Auxiliary device for male urethrostenosis operation

By designing a male urethral stenosis surgical assistance device including a soft sheath and an inner core, the problems of inaccurate positioning and low suture efficiency in the prior art are solved, and efficient and accurate urethral stenosis segment resection and urethral reconstruction surgery are achieved.

CN120130912APending Publication Date: 2025-06-13NORTHERN JIANGSU PEOPLES HOSPITAL
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Patent Information

Application Number
CN202510634613.9
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2025-05-16
Publication Date
2025-06-13

AI Technical Summary

Technical Problem

The prior art is difficult to accurately locate the proximal end of the urethral stenosis segment in male urethral stenosis surgery, and the auxiliary equipment lacks integrated guidance, sealing, positioning and suture functions, resulting in surgical positioning deviation, suture asymmetry and inefficiency.

Method used

A surgical assistance device for male urethral stenosis is designed, including a soft sheath sleeve and an inner core. The soft sheath sleeve has a built-in sealing cap and an annular convex strip to cooperate with the concave surface. The inner core is fixed with the soft sheath sleeve through a connecting sleeve, and a threaded surface and multiple grooves are provided at the distal end to improve guidance accuracy and suture efficiency.

Benefits of technology

Intraoperative accurate positioning of the stenosis segment, reliable guide resection and efficient positioning suture operations are achieved, which improves the accuracy and efficiency of the surgery and reduces the risk of urethral trauma and postoperative complications.

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Abstract

The auxiliary device comprises a soft sheath, a soft cystoscope, a sealing cap, an inner core and a connecting sleeve, the soft sheath is arranged outside the soft cystoscope in a sleeving mode, the sealing cap is arranged at the near end of the soft sheath, an annular protruding strip is arranged on the inner wall of the sealing cap, an annular concave face matched with the annular protruding strip is arranged on the outer wall of the soft sheath, and the inner core is inserted into the soft sheath. The connecting sleeve is fixed on the surface of the inner core, the connecting sleeve is provided with an extension strip and a limiting salient point, and the far end of the inner core is provided with a threaded surface and a plurality of groove structures for positioning and sewing; according to the device, the operation stability in the operation process can be improved, the problems of blind dilatation and difficult positioning of a traditional urine dilatation strip are solved, meanwhile, the mucosa exposure degree and suture efficiency of the narrow section of the urethra are improved, the anastomosis quality is improved, and complications in the operation are reduced.
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Description

Technical Field

[0001] The present invention belongs to the technical field of urethral reconstruction surgery, and particularly relates to a surgical assistant device for male urethral stricture. Background Art

[0002] Male urethral stricture is a common urological disease, and its causes include trauma, infection or iatrogenic injury, etc. The main manifestations are dysuria, thinning of the urine stream, urinary retention and other symptoms. Currently, the treatment methods for urethral stricture mainly include urethral dilation, internal urethrotomy and open surgery. When long-segment stricture / occlusion occurs in the membranous and bulbous urethra, urethral stricture segment resection and urethral end-to-end anastomosis are often required.

[0003] During clinical surgery, in order to successfully complete the resection of the stricture segment and urethral reconstruction, the surgeon needs to accurately expose the proximal position of the urethral stricture. However, the conventional urethral dilator used in the prior art has the risk of "blind dilation" operation, and is easily restricted by the patient's urethral anatomical structure, making it difficult to accurately reach the proximal end of the stricture segment. This method relies on the surgeon's experience to judge the urethral direction, with a large error, and has certain limitations in open surgery. At the same time, due to insufficient mucosal exposure, it is difficult to achieve accurate mucosa-to-mucosa suture during the suture process, affecting the anastomosis effect and postoperative recovery.

[0004] Specifically, during open surgery, in order to confirm the proximal position of the urethral stricture, a flexible cystoscope is usually used multiple times to enter the bladder, bladder neck, prostatic urethra, membranous urethra (and bulbous urethra) sequentially from the bladder stoma, and finally reach the position of urethral stricture / occlusion. After positioning, the urethral dilator is then advanced through the same path via the bladder stoma, attempting to guide the resection operation. However, due to the fixed shape of the urethral dilator, the distal end of the urethral dilator strip often cannot accurately reach the proximal end of the stricture, resulting in surgical positioning deviation or inability to perform the operation.

