Figure 5 is a schematic diagram of a dissection and exposure processing process provided by the embodiment of the present application;

[0047] Figure 6 is a schematic diagram of a suspension processing unit provided by the embodiment of the present application. DETAILED DESCRIPTION

[0048] In order to make the technical solutions in the embodiments of the present application clearer, the following will briefly introduce the drawings needed to be used in the embodiment description. Obviously, the drawings in the following description are only some embodiments of the present application, and other drawings can also be obtained according to these drawings without creative labor for those skilled in the art.

[0049] In some of the flowcharts described in the description and claims of the present application and in the above mentioned figures, a plurality of operations are included which occur in a particular order, but it should be clearly understood that these operations can be performed in the order in which they appear herein or in parallel, and the serial numbers of the operations, such as S101, S102, etc., are only used to distinguish different operations, and the serial numbers themselves do not represent any execution order. In addition, these flowcharts can include more or fewer operations, and the operations can be performed in sequence or in parallel. It should be noted that the descriptions of "first", "second", etc. herein are used to distinguish different messages, devices, modules, etc., and do not represent the order of precedence, nor do "first" and "second" represent different types.

[0050] The technical solutions in the embodiments of the present application will be described clearly and completely below in conjunction with the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only some of the embodiments of the present application, not all. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0051] Figure 1 is a system flowchart provided by an embodiment of the present application for evaluating transvaginal urethral mid-urethra pubic ligament linear suspension surgery for SUI, specifically, the system comprises:

[0052] The positioning and anatomical processing unit 101 is used to cut the mucosa of the anterior vaginal wall along the longitudinal line of the anterior vaginal wall to a certain depth below the urethral transverse groove.

[0053] In some embodiments, the preoperative steps of the surgery are consistent with the prior art. After the target area is cut, the mucosa of the anterior vaginal wall is cut along the longitudinal line of the anterior vaginal wall, and the cutting is stopped after reaching a certain depth below the urethral transverse groove.

[0054] In some embodiments, the system also has an intraoperative identification system that can accurately identify the longitudinal line of the anterior vaginal wall based on the results of computer vision. The projection system of the system projects the identified longitudinal line of the anterior vaginal wall after identifying the longitudinal line of the anterior vaginal wall, and guides the surgical knife of the system to cut the mucosa of the anterior vaginal wall, and stops cutting after reaching a certain depth below the urethral transverse groove.

[0055] In some embodiments, the system makes a longitudinal incision along the median of the anterior vaginal wall between 0.5 cm above the urethral transverse groove and the bladder groove, about 4-6 cm long, and the depth of the incision of the anterior vaginal wall reaches the lower layer of the vaginal mucosa wall, separates the space between the vagina and the bladder, and tries to preserve the fascial tissue on the bladder wall, about 0.2-0.3 cm (as shown). Figure 4

[0056] ​Separation exposure processing unit 102: used to separate the bladder and vaginal wall, separate the left and right side gaps of the bladder, free the left / right side urethral midsection lateral fascia, left / right side pubic ramus lateral ligament.

[0057] In some embodiments, the mechanical arm of the system will use tissue forceps to lift the cut edge of the dissection processing unit after cutting, free the vaginal wall on both sides along this plane, expose the bladder neck, try to preserve the urethral posterior ligament around the urethra, free the urethral lateral tissue above the urethra on both sides, separate the bladder and vaginal wall, and then further separate the left side gap of the bladder, separate the right side gap of the bladder, and free the left side urethral midsection lateral fascia, right side urethral midsection lateral fascia, left side pubic ramus lateral ligament, and right side pubic ramus lateral ligament.

[0058] In some embodiments, the separation of the left side gap of the bladder is as follows: the tissue forceps lift the cut edge of the vaginal wall, and the knife handle separates the fascial tissue between the submucosal layer of the vagina and the bladder and urethra to the outside, freeing the vaginal mucosal wall to expose the left pubic ramus, bladder neck, and urethral midsection (as shown in Figure 5 ).

[0059] Suspension processing unit 103: used to respectively suture and fix the left / right side urethral midsection lateral fascia to the left / right side pubic ramus lateral ligament above the urethra.

