Suture needle for treating pseudo hernial sac of direct inguinal hernia under laparoscope

Abstract

The invention relates to the technical field of surgical suture instruments, solves the problems of high difficulty and poor suture effect in suture of a pseudo-hernia sac of groin straight hernia under the field of view of a laparoscope, and particularly discloses a suture needle for treating the pseudo-hernia sac of groin straight hernia under the laparoscope, which is characterized by comprising a needle head section, a needle clamping section and a needle tail section, the needle head section and the needle tail section are connected to the two ends of the needle holder clamping section respectively, the needle head section and the needle tail section are both in an arc shape, and the needle holder clamping section is in a linear shape. Wherein the arc-shaped central angle of the needle head section is 90 degrees, and the arc-shaped central angle of the needle tail section is smaller than or equal to the arc-shaped central angle of the needle head section; the needle head section is used for positioning a transverse suture puncture point or a longitudinal suture puncture point through a 90-degree arc shape. The suture needle disclosed by the invention is used for a peritoneoscope pseudo hernia sac suture operation of the straight inguinal hernia, and has the characteristics that a puncture point is convenient to position, the suture difficulty is reduced, and the suture effect is improved.

Description

Technical Field

[0001] This invention relates to the field of surgical suture instruments, and in particular to a suture needle for laparoscopic treatment of pseudohernial sacs of direct inguinal hernia. Background Technology

[0002] Direct inguinal hernia is a common type of abdominal wall hernia, with a significantly increased incidence, especially among elderly men. In laparoscopic inguinal hernia repair, the management of the pseudohernial sac becomes a crucial factor affecting surgical outcomes and postoperative complications. Three-dimensional suturing is a suturing technique applied to incisional hernia repair. Its key feature is the use of continuous suturing with toothed sutures. By applying force at multiple points, it evenly reduces the dead space of the hernial sac while restoring abdominal wall thickness, thereby effectively closing the abdominal wall defect.

[0003] In existing techniques, laparoscopic suturing of the pseudo-hernial sac of a direct inguinal hernia is difficult and has poor results. This is because the pseudo-hernial sac is composed of loose tissue, with blurred boundaries and adhesion to surrounding tissues. In addition, the inguinal space is narrow, making it difficult to operate under laparoscopic vision. Furthermore, the length and curvature of traditional suture needles are not adapted to laparoscopic operation, making the operation difficult and prone to jamming. Summary of the Invention

[0004] To address the challenges and poor suturing results of suturing pseudo-hernial sacs of direct inguinal hernias under laparoscopic guidance in existing technologies, this invention provides a suture needle for laparoscopic treatment of pseudo-hernial sacs of direct inguinal hernias.

[0005] The technical solution adopted in this invention is:

[0006] A suture needle for laparoscopic treatment of pseudohernial sac of direct inguinal hernia includes a needle tip section, a needle holder section, and a needle tail section. The needle tip section and the needle tail section are respectively connected to the two ends of the needle holder section. Both the needle tip section and the needle tail section are arc-shaped, and the needle holder section is straight.

[0007] Wherein, the central angle of the arc of the needle tip segment is 90 degrees, and the central angle of the arc of the needle tail segment is less than or equal to the central angle of the arc of the needle tip segment; the needle tip segment is used to locate the transverse suture puncture point or the longitudinal suture puncture point through the arc shape of the 90-degree angle.

[0008] Furthermore, a 15cm long barbed thread is connected to the needle tail section. The barbed thread has multiple inclined barbed protrusions. The barbed thread is used to provide support for suturing through the contact of the barbed protrusions when it is taut.

[0009] Furthermore, the arc radius of the needle tip segment and the arc radius of the needle tail segment are both less than or equal to 5 mm and greater than or equal to 3 mm.

[0010] Furthermore, the central angle of the arc of the needle tail segment is 45 degrees to 75 degrees. Preferably, the central angle of the arc of the needle tail segment is 60 degrees.

[0011] Furthermore, the needle holding section is connected to a needle holder, the length direction of which is perpendicular to the needle holding section; the needle holder is used to apply clamping force to the suture needle through surface contact with the needle holding section.

[0012] Furthermore, the needle holder includes a needle holding rod and an adjusting head connected to the needle holding clamp section. An angle adjusting mechanism is connected between the adjusting head and the needle holding rod. The angle adjusting mechanism is used to adjust the mechanical locking structure through toothed engagement.

[0013] Furthermore, the needle holder clamping section is provided with a clamping point marking part or a scale line, which are used to position the clamping part of the needle holder clamping section.

