Locally strengthened surgical instruments, instrument kits, and methods of use

Abstract

A locally strengthened surgical instrument is presented that includes a handle assembly and a core assembly. The inner core assembly comprises an outer pipe, an inner pull rod, a first clamp, a second clamp, a first connecting piece, a second connecting piece and a main pin. The outer tube comprises a fork seat, a tube handle and an extension tube, and the fork seat comprises a fork seat root, a first arm and a second arm. The first clamp and the second clamp are fixed between the first arm and the second arm by the main pin to form a main rotating pair; the first clamp tail and the first sheet head are connected to form a first transmission pair; the second clamp tail and the second sheet head are connected to form a second transmission pair; the pull rod head is connected with the first sheet tail and the second sheet tail to form a main driving pair; when the pull rod is moved, the main driving pair moves and rotates to drive the first transmission pair and the second transmission pair to move and rotate, so that the main rotating pair is driven to rotate, and the first clamping jaw and the second clamping jaw are closed or opened.

Description

Technical Field

[0001] The present invention relates to surgical instruments, and particularly to a minimally invasive surgical instrument. Background Art

[0002] Endoscopic minimally invasive surgery uses lengthened instruments to enter the patient's body through natural body cavities or constructed puncture channels to complete operations such as tissue grasping, shearing, separating, coagulating, and suture closure. Compared with traditional open abdominal surgery, its main advantages are reducing trauma, alleviating pain, and accelerating recovery. So far, endoscopic surgeries usually establish multiple puncture channels with an outer diameter of about 13 mm for 10 mm instruments and an outer diameter of about 7 mm for 5 mm instruments on the patient's body wall at the same time. Among them, the 10 mm puncture channel is for 10 mm instruments to enter and exit the patient's body, and the 5 mm puncture channel is for 5 mm instruments to enter and exit the patient's body. Endoscopic clinical surgeries in the past 30 years have shown that the current 13 mm and 7 mm channels cause relatively large trauma to the muscles of the patient's body wall, resulting in a longer recovery time, and even causing the risk of body wall hernia holes or long-term pain. So far, there is no effective solution. Summary of the Invention

[0003] Therefore, to solve the problems of the prior art, various solutions have been proposed.

[0004] In one aspect of the present invention, a locally strengthened surgical instrument is proposed, which includes a handle assembly and an inner core assembly. The inner core assembly includes an outer tube, an inner pull rod, a first clamp, a second clamp, a first connecting piece, a second connecting piece, and a main pin.

[0005] The outer tube includes a fork seat, a tube handle, and an extension tube therebetween. The fork seat includes a fork seat root, a first arm and a second arm extending distally. The fork seat root extends proximally and its outer diameter gradually decreases to form a fork seat slope. Side holes penetrate the first arm and the second arm transversely. The extension tube includes a tube head, a tube tail, and a tube body extending therebetween. The tube head is integrally connected with the fork seat slope, and the tube tail is integrally connected with the tube handle. The first clamp includes a first clamp claw, a first clamp tail, and a first clamp wrist connecting them. The first clamp tail includes a first rotating shaft hole and a first clamp tail hole penetrating it. The second clamp includes a second clamp claw, a second clamp tail, and a second clamp wrist connecting them. The second clamp tail includes a second rotating shaft hole and a second clamp tail hole penetrating it. The first connecting piece includes a first piece head, a first piece tail, and a first piece body connecting them. The second connecting piece includes a second piece head, a second piece tail, and a second piece body connecting them. The inner pull rod includes a pull rod head, a pull rod tail, and a pull rod rod extending therebetween.

[0006] The first clamp and the second clamp are fixed between the first and second arms by a kingpin, forming a main rotating pair that can rotate around the kingpin; the first clamp tail and the first clamp head are connected to form a first transmission pair that can rotate relative to each other; the second clamp tail and the second clamp head are connected to form a second transmission pair that can rotate relative to each other; the pull rod head is connected to the first and second clamp tails and forms a main driving pair that can rotate relative to each other; moving the pull rod, the main driving pair moves and rotates, driving the first and second transmission pairs to move and rotate, and further driving the main rotating pair to rotate, realizing the closing or opening of the first and second jaws.

[0007] In one solution, the outer diameter of the extension tube is D1, and the maximum outer diameter of the fork seat is D2. D1 and D2 satisfy the relationship . In another solution, the fork seat slope forms an angle A1 with the fork seat axis, where 2° ≤ A1 ≤ 45°.

[0008] In another solution, the maximum outer diameters of the first and second arms of the fork seat are D2, and the outer diameter of the fork seat root is D7, D7 < D2. Among them, D1, D2, and D7 satisfy the relationship: , .

[0009] In another solution, the first jaw includes a first jaw tip, and the second jaw includes a second jaw tip; the thickness T1 of the first (second) jaw tip, the width W1 of the first (second) jaw tip, and the maximum circumscribed circle diameter D4 of the first (second) jaw wrist, where T1, W1, and D4 satisfy . In another solution, the length B1 of the first (second) jaw tip; the distance B2 from the proximal end of the first jaw to the first rotating shaft hole, where B1 and B2 satisfy .