[0060] In some embodiments, the surgical robot of the suspension processing unit of the system will suture and fix the left side urethral midsection lateral fascia to the left side pubic ramus lateral ligament above the urethra, and suture and fix the right side urethral midsection lateral fascia to the right side pubic ramus lateral ligament above the urethra. The above refers to the cross-sectional view of the patient in a supine position, and the suture is fixed to the pubic ramus lateral ligament above the urethral horizontal line, so that the pulling direction of the fixed left side urethral midsection lateral fascia and the pulling direction of the right side urethral midsection lateral fascia form an inverted "8" shape, as shown in Figure 3 .

[0061] In some embodiments, the purpose of lifting the urethra is achieved by suture in an inverted "8" shape, wherein the lifting amplitude is related to the position of the fixation on the pubic ramus lateral ligament. In the cross-sectional direction of the human body, the angle between the suture stitch of the inverted "8" shape and the urethral horizontal line is greater than 0° and less than 45°.

[0062] In some embodiments, the computer recognition module of the system can accurately locate the pubic ramus lateral ligament above the urethra based on the urethral position of the patient, and guide the suture fixation operation of the surgical robot based on the computer recognition result.

[0063] In some embodiments, the system further comprises a hemostatic suture processing unit 104: used to suture the mucosa of the anterior wall of the vagina along the midline of the anterior wall of the vagina.

[0064] In some embodiments, after the urethral middle segment is lifted, the anterior vaginal wall midline is modified sutured: first continuous suture, trim the excess vaginal wall tissue; the second continuous lock suture, the autologous tissue along the urethra has the effect of reinforcing the urethral middle segment.

[0065] In some embodiments, when the anterior vaginal wall midline is sutured, the first continuous horizontal mattress suture is performed. After the first suture is completed, the tightness of the vagina is judged by inserting a vaginal retractor with a width of about 4.5 cm into the vagina. If it is too tight or too loose, the suture can be removed and re-sutured to adjust the tightness of the vagina. After the tightness of the vagina is adjusted to be appropriate, the excess vaginal wall tissue is trimmed. The tightness of the vagina can be adjusted elastically. Then, the second continuous lock suture is performed after the tightness of the vagina is adjusted to be appropriate. The bleeding is stopped completely, and the autologous tissue along the urethra has the effect of reinforcing the urethral middle segment.

[0066] In some embodiments, the system simulates the effect of the first continuous horizontal mattress suture through a simulation suture device. If the tightness of the vagina is within a set interval, the actual suture operation is performed according to the simulation suture settings. After the excess vaginal wall tissue is removed, the second suture is performed, thereby realizing the modified anterior vaginal wall midline suture.

[0067] In some embodiments, the simulation suture device of the system adjusts the tightness of the vagina to the set interval to obtain a simulation suture line. After the first suture is performed according to the adjusted simulation suture line, the excess vaginal wall tissue is removed, and the second suture is performed.

[0068] In some embodiments, the system performs the following steps:

[0069] Step 1: (1) From the lower urethral groove to 0.5 cm above the bladder groove, longitudinally incise the anterior vaginal wall mucosa on the midline of the anterior vaginal wall, about 4-6 cm long. The depth of the incision of the anterior vaginal wall reaches the submucosal layer of the vagina, about 0.2-0.3 cm into the bladder-vaginal space.

[0070] (2) Use tissue forceps to symmetrically lift the incised edges of the vaginal wall, and use a knife handle to separate the submucosal layer of the vagina from the fascial tissue between the bladder and the urethra, making the vaginal mucosal wall loose to expose the left pubic ramus, bladder neck, and urethral middle segment, while retaining the urethral lateral fascia and bladder surface fascial tissue.

[0071] Specifically, it includes:

[0072] (1) Water separation of the bladder-urethra-vagina space: use 12U of pituitrin + 200mL of normal saline diluent, or 1:200,000 dilution of epinephrine salt solution, and inject it into the bladder-urethra-vagina space.

[0073] (2) Place a gas bag catheter to clearly locate the bladder neck.