[0014] The beneficial effects of this invention are:

[0015] The suture needle of this invention has a three-section structure. The needle tip section adopts a 90-degree arc shape, which can accurately locate the transverse or longitudinal suture puncture point required for the cross-shaped three-dimensional suture method under laparoscopic vision. This suture needle structure can flexibly adjust the angle in the narrow inguinal space, adapting to the complex anatomical environment of loose tissue and adhesion boundaries, reducing accidental damage to surrounding nerves and blood vessels during needle insertion, and solving the problem of insufficient puncture accuracy caused by tissue characteristics and space limitations. The linear shape of the needle holder provides stable support for operation. As the clamping area of ​​the needle holder, it can effectively reduce needle bounce during suture and avoid suture path deviation caused by unstable clamping. Through the above working principle, the suture needle of this invention achieves a significant improvement in puncture accuracy and reduces the risk of intraoperative tissue damage; the enhanced clamping stability makes the suture path more precise and controllable, effectively improving the problem of poor suturing effect of pseudohernia sac; the overall structure is adapted to the laparoscopic operation scenario, alleviating the operation limitations caused by the narrow inguinal space, and providing reliable support for improving surgical results and reducing postoperative complications. Attached Figure Description

[0016] Figure 1 This is a three-dimensional structural diagram of the connection between the suture needle and the needle holder of the present invention;

[0017] Figure 2 This is a schematic diagram of the suture needle structure of the present invention;

[0018] Figure 3 This is a schematic diagram showing the connection between the suture needle and the barbed suture of the present invention.

[0019] Figure label:

[0020] 1. Needle tip section; 2. Needle holder clamping section; 3. Needle tail section; 4. Barbed thread; 5. Needle holder; 6. Adjusting head; 7. Needle holder rod; 8. Angle adjustment mechanism. Detailed Implementation

[0021] The present invention will now be described in detail with reference to the accompanying drawings and embodiments.

[0022] Example 1

[0023] This embodiment describes a suture needle for laparoscopic treatment of pseudo-hernial sacs in direct inguinal hernias, particularly suitable for suturing pseudo-hernial sac defects in direct inguinal hernias using the cross-suture method. It includes a needle tip segment 1, a needle holder segment 2, and a needle tail segment 3. The needle tip segment 1 and needle tail segment 3 are respectively connected to both ends of the needle holder segment 2. Both the needle tip segment 1 and needle tail segment 3 are arc-shaped, while the needle holder segment 2 is straight. The central angle of the arc of the needle tip segment 1 is 90 degrees, and the central angle of the arc of the needle tail segment 3 is less than or equal to the central angle of the arc of the needle tip segment 1. The needle tip segment 1 is used to locate the transverse or longitudinal suture puncture point using its 90-degree arc shape.

[0024] In this embodiment, during laparoscopic surgery, the operator uses the needle holder 5 to clamp the straight needle holding segment 2. The 90-degree arc shape of the needle tip segment 1 can accurately locate the 3 o'clock to 9 o'clock puncture points for transverse suturing and the 12 o'clock to 6 o'clock puncture points for longitudinal suturing using the "cross-shaped three-dimensional suturing method." The "cross-shaped three-dimensional suturing method" is a non-existent suturing method used for pseudohernial sacs of direct inguinal hernias. It combines existing incisional hernia three-dimensional suturing techniques and improves the suturing of pseudohernial sacs of direct inguinal hernias by combining transverse and longitudinal suturing in a cross-shaped suturing method. The specific processing method is as follows:

[0025] First stitch: With the left hand, use forceps to completely pull the pseudo-hernial sac into the abdominal cavity. Use barbed suture 4 to suture from the outside of the pseudo-hernial sac (at the 3 o'clock position). After passing the needle through the loop at the end of the suture, suture continuously at 1-2 loop positions according to the actual size of the defect, and finally exit from the outside of the pseudo-hernial sac (at the 9 o'clock position). Tighten the suture to form a transverse three-dimensional contraction of the pseudo-hernial sac.

[0026] Second stitch: With your right hand outstretched, hold the needle firmly and use barbed suture 4 to suture into the pseudo-hernial sac from the head side (12 o'clock position). Similarly, suture 1-2 consecutive circumferential areas according to the actual size of the defect, and finally exit from the outside of the pseudo-hernial sac (6 o'clock position). Tighten the suture to create a longitudinal three-dimensional contraction of the pseudo-hernial sac.

[0027] After suturing, tie the barbed suture 4 at the lateral edge of the rectus abdominis muscle to secure it.