[0005] In addition, the existing auxiliary instruments lack integrated guiding, sealing, positioning and suture functions, and the coordination between the flexible cystoscope and tools such as cutting and suture is poor. During the operation, instruments need to be frequently replaced, the process is cumbersome, the efficiency is low, and it also increases the risk of urethral trauma. Summary of the Invention

[0006] Aiming at the problems existing in the prior art, the purpose of the present invention is to provide a surgical assistant device for male urethral stricture, which can achieve accurate positioning of the stricture segment during the operation, reliable guidance for resection, and efficient positioning and suture operations.

[0007] To achieve the above purpose, the present invention provides the following technical solution: A surgical assistant device for male urethral stricture, including a soft sheath, the soft sheath is sleeved on the flexible cystoscope when implanted, and a sealing cap is provided at the proximal end of the soft sheath, and the sealing cap is used for sealing the proximal end of the soft sheath; An inner core is placed inside the soft sheath, a connecting sleeve is fixed on the surface of the inner core, and the inner core is fixed to the soft sheath through the connecting sleeve; A circular concave surface is provided on the proximal surface of the soft sheath.

[0008] Furthermore, annular ridges are provided on the inner wall of the sealing cap, the annular ridges are adapted to the internal dimensions of the circular concave surface, and anti-slip patterns are provided on the outer surface of the sealing cap.

[0009] Furthermore, a plurality of extension strips are uniformly arranged on one end surface of the connecting sleeve, the plurality of extension strips are respectively disposed around the proximal end of the soft sheath, and limiting convex points are provided on the inner wall of the extension strips, and the plurality of limiting convex points are all disposed inside the circular concave surface.

[0010] Furthermore, the distal end top of the inner core is provided with a hemispherical structure, and the outer diameter of the hemisphere is slightly smaller than the inner diameter end of the soft sheath, so as to guide the excision of the scar of the urethral stricture.

[0011] Furthermore, the distal end of the inner core is solid, the distal end of the surface of the inner core extends beyond the end of the soft sheath, and a threaded surface is provided on the distal end of the surface of the inner core.

[0012] Furthermore, six grooves are uniformly opened at the distal end of the inner core.

[0013] Furthermore, eight grooves are uniformly opened at the distal end of the inner core.

[0014] Compared with the prior art, the beneficial effects of the present invention are as follows: By providing a sealing cap at the proximal end of the soft sheath and matching the annular ridges on the inner wall of the sealing cap with the circular concave surface on the outer surface of the soft sheath, the present invention realizes an effective seal during the intraoperative introduction of the flexible endoscope, thereby overcoming the problems of backflow of bladder irrigation fluid and overflow of intraoperative area fluid due to the lack of a sealing structure in the prior art, and helping to maintain a clear surgical field of view and smooth operation; By providing an inner core inside the soft sheath, and the inner core is fixed to the soft sheath through the connecting sleeve, and an extension strip with limiting convex points is provided at one end of the connecting sleeve, a stable snap structure can be formed after the inner core is inserted in place, thereby solving the problems that the traditional urethral dilator cannot accurately locate the proximal end of the urethral stricture segment and frequent intraoperative displacement, and effectively improving the accuracy of the guiding operation and intraoperative stability; The present invention provides a threaded surface structure at the distal end of the inner core, so that it can push out the urethral mucosa during the advancement process, improving the intraoperative field of view exposure, thereby solving the problems of insufficient mucosa exposure and difficulty in implementing mucosa-to-mucosa suture in the prior art, and ensuring the postoperative anastomosis quality and tissue alignment accuracy; The present invention is provided with a plurality of equally spaced groove structures at the distal end of the inner core, which supports self-positioning suture at 6 or 8 points. The operator can perform suture operations sequentially with the grooves as reference points, overcoming the problems of relying on experience for positioning, asymmetric suture, and low efficiency in the prior art, and realizing rapid and standardized suture operations during the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Figure 1 It is a schematic diagram of the installation structure of the soft sheath and the flexible endoscope of the present invention; Figure 2 It is a schematic cross-sectional installation structure diagram of the soft sheath and the sealing cap of the present invention; Figure 3 It is a schematic diagram of the installation structure of the inner core and the soft sheath of the present invention; Figure 4 It is a schematic diagram of the 6-groove inner core structure of the second embodiment of the present invention; Figure 5 It is a schematic diagram of the 8-groove inner core structure of the second embodiment of the present invention.