[0074] (3) Make a longitudinal incision about 5-6 cm long along the midline of the anterior vaginal wall between the inferior urethral groove and the transverse vaginal groove. The depth of the incision should be about 0.3-0.5 cm, until the bladder neck and the posterior urethral wall muscle layer are exposed.

[0075] (4) Lift the cutting edge with tissue forceps and free the vaginal wall to both sides along this plane to expose the bladder neck. Try to preserve the posterior urethral ligament around the urethra. Free the paraurethral tissue on both sides above the urethra until you touch the periosteum at the lower edge of the pubic symphysis.

[0076] Step 2: Separate the left vesicle space to expose the lateral ligament of the left descending pubis ramus, and treat the contralateral side in the same way;

[0077] In some embodiments, the specific steps performed by the system include: (5) separating and exposing the bladder neck: inserting a No. 16 catheter into the urethra, about 1-2 cm away from the junction of the bladder and urethra (i.e., the bladder neck), and suturing both sides of the bladder neck with No. 7 silk mattress sutures. After tying the knot, raise the bladder neck. It is important to note that the tension should not be too great when tying the knot. Pull the No. 16 catheter until it is slightly tight to avoid constricting the urethra and causing postoperative urinary retention.

[0078] (6) Mattress suture of the posterior urethral ligament: Use silk thread to make a transverse mattress suture on both sides of the posterior urethral wall to support the urethra.

[0079] The advantages of this step are: the surgical path is shorter than that of TVT-O, it is easier to expose, avoids the risk of damaging major blood vessels and nerves, and is easy to promote in clinical practice at the grassroots level.

[0080] Step 3: Using a 12×20mm angled needle and No. 7 silk suture, suture the left lateral ligament of the descending pubic ramus. Then, switch to a 6×10mm round needle and No. 7 silk suture, and subtrap one end of the suture to suture the left mid-urethral parafascia. The distance between the needle entry and exit points should be approximately 1.5-2cm. Be careful not to suture too deeply to avoid damaging the urethra and bladder. Tie a knot to fix the left mid-urethral parafascia in an inverted "V" shape to the left lateral ligament of the descending pubic ramus. Repeat the same process on the opposite side to elevate the urethra and bladder neck, restoring the angle between the urethra and bladder and improving urinary incontinence. The sutures on both sides should not cross at the midline of the urethra, forming an inverted "V" shape to avoid directly compressing the urethra and preventing postoperative urinary tract obstruction and urinary retention. Figure 6 (As shown).

[0081] like Figure 3 As shown, the fascia tissue in the middle of the urethra is fixed to the parapubic ligament using a figure-eight suture with No. 7 silk thread. The sutures do not cross in the middle and do not directly compress the urethra, thus avoiding postoperative urinary tract obstruction and urinary retention.

[0082] Suture the periosteum of the subpubic margin near the pubic symphysis on one side with non-absorbable suture, and suture the tissue beside the middle segment of the urethra with periosteum suture. The needle entry point and the needle exit point are about 1-1.5 cm apart, parallel to the urethra, about 1-1.5 cm away from the urethra, and after knotting, one side of the tissue beside the middle segment of the urethra is suspended on the pubic periosteum; the same method is used for the other side. After the suspension is completed, the vaginal mucosa is sutured with absorbable suture, the vagina is packed with sterile gauze to stop bleeding, and an 18-gauge urinary catheter is used for urinary catheterization.

[0083] The advantages of this step are: (1) the fascial tissue beside the middle segment of the urethra is linearly sutured in an inverted V shape with a 7-gauge silk thread to the pubic ligament, using autologous tissue instead of mesh surgery, following the "suspension bed theory" to anatomically restore the angle between the urethra and the bladder, avoiding the risk of mesh erosion and exposure caused by mesh implantation;

[0084] (2) the sutures on both sides do not cross at the urethral midline, avoiding the occurrence of urethral obstruction and urinary retention after TVT-O, TVT-A and other procedures.