[0028] It is evident that the key to locating the puncture point in the "cross-shaped three-dimensional suture method" lies in the four adjacent points that are all at a 90-degree angle to each other. The suture needle of this invention is specifically designed for this suture method. Through the 90-degree central arc shape of the needle tip, the puncture point can be located more accurately by comparing the shape, position, and angle of the suture needle during puncture point positioning, thus enabling needle insertion. Compared with the suture needles used in existing related technologies, it is more suitable for this suture method, making the operation more convenient and the suture effect better.

[0029] The curved head and tail sections of the suture needle in this invention allow for control of the puncture depth by adjusting the needle holding angle when penetrating different layers of abdominal wall tissue, preventing excessive penetration and damage to surrounding nerves and blood vessels. The straight structure of the needle holder section 2 reduces needle bounce during suturing, ensuring the straightness of the transverse and longitudinal suture paths, which is particularly suitable for single-handed operation under laparoscopy while coordinating with the other hand to adjust tissue tension. The curved shape of the needle tail section 3 facilitates smooth overall operation. This structure reduces the difficulty of suturing under laparoscopic vision, makes puncture at key anatomical locations more precise, improves suture stability, and is more conducive to learning and widespread application for beginners.

[0030] Example 2

[0031] This embodiment is based on the aforementioned embodiment. In this embodiment, a 15cm long barbed thread 4 is connected to the needle tail section 3. The barbed thread 4 is provided with multiple inclined barb-shaped protrusions. The barbed thread 4 is used to provide support for suturing through the contact of the barb-shaped protrusions when taut. The 15cm long barbed thread 4 reduces the number of thread-pulling actions (i.e., the action of pulling the thread taut) during the suturing process, simplifying the operation.

[0032] When treating the pseudo-hernial sac of a direct inguinal hernia laparoscopically, a cross-suture method is used. After completing continuous transverse and longitudinal sutures, the barbed suture 4 is tightened. At this point, the barbed protrusions on the barbed suture 4 contact the surrounding tissue, forming a multi-point support structure. When the barbed suture 4 is continuously sutured into a loop, it forms a gear-like shape, with each barbed protrusion acting as a tooth. This transforms the two-point force application of existing techniques into multi-point force application, effectively reducing tension between the sutured tissues. Because the tissue surrounding the direct inguinal hernia defect is elastic and under tension, the barbed suture 4 is not easily loosened after tightening. Repeated folding of the hernial sac eliminates dead space, and the edges of the fascial defect are brought together under low tension, achieving complete closure of the fascial layer without tissue cutting. The cooperation between the barbed suture 4 and the needle tail 3 makes the suture operation more stable. The gear structure formed by continuous sutures enhances the closure of the pseudo-hernial sac, improves the reliability of the suture, and solves the problem of poor results with traditional sutures.

[0033] Example 3

[0034] This embodiment is based on the aforementioned embodiment. In this embodiment, the arc radius of the needle tip segment 1 and the arc radius of the needle tail segment 3 are both less than or equal to 5mm and greater than or equal to 3mm. The arc radius of both the needle tip segment 1 and the needle tail segment 3 in this embodiment is between 3mm and 5mm. This size design is mainly to adapt to the use of a 5mm trocar in laparoscopic surgery. Existing sutures, due to their large radius, cannot pass through the 5mm operating hole and must be placed blindly through a 10mm observation hole, posing a risk of accidental injury to internal organs and loss of the suture. The radius range of this embodiment ensures that the overall outer diameter of the suture is compatible with the inner diameter of the 5mm trocar channel, allowing the surgeon to insert the suture into the abdominal cavity through the 5mm operating hole under direct vision, eliminating the risk of blind placement. During the surgery, the arc radius of 3mm to 5mm ensures that the needle tip segment 1 and the needle tail segment 3 maintain sufficient curvature to accommodate the composite structure of the arc at both ends of the suture, satisfying the adaptability to tissues during transverse and longitudinal suturing, while preventing operational obstruction due to excessive radius. This size range balances the structural strength and operational flexibility of the suture needle. When penetrating abdominal wall tissue and continuously suturing the pseudohernia sac, it allows for precise control of the puncture path while enabling safe insertion through a 5mm operating port, thus improving the safety and convenience of the surgery. The specific size can be selected according to the surgical needs. For example, when the hernia sac defect area is large, a 5mm radius arc can be used to meet the requirements for proper suturing; when the hernia sac defect area is small, a 3mm radius arc can be selected to better accommodate the suturing operation; in other cases, suture needles with radii of 3.5mm, 4mm, or 4.5mm can be selected depending on the patient's condition.

