Labial anastomat

Abstract

This application discloses a labial anastomosis device, belonging to the field of medical device technology. Addressing the problems of uneven cut edges, asymmetry, long operation time, and noticeable scarring caused by manual excision and suturing in existing technologies, this invention provides an integrated solution. The labial anastomosis device includes a main frame, a positioning and clamping assembly, a cutting unit, an abutment unit, a suture shaping assembly, and a drive control assembly. The positioning and clamping assembly is used to fix the tissue and form an arc-shaped cutting reference surface; the cutting unit and the abutment unit are arranged opposite each other, moving closer together under drive to cut the tissue; the suture shaping assembly is configured to insert fasteners into the incision simultaneously with or immediately after cutting to achieve immediate closure; the drive control assembly connects the various components to control the execution of actions. This invention achieves integrated operation of positioning, cutting, and anastomosis through a mechanical structure, ensuring smooth and symmetrical excision edges, significantly shortening operation time, reducing the risk of infection, and improving postoperative aesthetics and healing quality.

Description

Technical Field

[0001] This application relates to a labial stapler, belonging to the field of medical device technology. Background Technology

[0002] In the field of gynecological plastic and reconstructive surgery, labiaplasty is a primary means of addressing the inconvenience, friction pain, and aesthetic concerns caused by abnormal physiological structures. Current mainstream surgical procedures typically employ traditional free-hand excision or electrocautery. This involves the surgeon manually removing excess labial tissue using a scalpel or high-frequency electrocautery, based on pre-operative markings. The wound is then closed with interrupted or continuous sutures using absorbable sutures. During this process, to achieve a symmetrical and natural postoperative appearance, the surgeon often needs to rely on their clinical experience to make real-time judgments about the extent of excision and manually perform a series of steps, including tissue fixation, cutting, hemostasis, and multi-layer suturing. Some auxiliary instruments only serve to traction and expose the surgical field; the core excision and anastomosis procedures still heavily depend on the surgeon's manual surgical skills.

[0003] However, the current limitations lie in the fact that this traditional manual, step-by-step operation mode makes it difficult to precisely control the edge shape and thickness uniformity of the excised tissue. It is highly susceptible to postoperative asymmetry, jagged edges, or inconsistent excision amounts due to hand tremors or visual errors, thus affecting aesthetic results. Furthermore, since cutting and suturing are two independent and time-consuming procedures, the prolonged surgical time and extended wound exposure increase the risk of infection and bleeding. Uneven tension control during manual suturing can also lead to significant scar hyperplasia or poor healing. In addition, existing conventional surgical instruments lack dedicated devices that integrate tissue positioning, quantitative excision, and immediate anastomosis, making it impossible to automatically and standardizedly close the wound while cutting tissue. This results in low surgical efficiency and excessive reliance on the surgeon's experience, making it difficult to guarantee the consistency and stability of surgical quality across different cases. Summary of the Invention

[0004] This invention relates to a labial stapler, which aims to solve the technical problems in the prior art, such as inaccurate control of the excision edge shape, postoperative asymmetry, long operation time, high risk of wound exposure, and obvious scarring due to uneven suture tension caused by manual step-by-step operation.

[0005] To achieve the above objectives, this application provides the following technical solution: A labial stapler includes a main frame and a drive control component disposed on the main frame; It also includes a positioning clamping assembly for positioning and fixing the labial tissue to be treated, a cutting unit for cutting the fixed tissue, an abutting unit that cooperates with the cutting unit to form a shearing pair, and a suture shaping assembly for implanting fasteners at the cutting site to achieve wound closure. The positioning and clamping assembly is configured to define the shape and contour of the tissue to be removed and provide a cutting reference surface; The drive control component is connected to the cutting unit and the suture shaping component respectively, and is configured to drive the cutting unit to move relative to the abutment unit in a single operating stroke to complete tissue cutting, and synchronously or in conjunction with the suture shaping component to implant the fastener into the tissue at the cut site to complete immediate anastomosis.

