WO2023138124A1

WO2023138124A1 - Actuating mechanism for everting stapling device, stapling device, and stapling device quality inspection method

Info

Publication number: WO2023138124A1
Application number: PCT/CN2022/125848
Authority: WO
Inventors: 薛建新; 高子兵; 刘俊; 夏云; 蔡正茂
Original assignee: 薛建新; 南京五色石医疗科技有限公司
Priority date: 2022-01-20
Filing date: 2022-10-18
Publication date: 2023-07-27

Abstract

An actuating mechanism for an everting stapling device, comprising a staple cartridge mechanism (6), an anvil mechanism (7) and a transmission mechanism (5). Penetration slots (605, 616, 705) extending along the length direction of the actuating mechanism are formed on a staple cartridge cover (617), a staple cartridge base (606) and an anvil base (710). The penetration slots (605, 616, 705) are provided with openings at the distal ends of the staple cartridge cover (617), the staple cartridge base (606) and the anvil base (710). On the two sides of each penetration slot (605, 616, 705), the staple cartridge cover (617) and the anvil base (710) are further provided with guide slots (618, 711) extending in the length direction of the actuating mechanism. Staples (610) in the staple cartridge mechanism (6) are arranged in columns on the two sides of each penetration slot (605, 616, 705), and are located between the penetration slots (605, 616, 705) and the guide slots (618, 711). The actuating mechanism is provided with the penetration slots (605, 616, 705), and anastomotic tissue broken ends can be pulled from the opening to enter the penetration slots (605,616,705), then the two broken ends can be everted towards the two sides and tiled, and then aligned and stapled, and intracorporeal everting stapling can be implemented by means of the instrument.

Description

An executive mechanism for an eversion-type stapler, a stapler, and a quality inspection method for the stapler

technical field

The invention relates to the field of medical devices, and relates to an executive mechanism for an eversion-type stapler, a stapler and a quality inspection method for the stapler.

Background technique

Due to the development of modern science and technology, a cutting stapler that replaces traditional manual suturing has been born; the cutting stapler has the advantages of rapid anastomosis, reliability, and fewer postoperative complications. Its working principle is similar to that of a stapler, that is, the process of stapling and cutting tissues and organs with titanium nails and blades, respectively. Existing cutting staplers are mainly used for cutting and anastomosis of skin, digestive tract, blood vessels, lungs, etc., and are suitable for laparoscopic and open operations. The repair and reconstruction of many lumen-like internal structures (such as urinary tract: including urethra, vesicourethra, ureteral bladder, ureter; intestinal tract, blood vessels, etc.) currently mainly rely on manual anastomosis with wires and anastomosis with endoluminal circular staplers or multiple linear cutting staplers.

The current clinically used endoluminal staplers are mainly suitable for side-to-side suturing of digestive tract reconstruction, requiring the use of multiple linear cutting staplers or staple cartridges. This suturing method has at least three defects: (1) the normal anatomical structure of the human body is changed, and tissue necrosis, suture leakage, and bleeding are prone to occur at the junction of the suturing nails after surgery; (2) after suturing, when the contents of the lumen pass through the stoma, a 90° turn is formed in the lumen, which is not smooth enough to easily cause obstruction; (3) two or more sutures are required, which greatly increases the cost and difficulty of the operation. In addition, the existing endoluminal cutting and staplers are powerless in suturing small lumens such as biliary tract, fallopian tube, ureter, and urethra, or can only perform closed cutting functions. The existing problems of the prior art will be described in detail below in conjunction with the accompanying drawings.

As shown in FIG. 1 , two lumens to be sutured are formed during the operation, and the ends of the lumens need to be sutured together.

Combined with Figures 2, 3, and 5, it is a commonly used varus anastomosis operation. First, an incision A1 is made on the lumen at the right end, and the stapler with a curved end in Figure 3 is inserted into the lumen. The tissue is resected from the luminal tissue A2 and formed with a circle of inverted sutures in Figure 2. Then take the stapler out of the lumen through the wound A1, and then use the stapler shown in Figure 5 to suture the wound A1. This suturing method has at least three defects: (1) Inverted anastomosis is used to form an inverted suture lumen tissue A2 protruding from the inner wall of the lumen in the lumen, which is easy to cause many complications such as stenosis and obstruction after the operation. (2) An incision A1 needs to be made on the lumen and needs to be anastomosed again. This incision is additionally opened due to the operation, which increases the difficulty of the operation and unnecessary pain to the patient. (3) Use multiple staplers, greatly increasing the cost of surgery.

Combined with Figures 4 and 5, this is the second anastomosis method. Pull the lumen at the right end in Figure 1 and place the two broken ends side by side so that the outer walls of the two lumens are attached together, and then use the linear stapler shown in Figure 5 to anastomose the side-to-side of the attached lumen, that is, place the two lumen walls attached together between the staple magazine A6 and the anvil A7, and fire the staples in the staple magazine A6. Fistula A3, and finally the ends of the two lumens are anastomosed with the linear stapler shown in FIG. 5 . The ostomy port A3 has just become the communicating port of the two sections of the lumen. This anastomotic method has at least three defects: (1) Since the original orientation of a section of the lumen needs to be changed, the lumen is pulled by external force, and this method itself will cause damage to the lumen. (2) After the anastomosis, the flowing content in the lumen moves through the stoma A3, forming a 90° turn in the lumen, the flow is not smooth enough, and it is easy to block. (3) Two or more anastomoses are required, which greatly increases the cost and difficulty of the operation.

Figure 6 shows the eversion suture method. The two stumps are everted to form a circle of everted suture lumen tissue A5 after suturing. The advantages of this method are obvious. The suture point is outside the lumen, which will not cause complications such as postoperative stenosis and obstruction. However, in the current operation, this method is limited to manual suturing, and staplers cannot be used. It can be illustrated in conjunction with FIG. 3 that if the broken ends of the two sections of the lumen are turned outward on the circular anvil A8 and the circular staple bin A10 respectively, and then sutured together, there is no way to remove the stapler from the sutured lumen after suturing. In order to realize the eversion-type anastomosis of the stapler, the invention patent with application number 201510282427X provides an extraluminal anastomosis method. After the lumen is sutured, the annular structure of the staple cartridge and the base is cut off with scissors, thereby removing the staple cartridge and the base. However, this method is only an idea, without detailed structural features. There are at least four reasons why it cannot be applied clinically: (1) The surgical space is very small, and it is difficult to insert a pair of scissors between the tissue and the anastomotic ring after suturing to cut off the ring structure. (2) When using scissors to cut the annular structure, external force needs to be applied. If the operation is not done properly, it will cause secondary damage to the lumen tissue, or even break the lumen. (3) The rigidity of materials that are easy to be cut and damaged by scissors must be insufficient to form sufficient anastomotic traction, which is also destructive to surgical scissors. (4) The anastomosis method of pulling the anvil ring to the proximal end to squeeze the staples is adopted, because the distal end cannot be seen during the operation, which may easily cause tearing of the tissues and organs.

Contents of the invention

The object of the present invention is to provide an actuator for eversion-type sutures, so that the staplers can perform end-to-end, end-to-side, side-to-side, etc., valgus sutures in the human body through micro-channels such as sheath clips.

The executive mechanism for the eversion type stapler provided by the present invention comprises a staple bin mechanism, a nail anvil mechanism, and a transmission mechanism; the staple bin mechanism includes a staple bin cover and a staple bin seat, and a nail pushing mechanism is arranged in the space between the nail bin cover and the staple bin seat, and the anvil mechanism includes an anvil seat; the transmission mechanism includes a transmission mechanism shrapnel; Openings are formed; on both sides of the penetrating groove, guide grooves extending along the length direction of the actuator are also provided on the staple bin cover and the staple anvil; the staples in the staple bin mechanism are arranged on both sides of the penetrating groove, and are located between the penetrating groove and the guiding groove;

The transmission mechanism shrapnel includes a transmission mechanism shrapnel A and a transmission mechanism shrapnel B. The far ends of the transmission mechanism shrapnel A and the transmission mechanism shrapnel B extend into the space between the staple bin cover and the staple bin seat.

The important invention of the present invention is to break through the design structure of the conventional linear stapler. The staple cartridge mechanism and the staple anvil mechanism are divided into two, and a penetration groove is provided in the middle, so that the two ends of the tissue to be sutured can be respectively drawn and penetrated from the penetration groove of the staple cartridge mechanism and the penetration groove of the nail anvil mechanism, and then the broken ends of the tissue to be sutured are turned outward to realize end-to-end suture. The scheme design idea of the present invention is exquisite, only needs to change the conventional linear suturing device, can realize valgus suturing.