[0035] Example 4

[0036] This embodiment is based on the aforementioned embodiment. In this embodiment, the central angle of the arc of the needle tail segment 3 is 45 degrees to 75 degrees. Preferably, the central angle of the arc of the needle tail segment 3 is 60 degrees. The angle setting in this embodiment is based on the operational requirements of laparoscopic surgery. For example, a central angle of 60 degrees corresponds to 1 / 6 of the arc length of a circle. During the operation, this angle setting of the needle tail segment 3 facilitates passage through the puncture hole. When the suture needle enters the abdominal cavity through the puncture needle, the 60-degree arc allows the needle tail segment 3 to pass smoothly through the channel, avoiding jamming due to an excessively large angle. Simultaneously, the angle range of 45 to 75 degrees provides adaptability for different surgical scenarios, satisfying both the structural requirement of the needle tail segment 3 and the barbed suture 4 being integrally formed, and also coordinating with the 90-degree arc of the needle tip segment 1 during suturing to form a harmonious operating angle. The preferred 60-degree angle allows the needle tail section 3 to better transmit operating force when working with the needle holder 5. During continuous suturing, this ensures the stability of the needle body during suture tightening, reduces operational deviations caused by unsuitable angles, improves the smoothness of the suture needle passing through the puncture hole, and enhances the stability of the suturing operation, thus increasing the controllability of the surgery. In practice, the angle can be specifically set according to the arc radius of the needle tip section 1 and the needle tail section 3. For example, when the arc radius is large, a 45-degree angle can be used for the arc-shaped rounded corner of the needle tail section 3 to facilitate passage through the puncture channel; conversely, when the arc radius is small, a 75-degree angle can be used as needed to better adapt to the suturing requirements.

[0037] Example 5

[0038] This embodiment is based on the aforementioned embodiment. In this embodiment, the needle-holding clamping section 2 is connected to a needle holder 5, and the length direction of the needle holder 5 is perpendicular to that of the needle-holding clamping section 2. The needle holder 5 is used to apply clamping force to the suture needle through surface contact with the needle-holding clamping section 2. During laparoscopic surgery, the needle holder 5 vertically clamps the straight needle-holding clamping section 2, and the straight clamping section forms surface contact with the needle holder 5, rather than point contact with an arc-shaped surface. This structure reduces needle rotation or slippage during suturing, and is especially suitable for single-handed operation under laparoscopy to adjust tissue tension with the other hand. When suturing, stable clamping ensures a more accurate suture path, and the surface contact clamping method makes the needle less prone to bouncing, ensuring the stability of the suture path. The vertical clamping angle allows the 90-degree arc structure of the needle tip section 1 to achieve the optimal suture angle after the needle-holding clamping section 2 and the needle holder 5 are engaged, facilitating the adjustment of the needle tip position when suturing on the abdominal wall. This structure improves needle holding stability, reduces deviations during needle adjustment, lowers the difficulty of suturing, and makes the operation easier to learn and master.

[0039] In a preferred embodiment, the needle holder 5 includes a needle-holding rod 7 and an adjusting head 6 connected to the needle-holding clamping section 2. An angle adjusting mechanism 8 is connected between the adjusting head 6 and the needle-holding rod 7. The angle adjusting mechanism 8 is used to adjust the mechanical locking structure through toothed engagement. When it is necessary to adjust the suture angle to adapt to the transverse or longitudinal suture requirements, the angle between the adjusting head 6 and the needle-holding rod 7 can be changed by operating the angle adjusting mechanism 8 to adapt to the angle requirements. The toothed engagement structure of the angle adjusting mechanism 8 ensures stable locking after angle adjustment, avoiding accidental changes in angle during surgery. This structure is particularly suitable for the cross suture method for pseudo-hernial sacs of inguinal direct hernia. When adjusting to the longitudinal suture angle after completing the transverse suture, the angle adjusting mechanism 8 can precisely control the needle tip direction, ensuring the accuracy of puncture at key anatomical positions such as 12 o'clock to 6 o'clock. The mechanical locking structure, combined with the straight structure of the needle-holding clamping section 2, enhances the overall stability of the operation and reduces the shaking or deviation of the needle body during the suture process. This structure allows the suture needle to adapt to the angle requirements of different suture paths, improving the flexibility and precision of operation and further optimizing the suture effect.