[0085] Step 4: Perform modified midline suturing of the anterior vaginal wall: first layer continuous suture, trim excess vaginal wall tissue; second layer continuous lock suture, autologous tissue along the urethra has a reinforcing effect.

[0086] The advantages of this step are: bilateral suture of the anterior vaginal wall, complete hemostasis, autologous tissue reinforcement of the urethral midline, and elastic adjustment.

[0087] Therefore, compared with the prior art (TVT-O), the beneficial effects obtained by the present application mainly include:

[0088] (1) The surgical path of step 2 is shorter than that of TVT-O, easy to expose, avoiding the risk of damaging large blood vessels and nerves, easy to promote in clinical primary level.

[0089] (2) In step 4, ① the fascial tissue beside the middle segment of the urethra is linearly sutured in an inverted V shape with a 7-gauge silk thread to the pubic ligament, using autologous tissue instead of mesh surgery, following the "suspension bed theory" to anatomically restore the angle between the urethra and the bladder, avoiding the risk of mesh erosion and exposure caused by mesh implantation;

[0090] ② the sutures on both sides do not cross at the urethral midline, avoiding the occurrence of urethral obstruction and urinary retention after TVT-O, TVT-A and other procedures.

[0091] (3) Bilateral suture of the anterior vaginal wall in step 3, complete hemostasis, autologous tissue reinforcement of the urethral midline, and elastic adjustment.

[0092] In some embodiments, the above steps are completed by the mechanical arm carried by the system, and the camera system of the system can accurately locate the bladder, vagina, pubic ligament and other related tissues in the operation based on the training of computer vision.

[0093] In some embodiments, the above steps are performed by a surgical robot that works with the system. The system's electron microscope and other system-assisted imaging enable the computer vision-based recognition system to accurately identify and locate related tissues such as the bladder, vagina, and parapubic ligament during surgery.

[0094] Compared with the prior art (mid-urethral pubic suspension), the improvements and beneficial effects of this application mainly include:

[0095] 1. The suspension sites are different. In this application, the mid-urethra is suspended on the parapubic ramus ligament. Compared with the prior art, which suspends the mid-urethra on the periosteum of the lower edge of the pubis, the periosteum of the lower edge of the pubis is relatively deep and close to the bladder, which poses a greater risk of bladder and urethral injury. In contrast, the suspension site in this application is relatively shallow, with no major blood vessels or nerves around it, and is far from the bladder, thus reducing the risk of damage to blood vessels, nerves, bladder, urethra, etc.

[0096] 2. The suturing methods are different. In this application, No. 7 silk sutures are used to suture the fascia tissue in the middle of the urethra in an inverted "V" shape to fix it to the parapubic ramus ligament. Figure 3 As shown, the sutures do not cross in the middle. By reinforcing and elevating the fascia tissue surrounding the mid-urethra, the mid-urethra is elevated, increasing urethral resistance and restoring control of urination. Since the sutures are not directly closed, they do not compress the mid-urethra. Existing techniques use simulated mesh to create a "hammock" under the urethra; if the tightness of the "hammock" is not properly controlled, it can easily lead to postoperative urethral obstruction and urinary retention. In comparison, in this application, the sutures are not directly closed, therefore, the sutures do not compress the mid-urethra, which can restore physiological anatomy and avoid postoperative urethral obstruction and urinary retention caused by urethral compression. The risk of postoperative urethral obstruction and urinary retention is low.

[0097] 3. Different vaginal wall suturing methods: This application adopts a modified vaginal wall tissue suturing method (first horizontal mattress suture of the vaginal wall, then trimming of the vaginal wall tissue): The first continuous horizontal mattress suture is performed. After the first suture is completed, the tightness of the vagina is judged (a vaginal hook about 4.5cm wide is inserted into the vagina). If it is too tight or too loose, the sutures can be removed and re-sutured. After adjusting the tightness of the vagina to a suitable level, excess vaginal wall tissue is trimmed (the tightness of the vagina can be adjusted flexibly). Then, after adjusting the tightness of the vagina to a suitable level, a second continuous locking suture is performed. Hemostasis is thorough, and the autologous tissue running along the urethra has the effect of reinforcing and elevating the mid-urethra.