[0006] Optionally, the positioning clamping assembly includes a central fixing seat and a plurality of elastic fixing clamps circumferentially distributed around the central fixing seat; The central fixing base is a ring-shaped or arc-shaped base adapted to the shape of the vaginal opening. One end of the elastic fixing clamp is hinged or elastically connected to the central fixing base, and the other end is constructed to be able to fold outward and clamp the labial tissue to be removed, so that the tissue to be removed forms a preset arc-shaped cutting reference surface in the clamping state.

[0007] Optionally, the cutting unit includes an arc-shaped blade with a predetermined radius of curvature, and the abutting unit includes an arc-shaped anvil that matches the cutting edge trajectory of the arc-shaped blade. The surface of the arc-shaped anvil is provided with a plurality of nail grooves extending along its arc direction. The curved blade is able to embed itself in the staple groove during the closed stroke to cut the tissue located between them, while the staple groove is configured to allow the fasteners in the suture shaping assembly to pass through and act on the tissue at the cut site.

[0008] Optionally, the suture shaping assembly includes a staple storage compartment disposed on the back side of the arc-shaped anvil, a staple pusher slider slidably disposed in the staple storage compartment, and a staple forming washer disposed at the distal end of the arc-shaped blade or the arc-shaped anvil. The staple storage chamber is pre-loaded with several U-shaped or V-shaped staples arranged in an arc. The staple pusher slide moves linearly along the arc direction of the arc-shaped anvil under the drive of the drive control component, pushing the staple out of the staple groove and inserting it into the tissue. Subsequently, the staple feet undergo plastic deformation and bend inward to close when they impact the staple forming washer.

[0009] Optionally, the drive control assembly includes a handle, a rotary adjusting nut, a lead screw, and a transmission connecting rod; The rotary adjusting nut is rotatably mounted on the handle or main frame. One end of the lead screw is threaded into the rotary adjusting nut, and the other end is connected to the transmission link. The transmission link is connected to the cutting unit and the pusher slider, respectively, so that when the adjusting nut is rotated, the lead screw generates axial displacement and drives the transmission link to synchronously drive the cutting unit to perform the cutting action and the pusher slider to perform the firing action.

[0010] Optionally, the drive control component further includes a safety locking mechanism, which includes a safety pin and a corresponding limiting hole disposed on the handle or the rotary adjusting nut. When the safety pin is inserted into the limiting hole, the rotary adjusting nut is locked and cannot be rotated. Only after the safety pin is pulled out can the rotary adjusting nut be rotated to start the cutting and mating process.

[0011] Optionally, the curved blade of the cutting unit is made of medical-grade martensitic stainless steel or cemented carbide, and its cutting edge is passivated or coated with a biocompatible coating.

[0012] Optionally, the suture staples in the suture shaping assembly are made of medical titanium alloy or tantalum wire, and the central fixation seat, the arc-shaped anvil, and the main frame are all made of medical polymer material or aluminum alloy with surface anodizing treatment.

[0013] Optionally, the radius of curvature of the arc-shaped blade ranges from 15mm to 40mm to accommodate different sizes of labiaplasty needs; The spacing between the suture staples in the staple groove is 1.5mm to 2.5mm, and the number of suture staples is 8 to 20 within the effective working length of the arc-shaped anvil.

[0014] Optionally, the labial stapler is constructed as a modular assembly structure, wherein the cutting unit, the abutment unit, and the suture shaping component are integrated into a detachable disposable staple cartridge module, and the main frame and the drive control component are constructed as a reusable operating handle; The disposable staple cartridge module comes in various specifications, corresponding to three sizes: micro, small, and medium. Each size of the staple cartridge module corresponds to a different arc curvature and staple arrangement density, so as to achieve the postoperative morphological effect of a slit-like, willow-leaf, or teardrop shape, respectively.