[0040] Example 6

[0041] This embodiment is based on the aforementioned embodiment. In this embodiment, the needle holder clamping section 2 is provided with clamping point markings or scale lines, which are used to locate the clamping part of the needle holder clamping section 2. During operation, the operator can determine the optimal clamping position according to the markings or scale lines to ensure that the gripping point of the needle holder 5 is consistent in each surgery. Setting standardized clamping marks avoids needle tip direction deviation caused by clamping point deviation, especially for beginners learning the operation, reducing human operation errors. During suturing, in conjunction with the straight structure of the needle holder clamping section 2, the markings or scale lines guide the needle holder 5 to form a stable surface contact clamping, reducing needle rotation or slippage. Whether performing transverse 3-point to 9-point suturing or longitudinal 12-point to 6-point suturing, the stable clamping position ensures the accuracy of the suturing path, making the ring structure formed by continuous suturing more regular, improving the consistency and stability of the operation, reducing the learning difficulty, and making it more conducive to the promotion and application of this suture needle and its suturing method, while also ensuring the reliability of the suturing effect.

[0042] The following are the test results conducted to verify the effectiveness of the suture needle and suturing method of the present invention:

[0043] To further verify the effectiveness and safety of the suture needle and the "cross-shaped" suture method, and to provide a more scientific basis for its further application, this single-center, single-blind, randomized controlled preliminary trial was designed using the four-needle suture method, currently the most widely used technique in related technologies, as the control group. The aim is to improve surgical quality and patient prognosis through a safe, effective, simple, and easily promoted laparoscopic technique for treating pseudohernial sacs of direct inguinal hernias. The goal is to shorten surgical time, reduce surgical difficulty, and decrease the incidence of postoperative chronic complications, thereby improving surgical quality. The four-needle suture method uses a sled-shaped needle made of Vijo sutures with three sutures at the needle tail. The pseudohernial sac is held by the left hand, while the "sled needle" is held by the right hand, and four sutures are made along a specific path. A study of 156 patients by the inventors showed that although the four-needle method takes longer than the stapler fixation method, it reduces postoperative pain and saves patients money. Its advantages include improved sutures, a clear suture path, high repeatability, and ease of learning and promotion. The specific controlled trial design is as follows:

[0044] 1. Experimental Design

[0045] This was a single-center, single-blind, randomized controlled trial. Among patients with inguinal hernia who underwent laparoscopic transabdominal preperitoneal inguinal repair (TAPP) in the Department of Gastrointestinal Surgery and Day Surgery of our hospital, 17 patients were selected and randomly assigned to the "cross-shaped three-dimensional suture method" group and the "four-needle suture method" group. The subjects were unaware of the grouping results.

[0046] Standardized data tables were used to collect data on the following indicators: time to pseudohernia sac treatment, operation time, hospital stay, 24-hour postoperative visual analog scale (VAS) pain score, postoperative seroma incidence, and recurrence during follow-up. Results were analyzed using SPSS 27.0 statistical software. Normally distributed continuous data were expressed as mean ± standard deviation and analyzed using independent samples t-tests. Count data were expressed as percentages and analyzed using chi-square tests or Fisher's exact test. P < 0.05 was considered statistically significant.

[0047] 2. Trial population

[0048] Sample size considerations: This is a randomized controlled trial. The experimental group received the "cross-shaped three-dimensional" suture method, while the control group received the four-stitch suture method. The treatment time for the pseudohernia sac was the primary indicator. The experimental group consisted of 10 patients who received the cross-shaped three-dimensional suture technique, while the control group consisted of 7 patients who received the four-stitch suture technique.

[0049] 2.1 Selection Criteria

[0050] (1) Age ≥ 18 years old;

[0051] (2) Preoperative physical examination and imaging examination indicated that it was a primary inguinal hernia (classified as type I to III according to the domestic hernia classification in 2003);

[0052] (3) No obvious contraindications to surgery were found during the preoperative examination, and the heart and lung function could tolerate laparoscopic surgery under general anesthesia.

[0053] 2.2 Exclusion Criteria

[0054] (1) Other types of external abdominal hernias, such as inguinal hernia, femoral hernia, incarcerated hernia, or strangulated hernia;

[0055] (2) Patients with bleeding tendency or severe cardiopulmonary dysfunction who cannot tolerate general anesthesia for laparoscopic surgery;

[0056] (3) It is expected that there are extensive adhesions in the abdominal cavity that cannot be separated (with a history of major surgery in the middle and lower abdomen or a history of severe abdominal infection).

[0057] 2.3 Exit Criteria

[0058] (1) Intraoperative findings did not confirm the diagnosis of direct inguinal hernia;

[0059] (2) Transition to open inguinal hernia repair;

[0060] (3) Other unforeseen circumstances.