[0016] In the drawings, the list of components represented by each reference numeral is as follows: 1, flexible cystoscope; 2, soft sheath; 21, annular concave surface; 3, sealing cap; 31, annular rib; 32, anti-slip pattern; 4, inner core; 41, threaded surface; 42, groove; 5, connecting sleeve; 51, extension bar; 52, limiting bump. DETAILED DESCRIPTION OF THE EMBODIMENTS

[0017] In order to make the purpose and advantages of the present invention clearer, the present invention will be specifically described below in conjunction with embodiments. It should be understood that the following text is only used to describe one or several specific implementation manners of the present invention, and does not strictly limit the scope of protection specifically claimed by the present invention. Embodiment

[0018] Referring to Figures 1 - 5 As shown, a male urethral stricture surgical assistance device includes a soft sheath 2, and the soft sheath 2 is sleeved on the flexible cystoscope 1 when inserted; the flexible cystoscope 1 is an existing medical device, which can enter the bladder and then into the urethra through the cystostomy path for intraoperative observation and auxiliary positioning; a sealing cap 3 is provided at the proximal end of the soft sheath 2, and the sealing cap 3 is used to seal the proximal end of the soft sheath 2 to prevent liquid from leaking out of the proximal end of the soft sheath 2 during the flushing operation of the flexible cystoscope 1; by using the sealing cap 3 when inserting the soft sheath 2, the overall sealing performance of the catheter system can be significantly improved, effectively preventing liquid leakage during the operation, and avoiding causing contamination and operation interference in the surgical area; Inside the soft sheath 2, an inner core 4 is placed. The inner core 4 is a replaceable structure, and a connecting sleeve 5 is fixedly installed on its surface. A reliable mechanical fixing relationship is formed between the connecting sleeve 5 and the soft sheath 2 through a clamping structure to ensure the axial and radial stability of the inner core 4 and the soft sheath 2 synchronously during use, and improve the overall consistency and controllability of intraoperative guidance and suture operations.

[0019] Reference Figure 2 As shown, a circular concave surface 21 is provided on the proximal surface of the soft sheath 2, and a circular rib 31 is provided on the inner wall of the sealing cap 3. The matching dimensions of the circular rib 31 and the circular concave surface 21 have been clinically verified to achieve stable sealing; through the structural design of this concave-convex fit, the sealing cap 3 can be conveniently installed on the soft sheath 2 to form a physical locking structure and have good air and liquid sealing performance; the sealing cap 3 can be injection-molded from rubber or soft plastic materials to have certain elasticity and biocompatibility; anti-slip lines 32 are provided on the outer surface of the sealing cap 3, and the anti-slip lines 32 are regularly arranged so that the operator can still perform grasping, rotating, installing and disassembling operations efficiently while wearing gloves, ensuring the stability and continuity of the surgical process.

[0020] Reference Figure 3 As shown, a plurality of extension strips 51 are evenly arranged on one end face of the connecting sleeve 5. The plurality of extension strips 51 are symmetrically distributed along the circumferential direction and cover the outer ring of the proximal end of the soft sheath 2. The extension strips 51 are made of flexible elastic materials to generate controlled deformation when stressed axially; limiting bumps 52 are provided on the inner wall of the extension strips 51, and the plurality of limiting bumps 52 are evenly embedded in the inner groove of the circular concave surface 21 of the soft sheath 2 to form a firm fixing interface through a structural interlocking method; this snap structure has strong anti-pulling ability, can effectively avoid accidental displacement during surgery, ensure the firm and reliable connection between the inner core 4 and the soft sheath 2, and help to achieve precise operations in subsequent steps such as guidance, resection, and suture. Embodiment