Preferably, the guide groove includes a first guide segment at the proximal end, a second guide segment at the distal end, and a connecting segment connecting the first guide segment and the second guide segment, wherein the distance between the two first guide segments is smaller than the distance between the two second guide segments. At the proximal end, the transmission mechanism shrapnel A and the transmission mechanism shrapnel B are relatively close. After moving to the far end, the transmission mechanism shrapnel A and the transmission mechanism shrapnel B are separated far away by utilizing the deformation ability of the transmission mechanism shrapnel. The design of the second guide section avoids interference to the staples and the like. Simultaneously, staples can be arranged at the proximal end of the penetration groove, and the driving shrapnel is close at the proximal end, and the staples can be fired along the connecting section at the proximal end.

Preferably, staples are provided at the proximal end of the penetration groove of the staple cartridge seat. This design can ensure that both sides of the penetration groove and the tissue to be sutured at the proximal end can be sutured, and the sutured intestinal tissue is moved out of the penetration groove, and then the intestinal tissue located at the far end of the penetration groove is artificially sutured to complete the overall suture.

Preferably, the staples located on both sides and near ends of the penetration groove form a U-shape or a V-shape.

Preferably, the guiding grooves on both sides are arranged in parallel from the distal end to the proximal end.

Preferably, the staples are distributed in parallel on both sides of the penetration groove of the cartridge holder, and the broken ends of the tissues to be sutured on both sides can be sutured through the actuator, the sutured tissue can be moved out of the penetration groove, and then the overall stitching can be completed by manually suturing the tissues initially located at both ends of the penetration groove.

Preferably, the nail pushing mechanism includes a nail pushing mechanism A and a nail pushing mechanism B. When the distal ends of the transmission mechanism shrapnel A and the transmission mechanism shrapnel B move along the guide grooves on the nail bin cover and the nail anvil, they respectively push the nail pushing mechanism A and the nail pushing mechanism B to move on both sides of the penetration groove.

Preferably, the far ends of the transmission mechanism shrapnel A and the transmission mechanism shrapnel B are respectively connected with a sliding limiter A and a sliding limiter B with an I-shaped cross section, the upper and lower ends of the sliding limiter A and the sliding limiter B are respectively inserted into the guide grooves on one side of the nail bin cover and the nail anvil, and the top and bottom ends of the I-shape are respectively exposed outside the guide grooves on the nail bin cover and the nail anvil. .

Preferably, the pusher mechanism includes a pusher mechanism A and a pusher mechanism B, and the proximal ends of the two pusher mechanisms are respectively provided with connecting grooves, and the connecting columns of the vertical parts of the sliding limit block A and the slide limiter B can be respectively inserted into the connection grooves of the pusher mechanism A and the pusher mechanism B, so as to realize the detachable connection between the transmission mechanism shrapnel A, the transmission mechanism shrapnel B and the nail pusher mechanism A, pusher mechanism B.

Preferably, the connecting groove is arranged near the outer side of the nail pushing mechanism.

Preferably, a counterweight is provided on the outside of the nail pushing mechanism to ensure that the resistance on both sides is equal and the force is balanced, so that the nail pushing is smooth and the nail pushing mechanism will not be biased.

Preferably, a cutting blade is provided at the lower end of the connecting column of the vertical part of the sliding limit block A and the sliding limit block B, and the excess tissue on the edge after the valgus suturing is cut off with the cutting blade.

If the width of the staple bin cover and the anvil is relatively wide, and the width of the staple bin seat is relatively narrow, the transmission mechanism shrapnel A and the transmission mechanism shrapnel B are arranged on both sides of the staple bin seat, and there will be no interference with the staple bin seat when moving. Otherwise, a guide groove extending along the length direction of the actuator must also be provided on the staple bin seat.

Preferably, the openings of the staple cartridge cover, the staple cartridge seat, and the staple anvil are flaring with a wide outside and a narrow inside. This structure facilitates the insertion of the stump tissue to be sutured into the penetration groove.

Preferably, a supporting plate is provided at the bottom of the anvil, and a penetration groove extending along the length direction of the actuator is also provided on the supporting plate, and a guard plate is provided at the proximal end of the supporting plate.

Preferably, an elastic member is provided at the proximal connection of the anvil mechanism and the staple cartridge mechanism, and the elastic member promotes the opening state of the staple cartridge mechanism and the staple anvil mechanism, and when the transmission mechanism shrapnel A and the transmission mechanism shrapnel B move to the distal end, the staple cartridge mechanism and the nail anvil mechanism are urged to close.

Preferably, the transmission mechanism is arranged in the casing.

Preferably, the staple cartridge cover and the staple anvil are recessed inward, so that the size of the actuator is reduced to facilitate the passage of the sheath.

Preferably, the cartridge holder is detachably arranged under the cartridge cover, so that the cartridge holder can be replaced with a new cartridge holder after the staples are used up, so that the main structure of the actuator can be reused.

Preferably, the proximal end of the actuator is provided with a separation post for separating the spring piece A of the transmission mechanism and the spring piece B of the transmission mechanism. The separation column can ensure that the shrapnel A of the transmission mechanism and the shrapnel B of the transmission mechanism are always separated in parallel at the proximal end, and ensure that the shrapnel of the transmission mechanism will not interfere with each other when pushing forward or turning. The separation column is narrow at the proximal end and wide at the distal end, and can be spindle-shaped or semi-spindle-shaped.

As a medical device, the stapler has high requirements on product quality, and multiple verification tests are required to ensure that the quality is qualified. For this reason, the present invention also provides a quality inspection method for the stapler, which is characterized in that: the broken end B of the tissue to be sutured is penetrated into the actuator from the anvil seat, and the broken end B is turned outward, and laid on the upper surface of the nail anvil of the actuator; Flip outwards and lay on the lower surface of the staple bin seat; push the far ends of the transmission mechanism shrapnel A and the transmission mechanism shrapnel B of the stapler to move along the guide groove on the staple bin cover and the nail anvil, and the transmission mechanism shrapnel A and transmission mechanism shrapnel B push the nail pushing mechanism A and the nail pushing mechanism B to move on both sides of the penetration groove, thereby firing the staples; move the tissue to be sutured out of the actuator along the penetration groove, and check whether the broken ends A and B are placed between the guide groove and the penetration groove Stitch, and if it sews, the stapler passes.

Preferably, when the stumps A and B are everted, turn the stumps A and B to the outside of the guide groove, and use the cutting blade to cut off the excess tissue on the outer edge of the suture. If it is found that there is no cut or the cut is irregular, it means that the quality of the cutting blade is wrong or the setting position is wrong.

The present invention provides a brand-new executive mechanism for valgus and valgus suturing device, which has the following advantages: (1) The structure can realize valgus and valgus suturing through minimally invasive surgical channels such as sheath clips, which is a powerful supplement to open valgus sutures. Although they are all valgus sutures, the working principle of the mechanism is completely different and adapts to the requirements of clinical minimally invasive surgery; (2) There are new options for suturing tissues and organs (such as: blood vessels, urinary tract, etc.) (3) One-time suturing can basically achieve the reconstruction goal. Compared with the previous need for multiple sutures, the use of multiple staples saves surgical steps and surgical costs; (4) It can realize end-to-end, end-to-side, side-to-side valgus sutures in the cavity, and is applicable to a wide range of suture scenarios; The recovery is favorable, which greatly reduces the occurrence of related complications; (6) External staples, the staples are located outside the cavity after suturing, which reduces the complications related to the staples, such as stenosis of the suture opening, bleeding related to the staples, and stone thrombosis.

Description of drawings

Figure 1 is a schematic diagram of two sections of the lumen to be anastomosed;

Figure 2 is a schematic diagram of varus anastomosis;

Fig. 3 is a schematic diagram of a stapler for varus anastomosis;

Fig. 4 is a schematic diagram of the second way of lumen anastomosis;

Fig. 5 is a schematic diagram of a stapler for external anastomosis;

Figure 6 is a schematic diagram of valgus anastomosis;

Fig. 7 is a schematic diagram of a firing control mechanism commonly used in a linear cutting stapler;

Fig. 8 is a schematic diagram of the actuator of the present invention;

Fig. 9 is a schematic diagram of the stapler passing through the minimally invasive channel of the present invention;

Figure 10 is an exploded view of the actuator of the present invention;

Fig. 11 is a schematic diagram of a transmission mechanism and a steering mechanism of the present invention;

Fig. 12 is a schematic diagram of the nail anvil of the present invention;

Fig. 13 is a schematic diagram of the staple magazine mechanism (including opening shrapnel, metal grooves, staples, nail presses, etc.) of the present invention;

Fig. 14 is a schematic diagram of cooperation between the transmission mechanism and the push nail mechanism of the present invention;

Fig. 15 is a schematic diagram of the executive mechanism of Embodiment 2 of the present invention;

Fig. 16 is an exploded view of the actuator in Embodiment 2 of the present invention;

Fig. 17 is a schematic diagram of the nail anvil in Example 2 of the present invention;

Fig. 18 is a schematic diagram of the staple cartridge mechanism in Embodiment 2 of the present invention;

Fig. 19 is a schematic diagram of cooperation between the transmission mechanism and the push nail mechanism in Embodiment 2 of the present invention;

Fig. 20 is an exploded view of the executive mechanism of Embodiment 3 of the present invention;

Figure 21 is a schematic diagram of eversion suture of two broken ends.