[0061] 2.4 Termination of Test Criteria

[0062] (1) If significant safety hazards or ethical controversies are found in the intervention measures during the experiment, the study must be terminated immediately after evaluation by the ethics committee;

[0063] (2) If ≥3 serious adverse events (such as patch infection, severe vascular injury, irreversible nerve injury, etc.) occur in the experimental group or control group after surgery, and the data safety monitoring committee determines that they are directly related to the research intervention;

[0064] (3) If the intervention measures are found to be obviously ineffective during the trial (e.g., the treatment time of pseudohernia sac in the experimental group is significantly longer than that in the control group, or the incidence of postoperative recurrence or seroma exceeds the average value of existing studies), the interim analysis confirms that there is no scientific value for further research.

[0065] (4) The participants' compliance was seriously insufficient (e.g., the loss to follow-up rate was >20% or the key data was missing >15%), which made it impossible to effectively analyze the research results;

[0066] (5) The research could not be carried out as planned due to force majeure (such as policy adjustments, natural disasters, etc.).

[0067] 3. Test Content

[0068] 3.1 Experimental interventions (experimental drugs, experimental devices, surgical procedures, etc.)

[0069] (1) Screening period: Select suitable study participants according to the inclusion and exclusion criteria, and collect data on the age, gender, BMI (kg / m2) and inguinal hernia classification of the subjects.

[0070] (2) Intervention period:

[0071] ① Preoperative preparation: abstain from water for 4 hours and fast for 12 hours before surgery; clean the umbilicus before surgery and routinely prepare the surgical area; after successful induction of anesthesia, routinely place an indwelling urinary catheter to ensure that the bladder is empty during surgery.

[0072] ② Surgical method: All surgeries were performed by the same surgical team, and the specific procedures followed the "Guidelines for Laparoscopic Inguinal Hernia Surgery (2017 Edition)" formulated by the Laparoscopic and Endoscopic Surgery Group of the Chinese Medical Association. All patients underwent transabdominal preperitoneal hernia repair. In the experimental group, the "cross-shaped three-dimensional" suture method was used to treat the pseudohernial sac and then place the mesh, while in the control group, the four-stitch suture method was used to treat the pseudohernial sac and then place the mesh.

[0073] After general anesthesia, the patient is placed in a supine position with the head lower than the feet at approximately 15°. A transverse incision of about 1 cm in length is made 1 cm above the umbilicus. CO2 is injected using a pneumoperitoneum needle to establish pneumoperitoneum, and a 10 mm metal trocar is inserted. The pneumoperitoneum pressure is controlled at approximately 13 mmHg. Two puncture holes of about 5 mm in diameter are made at the same level as the umbilicus, at the outer edge of the bilateral rectus abdominis muscles, and 5 mm disposable puncture cards are inserted. The abdominal organs are routinely explored. After confirming that there are no abnormalities, the inguinal region is explored. The preperitoneal space is exposed by sharp dissection at the anterior superior iliac spine. The direct hernia sac is located in the direct hernia triangle area. The hernia sac and surrounding tissues are separated until the hernia sac is completely dissected, exposing the thickened transversalis fascia, i.e., the pseudohernia sac. Exploration continues until the pectineal foramen, inguinal ligament, transversus abdominis tendinous arch, and rectus abdominis muscle are fully exposed. The pseudohernia sac is treated with 3-0 barbed sutures, and the free area is covered with a patch. Cut a suitable patch to the size according to the free area of ​​the preperitoneal space. Pass the patch into the abdominal cavity through the umbilical puncture hole. Lay the patch flat on the free surface, completely covering the pubic muscle foramen. The upper edge covers the inguinal falx, the lower edge extends 2 cm below the pubis, the inner edge extends to the upper edge of the superior pubic ramus, and the outer edge extends beyond the inguinal ligament. Fix the patch with an absorbable hernia stapler. Close the peritoneal cavity with continuous sutures to eliminate pneumoperitoneum. Suture the incision to end the operation.

[0074] The processing method for the cross-shaped three-dimensional suture method is described in Embodiment 1 of this invention, and the processing method for the four-needle suture method is as follows:

[0075] First stitch: Use the left hand to grab the forceps and pull the false hernia sac completely into the abdominal cavity. Sew it in from the top of the false hernia sac (12 o'clock position) and exit from the right side (3 o'clock position).

[0076] Second needle: Hold the needle with your right hand and insert it with one hand. After holding the needle properly, insert the needle from the right side of the false hernia sac (3 o'clock position) and exit the needle below the false hernia sac (6 o'clock position).

[0077] The third stitch: Hold the needle with your right hand and insert it from the bottom of the false hernia sac (6 o'clock position). Exit the needle at the top of the false hernia sac (12 o'clock position) to form a through suture from bottom to top to the false hernia sac.