[0015] The beneficial effects that this application can produce include: First, this application achieves integrated "positioning-cutting-anastomosis" operation through integrated positioning and clamping, arc-shaped cutting, and automatic suturing and shaping components. Utilizing the precise cooperation between the arc-shaped blade and the arc-shaped anvil with staple grooves, excess tissue can be removed and the wound closed in a standardized manner in one operation. This completely changes the traditional surgical approach where cutting and suturing are performed in separate steps, are time-consuming, and rely on the surgeon's manual skills. It significantly shortens the operation time and reduces the risk of infection and bleeding caused by wound exposure.

[0016] Secondly, the arc-shaped cutting reference plane design and mechanical quantitative excision mechanism adopted in this application effectively overcome the problems of uneven edges, asymmetry, and inconsistent excision amounts caused by hand tremors or visual errors during manual excision. Through preset curvature radii and staple groove guidance, the smoothness of the excision edges and the uniform and neat arrangement of the staples are ensured, greatly improving the aesthetics of the labia after surgery (such as a narrow opening or a willow leaf shape) and reducing the risk of scar hyperplasia caused by uneven suture tension.

[0017] Finally, this application provides precise and controllable fine-tuning feed capability and operational safety through the combination of threaded drive and safety mechanism. Surgeons can precisely control the cutting depth and anastomosis force by rotating the adjusting nut, avoiding over-removal or accidental damage to healthy tissue. Simultaneously, the modular design allows for flexible selection of specifications based on the anatomical characteristics of different patients, ensuring personalized surgical adaptation while reducing medical costs through the combination of disposable consumables and a reusable main unit, thus improving the consistency and stability of surgical quality. Attached Figure Description

[0018] Figure 1 A schematic diagram of the overall structure of the labial stapler provided in one embodiment of this application; Figure 2 A schematic diagram of the overall structure of another labial stapler provided in one embodiment of this application; Figure 3 A schematic diagram of the overall structure of another labial stapler provided in one embodiment of this application; Figure label: 10-Main framework; 20-Drive control assembly; 201-Handle; 202-Rotary adjusting nut; 203-Lead screw; 204-Transmission connecting rod; 205-Safety mechanism; 2051-Safety pin; 2052-Limit hole; 1-Positioning clamping assembly; 11-Center fixing seat; 12-Elastic fixing clamp; 2-Cutting unit; 21-Arc-shaped blade; 3-Abutting unit; 31-Arc-shaped anvil; 311-Nail groove; 4-Suturing and shaping assembly; 41-Stabbing reservoir; 411-Suturing staple; 42-Stabbing pusher slider; 43-Stabbing washer. Detailed Implementation

[0019] The technical solutions of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of the embodiments. The components of this application described and shown in the accompanying drawings can generally be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely represents selected embodiments of this application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application. It should be noted that similar reference numerals and letters in the following drawings indicate similar items; therefore, once an item is defined in one drawing, it does not need to be further defined and explained in subsequent drawings. Furthermore, in the description of this application, the terms "first," "second," etc., are used only to distinguish descriptions and should not be construed as indicating or implying relative importance.

[0020] To address the issues of unstable fixation of labial tissue and difficulty in forming a cutting reference plane caused by the lack of a dedicated positioning device in existing technologies, please refer to... Figures 1-3 As shown: This application provides a labial anastomosis device, including a main frame 10, a positioning and clamping assembly 1 disposed at the front end of the main frame 10, a cutting unit 2, an abutment unit 3, a suture shaping assembly 4, and a drive control assembly 20; the positioning and clamping assembly 1 is used to fix the labial tissue to be removed and form a preset cutting reference surface; the cutting unit 2 and the abutment unit 3 are disposed opposite to each other and can approach each other under the drive of the drive control assembly 20 to cut the tissue located between them; the suture shaping assembly 4 is configured to implant fasteners into the tissue at the cut site at the same time as or immediately after the cutting unit 2 cuts the tissue to achieve immediate closure of the wound; the drive control assembly 20 is connected to the cutting unit 2 and the suture shaping assembly 4 for controlling the synchronous or sequential execution of the cutting action and the anastomosis action.