[0010] In another solution, the length L1 of the fork seat and the length L2 of the extension tube, where L1 ≤ 0.1 × L2.

[0011] In another solution, take , where 2.5 mm ≤ D1 ≤ 3.5 mm.

[0012] In another solution, take , where 1.5 mm ≤ D1 ≤ 2.6 mm.

[0013] In another solution, the first jaw includes a first jaw tip, a first inclined jaw handle, and a first jaw piece extending therebetween; the second jaw includes a second jaw tip, a second inclined jaw handle, and a second jaw piece extending therebetween; the maximum circumscribed circle diameter D5 of the first (second) jaw wrist; the width W2 of the first (second) jaw tip; where W2 and D5 satisfy the relationship: In another embodiment, the maximum circumscribed circle diameter D6 of the cross section of the first (second) claw piece, the length B3 of the first (second) claw piece, and the distance B4 from the claw mouth to the shaft hole, wherein: , .

[0014] In another embodiment, the inclination angle A2 of the first claw oblique handle (the second claw oblique handle) is 2°≤A2≤45°.

[0015] In another embodiment, the total length from the fork seat to the distal ends of the first and second clamps is Y1, wherein the total length of the fork seat and the first and second clamps whose diameters are greater than or equal to D2 is Y2, wherein .

[0016] In another embodiment, the first clamp tail further comprises a first reinforced outer edge protruding outwardly arranged on the outer side of the proximal end of the first clamp tail; the second clamp tail further comprises a second reinforced outer edge protruding outwardly arranged on the outer side of the proximal end of the second clamp tail. The first clamp comprises a first matching reference plane, a first movement reference plane and a first clamp axis; the second clamp comprises a second matching reference plane, a second movement reference plane and a second clamp axis; measured along the first (second) clamp axis, the radius of the circumscribed circle of the first (second) clamp wrist is R1, and the maximum distance between the first reinforced outer edge and the first matching reference plane (between the second reinforced outer edge and the second matching reference plane) is X1. Where R 1， The value of X1 satisfies the relationship: In another embodiment, the first reinforced outer edge and the second reinforced outer edge include smooth arc-shaped convex outer edge side surfaces, and the corners of the intersection area between the first (second) reinforced outer edge and other structures of the first (second) clip tail include smooth rounded corner transitions without sharp edges or sharp corners.

[0017] In another embodiment, the first clamping jaw includes a first jaw mouth, a first jaw slope and a first jaw piece extending therebetween; the second clamping jaw includes a second jaw mouth, a second jaw slope and a second jaw extending therebetween. The radius of the circumscribed circle of the first (second) jaw piece is R2, where R1 and R2 satisfy the relationship: .

[0018] In another embodiment, the outer diameter of the extension tube is D1, the maximum outer diameter of the fork seat is D2, and D1 and D2 satisfy the relationship: In another solution, D1 and X1 satisfy the relationship: In another embodiment, the outer diameter of the fork base is D7, D7 <D2。其中D1,D2,D6满足关系式: , .

[0019] In another aspect of the present invention, a surgical instrument kit is provided, which includes one or more of the aforementioned instruments; it also includes a micro-puncture needle, the puncture needle includes a proximal puncture handle and a distal puncture rod with a diameter of D0, the puncture rod includes a distal needle tip, where 1.5 mm ≤ D0 ≤ 2.5 mm. Take 1.5 mm ≤ D1 ≤ 2.6 mm.

[0020] In another aspect of the present invention, a method for using the surgical instrument kit is provided: S1 Puncture: First, make an incision at the patient's navel and insert a channel, then access the endoscope through this channel for real-time observation, and use the micro-puncture needle to puncture the patient's body wall under the condition of real-time image monitoring.

[0021] S2 Dilation: Remove the micro-puncture needle, keep the first clip and the second clip of the surgical instrument in a mutually clamped state, utilize the guiding effect of the first jaw and the second jaw, squeeze and dilate the micro-puncture wound created by the micro-puncture needle until the first clip, the second clip, and the fork seat all pass through the patient's body wall.

[0022] S3 Operation: Move the surgical instrument to perform the surgical operation, and do not switch the instruments in the same micro-puncture wound during the operation.