[0098] The conventional method involves first trimming the vaginal wall tissue, and then continuously suturing the vaginal wall. If there is insufficient experience or an incorrect assessment, excessive trimming of the vaginal wall tissue can lead to an overly tight vagina, postoperative vaginal stenosis, and affect the patient's sexual life.

[0099] The improved bilateral suture of the vaginal wall in the present application: first horizontal mattress suture of the first pass of the vaginal wall, and then trimming the vaginal wall tissue, which can elastically adjust the tightness of the vagina, to avoid excessive trimming of the vaginal tissue, leading to postoperative vaginal stenosis and affecting sexual life. Two suture hemostasis is complete, and the urethral midline autologous tissue is reinforced to elevate the urethra and help urinary control.

[0100] The present application leaves the urinary catheter for 48-72 hours after surgery, and the effective urinary control rate after catheter removal can reach 95%. In the prior art, the urinary catheter is left for 72-120 hours after surgery, and the effective urinary control rate after catheter removal is 90%. The present application has a shorter urinary catheter retention time after surgery and a higher effective urinary control rate.

[0101] In addition, the system and device of the present application are easy for primary medical personnel in remote areas, mountainous areas, etc. to master, easy to promote, have a relatively short surgical path, no large blood vessels or nerves in the surgical area, low surgical complications, easy to master, and easy to promote in primary hospitals in remote areas, mountainous areas, etc.

[0102] Data support:

[0103] Retrospective analysis: 80 patients underwent transvaginal urethral mid-urethral pubic ligament linear suspension surgery in our department from January 1, 2018 to December 31, 2022 due to POP combined with SUI (17 cases lost to follow-up): postoperative treatment effect of urinary incontinence: 60 cases were cured, 95%, 3 cases were improved, 3%; Urinary retention (48 hours to remove the urinary catheter): 1 case of urinary retention, recovered after 1 week of urinary catheter retention, 1%; Intraoperative blood loss: 10-50 ml, postoperative rebleeding and hematoma: 0 cases; Postoperative pain: 0 cases; Postoperative improvement of sexual life: increased satisfaction: 20 cases, 25%, satisfaction as before: 28 cases, 35%, no sexual life after surgery: 15 cases, 18%;

[0104] Complications: None of the 63 patients followed up had complications that required intervention.

[0105] The prior art TVT and TVT-O require a mesh, which has the risk of mesh exposure and erosion, and the cost of the mesh is high. TVT has the risk of damaging the bladder during surgery, and cystoscopy is required to rule out bladder damage, while TVT-O has the risk of damaging nerves during surgery, and the incidence of postoperative groin pain is high.

[0106] The present technology uses autologous tissue repair and does not require a mesh, has a low cost, no risk of mesh exposure and erosion, a short surgical path, only requires exposure of the vaginal anterior wall and bladder lateral space and bilateral pubic ramus ligaments, has a low risk of damaging the bladder, does not require cystoscopy, has a low risk of damaging nerves, no risk of groin pain, and is easy to promote in primary care.

[0107] The urethra para-fascial No. 7 silk thread inverted "8" linear suture suspension is fixed to the pubo-ramus ligament, the suture thread does not cross at the urethral midline to avoid urethral obstruction, uses human body autologous tissue repair, does not use mesh, has no mesh exposure, erosion and other risks, has a short surgical path, low risk of bladder injury, nerve injury and postoperative pain.

[0108] The second aspect of the present application discloses a device for transvaginal urethral mid-segment pubic ligament linear suspension for treating SUI, the device comprising: a single or multiple processors, and a memory; the memory is used to store single or multiple computer program instructions; when the single or multiple computer programs are executed by the single or multiple processors, the following steps are implemented:

[0109] S101: positioning the midline of the anterior vaginal wall, longitudinally incising the anterior vaginal wall mucosa at the midline of the anterior vaginal wall, reaching a certain distance below the urethral transverse groove, separating the bladder and the vaginal wall;

[0110] S102: separating the bladder and the vaginal wall, and then separating the left / right side space of the bladder to obtain the free left / right side para-fascial of the urethral mid-segment, exposing the left / right side pubo-ramus lateral ligament;

[0111] S103: respectively lifting the left / right side para-fascial of the urethral mid-segment to the left / right side pubo-ramus lateral ligament above the urethra and suture fixing.