[0021] In its implementation, the main frame 10 is injection molded from medical-grade polycarbonate (PC), which has sufficient rigidity and transparency to allow observation of the internal operation; the positioning and clamping assembly 1 is installed at the front opening of the frame, and its inner surface is frosted to increase friction; the cutting unit 2 contains a high-hardness blade, and the abutment unit 3 is a metal anvil that mates with the blade; the suture shaping assembly 4 is built behind the anvil and contains a push-nail mechanism; the drive control assembly 20 extends through the handle 201 to the front end and transmits power through a mechanical linkage.

[0022] The device works as follows: the doctor operates the drive control component 20, which first clamps and stretches the tissue to be removed by the positioning clamping component 1 to form a tension surface. Then, the drive cutting unit 2 and the abutment unit 3 close to complete the cut. Immediately afterwards, the suture shaping component 4 drives the staples into the tissue to complete the anastomosis. This integrated design realizes a continuous automated process from fixation to resection to suturing, significantly improving surgical efficiency, ensuring neat cut edges and consistent suturing, and reducing human error.

[0023] To address the issue that existing clamping methods are ill-suited to the complex shape of the vaginal opening and cannot create a stable arc-shaped cutting surface, please refer to... Figures 1-3 As shown: Furthermore, the positioning and clamping assembly 1 includes a central fixing seat 11 and a plurality of elastic fixing clips 12 distributed circumferentially around the central fixing seat 11. The central fixing seat 11 is constructed as a ring-shaped or arc-shaped base adapted to the shape of the vaginal opening. One end of the elastic fixing clip 12 is hinged or elastically connected to the central fixing seat 11, and the other end is constructed as a clamping end that can be folded outward and clamped to the labial tissue to be removed, so that the tissue to be removed forms a preset arc-shaped cutting reference surface in the clamping state.

[0024] In practice, the central fixation base 11 is constructed from a medical-grade silicone-coated aluminum alloy frame with an outer diameter ranging from 20mm to 35mm to match the anatomical structures of different patients. The elastic fixation clip 12 is made of spring steel sheet with a thickness of 0.3mm to 0.5mm and a surface coated with an anti-slip rubber layer. One end is hinged to the edge groove of the central fixation base via a miniature pin, and the other end has an arc-shaped hook structure. When the device is inserted, the elastic fixation clip 12 naturally opens and hooks onto the edge of the labia. With a slight pull of the handle 201, the clip automatically locks and converges the tissue towards the center, thus forming a taut arc-shaped working surface with a constant radius of curvature in the central area. This structure utilizes the elastic deformation of the material to adapt to tissues of different thicknesses, ensuring the flatness and tension uniformity of the tissue before cutting, effectively avoiding cutting skew caused by tissue relaxation, and laying a physical foundation for subsequent high-precision resection.

[0025] To address the issues of traditional straight-line cutting failing to create natural physiological curvature and the separation of cutting and suturing processes, please refer to... Figures 1-3 As shown: Furthermore, the cutting unit 2 includes an arc-shaped blade 21 with a predetermined radius of curvature, and the abutment unit 3 includes an arc-shaped anvil 31 that matches the cutting edge trajectory of the arc-shaped blade 21. The surface of the arc-shaped anvil 31 is provided with a plurality of nail grooves 311 extending along its arc direction. The arc-shaped blade 21 can be embedded in the nail grooves 311 during the closed stroke to cut the tissue located between them. At the same time, the nail grooves 311 are configured to allow fasteners in the suture shaping assembly to pass through and act on the tissue at the cut.