[0023] S4 Withdrawal: Pull out the surgical instrument out of the body, utilize the guiding effect of the fork seat ramp, squeeze and dilate the micro-puncture wound until the fork seat and the first clip and the second clip all withdraw out of the body through the micro-puncture wound. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more fully understand the essence of the present invention, the following will be described in detail in conjunction with the drawings, where: Figure 1 is a side projection view of Instrument 1; Figure 2 is another side projection view of Instrument 1; Figure 3 is an exploded schematic view of the inner core assembly 3; Figure 4 is a partial side broken projection view of the outer tube 10; Figure 5 is Figure 4 a 5-5 cross-sectional view of Figure 6 is a side projection view of the first clip 30 (second clip 40); Figure 7 is another side projection view of the first clip 30 (second clip 40); Figure 8 is a projection view of the first clip 30 (second clip 40) from the distal end to the progress; Figure 9 is a 3D schematic view of the first connecting piece 50 (second connecting piece 60); Figure 10 is a partial projection view of the distal head of the inner core assembly 3; Figure 11 is Figure 10 a partial sectional view taken along line 11-11 of Figure 12 is Figure 10 a partial sectional view taken along line 12-12 of Figure 13 is a partial sectional view of the cooperation between the inner core assembly and the handle assembly; Figure 14 is a schematic diagram of the puncture channel setting for a typical laparoscopic cholecystectomy; Figure 15 is a schematic diagram of the puncture channel setting for a typical laparoscopic esophageal surgery; Figure 16 is a three-dimensional schematic diagram of a typical single-port multi-channel trocar (platform); Figure 17 is a schematic diagram of the puncture channel setting for the variable orifice new minimally invasive technique; Figure 18 is a schematic diagram of the puncture channel setting for the shrinking orifice new minimally invasive technique; Figure 19 is a three-dimensional schematic diagram of the micro-puncture needle 80; Figure 20 is a side projection view of the first clip 30a (second clip 40a); Figure 21 is another side projection view of the first clip 30a (second clip 40a); Figure 22 is a projection view of the first clip 30a (second clip 40a) from the distal end to the proximal end; Figure 23 is a side projection view of the outer tube 10a; Figure 24 is another side projection view of the outer tube 10a; Figure 25 is a partial side projection view of the head of the inner core assembly 3a; Figure 26 is another partial side projection view of the head of the inner core assembly 3a; Figure 27 is a side projection view of the first clip 30b (second clip 40b); Figure 28 is another side projection view of the first clip 30b (second clip 40b); Figure 29 is a projection view of the first clip 30b (second clip 40b) from the distal end to the proximal end; Figure 30 is a partial side projection view of the head of the inner core assembly 3b; Figure 31 is a partial projection view of the other side of the head of the inner core assembly 3b; Figure 32 is Figure 31 a sectional view taken along line 32-32 of Figure 33 is Figure 31 a sectional view taken along line 33-33 of Figure 34 is Figure 31 a sectional view taken along line 34-34 of Figure 35 is Figure 31 a sectional view taken along line 35-35 of Figure 36 is a partial projection view of the side of the head of the inner core assembly 3b when R1 = R2; Figure 37 is Figure 36 the other projection view of Figure 38 is a partial projection view of the side of the head of the inner core assembly 3b when R1 = R2 and D1 = D2; Figure 39 is Figure 38 the other projection view of Figure 40 is a perspective schematic view of the first base 12a; Figure 41 is a perspective schematic view of the second base 13a; Figure 42 is a perspective partial broken schematic view of the outer tube 10a; Figure 43 is a perspective schematic view of the first base 12b; Figure 44 is a perspective schematic view of the second base 13b; In all the views, the same reference numerals denote equivalent parts or components. DETAILED DESCRIPTION

[0025] Embodiments of the present invention are disclosed herein, however, it should be understood that the disclosed embodiments are merely examples of the present invention and the present invention may be implemented in different ways. Therefore, the content disclosed herein is not to be construed as limiting but only as a basis for the claims and as a basis for teaching those skilled in the art how to use the present invention.

[0026] Reference Figure 1, for the convenience of description, in the following, the side closer to the operator is defined as the proximal end, and the side farther from the operator is defined as the distal end. When performing a laparoscopic surgery, a trocar assembly is usually used to establish a surgical channel for instruments to enter and exit the patient's body through the patient's body wall, and various minimally invasive instruments can be inserted into the body cavity through the established channel. During the operation, one or more trocar assemblies may be used simultaneously, and one or more instruments are configured for simultaneous operation according to the surgical needs.

[0027] Figure 1 Depicts a locally enhanced minimally invasive percutaneous surgery instrument 1 including a handle assembly 2 and a core assembly 3.

[0028] Figures 2 - 3 Depicts the structure and composition of the core assembly 3. The shown core assembly 3 includes an outer tube 10, an inner pull rod 20, a first clip 30, a second clip 40, a first connecting piece 50, a second connecting piece 60, and a main pin 70.

[0029] Figures 3 - 5 Depicts the structure and composition of the outer tube 10. The outer tube 10 includes a distal fork seat 11 and a proximal tube handle 17 and an extension tube 15 extending therebetween. The fork seat 11 includes a fork seat root 111 and a first arm 112 and a second arm 113 extending distally. The fork seat root 111 extends proximally and the outer diameter gradually decreases to form a fork seat ramp 115. The first arm 112 and the second arm 113 define a U-shaped fork 114. Side holes 116 are provided at the distal end of the fork seat and penetrate the first arm and the second arm laterally. An axial hole 117 penetrates the fork seat and communicates with the U-shaped fork 114. The extension tube 15 includes a distal tube head 151 and a proximal tube tail 155 and a tube body 153 extending therebetween. The tube handle 17 includes a distal handle head 171 and a proximal handle tail 175 and a handle body 173 extending therebetween. The adjacent area of the handle tail 175 includes a handle ring groove 177. The tube head 151 is integrally connected with the ramp 115, and the tube tail 155 is integrally connected with the handle head 171. Those skilled in the art should be able to think that the outer tube 10 can be disassembled into two or more parts and then welded into a whole. It can also be processed by cutting materials from the same base tube or bar.