In the figure; 1-firing control mechanism, 101-trigger, 102-ratchet, 103-propelling rod, 104-resetting button, 105-direction adjustment button, 106-turning propelling rod, 107-firing safety;

2-sleeve, 201-upper half pipe, 202-lower half pipe;

3-limiting block, 301-limiting block A, 302-limiting block B;

4-steering mechanism, 401-sheet metal rod, 402-hook-shaped protrusion;

5-transmission mechanism, 501-connecting part, 5031-transmission mechanism shrapnel A, 5032-transmission mechanism shrapnel B, 5041-sliding limit block A, 5042-sliding limit block B, 5045-connecting column, 5046-cutting blade, 5047-connecting column A, 5048-connecting column B;

6-Nail cartridge mechanism, 601-Joint joint, 602-First guide section of staple cartridge, 603-Anchor mechanism, 604-Opening shrapnel, 605-Nail cartridge cover penetration groove, 606-Nail cartridge seat, 607-Second cartridge guide section, 608-Nail cartridge scale line, 609-Nail hole, 610-Stapling staple, 611-Nail press, 612-Proximal platform, 613-Nail cartridge cover expansion , 614-Nail bin connecting section; 615-Nail bin seat expansion, 616-Nail bin seat penetration groove, 617-Nail bin cover, 618-Nail bin cover guide groove, 619-Separation column;

7-anvil mechanism, 701-staple forming pit, 702-shield plate, 703-anvil connection section, 704-anvil first guide section, 705-anvil penetration groove, 706-anvil second guide section, 707-anvil flare, 708-support plate, 709-support plate penetration groove, 710-anvil seat, 711-anvil guide groove;

8-Nail pushing mechanism, 801-Connecting groove, 802-Nail pushing protrusion, 803-Nail pushing mechanism A, 804-Nailing mechanism B;

Detailed ways

The technical solution of the present invention will be described in detail below with reference to FIGS. 7-21 .

In order to clarify the description, the directional terms we use in the drawings and the following description are relative to the operator holding the stapler handle horizontally with his right hand, that is, the fixed handle is located in the jaw of the right hand, and the other four fingers except the thumb hold the movable handle. Specifically, the terms "proximal" and "rear" refer to a position close to the operator, while the terms "distal" and "anterior" refer to a position remote from the operator. The term "left" refers to the left side of the operator, while the term "right" refers to the right side of the operator; "up" refers to the direction opposite to gravity, and "down" refers to the direction of gravity. Other directional terms can be understood in light of the figures and description below.

Example 1:

The executive mechanism provided by the present invention needs to be used in connection with the firing control mechanism of a traditional linear cutting and stapler. As shown in FIG. For traditional linear cutting and staplers, please refer to CN101156793A and US5762256B, which describe the structure of the firing control mechanism in detail, and will not be repeated in this application. The actuator is usually a one-time loading part, which is discarded after use, and the firing control mechanism can be reused many times, and can be matched with the actuator of the traditional linear cutting stapler. It is also possible to make the disposable loading part and the firing control mechanism an integral disposable part.

The executive mechanism provided by the present invention is similar to the traditional linear stapler as a whole. It includes a staple bin mechanism 6, an anvil mechanism 7, a transmission mechanism 5, and a steering mechanism 4.

As shown in FIG. 11 , the steering mechanism 4 includes a sheet-shaped metal rod 401 , and a hook-shaped protrusion 402 is provided at the proximal end of the sheet-shaped metal rod. As shown in Figures 11 and 14, the transmission mechanism 5 includes a transmission mechanism shrapnel A 5031, a transmission mechanism shrapnel B 5032, a sliding limit block A 5041, and a sliding limit block B 5042. The shrapnel (A, B) of the transmission mechanism can be made of elastic material or non-elastic material, as long as it can produce a certain deformation. The shrapnel A of the transmission mechanism is connected with the sliding limit block A, and the shrapnel B of the transmission mechanism is connected with the sliding limit block B. The sliding limit block A and the sliding limit block B are I-shaped structures, and the lower part of the connecting column 5045 in the middle of the I-shaped structure is provided with a cutting blade 5046 . The proximal end of the pusher mechanism 8 is provided with two connecting grooves 801, and the connecting posts of the shrapnel A and B of the transmission mechanism can be respectively inserted into one of the connecting grooves 801, and the bottom of the pusher mechanism 8 is provided with an estimating protrusion 802.

As shown in FIGS. 8 and 10 , the steering mechanism 4 and the transmission mechanism 5 are installed in the casing 2 . For the convenience of installation, an upper half pipe 201 and a lower half pipe 202 are provided, and the transmission mechanism shrapnel A and the transmission mechanism shrapnel B are set in the groove of the lower half pipe, and then the upper half pipe and the lower half pipe are combined, which is convenient for installation and plays a guiding role. In addition, an anchoring mechanism 603 may be provided at the distal end, and the distal ends of the transmission mechanism shrapnel A and the transmission mechanism shrapnel B pass through the anchoring mechanism 603 to play a guiding role. The transmission mechanism 4 is arranged on the side part after the upper and lower half pipes are assembled, and then placed in the casing 2 as a whole. The proximal end of the lower half pipe is provided with a limit block 3, including a limit block A 301 and a limit block B 302.

As shown in Figures 7, 8, and 9, the proximal side of the actuator is combined with the firing control mechanism 1 of the linear cutting stapler and inserted into the firing control mechanism 1, and rotated 90°. The limit block A 301 and the limit block B 302 are inserted into the corresponding holes on the firing control mechanism 1 to complete their docking; In the groove of the push rod 106, the two are fixedly connected.

As shown in FIGS. 8 , 10 , and 13 , the cartridge mechanism 6 includes a cartridge cover 617 and a cartridge seat 606 . A staple hole 609 is provided on the staple cartridge seat 606, and a staple 610 is placed in the staple hole 609. A staple pusher 611 is located above the staple 610, and the staple pusher 611 is pressed downward, and the staple pusher 611 fires the staple 610 toward the anvil mechanism 7. The staple cartridge cover 617 covers the staple cartridge seat 606, and the space between the staple cartridge cover 617 and the staple cartridge seat 606 is accommodated for the nail pushing mechanism 8, so that the staple pushing mechanism 8 can move from the proximal end to the distal end of the actuator. The side of the staple cartridge cover 617 is provided with a staple cartridge scale line 608 for indicating the positions of the staple holes and preventing tissue displacement. In the present invention, a magazine cover penetration groove 605 and a magazine cover guide groove are provided in the middle of the magazine cover, and the magazine cover penetration groove and the magazine cover guide groove all extend from the distal end to the proximal end along the length direction of the actuator. The nail bin cover penetration groove is formed with an opening at the far end of the nail bin cover, and the opening is a nail bin cover flare 613 that is wide on the outside and narrow on the inside. There are two nail bin cover guide grooves, and the nail bin cover penetrates both sides of the groove 605, including the first nail bin guide section 602, the nail bin connecting end 614, and the second nail bin guide section 607, wherein the distance between the two nail bin first guide sections 602 is smaller than the distance between the two nail bin second guide sections 607, and the nail bin connecting section 614 connects the nail bin first guide section 602 and the nail bin second guide section 607 to form a transition. The staple cartridge seat 606 is also provided with a corresponding staple cartridge seat penetration groove 616 extending along the length direction of the actuator and corresponding to the staple cartridge cover penetration groove 605. The staple cartridge seat penetration groove 616 is formed with an opening at the far end of the staple cartridge seat. The opening is a staple cartridge seat flare 615 that is wide outside and narrow inside. There are one or more rows of staples on both sides of the insertion groove of the staple cartridge seat. Staples can also be set at the proximal end of the staple cartridge seat penetration groove 616, the staples converge inwards, cross as far as possible at the proximal end of the penetration groove, and the staples on both sides and ends form a V shape or a U shape.