[0026] Specifically, the curved blade 21 is made of martensitic stainless steel (such as 440C), and after heat treatment, its hardness reaches HRC 58-60. The cutting edge angle is 15 to 20 degrees, and the radius of curvature is set to 25 mm. The curved anvil 31 is made of cemented carbide, with a guide groove whose width is slightly larger than the blade thickness precisely machined onto its surface. Simultaneously, 1.2 mm diameter nail holes are spaced at intervals at the bottom of the groove, serving as nail grooves 311. The blade is mounted on a sliding block and moves in an arc along the guide rail under the driving force, precisely cutting into the groove of the anvil. The depth of the nail groove 311 is designed to accommodate the blade tip without obstructing the passage of the suture nail 411.

[0027] During operation, the blade rapidly cuts through the clamped tissue along an arc-shaped trajectory, instantly forming an incision. Simultaneously, the staple groove 311 serves as a channel to guide the suture staple 411 through the tissue on both sides of the incision. This curved surface cutting design, combined with the through-hole anvil, not only achieves an aesthetically pleasing arc-shaped resection in one go but also cleverly utilizes the cutting path as a suture channel, achieving simultaneous cutting and suturing, greatly shortening the operation time and ensuring the smoothness of the cut edges.

[0028] For the issues of time-consuming manual sewing and uncontrollable nail formation, please refer to... Figures 1-3 As shown: Furthermore, the suture shaping component 4 includes a staple reservoir 41 disposed on the back side of the arc-shaped anvil 31, a staple pusher 42 slidably disposed in the staple reservoir 41, and a staple forming washer 43 disposed at the distal end of the arc-shaped blade 21 or the arc-shaped anvil 31. The staple reservoir 41 is pre-loaded with a plurality of U-shaped or V-shaped staples 411 arranged in an arc. Under the drive of the drive control component 20, the staple pusher 42 moves linearly along the arc direction of the arc-shaped anvil 31, pushing the staples 411 out of the staple groove 311 and into the tissue. Subsequently, the staple feet of the staples 411 undergo plastic deformation and bend inward to close when they impact the staple forming washer 43.

[0029] In practical applications, the staple reservoir 41 is an arc-shaped plastic guide rail, with U-shaped staples made of medical-grade titanium alloy closely arranged inside, and the staple legs are 4mm to 6mm long. The staple pusher slider 42 is made of high-strength engineering plastic POM, with push teeth at the front end that fit with the tail of the staple, and the rear end connected to the drive rod. The staple forming washer 43 is a hard metal block embedded in the end of the anvil, with hemispherical recesses on its surface. After cutting, the drive mechanism pushes the staple pusher slider 42 forward, pushing a row of staples out of the staple grooves 311 and into the tissue. When the staple tips touch the recesses of the staple forming washer 43, they are curled under force, and the two legs are closed inward to form a B-type closure. This mechanism uses mechanical thrust to replace manual needle threading, ensuring that all staples are inserted to a consistent depth and that the closing force is uniform, effectively preventing tissue ischemia and necrosis or dehiscence caused by loose sutures, and significantly improving the healing quality.

[0030] For the transmission requirements of converting rotary operation into linear cutting and firing motions, please refer to... Figures 1-3 As shown: Furthermore, the drive control assembly 20 includes a handle 201, a rotary adjusting nut 202, a lead screw 203, and a transmission link 204. The rotary adjusting nut 202 is rotatably mounted on the handle 201 or the main frame 10. One end of the lead screw 203 is threaded into the rotary adjusting nut 202, and the other end is connected to the transmission link 204. The transmission link 204 is connected to the cutting unit 2 and the pusher slider 42, respectively, so that when the adjusting nut 202 is rotated, the lead screw 203 generates axial displacement and drives the transmission link 204 to synchronously drive the cutting unit 2 to perform the cutting action and the pusher slider 42 to perform the firing action.

[0031] In the specific structure, the handle 201 housing is made of ergonomically designed ABS material, and the internal cavity accommodates the transmission mechanism; the rotary adjusting nut 202 is a metal ring with knurled texture, which is convenient for applying force with fingers; the lead screw 203 adopts a trapezoidal thread with a pitch of 1.0mm to ensure the precision of the feed; the transmission connecting rod 204 is a rigid metal rod, which is connected to the blade slider and push pin slider 42 through a universal joint or slide groove structure.