[0030] Figure 3 Depicts the structure of the inner pull rod 20. The inner pull rod 20 includes a pull rod head 21 and a pull rod tail 27 and a pull rod bar 25 extending therebetween. The pull rod tail 27 includes a pull rod ring groove 271, and the pull rod head 21 includes a pull rod transverse axis 271.

[0031] Figures 6 - 8Depicts the structure and composition of the first clamp 30 and the second clamp 40. The first clamp 30 includes a first jaw 31, a first tail 35, and a first wrist 33 connecting them. The first jaw 31 includes a first jaw tip 311. The first tail includes a first rotating shaft hole 351 and a first tail hole 352 penetrating through it. The second clamp 40 includes a second jaw 41, a second tail 45, and a second wrist 43 connecting them. The second jaw 41 includes a second jaw tip 411. The second tail includes a second rotating shaft hole 451 and a second tail hole 452 penetrating through it.

[0032] Figure 9 Depicts the structure and composition of the first connecting piece 50 and the second connecting piece 60. The first connecting piece 50 includes a first head 51 and a first tail 55, and a first body 53 connecting them. The first head includes a first transmission shaft 511 extending outwards. The first tail includes a first tail hole 551 penetrating through it. The second connecting piece 60 includes a second head 61 and a second tail 65, and a second body 63 connecting them. The second head includes a second transmission shaft 611 extending outwards. The second tail includes a second tail hole 651 penetrating through it.

[0033] Figures 10 - 12 Depicts the assembly relationship of the inner core assembly 3. The first clamp 30 and the second clamp 40 are installed in a U-shaped fork 114 between the first arm 112 and the second arm 113; a kingpin passes through the first rotating shaft hole 351, the second rotating shaft hole 451, and the side hole 116 to fix the first and second clamps between the first and second arms; wherein the first clamp and the second clamp can rotate around the kingpin to form a main rotating pair. The first connecting piece and the second connecting piece are installed in the U-shaped fork; the first transmission shaft 511 passes through the first tail hole 352 to connect the first tail 35 and the first head 51, and can rotate relative to each other to form a first transmission pair; the second transmission shaft 611 passes through the second tail hole 452 to connect the second tail and the second head, and can rotate relative to each other to form a second transmission pair. The pull rod head 21 is clamped between the first tail 55 and the second tail 65. The pull rod cross shaft 271 passes through the first tail hole 551 and the second tail hole 651 to connect the pull rod head with the first and second connecting pieces, and can rotate relative to each other to form a main driving pair.

[0034] Now in combination with Figure 1 , Figure 2 , Figure 10 and Figure 13Understanding. The handle assembly 2 includes a first handle 92 and a second handle 93 connected by a handle rotating shaft 91, and the first handle and the second handle can rotate around the handle rotating shaft. The rotating wheel assembly 95 includes a rotating wheel 951, an outer sleeve 953 and an inner sleeve 955. The outer sleeve 953 is integrally connected with the rotating wheel 951, and the inner sleeve 955 is integrally connected with the first handle 92. The outer sleeve 953 and the inner sleeve 955 form a rotating mechanism to enable the rotating wheel 951 to rotate relative to the first handle. The button assembly 97 is installed in the button installation bin 98 of the first handle 92. The button assembly 97 includes a locking member 972. One end of the locking member 972 is connected to an elastic element 971 and the other end is connected to a button 974. A fastener 973 restricts the locking member 972 in the installation bin 98, and the elastic element 971 drives the locking member 972 to move laterally in the installation bin 98 to the locking position. The surgical instrument 1 includes a handle assembly 2 and an inner core assembly 3. Among them, the pull rod tail 27 matches the second handle 93. The elastic element 971 drives the locking member 972 to move laterally in the installation bin 98 to the locking position and matches with the handle ring groove 177. The handle body 173 matches with the rotating wheel 951 and transmits the rotational torque from the rotating wheel to the inner core assembly. The first handle and the second handle rotate around the handle rotating shaft, thereby pushing the pull rod tail 27 to move axially, and further pushing the pull rod head to move axially, and further driving the first and second connecting pieces to move and rotate, driving the first and second clamping tails to rotate, and realizing the closing or opening of the first and second clamping jaws. Pressing the button 97 compresses the elastic element 971 to make the locking member 972 move laterally away from the locking position, separating the handle ring groove 177 from the locking member 972, thereby separating the inner core assembly 3 and the handle assembly 2.

[0035] In current clinical laparoscopic minimally invasive surgeries, multiple puncture channels are usually established on the patient's body wall. Various lengthened surgical scissors, surgical forceps, clip applicators, energy instruments, etc. enter the patient's body through the puncture channels to complete surgical operations such as lesion exposure, organ dissection, lesion resection, hemostasis in the body, suturing in the body, and removal of lesions and foreign bodies. Compared with traditional open abdominal surgeries, laparoscopic surgeries have smaller incisions and faster recovery. So far, in the field of general surgery, most laparoscopic surgeries have gradually replaced traditional open abdominal surgical procedures.