As shown in Figures 8, 10, and 12, the anvil mechanism 7 includes an anvil base 710, which is provided with an anvil penetration groove 705 extending along the length direction of the actuator and corresponding to the staple cartridge base penetration groove 616. The anvil penetration groove 705 forms an opening at the far end of the anvil base 710, and the opening is an anvil flare 707 that is wide on the outside and narrow on the inside. Anvil guide grooves extending along the length direction of the actuator are provided on both sides of the anvil penetration groove 705. The anvil guide grooves include a first anvil guide section 704, an anvil second guide section 706, and an anvil connecting section 703, wherein the distance between the two anvil first guiding sections 704 is less than the distance between the two anvil second guiding sections 706, and the anvil connecting section 703 connects the anvil first guiding section 704 and the nail anvil second guiding section 706 to form a transition. A supporting plate 708 is provided at the bottom of the nail anvil 710, and a supporting plate penetration groove 709 extending along the length direction of the actuator is arranged on the supporting plate 708. The supporting plate penetration groove 709 forms an opening at the far end of the supporting plate 708. The proximal end of the supporting plate 708 is provided with a guard plate 702. Referring to FIG. 8, after the staple cartridge mechanism is connected to the anvil mechanism, the guard plate 702 prevents deviation from left and right from both sides. Between the anvil guide groove and the anvil penetration groove, the anvil base 710 is also provided with a staple forming recess 701 for matching with the staple.

8 and 10, the proximal end of the staple cartridge mechanism 6 and the staple anvil mechanism 7 are connected together, and an opening elastic piece 604 is provided between the staple cartridge mechanism and the staple anvil mechanism 7. Under no external force, the opening elastic piece 604 keeps the staple cartridge mechanism and the staple anvil mechanism separated, except for the part connected together at the proximal end. The proximal end of the staple bin mechanism and the nail anvil mechanism is connected to the far end of the sheet metal rod 401 of the steering mechanism 4 through the connecting joint 601, and the sheet metal rod 401 can drive the nail bin mechanism 6 and the nail anvil mechanism 7 to swing. The shrapnel A of the transmission mechanism and the shrapnel B of the transmission mechanism pass through the connecting joint 601 and can move in the space between the magazine cover and the magazine seat of the magazine mechanism 6 under the drive of the push rod 103 of the firing control mechanism. The sliding limit block A 5041 and the sliding limit block B 5042 run through the nail bin cover guide groove and the nail anvil guide groove on one side respectively to play a guiding role. The sliding limit block A 5041 and the sliding limit block B 5042 are in an I-shaped structure, and the upper end and the lower end are respectively located on the upper part of the nail bin cover and the bottom of the nail anvil to avoid falling off from the guide groove during the movement. The same guide groove as that on the staple bin cover may also need to be set on the staple bin seat 606 for the sliding stoppers A and B to pass through. Whether it is set or not depends on the width of the nail anvil.

The quantity of the nail pushing protrusions 802 of the nail pushing mechanism 8 is determined according to the number of rows of staples. For example, if a row of staples is respectively set on both sides of the penetration groove, then the nail pushing mechanism 8 is provided with two nail pushing protrusions. If multiple rows are set, a plurality of nail pushing protrusions are set. The protrusion of the push nail has an inclined surface, the inclined angle is the same as the angle of the nail pressing, and the directions are opposite. At the proximal end of the cartridge holder insertion slot, the staples converge inwardly.

The use process of the present invention will be described in detail below.

As shown in Figures 8 and 9, in the resting state, the staple cartridge mechanism 6 and the anvil mechanism 7 are in a separated state due to the action of the opening shrapnel 604, the transmission mechanism shrapnel A 5031 and the transmission mechanism shrapnel B 5032, the sliding limit block A 5041 and the sliding limit block B 5042 are located at the proximal end of the stapler, at this time the sliding limit block A 5041 and the sliding limit block B 5042 are located at the proximal platform 612 of the metal groove 605 of the staple bin Connect the joint 601, and the sliding limit blocks A and B squeeze the guide groove of the staple bin cover to prevent the opening angle of the staple bin mechanism and the anvil mechanism from being too large;

When the operator pulls the trigger 101, squeezes the ratchet bar 102, and pushes the push rod 103 to move to the far end, the push rod 103 respectively drives the transmission mechanism shrapnel A 5031 and the transmission mechanism shrapnel B 5032 to move to the far end through the connecting part 501; at this time, the sliding limiting block A 5041 and the sliding limiting block B 5042 move distally along the guide groove until they move out of the proximal platform 612 as a whole; due to the sliding limiting block A 50 41 and the I-shaped structure of the sliding limit block B 5042 work together to lock, squeeze the staple cartridge mechanism 6 to move closer to the nail anvil mechanism 7, and compress the opening shrapnel 604 until the staple cartridge mechanism 6 and the staple anvil mechanism 7 are closed. As shown in Figure 9, at this time, the operator can insert the head of the stapler into the patient's body through a minimally invasive channel such as the laparoscopic sheath card 9, and prepare for suturing;

The following takes the end-to-end suture of the intestinal tract in the cavity as an example. The present invention can be used for but not limited to intestinal suture, and can be used for all hollow organs that can be sutured everted.

With the assistance of the assistant, the operator adjusts the two ends of the intestinal tract to an anatomically appropriate position, and sutures one or two traction lines on the sides of the two intestinal ends to be sutured corresponding to the side near the operator. Pull the reset button 104 of the firing control mechanism of the stapler to move proximally in conjunction with the push rod 103, and the push rod 103 moves to the proximal end through the connection part 501 to link the shrapnel A 5031 of the transmission mechanism, the shrapnel B 5032 of the transmission mechanism, and the sliding limit block A 5041 and the sliding limit block B 5042 to move proximally. At 2 places, the pressure on both sides of the staple cartridge 6 and the staple anvil 7 is quickly and partially released, the opening shrapnel 604 is reset, and the staple cartridge mechanism 6 and the staple anvil mechanism 7 are re-separated to the initial state.

As shown in Figures 7, 8, and 9, the direction adjustment button 105 on the firing control mechanism 1 of the rotary stapler drives the steering propulsion rod 103 and then drives the steering mechanism 4 to move back and forth, and further promotes the swing of the overall structure of the connecting joint 601, the staple bin 6 mechanism and the nail anvil mechanism 7, and adjusts the direction. At this time, it is necessary to keep the cross-sections of the two broken ends of the intestinal tract parallel to the staple bin mechanism 6 and the nail anvil mechanism 7 as much as possible, and fix the direction adjustment knob 105. Pull the intestine traction line, when the staple cartridge mechanism 6 and the staple anvil mechanism 7 as a whole are consistent with the section diameter of the stumped intestinal tract, insert the stumped intestinal tract from the distal opening of the staple cartridge penetration groove (the staple cartridge cover penetration groove 605, the staple cartridge seat penetration groove 616) and pull it proximally until reaching the proximal end of the staple cartridge penetration groove (the staple cartridge cover penetration groove 605, the staple cartridge seat penetration groove 616), and ensure that the opening of the broken end of the intestinal tract exposes the bottom surface of the staple cartridge seat 606 high enough. In the same way, pull the other side's stump intestinal tract to be penetrated by the nail-anvil mechanism 7 . Turn the intestinal tract exposed on the bottom surface of the staple cartridge holder 606, cover the nail holes on both sides of the bottom surface of the staple cartridge holder 606 and extend the moving path of the sliding stoppers A and B, turn the intestinal tract exposed on the surface of the staple anvil 710, cover the staple forming pits and extend the moving path of the sliding stopper blocks A and B, and pay special attention to the proximal and distal ends of the intestinal cross section must be within the staple cartridge scale line 608. The operator pulls the trigger 101, squeezes the ratchet bar 102 to push the pusher rod 103 to move distally, and the pusher rod 103 moves to the distal end through the connection part 501 and the shrapnel A 5031 of the transmission mechanism, the shrapnel B 5032 of the transmission mechanism, the sliding limiter A 5041 and the sliding limiter B 5042, and locks and closes the staple bin mechanism 6 and the anvil mechanism 7 again. Check whether the staple cartridge mechanism 6 and the staple anvil mechanism 7 are completely covered, and observe whether the intestinal tract at the closed part is shifted back and forth beyond the staple cartridge scale line 608 . If the valgus intestinal tract is incompletely covered or both ends protrude beyond the staple cartridge scale line 608, it is necessary to open the staple cartridge mechanism 6 again at this time, adjust the broken intestinal tract to be sutured to a suitable position, and close the staple cartridge mechanism 6 again to be sutured.