[0021] Reference Figures 1 - 3 As shown, the distal end of the inner core 4 is a solid structure. The solid part is integrally formed or post-installed with the main body of the inner core 4 and is firmly supported by the connecting sleeve 5; the distal end surface of the inner core 4 extends beyond the end of the soft sheath 2 to achieve rigid structural support during the advancement process; a threaded surface 41 is provided on the distal end surface of the inner core 4, and the threaded surface 41 is in a circular spiral structure, which is used to moderately push the inner wall mucosa of the urethra to the visible area during the suture stage, improving the mucosal exposure degree and suture accuracy; the pushing effect of the threaded surface 41 solves the problem that it is difficult to achieve accurate mucosal-to-mucosal contact in the background technology and optimizes the postoperative healing quality; at this stage, the connecting sleeve 5 is combined with the inner core 4 through a threaded connection method, and bolts or tightening parts can be provided at the connection for limiting installation, so as to adjust the advancement depth of the inner core 4 according to the length of different lesions and ensure that it is not blocked by anatomical structures.

[0022] ReferenceFigure 5 As shown, six grooves 42 are evenly formed at the distal end of the inner core 4. The grooves 42 are distributed at equal intervals on the circumferential surface of the distal end of the inner core 4, facilitating the operator to quickly achieve six-point positioning suture. The groove 42 is a V-shaped or U-shaped grooving structure to assist in positioning the suture needle tip and prevent slipping. With this structural arrangement, the operator can perform continuous suture operations successively from each groove 42, thereby improving the suture speed and symmetry and solving the problem of low suture efficiency relying on the operator's experience in the prior art.

[0023] Reference Figure 4 As shown, eight grooves 42 can also be evenly formed at the distal end of the inner core 4. The structural form of the groove 42 is the same as that of the six-point groove, only adjusted in terms of quantity and distribution angle. This design is applicable to surgical situations that require a higher suture density during the operation, and can further improve the urethral anastomosis accuracy. With the multi-point self-positioning structure, the operator can complete rapid suture one by one from the grooves on the basis of sufficient exposure, thereby effectively shortening the operation time and enhancing the anastomosis stability. Combined with the pushing effect of the threaded surface 41, the problems of difficult proximal exposure, low suture efficiency, and anastomosis asymmetry in traditional operations are overall solved. Embodiment

[0024] Reference Figure 1 and Figure 2 As shown, in this embodiment, the soft sheath 2 is made of medical polyurethane material, which has strong flexibility and pressure resistance. A sealing cap 3 is installed at the proximal end of the soft sheath 2. The sealing cap 3 is injection-molded with medical silicone material. An annular rib 31 is provided on the inner wall of the sealing cap 3, and an annular concave surface 21 with a matching size is provided on the outer wall of the proximal end of the soft sheath 2. During the operation, the cystoscope 1 is inserted into the soft sheath 2, and then the whole is inserted into the patient's urethra. When approaching the stenosis segment, the cystoscope 1 is removed, and only the soft sheath 2 is left in the urethra. The sealing cap 3 effectively seals the proximal end to prevent the flushing liquid from leaking, ensuring a clean and tidy surgical area. In the prior art, when the soft sheath and the endoscope are used in combination, there is no sealing structure, and the liquid flows back through the catheter port during flushing, resulting in a continuously wet surgical area and frequent interruption of the operation, affecting the efficiency and safety. In this embodiment, the sealing performance is enhanced through the annular matching structure, the surgical environment is improved, and clear and efficient operation under the mirror is ensured. Embodiment

[0025] Reference Figure 3As shown, in this embodiment, an inner core 4 is inserted inside the soft sheath 2. The inner core 4 is made of medical rigid polypropylene, and a connecting sleeve 5 is sleeved on the surface. The connecting sleeve 5 is integrally injection-molded from nylon material; multiple extension strips 51 are provided at the proximal end of the connecting sleeve 5. The extension strips 51 are distributed around the proximal end of the soft sheath 2, and limiting bumps 52 are provided on the inner wall thereof; after the inner core 4 is inserted in place, the limiting bumps 52 are engaged with the annular concave surface 21 to form a firm connection, avoiding loosening during operation; this structure ensures that the relative positions of the inner core 4 and the soft sheath 2 remain unchanged, making the subsequent resection or suture positioning accurate; The traditional urethral dilator is an integral structure. During the operation, the advancement depends on the judgment of experience, making it difficult to accurately reach the proximal end of the stricture segment, and there are risks of slippage and position deviation; this solution fixes the position of the inner core through a mechanical limiting structure, solves the problem of instability of the traditional dilator, and improves the guiding accuracy. Embodiment