[0032] When the doctor rotates the nut, the lead screw 203 moves back and forth, first pushing the blade to complete the cut via the connecting rod, and then continuing to rotate pushes the pusher slider 42 to complete the nail insertion. Alternatively, a specific cam profile design can be used to achieve the timing coordination of the two. This helical transmission method converts rotational torque into stable linear thrust, providing enormous cutting and firing forces, while allowing the doctor to precisely control the stroke by rotating the angle, achieving fine-tuning and controllability of the operation.

[0033] To address the potential security risks associated with accidental operation, please refer to [the relevant documentation / reference]. Figures 1-3 As shown: Furthermore, the drive control assembly 20 also includes a safety mechanism 205. The safety mechanism 205 includes a safety pin 2051 and a corresponding limiting hole 2052 disposed on the handle 201 or the rotary adjusting nut 202. When the safety pin 2051 is inserted into the limiting hole 2052, the rotary adjusting nut 202 is locked and cannot be rotated. Only after the safety pin 2051 is pulled out can the rotary adjusting nut 202 be rotated to start the cutting and mating process.

[0034] In practice, the safety pin 2051 is a stainless steel cylindrical pin with a red warning ring on its head, held in the popped or inserted state by spring loading. The limiting hole 2052 is located on the side of the nut, corresponding to the handle fixing seat, with a tight tolerance fit. When the safety pin 2051 is not removed, the pin physically restricts the rotational freedom of the nut, preventing accidental triggering before the instrument is inserted into the body. Only after confirming the correct position and the doctor actively removes the safety pin 2051 to release the lock can the operation be performed. This simple mechanical interlocking structure effectively prevents unintended cuts caused by hand tremors or accidental touches, ensuring the safety of surrounding healthy tissues and improving the overall safety of the surgery.

[0035] For requirements regarding biocompatibility and durability, please refer to [reference needed]. Figures 1-3 As shown: Furthermore, the curved blade 21 of the cutting unit 2 is made of medical-grade martensitic stainless steel or cemented carbide, and its cutting edge is passivated or coated with a biocompatible coating; the suture staples in the suture shaping assembly are made of medical-grade titanium alloy or tantalum wire, and the central fixation seat 11, the curved anvil 31 and the main frame 10 are all made of medical-grade polymer materials or aluminum alloy with surface anodizing treatment.

[0036] In terms of specific material selection, the blade material is stainless steel conforming to ASTM F899 standards, with a diamond-like carbon (DLC) coating to reduce the coefficient of friction; the suture staples are made of pure titanium of Grade 1 or 2, which has good ductility and corrosion resistance; the main frame 10 is made of PEEK material or 6061-T6 aluminum alloy with hard anodizing treatment, and the surface roughness Ra < 0.4μm. These material choices ensure the chemical stability of the instrument in bodily fluid environments, avoiding allergic reactions caused by metal ion release. At the same time, the high hardness of the blade and anvil ensures sharpness and dimensional stability for repeated use (if designed for reusability), or guarantees reliable performance for single use, extending the instrument's lifespan and meeting the stringent biosafety requirements of medical regulations.

[0037] To address the diverse anatomical differences and postoperative morphological variations among patients, please refer to [the relevant documentation / reference]. Figures 1-3 As shown: the radius of curvature of the arc-shaped blade 21 ranges from 15mm to 40mm to accommodate different sizes of labiaplasty; the spacing between the suture pins 411 in the pin groove 311 is 1.5mm to 2.5mm, and the number of suture pins 411 is 8 to 20 within the effective working length of the arc-shaped anvil 31.