The operator unlocks the firing safety 107 on the firing control mechanism 1, pulls the trigger 101, squeezes the ratchet bar 102 to push the push rod 103 to move to the distal end, and the push rod 103 passes through the connecting part 501 to link the shrapnel A 5031 of the transmission mechanism, the shrapnel B 5032 of the transmission mechanism, and the sliding limit block A 5041 and B 5042 to move to the distal end, and the shrapnel A 5031 of the transmission mechanism and the shrapnel B 504 of the transmission mechanism move to the distal end 32, under the action of the first guide section (the first guide section 602 of the nail cartridge, the first guide section 704 of the nail anvil), continue to slide forward respectively. After the connecting column 5045 of the sliding limit block is in contact with the nail pushing mechanism 8, the two are engaged through the connecting groove 801; the transmission mechanism shrapnel A 5031 and the transmission mechanism shrapnel B 5032 push the nail pushing mechanism 8 to move to the far end, and when reaching the nail hole 609 and the nail pushing 611 proximal end, the nail pushing protrusion 802 at the far end of the nail pushing mechanism 8 is paired with the nail pushing 611 and pushes the nail pushing 611 and the staple 610 along the nail pushing 610. The direction of the holes 609 is shifted longitudinally in the direction of the anvil 710 . The staple 610 quickly pierces the intestinal tissue, and when the staple 610 touches the staple forming pit 701 on the surface of the anvil 710 , it curls inward with both ends in the direction of the pit, presenting a "B" shape or an encircling pattern. The trigger 101 is fired continuously to push the staple pushing mechanism 8 to move to the distal end, and the staples 610 are sutured in sequence until the distal end; at this time, the cutting blade 5046 is pushed to the distal end along the outer peripheral track of the staple cartridge mechanism 6 under the action of thrust and excises excess intestinal tissue outside the staples 610.

Back the stapler along the diameter direction of the sutured intestinal section, withdraw from the operation area, close the staple cartridge mechanism 6 and the anvil mechanism 7 again, and withdraw the stapler from the patient's body along the minimally invasive channel such as the sheath card. Observe the staple nailing and intestinal stump tissue cutting. If the staples are not firmly sutured or the staples are skipped, manual suturing can be used; at the same time, the intestines are turned over at the two ends of the diameter of the intestinal section, and the residual excess tissue is removed with scissors. It should be noted that there are no staples at the opening of the staple bin cover and the opening of the anvil, and after being sutured with a stapler, this part needs to be sutured manually. If no staples are set at the proximal end of the guide groove, then correspondingly, manual suturing is also required at this position. In conjunction with Fig. 8, the present invention lays the two intestinal stumps on the upper surface of the staple anvil and the lower surface of the staple cartridge respectively to form an ellipse, and then squeezes the staples to sew up the edges on both sides of the elliptical long axis. Of course, it is also possible to sew up the edges of the proximal end of the long axis simultaneously (place the staples at this position). Since it is difficult to place the staples at the far end of the long axis, this part requires manual sewing needles. Although a small part of the head end needs manual sewing needles, the present invention still solves the problem of cavity-inside-out suturing to a large extent, realizes instrumental operation, and has a very broad market prospect.

Example 2:

As shown in Figures 7-9, 11, 12, 13, 19, and 20, the stapler provided in this embodiment includes an executive mechanism and a firing control mechanism. The specific structure of the firing control mechanism is as described in Embodiment 1. Except for the linear cutting stapler firing control mechanism, other devices that can drive the actuator of the present invention can be applied to the present invention, and the present invention does not involve the improvement of the firing control mechanism. The executive mechanism of this embodiment includes a staple cartridge mechanism 6 , an anvil mechanism 7 , a transmission mechanism 5 , and a steering mechanism 4 .

As shown in FIG. 11 , the steering mechanism 4 includes a sheet-shaped metal rod 401 , and a hook-shaped protrusion 402 is provided at the proximal end of the sheet-shaped metal rod. As shown in Figures 11 and 19, the transmission mechanism 5 includes a transmission mechanism shrapnel A 5031, a transmission mechanism shrapnel B 5032, a sliding limit block A 5041, and a sliding limit block B 5042. The shrapnel (A, B) of the transmission mechanism can be made of elastic material or non-elastic material, as long as it can produce a certain deformation. The shrapnel A of the transmission mechanism is connected with the sliding limit block A, and the shrapnel B of the transmission mechanism is connected with the sliding limit block B. The sliding limit block A and the sliding limit block B are I-shaped structures, and the bottom of the connecting column (connecting column A 5047, connecting column B 5048) in the middle part of the I-shaped structure is provided with a cutting blade 5046. The pusher mechanism 8 includes a pusher mechanism A 803 and a pusher mechanism B 804. The proximal ends of the two pusher mechanisms are respectively provided with connection grooves 801. The shrapnel A and B of the transmission mechanism cooperate with the pusher mechanisms A and B respectively to push a pusher mechanism. The connecting posts of the transmission mechanism shrapnel A and B can be respectively inserted into the connection grooves 801 of the pusher mechanisms A and B. The cooperation of the connection post and the connection groove can enhance the stability of pushing. It can be seen from Figure 19 that the connecting groove is arranged on the side of the nail pushing mechanism, and the force point is located near the outer side of the staple cartridge cover. The force is not particularly uniform. When the staple cartridge seat penetrates into the groove near the proximal end of the staple, it may be difficult to fire. The bottom of the staple-pushing mechanism 8 is provided with a staple-pushing protrusion 802. Two staple-pushing projections are shown in the figure, and two rows of staples can be fired. If there are more rows of staples, more staple-pushing projections can be provided. Of course, the thickness of the staple-pushing projections can also be increased to cover multiple rows of staples. In a word, the number of the staple pushing protrusions 802 of the staple pushing mechanism 8 is determined according to the number of rows of staples, and the staples need only be fired. The protrusion of the push nail has an inclined surface, the inclined angle is the same as the angle of the nail pressing, and the directions are opposite. At the proximal end of the cartridge holder insertion slot, the staples converge inwardly. In this embodiment, the shrapnel of the transmission mechanism and the push nail mechanism can be detachably connected through the cooperation of the connecting column and the connecting groove, and a fixed connection can also be adopted.

As shown in FIGS. 8 and 20 , the steering mechanism 4 and the transmission mechanism 5 are installed in the casing 2 . For the convenience of installation, an upper half pipe 201 and a lower half pipe 202 are provided, and the transmission mechanism shrapnel A and the transmission mechanism shrapnel B are set in the groove of the lower half pipe, and then the upper half pipe and the lower half pipe are combined, which is convenient for installation and plays a guiding role. In addition, an anchoring mechanism 603 may be provided at the distal end, and the distal ends of the transmission mechanism shrapnel A and the transmission mechanism shrapnel B pass through the anchoring mechanism 603 to play a guiding role. The transmission mechanism 4 is arranged on the side part after the upper and lower half pipes are assembled, and then placed in the casing 2 as a whole. The proximal end of the lower half pipe is provided with a limit block 3, including a limit block A 301 and a limit block B 302.

As shown in FIGS. 8 , 13 , and 20 , the cartridge mechanism 6 includes a cartridge cover 617 and a cartridge seat 606 . A staple hole 609 is provided on the staple cartridge seat 606, and a staple 610 is placed in the staple hole 609. A staple pusher 611 is located above the staple 610, and the staple pusher 611 is pressed downward, and the staple pusher 611 fires the staple 610 toward the anvil mechanism 7. The staple cartridge cover 617 covers the staple cartridge seat 606, and there is a space between the staple cartridge cover 617 and the staple cartridge seat 606 for accommodating the staple pushing mechanism 8, so that the staple pushing mechanism 8 can move from the proximal end to the distal end of the actuator. The side of the nail bin cover 617 is provided with a nail bin scale line 608, which is used to indicate the position of the nail hole and prevent the tissue from shifting. When the tissue is everted, the end of the tissue is located in the nail bin scale line, and once shifted, it is easy to find. The present invention sets the nail bin cover penetrating groove 605 and the nail bin cover guiding groove in the middle of the nail bin cover. The nail bin cover piercing groove and the nail bin cover guiding groove all extend from the far end to the proximal end along the length direction of the actuator, and the guiding grooves are distributed on both sides of the penetrating groove. The nail bin cover penetration groove is formed with an opening at the far end of the nail bin cover, and the opening is a nail bin cover flare 613 that is wide on the outside and narrow on the inside. There are two nail bin cover guide grooves, and the nail bin cover penetrates both sides of the groove 605 in rows. As shown in the figure, the guide groove in this embodiment includes a first cartridge guide section 602, a staple cartridge connecting end 614, and a second cartridge guide section 607, wherein the first cartridge guide section 602 extends to the proximal platform 612, and the distance between the two first cartridge guide sections 602 is smaller than the distance between the two staple cartridge second guide sections 607, and the staple cartridge connecting section 614 connects the staple cartridge first guide section 602 and the staple cartridge second guide section 607 to form a transition. The staple cartridge seat 606 is also provided with a corresponding staple cartridge seat penetration groove 616 extending along the length direction of the actuator and corresponding to the staple cartridge cover penetration groove 605. The staple cartridge seat penetration groove 616 is formed with an opening at the far end of the staple cartridge seat. The opening is a staple cartridge seat flare 615 that is wide outside and narrow inside. There are one or more rows of staples on both sides of the insertion groove of the staple cartridge seat. Staples can also be set at the proximal end of the staple cartridge seat penetration groove 616, the staples converge inwards, cross as much as possible at the proximal end of the penetration groove, and the staples on both sides and ends form a V shape or a U shape.