[0078] 4th stitch: Hold the needle with your right hand and insert it into the right side of the pseudohernia sac (3 o'clock position). Exit the needle on the left side of the pseudohernia sac (9 o'clock position) and sew the sled needle into the right rectus abdominis muscle to form a through suture from right to left to the pseudohernia sac.

[0079] After suturing, tie the barbed suture at the outer edge of the rectus abdominis muscle to secure it.

[0080] ③ Postoperative management

[0081] The urinary catheter should be removed immediately after surgery while the patient is still under anesthesia; a hernia trouser should be routinely worn to compress the surgical area after surgery; a semi-liquid diet can be resumed 6 hours after surgery if there is no discomfort; no analgesics, hemostatic agents or antibiotics should be used after surgery; the patient can be discharged 24 to 48 hours after surgery unless there are special circumstances.

[0082] (3) Follow-up period: If the patient’s condition is not special, outpatient follow-up will be conducted at 7 days, 1 and 3 months after the operation. In the first month after the operation, routine ultrasound examination of the groin area will be performed. The patient’s chief complaint, physical examination and examination results will be recorded in detail.

[0083] 4. Evaluation indicators / experimental endpoints;

[0084] 4.1 Key evaluation indicators;

[0085] The time for handling the pseudohernial sac (the time from the start of handling the pseudohernial sac to the end of suturing, recorded in seconds).

[0086] 4.2 Secondary evaluation indicators;

[0087] Inguinal hernia recurrence rate 3 months postoperatively (confirmed by clinical examination and ultrasound examination).

[0088] Incidence of seroma 3 months postoperatively (hypoechoic area with a diameter ≥2cm as diagnosed by ultrasound).

[0089] Postoperative pain score at 24 hours (VAS score, 0-10 points).

[0090] 4.3 Observation time points;

[0091] Key indicators: Intraoperative real-time recording;

[0092] Secondary endpoints were collected at 24 hours post-surgery, at discharge, 7 days post-surgery, 1 month post-surgery, and 3 months post-surgery.

[0093] 5. Arrangements for visits and data collection during the research period;

[0094] 5.1 Visit Plan;

[0095] Preoperative baseline visit: age, sex, BMI (kg / m2) and direct hernia classification;

[0096] Intraoperative visit: Record the time for handling the pseudohernia sac and the operation time;

[0097] 24 hours post-surgery: Assess pain score (VAS), vital signs, and early complications;

[0098] 7 days post-surgery: Outpatient follow-up for hernia recurrence and seroma (physical examination);

[0099] Postoperative 1 and 3 months: Outpatient follow-up for hernia recurrence and seroma (physical examination + ultrasound);

[0100] 5.2 Data Collection Content

[0101] Objective data: surgical procedure time, ultrasound results;

[0102] Subjective data: VAS score;

[0103] Safety data: type of adverse event, time of occurrence, handling measures and outcome.

[0104] 5.3 Data Management

[0105] Data was entered using Excel software.

[0106] IV. Statistical Processing

[0107] Data analysis was performed using SPSS 27.0 statistical software. Normally distributed continuous data were expressed as mean ± standard deviation and analyzed using independent samples t-test. Count data were expressed as percentages and analyzed using chi-square test or Fisher's exact test. P < 0.05 was considered statistically significant.

[0108] V. Quality Control and Quality Assurance of the Experiment

[0109] 1. Selection bias

[0110] (1) Strictly control the inclusion and exclusion criteria of the trial subjects: To ensure the accuracy and reliability of the trial, we will strictly screen patients according to the established inclusion and exclusion criteria to ensure that the experimental group and the control group are comparable in baseline characteristics.

[0111] (2) Surgical intervention using random grouping: To reduce the influence of selection bias, we will use random grouping to assign patients to the experimental group and the control group. Random grouping will ensure that each patient has an equal probability of being assigned to different groups, thereby eliminating grouping bias caused by differences in patient characteristics.

[0112] (3) All surgeries were performed by the same surgeon.

[0113] 2. Measurement bias

[0114] (1) Collecting objective data: To reduce measurement bias, we will collect objective and quantifiable data (such as operation time) as much as possible. For more subjective indicators, we will use standardized measurement tools for evaluation, such as using the VAS score to assess the patient's pain level. These measures can more accurately reflect the actual postoperative results and reduce errors caused by subjective judgment.

[0115] (2) Reduce the loss to follow-up rate: ① Strengthen health education for patients before discharge, inform patients of the specific postoperative follow-up time and follow-up method (offline outpatient registration method and online outpatient use method, etc.), and enhance patients' postoperative compliance; ② Track and remedy patients who are lost to follow-up, and collect their relevant information and data as much as possible through telephone, SMS and other means.