[0112] It should be noted that the flowcharts and block diagrams in the drawings illustrate the possible implementation architecture, function and operation of the system, method and computer program product according to various embodiments of the present disclosure. In this regard, each block in the flowchart or block diagram can represent a module, a program segment, or a part of code containing one or more executable instructions for implementing a specified logic function. It should also be noted that in some alternative implementations, the functions noted in the blocks can occur in different order from that noted in the drawings. For example, two blocks represented in succession can actually be executed substantially in parallel, and sometimes they can be executed in reverse order, depending on the functions involved. It should also be noted that each block in the block diagram and / or flowchart, and the combination of blocks in the block diagram and / or flowchart, can be implemented by a dedicated hardware-based system that performs the specified function or operation, or can be implemented by a combination of dedicated hardware and computer instructions.

[0113] In general, the various example embodiments of the present disclosure can be implemented in hardware or special-purpose circuits, software, firmware, logic, or any combination thereof. Some aspects can be implemented in hardware, while other aspects can be implemented in firmware or software which can be executed by a controller, microprocessor or other computing device. While various example embodiments of the disclosure can be illustrated and described as block diagrams, flow charts, or using some other pictorial representation, it is well understood that these blocks, apparatus, systems, techniques or methods described herein can be implemented in, as non-limiting examples, hardware, software, firmware, special purpose circuits or logic, general purpose hardware or controler or other computing devices, or some combination thereof.

[0114] The specific working process of the system, device and unit described above can be clearly understood by those skilled in the art, and reference can be made to the corresponding process in the foregoing method embodiments for description and simplification, which will not be repeated here.

[0115] In several embodiments provided in the present application, it should be understood that the disclosed system, device and method can be implemented in other ways. For example, the device embodiments described above are only schematic, and the division of the units is only a logical function division, and actual implementation can have another division manner, for example, a plurality of units or components can be combined or integrated into another system, or some features can be ignored or not executed. In addition, the coupling or direct coupling or communication connection between the units shown or discussed can be indirect coupling or communication connection through some interface, device or unit, and can be electrical, mechanical or other forms.

[0116] The units described as separate components can or can not be physically separated, and the components shown as units can or can not be physical units, that is, they can be located in one place, or can be distributed on a plurality of network units. Some or all of the units can be selected according to actual needs to achieve the purpose of the embodiment scheme.

[0117] In addition, each functional unit in each embodiment of the present application can be integrated into a processing unit, or each unit can exist physically, or two or more units can be integrated into one unit. The integrated unit can be realized in the form of hardware or software functional unit.

[0118] The example embodiments of the present disclosure described in detail above are only illustrative, not restrictive. Those skilled in the art should understand that various modifications and combinations of these embodiments or their features can be made without departing from the principles and spirits of the present disclosure, and such modifications should fall within the scope of the present disclosure.

Claims

1. A system for treating SUI via transvaginal mid-urethral parapubic ligament linear suspension, characterized in that, The system includes: Positioning anatomical processing unit (101): used to longitudinally cut the anterior vaginal wall mucosa along the midline of the anterior vaginal wall, reaching a set depth below the transverse urethral groove; Separation and exposure treatment unit (102): used to separate the bladder from the vaginal wall, and then separate the left / right bladder space to obtain the free left / right mid-urethral parafascia, and expose the left / right lateral pubic ramus ligament; Suspension treatment unit (103): used to lift the left / right mid-urethral parafascia to the left / right left / right descending pubic ramus lateral ligament obliquely above the urethra and suture it in place; the suture in the suspension treatment unit (103) is an inverted "V" suture, specifically: the left / right mid-urethral parafascia is lifted to the left / right descending pubic ramus lateral ligament obliquely above the urethra, so that the left and right fascia after lifting form an inverted "V" and are then sutured in place; the suture stitches on both sides do not cross at the midline of the urethra and are spaced apart by a set width at the midline of the urethra; Hemostasis and suturing unit (104): used to suture the anterior vaginal wall mucosa along the midline of the anterior vaginal wall; the anterior vaginal wall mucosa suturing is specifically as follows: firstly, continuous suturing is used for hemostasis in the first pass, and excess vaginal wall tissue is trimmed after suturing; then, continuous locking suturing is used for the second pass to run autologous tissue along the urethra.