As shown in Figures 8, 12, and 20, the anvil mechanism 7 includes an anvil base 710, which is provided with an anvil penetration groove 705 extending along the length direction of the actuator and corresponding to the staple cartridge base penetration groove 616. The anvil penetration groove 705 forms an opening at the far end of the anvil base 710, and the opening is an anvil flare 707 that is wide on the outside and narrow on the inside. Anvil guide grooves extending along the length direction of the actuator are provided on both sides of the nail anvil penetration groove 705 . The anvil guiding groove in this embodiment comprises a first anvil guiding section 704, an anvil second guiding section 706, and an anvil connecting section 703, wherein the distance between the two anvil first guiding sections 704 is smaller than the distance between the two anvil second guiding sections 706, and the nail anvil connecting section 703 connects the nail anvil first guiding section 704 and the nail anvil second guiding section 706 to form a transition. A supporting plate 708 is provided at the bottom of the nail anvil 710, and a supporting plate penetration groove 709 extending along the length direction of the actuator is arranged on the supporting plate 708. The supporting plate penetration groove 709 forms an opening at the far end of the supporting plate 708. The proximal end of the supporting plate 708 is provided with a guard plate 702. Referring to FIG. 8, after the staple cartridge mechanism is connected to the anvil mechanism, the guard plate 702 prevents left and right movement from both sides to avoid deviation. Between the anvil guide groove and the anvil penetration groove, the anvil base 710 is also provided with a staple forming recess 701 for matching with the staple. As the staples converge inwardly at the proximal end, the staple forming pockets are also configured to converge inwardly, forming a U-shape or a V-shape. The staple bin cover and the staple anvil can be designed as an inwardly recessed structure to reduce the overall size and avoid being too large to penetrate the sheath card.

8 and 20, the proximal end of the staple cartridge mechanism 6 and the staple anvil mechanism 7 are connected together, and the staple cartridge cover and the staple anvil can be connected as a whole. The staple cartridge seat can be designed as an independent component, which can be detachably arranged under the staple cartridge cover and can be removed from the actuator. In this way, only the staple cartridge seat can be replaced without replacing the entire actuator, so that the actuator can be reused. An opening elastic piece 604 is arranged between the staple cartridge mechanism and the nail anvil mechanism 7, and under no external force, the opening elastic piece 604 keeps the staple cartridge mechanism and the nail anvil mechanism separated, except for the part connected together at the proximal end. The proximal end of the staple cartridge mechanism and the staple anvil mechanism is connected to the distal end of the sheet metal rod 401 of the steering mechanism 4 through the connecting joint 601, and the sheet metal rod 401 can drive the staple cartridge mechanism 6 and the staple anvil mechanism 7 to swing. The shrapnel A of the transmission mechanism and the shrapnel B of the transmission mechanism pass through the connecting joint 601 and can move in the space between the magazine cover and the magazine seat of the magazine mechanism 6 under the drive of the push rod 103 of the firing control mechanism. The sliding limit block A 5041 and the sliding limit block B 5042 run through the nail bin cover guide groove and the nail anvil guide groove on one side respectively to play a guiding role. The sliding limit block A 5041 and the sliding limit block B 5042 are in an I-shaped structure, and the upper end and the lower end are respectively located on the upper part of the nail bin cover and the bottom of the nail anvil to avoid falling off from the guide groove during the movement. The same guide grooves distributed on both sides of the penetrating groove as on the nail bin cover may also need to be set on the staple bin seat 606, so that the sliding limit blocks A and B can pass through. Whether it is set or not depends on the width of the nail anvil.

The quality inspection process of the present invention will be described in detail below, and the operation process will be simulated during the quality inspection to ensure that the instrument will not have quality problems during the surgical operation.

As shown in Figures 8 and 9, in the resting state, the staple cartridge mechanism 6 and the anvil mechanism 7 are separated due to the action of the opening shrapnel 604, the transmission mechanism shrapnel A 5031 and the transmission mechanism shrapnel B 5032, the sliding limiter A 5041 and the sliding limiter B 5042 are located at the proximal end of the stapler, and at this time the sliding limiter A 5041 and the sliding limiter B 5042 are located at the proximal platform 612 of the metal groove 605 of the staple bin Relying on the connecting joint 601, the sliding limit blocks A and B squeeze the guide groove of the staple bin cover, which can prevent the opening angle of the staple bin mechanism and the nail anvil mechanism from being too large;

When the inspector pulls the trigger 101, squeezes the ratchet bar 102, and pushes the push rod 103 to move to the far end, the push rod 103 respectively drives the transmission mechanism shrapnel A 5031 and the transmission mechanism shrapnel B 5032 to move to the far end through the connecting part 501; at this time, the sliding limit block A 5041 and the sliding limit block B 5042 move far away along the guide groove until they move out of the proximal platform 612 as a whole; due to the sliding limit block A 50 41 and the I-shaped structure of the sliding limit block B 5042 cooperate to lock, squeeze the staple cartridge mechanism 6 to move closer to the anvil mechanism 7, and compress the opening shrapnel 604 until the staple cartridge mechanism 6 and the staple anvil mechanism 7 are closed. At this time, the staple pushing mechanism will not reach the position of the staples. As shown in Figure 9, at this time, the inspector can insert the stapler head into the simulated object through a minimally invasive channel such as the laparoscopic sheath card 9, and prepare for suturing; Figure 9 shows the state after the actuator passes through the sheath card, when passing through the sheath card, the staple cartridge mechanism and the anvil mechanism are closed. It should be pointed out that the present embodiment utilizes the sliding limit block to close the staple cartridge mechanism and the anvil mechanism. In this field, other structures are also provided to pre-close the staple cartridge mechanism and the staple anvil mechanism instead of the sliding limit block. This method has been widely realized. For example, a tubular structure is arranged at the proximal end of the actuator, and the actuator is pulled back, and the proximal end is pulled into the tubular structure, and the tubular structure squeezes the opening shrapnel to close the staple cartridge and the anvil.

With the assistance of the assistant, the examiner adjusts the two ends of the intestinal tract to an anatomically appropriate position, and sutures one or two traction lines on the two ends of the intestinal tract to be sutured corresponding to the side close to the examiner. Pull the reset button 104 of the firing control mechanism of the stapler to move proximally in conjunction with the push rod 103, and the push rod 103 moves to the proximal end through the connection part 501 to link the shrapnel A 5031 of the transmission mechanism, the shrapnel B 5032 of the transmission mechanism, and the sliding limit block A 5041 and the sliding limit block B 5042 to move proximally. At 2 places, the pressure on both sides of the staple cartridge 6 and the staple anvil 7 is quickly and partially released, the opening shrapnel 604 is reset, and the staple cartridge mechanism 6 and the staple anvil mechanism 7 are re-separated to the initial state.

As shown in Figures 7, 8, and 9, the direction adjustment button 105 on the firing control mechanism 1 of the stapler is rotated to drive the steering push rod 103 to drive the steering mechanism 4 to move back and forth, and further promote the overall structure of the staple bin mechanism 6 and the nail anvil mechanism 7 to swing and adjust the direction. As the directions of the staple bin mechanism 6 and the nail anvil mechanism 7 change, the transmission mechanism shrapnel A 5031 and the transmission mechanism shrapnel B 5032 bend left and right. At this time, it is necessary to keep the cross-sections of the two broken ends of the intestinal tract parallel to the staple cartridge mechanism 6 and the staple anvil mechanism 7, and fix the direction adjustment knob 105. In conjunction with Fig. 21, pull the traction line of the intestinal tract. When the diameter of the staple cartridge mechanism 6 and the staple anvil mechanism 7 is consistent with the cross-section of the broken end of the intestinal tract, the broken end A 1001 of the intestinal tract on one side is inserted through the opening of the distal end of the staple cartridge penetration groove (the staple cartridge cover penetration groove 605, the staple cartridge seat penetration groove 616) and pulled toward the proximal end until it reaches the proximal end of the staple cartridge penetration groove (the staple cartridge cover penetration groove 605, the staple cartridge seat penetration groove 616). The intestinal opening at the broken end will expose the bottom surface of the staple cartridge seat 606 to a sufficient height. In the same way, the stump B 1101 of the stump intestinal tract on the other side is pulled and penetrated by the anvil mechanism 7. The broken end A 1001 of the intestinal tract exposed to the bottom surface of the staple cartridge seat 606 is everted, and the first everted part 1002 and the second everted part 1003 are formed on the bottom surface of the staple cartridge seat. , valgus part 4 1103, valgus part 3, valgus part 4 cover the forming pit of the staple and extend out the moving path of the sliding limit blocks A and B, especially note that both the proximal end and the distal end of the intestinal section must be located within the staple bin scale line 608. The examiner pulls the trigger 101, squeezes the spine 102 and pushes the push rod 103 to move to the distal end, and the push rod 103 moves to the distal end through the connection part 501 and the shrapnel A 5031 of the transmission mechanism and the shrapnel B 5032 of the transmission mechanism to move to the distal end, and then closes the magazine mechanism 6 and the nail anvil mechanism 7 again. And beyond the nail bin scale line 608 . If the valgus intestinal tract is incompletely covered or both ends protrude beyond the scale line 608 of the staple cartridge, it is necessary to open the staple cartridge mechanism 6 again at this time, and the staple cartridge mechanism and the staple anvil mechanism are opened to adjust the stumped intestinal tract to be sutured to a suitable position, and close the staple cartridge mechanism 6 again to wait for suturing.