[0036] Figure 14 Depicts the puncture channel settings for a typical laparoscopic cholecystectomy: A trocar P1 with a specification of 10 mm (inner diameter 10.8 mm, outer diameter 13 mm) is set at the navel as the endoscopic channel; a trocar P2 with a specification of 10 mm is the main channel; two 5 mm trocars (inner diameter 5.8 mm, outer diameter 7 mm) P3 and P4 are used as auxiliary channels. Figure 15 Depicts the puncture channel settings for a typical laparoscopic esophageal surgery: A trocar P1 with a specification of 10 mm is set at the navel as the endoscopic channel; a trocar P2 with a specification of 10 mm is the main channel; four 5 mm trocars P3, P4, P5, and P6 are used as auxiliary channels.

[0037] As laparoscopic surgery becomes increasingly mature, the verification of the effectiveness of laparoscopic surgery has also become more in-depth. Research shows that laparoscopic surgery creates relatively large puncture channels in the patient's body wall, especially channels over 10 mm, which damages muscle fibers and results in a longer recovery period for patients. Some patients are prone to incisional hernia, and most patients experience pain for a long time after surgery, especially when the muscles at the incision site are stressed or affected by external environmental factors such as weather changes.

[0038] In recent years, in order to reduce functional muscle damage, single-port laparoscopic surgery has gradually become a new hotspot. For example Figure 16 , so-called single-port laparoscopic surgery means making an incision of about 30 mm at the patient's navel, then inserting an incision protector and expanding the incision to about 50 mm, so as to complete surgical operations such as lesion exposure, organ dissection, lesion resection, hemostasis in vivo, suture in vivo, and removal of lesions and foreign bodies through a single incision. The trauma at the navel in single-port laparoscopic surgery is greater than the sum of the traumas caused by traditional multiple puncture channels, and multiple instruments in single-port laparoscopy enter through one incision, lacking the triangular area of instrument cooperation, which requires higher surgical skills from doctors.

[0039] In traditional multi-port laparoscopic surgery, various instruments such as tissue forceps, energy forceps, needle holders, clip appliers, irrigation tubes, and extractors need to be replaced multiple times through the main puncture channel with a specification of 10 mm or 12 mm. Among them, instruments with a diameter of 5 mm are used about 90% of the time, and instruments with a diameter of 10 mm are used about 10% of the time; other auxiliary or cooperative puncture channels use instruments with a diameter of 5 mm for a long time. The main operating hole constructed by the large-diameter puncture channel has multiple instruments entering and exiting and extreme-angle deviation operations, which cause great muscle tearing damage at the puncture channel. In single-port laparoscopic surgery, its essence is to expand the main operating hole, and all instruments enter the patient's body through a single incision and adopt complex techniques with large inclination angles. The patient's incision is larger, and the additional damage to the incision is also greater.

[0040] For example Figure 17 As shown, the present invention proposes a new minimally invasive surgical method combining multi-port laparoscopy and single-port laparoscopy with variable holes. An incision with a diameter of about 15 mm is set at the patient's navel, and a simplified single-port access platform P0 is adopted. The shown single-port access platform P0 includes an incision protector with a diameter of about 15 mm, and the incision protector is externally connected to a multi-port sealing platform. The shown multi-port access platform contains a channel P1 with a diameter of 5 mm and a channel P2 with a diameter of 10 mm. At appropriate positions around the 15-mm incision, multiple micro-incisions are set, for example Figure 17For the P4, P5, P6, and P7 micro-wound openings shown, the instrument directly enters the patient's body through the micro-wound openings. In one solution, a 5-mm endoscope enters through P1, and large-diameter instruments for short-term use, such as clip appliers and extractors, enter through P2. In another solution, a 10-mm endoscope for routine operations enters through P2. When a 10-mm instrument is used for a short time, a 5-mm endoscope is switched to enter through P1, and at the same time, large-diameter instruments for short-term use, such as clip appliers and extractors, enter through P2.

[0041] As Figure 18 As shown, the present invention proposes another new minimally invasive technique for pore reduction based on the improvement of traditional minimally invasive surgery. A 5-mm specification channel P1 (outer diameter about 7 mm) is set at the patient's navel for the entry and exit of the endoscope. A 5-mm specification channel P2 is set to avoid the patient's functional muscle tissue for compatibility with existing 5-mm specification conventional instruments, and the P2 channel allows instrument switching. At appropriate positions on the patient's body wall, multiple micro-wound openings (P3, P4, P5) are set, and the instrument directly enters the patient's body through the micro-wound openings. In such a new minimally invasive technique for pore reduction, a clip applier is not used to close the blood vessels in the body that need to be excised, and a suture is used for ligation and closure.

[0042] Contrary to traditional laparoscopic surgery, in the new variable pore minimally invasive technique and the new pore reduction minimally invasive technique, the number of micro-wound openings is not reduced. An adequate number of micro-wound openings are set according to the surgical needs, and the instruments in the micro-wound openings are not replaced during the minimally invasive surgery. In traditional laparoscopic surgery, the number of puncture channels is reduced, and usually multiple surgical instruments are switched through the main puncture channel multiple times.

[0043] Now referring to Figures 4 - 5 , in one solution, the outer diameter of the extension tube is D1, the outer diameter of the fork base 11 is D2, and the diameter of the tube handle is D3. D1 and D2 satisfy the relationship: . This design can not only make the instrument have sufficient strength but also reduce the degree of expansion of the fork base when passing through the micro-wound opening, reducing the additional damage to the micro-wound opening.