[0026] Reference Figures 1 - 3 As shown, in this embodiment, the distal end of the inner core 4 is a solid structure, and its surface is a spiral thread surface 41 with a thread pitch of 1 mm and a material of stainless steel 304; when the thread surface 41 is advanced to the mucosa, it can moderately push out the edge of the urethral mucosa, making it fully exposed in the endoscopic field of view, providing good tissue docking conditions for suture operations; the connecting sleeve 5 is connected to the inner core 4 through a detachable bolt and can be quickly locked after adjusting the position; In traditional surgeries, due to the tight adhesion of soft tissues, it is difficult for surgeons to identify the edge of the mucosa, and it is easy to sew off or miss during suturing, resulting in poor anastomosis; this embodiment improves the exposure of the mucosa through a thread pushing structure, ensures accurate alignment of the suture site, and effectively reduces postoperative complications. Embodiment

[0027] Reference Figure 4 and Figure 5 As shown, six or eight grooves 42 can be selected and configured at the distal end of the inner core 4 according to the surgical requirements. The grooves 42 are equally spaced and distributed, with a semi-elliptical notch. The width of the notch is 1.2 mm; during the operation, the doctor can suture along the grooves 42 in sequence to form a standard six-point or eight-point suture method, simplifying the operation steps and ensuring symmetry and stability; this groove positioning method is suitable for novice surgeons and also helps to shorten the overall suture time; In conventional operations, doctors rely on experience for suturing, and the points are random, resulting in uneven mucosal docking or uneven suturing, and a high rate of scar formation at the urethral orifice after surgery; this embodiment adopts a standard groove positioning method, improving the suture consistency and replicability, and significantly enhancing the postoperative recovery effect. Embodiment

[0028] In this embodiment, the inner core 4 has an integral solid structure and is integrally injection-molded using a medical-grade polyetheretherketone (PEEK) material, which has good rigidity and biocompatibility; the distal end of the inner core 4 is provided with a hemispherical structure, and the outer diameter of the hemisphere is slightly smaller than the inner diameter end of the soft sheath 2, and it naturally transitions with the end of the soft sheath 2 to form a compliant propulsion transition interface; the surface of the hemispherical top is smooth and has no sharp corners, with good directivity, and can smoothly pass through the tortuous section of the urethra and be positioned at the proximal region of the stenosis during the propulsion process; This hemispherical structure not only reduces the insertion resistance, but also provides a natural positioning stop point under intraoperative conditions with insufficient visual or tactile feedback, avoiding damage to urethral tissue caused by excessive propulsion; this structure is particularly suitable for patients with anatomical variations or large differences in tube diameters, and helps the surgeon quickly identify the ideal suture starting point position through "tactile positioning", thereby improving intraoperative efficiency and safety; In this embodiment, a hemispherical end is adopted, which significantly improves the propulsion smoothness and positioning accuracy while retaining the structural rigidity, reduces the risk of intraoperative accidental injury, and optimizes the auxiliary guiding experience.