The inspector unlocks the firing safety 107 on the firing control mechanism 1, pulls the trigger 101, squeezes the ratchet bar 102 to push the push rod 103 to move to the far end, and the push rod 103 passes through the connecting part 501 to link the transmission mechanism shrapnel A 5031 and the transmission mechanism shrapnel B 5032 and the sliding limit block A 5041 and the sliding limit block B 5042 to move to the distal end, and the transmission mechanism shrapnel A 5031 and the transmission mechanism shrapnel B 50 32, under the action of the first guide section (the first guide section 602 of the nail cartridge, the first guide section 704 of the nail anvil), continue to slide forward respectively. The push nail mechanism 8 is preset near the first guide section. As shown in Figures 10 and 13, the two push nail mechanisms are close together at first. When the connecting column A 5047 of the sliding limit block A and the connecting column B 5048 of the sliding limit block B contact the screw pushing mechanism A 803 and the screw pushing mechanism B 804 respectively, the connecting columns are respectively inserted into the corresponding connecting grooves 801; the transmission mechanism shrapnel A 5031 and the transmission mechanism shrapnel B 5032 push the nail pushing mechanism A 80 3. The nail pushing mechanism B 804 moves to the far end. When reaching the proximal end of the nail hole 609 and the nail pressing 611, the nail pushing protrusion 802 on the nail pushing mechanism 8 is combined with the nail pressing 611 to push the nail pressing 611 and the staple 610 to longitudinally shift along the direction of the nail hole 609 to the direction of the anvil 710. The staple 610 quickly pierces the intestinal tissue, and when the staple 610 touches the staple forming pit 701 on the surface of the anvil 710 , it curls inward with both ends in the direction of the pit, presenting a "B" shape or an encircling pattern. The trigger 101 is fired continuously to push the staple pushing mechanism 8 to move to the distal end, and the staples 610 are sutured in sequence until the distal end; at this time, the cutting blade 5046 is pushed to the distal end along the outer peripheral track of the staple cartridge mechanism 6 under the action of thrust and excises excess intestinal tissue outside the staples 610. Referring to Figures 8 and 20, during the nail pushing process, the nail pushing mechanism moves in the space between the staple magazine cover and the staple magazine seat. When the shrapnel moves in the first guiding section, the shrapnel A and B are relatively close. When entering the connecting section, the two shrapnels begin to move to both sides, driving the nail pushing mechanism A and B to move on both sides. Specifically, they move in the space between the penetration groove and the guide groove. The two nail pushing mechanisms are respectively located on both sides of the penetration groove. Take the angle of view shown in Figures 19 and 21 as an example (during operation, the broken ends A and B will not form such a regular cylindrical shape), the staple pushing mechanism B 804 is located on the left outer side of the broken end A 1001 (the broken end of the tissue to be sutured is separated from the staple pushing mechanism by the staple cartridge cover and the staple pushing mechanism, and will not touch), the staple pushing mechanism A 803 is located on the right outer side of the broken end A 1001, and the staples are fired from top to bottom, and the eversion part 2 1003 and the eversion part are separated Four 1103 are sewn together, and the valgus part 1 1002 and valgus part 3 1102 are sewed together. In the second guiding section, the two nail pushing mechanisms respectively move between the guiding groove and the penetration groove. Obviously, the width of the nail pushing mechanism should not be greater than the distance between the guiding groove and the penetration groove, otherwise interference will occur.

Retreat the shrapnel of the stapler, evacuate the operation area, close the staple cartridge mechanism 6 and the anvil mechanism 7 again, and withdraw the stapler from the simulated subject through the minimally invasive channel such as the sheath card. Observe the staple nailing and intestinal stump tissue cutting. If the staples are not firmly sutured or the staples are skipped, the stitches can be manually sutured; at the same time, the intestinal tract is turned over at the two ends of the diameter of the intestinal section, and the remaining excess tissue is removed with scissors. It should be noted that there are no staples at the opening of the staple bin cover and the opening of the anvil, and after being sutured with a stapler, this part needs to be sutured manually. If no staples are set at the proximal end of the guide groove, then correspondingly, manual suturing is also required at this position. If the position of the staple is not sewn up, especially if the staple at the position of the second guide section is not firmly nailed, then there is a problem in the quality of the stapler, which cannot be sold externally and needs to be adjusted. With reference to Fig. 8, the present invention spreads the two intestinal stumps on the upper surface of the staple anvil and the lower surface of the staple cartridge respectively to form an ellipse, and then squeezes the staples to sew up the edges on both sides of the elliptical long axis. Of course, the edges of the proximal end of the long axis can also be sutured synchronously (place the staples at this position). Since it is difficult to place the staples at the far end of the long axis, this part requires manual sewing needles. Although a small part of the head end needs manual sewing needles, the present invention still solves the problem of cavity-inside-out suturing to a large extent, realizes instrumental operation, and has a very broad market prospect.

The above is a very complete inspection process. In a simplified view, that is, the broken end B of the tissue to be sutured is penetrated into the actuator from the anvil block insertion groove, and the broken end B is turned outward, and spread on the upper surface of the nail anvil seat of the actuator; The distal end moves along the guide groove on the staple bin cover and the staple anvil, and the transmission mechanism shrapnel A and transmission mechanism shrapnel B push the nail pushing mechanism A and the nail pushing mechanism B to move on both sides of the penetration groove, thereby firing the staples; move the tissue to be sutured out of the actuator along the penetration groove, and check whether the broken end A and the broken end B are sutured at the position between the guide groove and the penetration groove. If they are sutured, the stapler is qualified. When the broken ends are everted, try to extend the broken ends A and B out of the guide groove, so as to ensure the suture effect, and also use the blades on the transmission mechanism shrapnel A and transmission mechanism shrapnel B to cut off the excess part.

Example 3:

As shown in Figures 7, 9, 11, 15, 16, 17, 18, and 19, the stapler provided in this embodiment includes an executive mechanism and a firing control mechanism. The specific structure of the firing control mechanism is as described in Embodiment 1. Except for the linear cutting stapler firing control mechanism, other devices that can drive the actuator of the present invention can be applied to the present invention, and the present invention does not involve the improvement of the firing control mechanism. The executive mechanism includes a staple bin mechanism 6 , an anvil mechanism 7 , a transmission mechanism 5 and a steering mechanism 4 .

The structure of this embodiment is basically the same as that of Embodiment 2. For the parts not described, please refer to Embodiment 2. The setting method of the guide groove of this embodiment will be introduced in detail below. A staple cover guide groove 618 is respectively provided on both sides of the staple cover penetration groove 605, and two staple cover guide grooves are arranged in parallel, extending from the distal end of the staple cover to the proximal end of the staple cover, and to the proximal platform 612, keeping parallel from the distal end to the proximal end. An anvil guide groove 711 is respectively arranged on both sides of the anvil penetration groove 705, and the two anvil guide grooves are arranged in parallel, extending from the distal end to the proximal end of the anvil block, and keeping parallel from the distal end to the proximal end. The nail holes on the staple cartridge mechanism are set on both sides of the staple cartridge seat penetration groove 616, and the proximal end of the staple cartridge seat penetration groove is no longer provided with inward converging nail holes. If the cartridge holder is relatively wide and the moving path of the shrapnel conflicts with the cartridge holder, two parallel guide grooves are also provided on the cartridge holder. As shown in Figures 16 and 17, this embodiment is also provided with a separation column 619, which is located at the proximal end of the actuator and at the proximal platform. The separation column enables the shrapnel to move more stably along the guide groove, avoiding side bending during the movement. As shown in Figure 16, at the connection between the elastic piece and the sliding limit block, the elastic pieces A, B of the transmission mechanism and the sliding limit block A, B form a U-shaped or V-shaped opening, which is more conducive to being separated by the separation column. As shown in FIG. 20 , in Embodiment 2, a separation column 619 may also be provided with reference to this embodiment.