[0044] The fork base root 111 extends towards the proximal end and the outer diameter gradually decreases to form a fork base slope 115. The fork base slope 115 forms an acute angle A1 with the fork base axis 119, where 2° ≤ A1 ≤ 45°. This setting is beneficial to reducing the degree of expansion of the fork base when it exits from the patient's body through the micro-wound opening, reducing the additional damage to the micro-wound opening.

[0045] The length of the fork base is L1, and the length of the extension tube is L2, where L1 ≤ 0.1 × L2. This setting can not only ensure the operation of the instrument at various extreme angles and depths during the surgery but also prevent the fork base from causing additional damage to the patient's wound.

[0046] Now referring to Figures 6 - 8, the first clamp 30 includes a first anastomosis reference surface 38 and a first movement reference surface 39; the second clamp 40 includes a second anastomosis reference surface 48 and a second movement reference surface 49. The thickness T1 of the first (second) jaw tip (measured perpendicular to the anastomosis reference surface); the width W1 of the first (second) jaw tip (measured perpendicular to the movement reference surface); the maximum circumscribed circle diameter D4 of the first (second) clamp wrist; where T1, W1, D4 satisfy the relationship: . This design can not only ensure that the first and second jaws have a sufficiently large contact area with the tissue or organ clamped therebetween, but also ensure that the instrument has a good guiding effect when inserted into the patient's body through a micro-hole wound, reducing the additional damage to the micro-hole wound.

[0047] The length B1 of the first (second) jaw tip; the distance B2 from the proximal end of the first jaw to the first rotation shaft hole (from the proximal end of the second jaw to the second rotation shaft hole); where B1, B2 satisfy the relationship: . This design can not only ensure that the first and second jaws have a sufficiently large contact area with the tissue or organ clamped therebetween, but also ensure that the instrument has a good guiding effect when inserted into the patient's body through a micro-hole wound, reducing the additional damage to the micro-hole wound.

[0048] Figure 19 A micro-hole puncture needle 80 is depicted, which includes a proximal puncture handle 81 and a distal puncture rod 83 with a diameter of D0. The puncture rod includes a distal needle tip 85.

[0049] In one aspect of the present invention, a super-micro surgical instrument kit is proposed, which includes one of the aforementioned micro-hole puncture needles and also includes one or more of the aforementioned surgical instruments 1. The method for implementing a new minimally invasive surgical procedure using it is as follows: S1 Puncture: First, an incision is made at the patient's navel and a channel is inserted. Then, an endoscope is accessed through this channel for real-time observation, and the micro-hole puncture needle is used to puncture the patient's body wall under the condition of real-time image monitoring.

[0050] S2 Dilation: The micro-hole puncture needle is removed, and the first and second clamps of the surgical instrument are kept in a mutually clamped state. Using the guiding effect of the first and second jaw tips, the micro-hole wound created by the micro-hole puncture needle is squeezed and dilated until the first and second clamps and the fork seat all pass through the patient's body wall.

[0051] S3 Operation: Move the surgical instrument to perform the surgical operation, and do not switch the instruments in the same micro-hole wound during the operation.

[0052] S4 Withdrawal: Pull out the surgical instrument out of the body, and using the guiding effect of the fork seat slope, squeeze and dilate the micro-hole wound until the fork seat and the first and second clamps all withdraw out of the body through the micro-hole wound.

[0053] So far, in scenarios such as flexible endoscopic surgery, urological endoscopic surgery, otolaryngological endoscopic surgery, and hysteroscopic surgery, the surgical forceps with a diameter less than 3.0 mm used must pass through the channels with a fixed diameter on the endoscope. It has no clinical significance that the diameter of the distal head of such forceps is designed to be larger than the diameter of the extension tube. Those skilled in the art should be able to understand that such forceps passing through the endoscope channels usually must be flexible or semi-rigid, limited to surgical operations under simple or specific scenario conditions, and such instruments cannot replace the existing 5 mm series of instruments for complex surgeries in general surgery.

[0054] In a design scheme, take , where 2.0 ≤ D0 ≤ 3.0 mm and 2.5 ≤ D1 ≤ 3.5 mm. In a specific embodiment: D0 = 3.0 mm, D1 = 3.5 mm, D2 = 5.0 mm. That is, a puncture needle with a diameter of 3.0 mm is used to puncture the patient's body wall. After removing the puncture needle, an instrument head with a diameter of 5.0 mm is used to expand the wound. After entering the patient's body, the outer tube with a diameter of 3.5 mm maintains a slightly dilated contact with the patient's incision. This instrument can achieve the strength of a 5 mm diameter instrument. In another specific embodiment: D0 = 2.5 mm, D1 = 3.0 mm, D2 = 4.5 mm. That is, a puncture needle with a diameter of 2.5 mm is used to puncture the patient's body wall. After removing the puncture needle, an instrument head with a diameter of 4.5 mm is used to expand the wound. After entering the patient's body, the outer tube with a diameter of 3.0 mm directly maintains a slightly dilated contact with the patient's incision. This instrument can achieve or approach the strength of a 5 mm diameter instrument.