[0116] The above clinical research trials will comply with the relevant regulations, including the Declaration of Helsinki from the World Medical Association. The research protocol will be approved by the ethics committee before the clinical research can begin. Before each participant is enrolled in this study, the researchers will fully and comprehensively explain the purpose, procedures, and potential risks of the study to the participant or their legal guardian, and the participant will sign a written informed consent form. The participant acknowledges their right to withdraw from the trial at any time, and this informed consent will be retained as part of the clinical research documentation for future reference. The personal privacy and data confidentiality of the participants will be protected throughout the research process.

[0117] The following are the test results:

[0118] Comparison of intraoperative pseudo-hernia sac suturing time showed that the average suturing time in the experimental group was (202.50 ± 59.41) seconds, while that in the control group was (275.14 ± 64.52) seconds (data expressed as mean ± standard deviation). An independent samples t-test was used to compare the means of the two groups. Statistical analysis showed that the difference between the two groups was statistically significant (t = 2.397, p = 0.030). The results indicate that the novel suturing technique using the suture needle of this invention can shorten the suturing time by an average of 72.64 seconds (95% confidence interval: 8.04–137.24). All patients were followed up for 3 months postoperatively. No difference was found in the postoperative VAS scores between the two groups, and no postoperative complications such as seroma or recurrence were observed, preliminarily demonstrating the safety of the new technology.

[0119] In summary, this invention, through a preliminary randomized controlled trial design, confirms that the suture needle and suturing technique of this invention can significantly shorten surgical suturing time and reduce suturing difficulty, with statistically significant differences and significant clinical value. Table 1 compares the suturing time between the experimental group and the control group:

[0120]

[0121] Table 1 Comparison of suture time between the two groups of patients

[0122] The independent samples t-test was used; p < 0.05 indicates that the difference is statistically significant; CI is the confidence interval.

[0123] The embodiments described above are merely illustrative of specific implementations of the present invention, and while the descriptions are detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention.

Claims

1. A suture needle for laparoscopic treatment of the pseudohernial sac of a direct inguinal hernia, characterized in that, It includes a needle tip section, a needle holder section, and a needle tail section. The needle tip section and the needle tail section are respectively connected to the two ends of the needle holder section. Both the needle tip section and the needle tail section are arc-shaped, and the needle holder section is straight. Wherein, the central angle of the arc of the needle tip segment is 90 degrees, and the central angle of the arc of the needle tail segment is less than or equal to the central angle of the arc of the needle tip segment; the needle tip segment is used to locate the transverse suture puncture point or the longitudinal suture puncture point through the arc shape of the 90-degree angle.

2. The suture needle for laparoscopic treatment of the pseudohernial sac of a direct inguinal hernia according to claim 1, characterized in that, The needle tail section is connected to a 15cm long barbed thread, which has multiple inclined barbed protrusions. The barbed thread is used to provide support for suturing through the contact of the barbed protrusions when it is taut.

3. The suture needle for laparoscopic treatment of the pseudohernial sac of a direct inguinal hernia according to claim 1, characterized in that, The arc radius of the needle tip segment and the arc radius of the needle tail segment are both less than or equal to 5 mm and greater than or equal to 3 mm.

4. The suture needle for laparoscopic treatment of the pseudohernial sac of a direct inguinal hernia according to claim 1, characterized in that, The arc-shaped central angle of the needle tail section is 45 degrees to 75 degrees.

5. A suture needle for laparoscopic treatment of a pseudo-hernial sac of a direct inguinal hernia according to claim 4, characterized in that, The central angle of the arc at the tail of the needle is 60 degrees.

6. The suture needle for laparoscopic treatment of the pseudohernial sac of a direct inguinal hernia according to claim 1, characterized in that, The needle holding section is connected to a needle holder, the length direction of which is perpendicular to the needle holding section; the needle holder is used to apply clamping force to the suture needle through surface contact with the needle holding section.

7. A suture needle for laparoscopic treatment of a pseudo-hernial sac in a direct inguinal hernia according to claim 6, characterized in that, The needle holder includes a needle holding rod and an adjusting head connected to the needle holding clamp section. An angle adjusting mechanism is connected between the adjusting head and the needle holding rod. The angle adjusting mechanism is used to adjust the mechanical locking structure through toothed engagement.

8. A suture needle for laparoscopic treatment of a pseudohernial sac of a direct inguinal hernia according to claim 1, characterized in that, The needle holder clamping section is provided with a clamping point marking part or scale line, which is used to position the clamping part of the needle holder clamping section.

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