The difference between the process of firing the staples in this embodiment and that in Embodiment 2 will be introduced below. Under the resting state, the staple bin mechanism 6 and the nail anvil mechanism 7 are separated due to the action of the opening shrapnel 604, the far ends of the transmission mechanism shrapnel A 5031 and the transmission mechanism shrapnel B 5032 are naturally separated by the separation column 614, and the sliding limit block A 5041 and the sliding limit block B 5042 are located at the proximal end of the stapler. When the shrapnel A 5031 and the shrapnel B 5032 of the pushing mechanism move from the proximal end to the distal end, they are guided by the guide groove and move in parallel. During the nail pushing process, the nail pushing mechanism moves in the space between the staple cartridge cover and the staple cartridge seat, and when moving from the proximal end to the distal end, under the guidance of the guide groove, the shrapnel A and the shrapnel B move in parallel. Two nail pushing mechanisms are set separately on both sides of the penetration groove. When the shrapnel comes into contact with the nail pushing mechanism, the shrapnel drives the nail pushing mechanism along the direction of the guide groove to move in the space between the penetration groove and the guide groove. The two nail pushing mechanisms are respectively located on both sides of the penetration groove. Since there is no inwardly converging staple at the staple cartridge seat, when suturing, the tissue to be sutured is not sutured at the proximal end and the far end, requiring manual suturing needles.

Various modifications to this embodiment will be obvious to those skilled in the art, and the modifications and changes made by those skilled in the art do not depart from the spirit and scope of this embodiment, and then all fall within the protection scope of the appended claims of the present invention.

Claims

An actuator for an eversion-type stapler, comprising a staple cartridge mechanism, an anvil mechanism, and a transmission mechanism; the staple cartridge mechanism includes a staple cartridge cover and a staple cartridge seat, a nail pushing mechanism is arranged in a space between the staple cartridge cover and the staple cartridge seat, and the anvil mechanism includes an anvil seat; the transmission mechanism includes transmission mechanism shrapnel;

It is characterized in that: the staple bin cover, the staple bin seat, and the staple anvil are respectively provided with penetration grooves extending along the length direction of the actuator, and the penetration grooves are formed with openings at the distal ends of the staple bin cover, the staple bin seat, and the staple anvil; on both sides of the penetration grooves, the staple bin cover and the staple anvil are also provided with guide grooves extending along the length direction of the actuator; the staples in the staple bin mechanism are arranged on both sides of the penetration grooves, and are located between the penetration grooves and the guide grooves;

The transmission mechanism shrapnel includes a transmission mechanism shrapnel A and a transmission mechanism shrapnel B. The far ends of the transmission mechanism shrapnel A and the transmission mechanism shrapnel B extend into the space between the staple bin cover and the staple bin seat.
The actuator for an eversion-type stapler according to claim 1, wherein the guide groove comprises a first guide section at a proximal end, a second guide section at a distal end, and a connecting section connecting the first guide section and the second guide section, wherein the distance between the two first guide sections is smaller than the distance between the two second guide sections.
The actuator for an eversion-type stapler according to claim 2, wherein a staple is provided at the proximal end of the penetration groove of the staple cartridge seat.
The actuator for an eversion-type stapler according to claim 3, wherein the staples located on both sides and near ends of the penetration groove form a U-shape or a V-shape.
The actuator for an eversion-type stapler according to claim 1, wherein the guiding grooves on both sides are arranged in parallel from the distal end to the proximal end.
The actuator for an eversion-type stapler according to claim 5, wherein the staples are distributed in parallel on both sides of the insertion groove of the cartridge holder.
The actuator for an eversion-type stapler according to any one of claims 1-6, wherein the nail pushing mechanism comprises a nail pushing mechanism A and a nail pushing mechanism B, and when the distal ends of the transmission mechanism shrapnel A and the transmission mechanism shrapnel B move along the guide grooves on the nail bin cover and the nail anvil, the nail pushing mechanism A and the nail pushing mechanism B are respectively pushed to move on both sides of the penetration groove.
The actuator for an eversion-type stapler according to any one of claims 1-7, characterized in that: the far ends of the transmission mechanism shrapnel A and the transmission mechanism shrapnel B are respectively connected with H-shaped sliding limiters A and B, the upper and lower ends of the sliding limiters A and B are respectively inserted into the guide grooves on one side of the nail bin cover and the nail anvil, and the top and bottom ends of the I-shape are respectively exposed outside the guide grooves on the nail bin cover and the nail anvil. .
The executive mechanism for eversion type stapler as claimed in claim 8, characterized in that: said nail pushing mechanism comprises a nail pushing mechanism A and a nail pushing mechanism B, and the proximal ends of the two nail pushing mechanisms are respectively provided with connection grooves, and the connecting columns of the vertical parts of the sliding limit block A and the sliding limit block B can be respectively inserted into the connecting grooves of the nail pushing mechanism A and the nail pushing mechanism B, so as to realize the detachable connection between the transmission mechanism shrapnel A, the transmission mechanism shrapnel B and the nail pushing mechanism A and the nail pushing mechanism B.
The actuator for an eversion-type stapler according to claim 9, characterized in that: the connecting groove is arranged near the outer side of the nail pushing mechanism.
The actuator for an eversion-type stapler according to claim 10, wherein a counterweight is arranged on the outside of the nail pushing mechanism.
The actuator for eversion-type stapler according to claim 8, characterized in that: the lower ends of the connecting columns of the vertical parts of the sliding limiting block A and the sliding limiting block B are provided with cutting blades.
The actuator for an eversion-type stapler according to claim 8, wherein a guide groove extending along the length direction of the actuator is also provided on the cartridge holder.
The actuator for an eversion-type stapler according to any one of claims 1-6, wherein the openings of the staple cartridge cover, the staple cartridge seat and the staple anvil seat are flaring openings that are wide on the outside and narrow on the inside.
The actuator for an eversion-type stapler according to any one of claims 1-6, characterized in that: the bottom of the anvil is provided with a supporting plate, and the supporting plate is also provided with a penetration groove extending along the length direction of the actuator, and the proximal end of the supporting plate is provided with a guard plate.
The executive mechanism of the stapler according to any one of claims 1-6, wherein an elastic member is provided at the proximal connection of the anvil mechanism and the staple bin mechanism, and the elastic member promotes the opening state of the staple bin mechanism and the nail anvil mechanism, and when the transmission mechanism shrapnel A and the transmission mechanism shrapnel B move to the distal end, the staple bin mechanism and the nail anvil mechanism are urged to close.
The actuator for a stapler according to any one of claims 1-6, characterized in that: the transmission mechanism is arranged in the casing.
The actuator for a stapler according to any one of claims 1-6, characterized in that: the staple cartridge cover and the staple anvil are recessed inward.
The actuator for a stapler according to any one of claims 1-6, wherein the staple cartridge seat is detachably arranged under the staple cartridge cover.
The actuator of the stapler according to any one of claims 1-6, characterized in that: the proximal end of the actuator is provided with a separation column for separating the elastic piece A of the transmission mechanism and the elastic piece B of the transmission mechanism.
A stapler, comprising an actuator and a firing control mechanism, characterized in that: the actuator adopts the actuator for an eversion-type stapler according to any one of claims 1-20.
A quality inspection method for a stapler, which is characterized in that: the broken end B of the tissue to be sutured is penetrated into the actuator from the nail anvil base, and the broken end B is turned outward, and spread on the upper surface of the nail anvil of the actuator; the broken end A of the tissue to be sutured is penetrated from the nail magazine cover into the groove and the staple magazine seat through the groove into the actuator of the stapler, and the broken end A is turned outward, and laid on the lower surface of the staple magazine; The distal end of B moves along the guide groove on the staple bin cover and the nail anvil, and the transmission mechanism shrapnel A and transmission mechanism shrapnel B push the nail pushing mechanism A and the nail pushing mechanism B to move on both sides of the penetration groove, thereby firing the staple; move the tissue to be sutured out of the actuator along the penetration groove, check whether the broken end A and the broken end B are sutured at the position between the guide groove and the penetration groove, and if they are stitched, the stapler is qualified.
The method for quality inspection of a stapler according to claim 21, characterized in that: when the broken end A and the broken end B are everted, the broken end A and the broken end B are turned to the outside of the guide groove.