[0055] In another more delicate design scheme, take , where 1.5 ≤ D0 ≤ 2.5 mm and 1.5 ≤ D1 ≤ 2.6 mm. In a specific embodiment: D0 = 2.0 mm, D1 = 2.5 mm, D2 = 4.0 mm. That is, a puncture needle with a diameter of 2.0 mm is used to puncture the patient's body wall. After removing the puncture needle, an instrument head with a diameter of 4.0 mm is used to expand the wound. After entering the patient's body, the outer tube with a diameter of 2.5 mm directly maintains a slightly dilated contact with the patient's incision. This instrument can approach the strength of a 5 mm diameter instrument. In another specific embodiment: D0 = 1.5 mm, D1 = 1.9 mm, D2 = 3.8 mm. That is, a puncture needle with a diameter of 1.5 mm is used to puncture the patient's body wall. After removing the puncture needle, an instrument head with a diameter of 3.8 mm is used to expand the wound. After entering the patient's body, the outer tube with a diameter of 1.9 mm directly maintains a slightly dilated contact with the patient's incision. This kind of instrument can approach the strength of a 5 mm diameter instrument.

[0056] Those skilled in the art should understand that the extension tube and the inner pull rod can be made of high-strength stainless steel (such as 17-4PH, 17-7PH, 15-5PH), and the first clip, the second clip, the first connecting piece, and the second connecting piece can be made of ultra-high-strength stainless steel (such as Custom465, F863). Combining the above-mentioned design can make the strength of the instrument close to or equivalent to that of the existing instrument with a diameter of 5 mm.

[0057] Research shows that when the wound ≤ 2.6 mm, the damage to the patient's muscles or tissues is very small, and there is almost no scar after the wound heals. Based on this, in a preferred solution, 1.5 ≤ D0 ≤ 2.5 mm, 1.5 ≤ D1 ≤ 2.6 mm, 。

[0058] Contrary to traditional laparoscopic surgery, the present invention does not recommend using multiple instruments to pass through the same main channel and repeatedly switch multiple times to enter and exit the patient's body to perform surgery. Instead, it is recommended to set multiple micro-wound openings according to the surgical needs, insert the tissue forceps, energy forceps, dissection forceps, needle holder, etc. required for the surgery into the patient's body respectively, and do not switch the instruments during the operation, and operate the corresponding instruments as needed. With the current material technology and processing technology, although the instrument with a diameter ≤ 1.5 mm causes less trauma to the patient, its strength and stiffness are not sufficient to support the complex operations of general surgery laparoscopic surgery.

[0059] Figures 20 - 22 Depicts the structure and composition of the first clip 30a and the second clip 40a. The first clip 30a includes a first jaw 31a, a first tail 35a, and a first wrist 33a connecting them. The first tail 35a includes a first rotating shaft hole 351a and a first tail hole 352a penetrating through it. The first jaw 31a includes a first jaw tip 311a, a first inclined jaw handle 315a, and a first jaw piece 313a extending therebetween. The second clip 40a includes a second jaw 41a, a second tail 45a, and a second wrist 43a connecting them. The second tail 45a includes a second rotating shaft hole 451a and a second tail hole 452a penetrating through it. The second jaw 41a includes a second jaw tip 411a, a second inclined jaw handle 415a, and a second jaw piece 413a extending therebetween.

[0060] The first clip 30a includes a first anastomosis reference surface 38a and a first movement reference surface 39a; the second clip 40a includes a second anastomosis reference surface 48a and a second movement reference surface 49a. The thickness T2 of the first (second) jaw tip (measured perpendicular to the anastomosis reference surface); the width W2 of the first (second) jaw tip (measured perpendicular to the movement reference surface); the maximum circumscribed circle diameter D5 of the first (second) wrist; where W2 and D5 satisfy the relationship: This design can not only ensure that the first and second jaws have a sufficiently large contact area with the tissue or organ clamped therebetween, but also ensure that the instrument has a good guiding effect when inserted into the patient's body through a micro-pore wound, reducing the additional damage to the micro-pore wound.

[0061] In one solution, the maximum circumscribed circle diameter D6 of the cross-section of the first (second) jaw piece, the length B3 of the first (second) jaw piece (measuring the length of the jaw tip to the distal part with an outer circumscribed circle diameter ≤ D6), and the distance B4 from the jaw tip to the rotating shaft hole, where: , This design can not only ensure that the first and second jaws have a sufficiently large contact area with the tissue or organ clamped therebetween, but also ensure that the instrument has a good guiding effect when inserted into the patient's body through a micro-pore wound, reducing the additional damage to the micro-pore wound.

[0062] The proximal end of the first jaw inclined handle 315a is integrally connected with the first clamping wrist 33a, and extends obliquely towards the distal end with its size gradually decreasing. The proximal end of the second jaw inclined handle 415a is integrally connected with the second clamping wrist 43a, and extends obliquely towards the distal end with its size gradually decreasing. The inclination angle A2 of the first jaw inclined handle with respect to the anastomosis reference plane, where 2° ≤ A2 ≤ 45°. This design can not only ensure that the first and second jaws have a sufficiently large contact area with the tissue or organ clamped therebetween, but also ensure the guiding effect of the instrument when inserted into the patient's body through a micro-pore wound, reducing the additional damage to the micro-pore wound.