[0038] Within the specific product series, three sizes are offered: small, medium, and large. The small size has a curvature radius of 15mm-20mm and comes with 8-10 screws, suitable for young or childless women; the medium size has a curvature radius of 20mm-30mm and comes with 12-16 screws, suitable for most adult women; and the large size has a curvature radius of 30mm-40mm and comes with 18-20 screws, suitable for cases with severe tissue hypertrophy. The differentiated screw spacing directly determines the density and aesthetics of the postoperative scar. A denser screw spacing is suitable for patients seeking an extremely smooth result, while a more sparser spacing facilitates drainage during the tissue edema period. By providing a variety of specifications with multiple parameter combinations, this approach can precisely match individual differences, achieving personalized plastic surgery results, such as a slit-like or willow-leaf shape, thus improving the surgical adaptability and patient satisfaction.

[0039] For the needs of reducing medical costs and increasing operational flexibility, please refer to Figures 1-3 As shown: The labial stapler is constructed as a modular assembly structure, in which the cutting unit 2, the abutment unit 3 and the suture shaping component 4 are integrated into a detachable disposable staple cartridge module, and the main frame 10 and the drive control component 20 are constructed as a reusable operating handle; the disposable staple cartridge module has a variety of specifications, corresponding to three sizes: micro, small and medium, and each size of the staple cartridge module corresponds to a different arc curvature and suture staple 411 arrangement density, so as to achieve the postoperative morphological effect of a slit-like, willow-leaf-shaped or teardrop-shaped suture respectively.

[0040] In its specific structure, the staple cartridge module has a snap-fit ​​interface at the rear, which can quickly engage with the locking mechanism at the front of the handle, and the module type is identified through electrical or mechanical contacts; the internal motor or mechanical structure of the handle 201 automatically adjusts the stroke parameters based on the identification result. Doctors can select the appropriate staple cartridge based on preoperative assessment, and it is ready for use after installation. The staple cartridge is discarded postoperatively, while the handle 201 can be reused after disinfection. This design, separating consumables from the main unit, reduces the instrument cost per surgery, eliminates assembly errors through pre-installed standardized modules with blades and staples, ensures consistent performance in every surgery, and the wide range of module specifications meets diverse clinical aesthetic needs.

[0041] The above description is merely a few embodiments of this application and is not intended to limit this application in any way. Although this application discloses preferred embodiments as described above, it is not intended to limit this application. Any changes or modifications made by those skilled in the art without departing from the scope of the technical solution of this application using the disclosed technical content are equivalent to equivalent implementation cases and fall within the scope of the technical solution.

Claims

1. A labial stapler, comprising a main frame (10) and a drive control assembly (20) disposed on the main frame (10), characterized in that: It also includes a positioning clamping assembly (1) for positioning and fixing the labial tissue to be treated, a cutting unit (2) for cutting the fixed tissue, an abutting unit (3) that cooperates with the cutting unit (2) to form a shearing pair, and a suture shaping assembly (4) for implanting fasteners at the cutting site to achieve wound closure. The positioning clamping component (1) is configured to define the morphological contour of the tissue to be removed and provide a cutting reference surface; The drive control component is connected to the cutting unit (2) and the suture shaping component (4) respectively, and is configured to drive the cutting unit (2) to move relative to the abutment unit (3) in a single operation stroke to complete tissue cutting, and synchronously or in conjunction drive the suture shaping component (4) to implant the fastener into the tissue at the cut site to complete immediate anastomosis.

2. The labial stapler according to claim 1, characterized in that: The positioning clamping assembly (1) includes a central fixing seat (11) and a plurality of elastic fixing clamps (12) distributed circumferentially around the central fixing seat (11). The central fixing seat (11) is constructed as a ring-shaped or arc-shaped base adapted to the shape of the vaginal opening. One end of the elastic fixing clip (12) is hinged or elastically connected to the central fixing seat (11), and the other end is constructed as a clamping end that can be folded outward and clamped to the labial tissue to be removed, so that the tissue to be removed forms a preset arc-shaped cutting reference surface in the clamping state.