2. The system for treating SUI via transvaginal mid-urethral parapubic ligament linear suspension according to claim 1, characterized in that, After fascia traction, the angle between the fascia and the horizontal line of the urethra is 10°~30°.

3. In the system for treating SUI via transvaginal mid-urethral parapubic ligament linear suspension according to claim 2, the angle between the fascia after traction and the horizontal line of the urethra is 25°.

4. The system for treating SUI via transvaginal mid-urethral parapubic ligament linear suspension as described in claim 1, wherein the left / right mid-urethral parafascia is pulled up to the left / right descending pubic ramus lateral ligament obliquely above the urethra and sutured and fixed in the cross-sectional direction of the human body.

5. The system for treating SUI via transvaginal mid-urethral parapubic ligament linear suspension according to claim 1, wherein the suture fixation is performed using No. 7 silk suture.

6. The system for treating SUI via transvaginal mid-urethral parapubic ligament linear suspension according to claim 1, wherein the set width is 0.3~1cm.

7. The system for treating SUI via transvaginal mid-urethral parapubic ligament linear suspension according to claim 1, wherein the set width is 0.5 cm.

8. The system for treating SUI via transvaginal mid-urethral parapubic ligament linear suspension according to claim 1, characterized in that, The set depth is 0.2~0.5cm.

9. The system for treating SUI via transvaginal mid-urethral parapubic ligament linear suspension according to claim 8, wherein the set depth is 0.3 cm.

10. A device for treating SUI via transvaginal mid-urethral parapubic ligament linear suspension, characterized in that, The device includes: one or more processors, and a memory; the memory is used to store one or more computer program instructions; when the one or more computer programs are executed by the one or more processors, the following steps are performed: S101: Locate the midline of the anterior vaginal wall, make a longitudinal incision in the anterior vaginal wall mucosa along the midline of the anterior vaginal wall, and reach a predetermined distance below the transverse urethral groove to separate the bladder from the vaginal wall; S102: Separate the bladder from the vaginal wall, then separate the left / right bladder space to obtain the free left / right mid-urethral parafascia, exposing the left / right lateral pubic ramus ligaments; S103: The left / right mid-urethral parafascia is pulled up to the left / right lateral pubic ramus ligaments obliquely above the urethra and sutured and fixed. Specifically, the left / right mid-urethral parafascia is pulled up to the left / right lateral pubic ramus ligaments obliquely above the urethra, so that the left and right pulled fascia form an inverted "V" shape and is then sutured and fixed. The sutures on both sides do not cross at the midline of the urethra and are spaced apart by a set width at the midline of the urethra. S104: Suture the anterior vaginal wall mucosa along the midline of the anterior vaginal wall. Specifically, perform a modified midline suture for the anterior vaginal wall: the first layer is a continuous suture, trimming excess vaginal wall tissue; the second layer is a continuous locking suture, with the autologous tissue running along the urethra providing reinforcement.

11. The device for treating SUI via transvaginal mid-urethral parapubic ligament linear suspension according to claim 10, characterized in that, The device includes: a positioning component, a dissecting component, a separating component, and a suture component; The positioning components include: a microscope, a camera, and a positioning computer; The anatomical components include: tissue scissors, micro scissors, dissecting scissors, electrocautery, No. 10 blade, fine-toothed forceps, mosquito-curved forceps, curved hemostatic forceps, and curved blood vessel forceps. The separating components include: a No. 10 knife handle, a vaginal pressure plate, and a vaginal pull hook; The sutures include: No. 7 silk thread, No. 12×20 angled needle, No. 6×10 round needle, needle holder, and 2-0 absorbable surgical suture.

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