[0029] Working principle: Step 1: After the soft sheath 2 is sleeved outside the flexible cystoscope 1, the whole is inserted into the patient's urethra through the cystostomy path; as the flexible cystoscope 1 is advanced, the soft sheath 2 follows synchronously and finally reaches the proximal end of the urethral stenosis; a sealing cap 3 is provided at the proximal end of the soft sheath 2, and the inner wall of the sealing cap 3 has an annular rib 31, which can be closely fitted with the annular concave surface 21 on the outer wall of the soft sheath 2, so as to effectively seal the proximal channel during the introduction process; this structure can effectively prevent the liquid from flowing back during the intraoperative flushing of the flexible cystoscope 1, and improve the cleanliness of the surgical area and the clarity of the visual field; Step 2: After the soft sheath 2 is positioned, the flexible cystoscope 1 is withdrawn, and the soft sheath 2 remains in the urethra as an intraoperative channel stent; this structure provides a stable surgical channel and avoids mucosal damage caused by repeated insertion during the operation; then the sealing cap 3 is opened to prepare for inserting the inner core 4; Step 3: The inner core 4 is inserted axially along the soft sheath 2. A connecting sleeve 5 is arranged on the outer surface of the inner core 4. One end of the connecting sleeve 5 is evenly provided with a plurality of extension strips 51, and limiting convex points 52 are arranged on the inner wall of the extension strips 51. The limiting convex points 52 are engaged with the annular concave surface 21 of the soft sheath 2, so as to form a stable clamping structure; this connection method can ensure that the inner core 4 remains axially and radially fixed with the soft sheath 2 during the operation, avoiding sliding or offset during the operation, and improving the accuracy of instrument guidance; Step 4: In the initial operation stage, the inner core 4 has a solid structure, and the distal end of the inner core is provided with a hemispherical structure, and the outer diameter of the hemisphere is slightly smaller than the inner diameter end of the soft sheath, so as to guide the excision of the scar of the urethral stenosis; Step Five: After the scar in the narrow segment is removed, the distal end of the solid inner core 4 is provided with a threaded surface 41. This structure can slightly expand and push out the edge of the urethral mucosa during continuous advancement, facilitating the surgeon to clearly identify the suture site under the endoscope; the threaded pushing structure improves the exposure degree of the mucosa, solving the problems of limited suture vision and difficulty in achieving precise mucosal apposition in traditional surgeries. Step Six: According to the requirements of the surgical procedure, six or eight grooves 42 are evenly arranged at the distal end of the inner core 4 to provide standard suture positioning points; the surgeon can directly thread the suture point by point along the grooves 42 to form a urethral end-to-end anastomosis line with six or eight points evenly distributed; this structure solves the problems of inaccurate suture points, poor symmetry, and low suture efficiency in traditional suturing, improving the postoperative anastomosis quality and recovery speed.

[0030] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention. The structures, devices, and operation methods not specifically described and explained in the present invention, unless otherwise specifically stated and limited, are implemented according to the conventional means in the art.

Claims

1. A male urethral stricture surgical auxiliary device, comprising a soft sheath (2), characterized in that: The soft sheath (2) is placed on the soft cystoscope (1) when inserted, and a sealing cap (3) is provided at the proximal end of the soft sheath (2), and the sealing cap (3) is used to seal the proximal end of the soft sheath (2); An inner core (4) is placed inside the soft sheath (2), a connecting sleeve (5) is fixed on the surface of the inner core (4), and the inner core (4) is fixed to the soft sheath (2) via the connecting sleeve (5); The proximal surface of the soft sheath (2) is provided with an annular concave surface (21).

2. The male urethral stricture surgery auxiliary device according to claim 1, characterized in that: The inner wall of the sealing cap (3) is provided with an annular convex strip (31), the annular convex strip (31) is adapted to the inner dimensions of the annular concave surface (21), and the outer surface of the sealing cap (3) is provided with anti-slip grooves (32).

3. The male urethral stricture surgery auxiliary device according to claim 1, characterized in that: A plurality of extension strips (51) are evenly arranged on one end surface of the connecting sleeve (5), and the plurality of extension strips (51) are respectively arranged on the periphery of the proximal end of the soft sheath sleeve (2). A limiting convex point (52) is arranged on the inner wall of the extension strip (51), and the plurality of limiting convex points (52) are all arranged on the inner side of the annular concave surface (21).

4. The male urethral stricture surgery auxiliary device according to claim 1, characterized in that: The distal end of the inner core (4) is configured as a hemispherical structure, and the outer diameter of the hemisphere is slightly smaller than the inner diameter end of the soft sheath (2), so as to guide the removal of scars caused by urethral stenosis.

5. The male urethral stricture surgery auxiliary device according to claim 1, characterized in that: The distal end of the inner core (4) is solid, the distal end of the surface of the inner core (4) exceeds the end of the soft sheath (2), and the distal end of the surface of the inner core (4) is provided with a threaded surface (41).

6. The male urethral stricture surgery auxiliary device according to claim 5, characterized in that: Six grooves (42) are evenly arranged at the distal end of the inner core (4).

7. The male urethral stricture surgery auxiliary device according to claim 5, characterized in that: Eight grooves (42) are evenly arranged at the distal end of the inner core (4).