3. The labial stapler according to claim 1, characterized in that: The cutting unit (2) includes an arc-shaped blade (21) with a predetermined radius of curvature, and the abutting unit (3) includes an arc-shaped anvil (31) that matches the cutting edge trajectory of the arc-shaped blade (21). The surface of the arc-shaped anvil (31) is provided with a plurality of nail grooves (311) extending along its arc direction. The curved blade (21) can be embedded in the staple groove (311) during the closed stroke to cut the tissue located between them, while the staple groove (311) is configured to allow the fastener in the suture shaping assembly (4) to pass through and act on the tissue at the cut.

4. The labial stapler according to claim 3, characterized in that: The suture shaping component (4) includes a staple storage compartment (41) disposed on the back side of the arc-shaped anvil (31), a staple pusher (42) slidably disposed in the staple storage compartment (41), and a staple forming washer (43) disposed at the distal end of the arc-shaped blade (21) or the arc-shaped anvil (31). The staple storage compartment (41) is pre-loaded with a number of U-shaped or V-shaped staples (411) arranged in an arc. The staple pusher (42) moves linearly along the arc direction of the arc-shaped anvil (31) under the drive of the drive control component, pushing the staples (411) out of the staple groove (311) and into the tissue. Then, the staple feet of the staples (411) undergo plastic deformation and bend inward to close when they hit the staple forming washer (43).

5. The labial stapler according to claim 1, characterized in that: The drive control assembly (20) includes a handle (201), a rotary adjusting nut (202), a lead screw (203), and a transmission connecting rod (204). The rotary adjusting nut (202) is rotatably mounted on the handle (201) or the main frame (10). One end of the lead screw (203) is threaded into the rotary adjusting nut (202), and the other end is connected to the transmission link (204). The transmission link (204) is connected to the cutting unit (2) and the pusher slider (42) respectively, so that when the adjusting nut is rotated, the lead screw (203) generates axial displacement and drives the transmission link (204) to synchronously drive the cutting unit (2) to perform the cutting action and the pusher slider (42) to perform the firing action.

6. The labial stapler according to claim 5, characterized in that: The drive control component (20) also includes a safety locking mechanism (205), which includes a safety pin (2051) and a corresponding limiting hole (2052) disposed on the handle (201) or the rotary adjusting nut (202). When the safety pin (2051) is inserted into the limiting hole (2052), the rotary adjusting nut (202) is locked and cannot be rotated. Only after the safety pin (2051) is pulled out can the rotary adjusting nut (202) be rotated to start the cutting and mating process.

7. The labial stapler according to claim 1, characterized in that: The arc-shaped blade (21) of the cutting unit (2) is made of medical martensitic stainless steel or hard alloy, and its cutting edge is passivated or coated with a biocompatible coating.

8. The labial stapler according to claim 1, characterized in that: The suture staples (411) in the suture shaping component (4) are made of medical titanium alloy or tantalum wire, and the central fixation seat (11), the arc-shaped anvil (31) and the main frame (10) are all made of medical polymer material or aluminum alloy with surface anodizing treatment.

9. The labial stapler according to claim 3, characterized in that: The radius of curvature of the arc-shaped blade (21) ranges from 15 mm to 40 mm to accommodate different sizes of labiaplasty needs; The spacing between the suture staples (411) in the staple groove (311) is 1.5 mm to 2.5 mm, and the number of suture staples (411) is 8 to 20 within the effective working length of the arc-shaped anvil (31).

10. The labial stapler according to claim 1, characterized in that: The labial stapler is constructed as a modular assembly structure, wherein the cutting unit (2), the abutment unit (3) and the suture shaping component (4) are integrated into a detachable disposable staple cartridge module, and the main frame (10) and the drive control component (20) are constructed as a reusable operating handle; The disposable staple cartridge module comes in various specifications, corresponding to three sizes: micro, small, and medium. Each size of the staple cartridge module corresponds to a different arc curvature and staple arrangement density, so as to achieve the postoperative morphological effect of a slit-like, willow-leaf, or teardrop shape, respectively.

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