[0063] Figures 23 - 24 Depicts the structure and composition of the outer tube 10a. The outer tube 10a includes a fork base 11a, a tube handle 17, and an extension tube 15 extending therebetween. The fork base 11a includes a fork base root 111a and a first arm 112a and a second arm 113a extending towards the distal end. The fork base root 111a extends towards the proximal end with its outer diameter gradually decreasing to form a fork base ramp 115a. The first arm 112a and the second arm 113a define a U-shaped fork 114a. Side holes 116a are provided at the distal end of the fork base and penetrate the first arm and the second arm transversely. A shaft hole 117a (not shown in the figure) penetrates the fork base and communicates with the U-shaped fork 114a. The fork base ramp 115a is integrally connected with the extension tube 15.

[0064] The outer diameter of the extension tube is D1, the maximum outer diameter of the first arm and the second arm of the fork base 11a is D2, and the outer diameter of the fork base root 111a is D7, D7 < D2. Where D1, D2, D7 satisfy the relationship: , .

[0065] This design can not only endow the instrument with sufficient strength, but also reduce the degree of expansion of the fork base when passing through the micro-hole wound, thereby reducing the additional damage to the micro-hole wound. The settings of D7 and D2 are beneficial to both the strength design and manufacturing of the fork base and the gradual expansion of the micro-hole wound during the withdrawal of the instrument.

[0066] The root 111a of the fork base extends towards the proximal end and its outer diameter gradually decreases to form a fork base ramp 115a. The fork base ramp forms an acute angle A1 with the axis of the fork base, and 2° ≤ A1 ≤ 45°. There is a transition ramp 118a between the first and second arms and the root 111a of the fork base. The transition ramp forms an acute angle A3 with the axis of the fork base, and 2° ≤ A3 ≤ 45°. This setting is beneficial to reducing the degree of expansion of the fork base when it exits from the patient's body through the micro-hole wound to the outside, and reducing the additional damage to the micro-hole wound.

[0067] Figures 25 - 26 Depicts the assembly relationship of another inner core assembly 3a. The inner core assembly 3a includes an outer tube 10a, an inner pull rod 20, a first clamp 30a, a second clamp 40a, a first connecting piece 50, a second connecting piece 60 and a main pin 70. The structure and composition of the inner core assembly 3 are similar to those of the inner core assembly 3a, and their assembly relationships are basically the same. Combining Figure 10 , Figure 11 , Figure 12 , Figure 25 and Figure 26 Understand that the first and second clamps are fixed between the first and second arms by the main pin to form a main rotating pair; the tail of the first clamp and the head of the first piece are connected to form a first transmission pair; the tail of the second clamp and the head of the second piece are connected to form a second transmission pair; the head of the pull rod is connected to the tails of the first and second pieces to form a main driving pair; when the pull rod is moved, the main driving pair moves and rotates, driving the first and second transmission pairs to move and rotate, and further driving the main rotating pair to rotate, realizing the closing or opening of the first and second jaws.

[0068] As Figures 25 - 26 , in one solution, the total length from the fork base 11a to the distal ends of the first and second clamps is Y1, and the total length Y2 of the fork base 11a and the parts of the first clamp 30a and the second clamp 40a with a diameter ≥ D2, where This setting is conducive to establishing a micro-pore wound and enabling the relatively thick fork base and the first and second clamping bowls to smoothly expand the patient's wound, reducing the additional damage to the patient's micro-pore wound to a relatively low level. In a specific design, Y2 ≤ 20 mm. For example, a 2.0-mm micro-pore wound is established through the patient's body surface. The maximum width after the combination of the first jaw tip and the second jaw tip is about 2.0 mm. The maximum circumscribed circle diameter D6 of the first jaw piece and the second jaw piece is about 2.4 mm. The total length of the first jaw piece and the second jaw piece is about 15 mm. The maximum diameter D2 of the fork base and the first and second clamps is about 4.0 mm, and its total length Y2 is about 15 mm. The total length from the fork base to the distal ends of the first and second clamps is Y1, which is about 35 mm. Research shows that the average abdominal wall thickness of Chinese adults is about 23.4 ± 6.6 mm. Y2 ≤ 20 mm is conducive to reducing the force during the expansion of the micro-pore wound and reducing additional damage.

[0069] Figures 27 - 29 Illustrates the structure and composition of the first clamp 30b and the second clamp 40b. The first clamp 30b includes a first jaw 31b, a first tail 35b, and a first wrist 33b connecting them. The first tail 35b includes a first rotation shaft hole 351b and a first tail hole 352b penetrating through it, and also includes a first reinforcing outer edge 353b protruding outwardly on the outer side of the proximal end of the first tail. The first jaw 31b includes a first jaw tip 311b, a first jaw slope 314b, and a first jaw piece 313b extending therebetween. One end of the first jaw handle 315b is integrally connected to the first jaw slope, and the other end is integrally connected to the first wrist. The second clamp 40b includes a second jaw 41b, a second tail 45b, and a second wrist 43b connecting them. The second tail 45b includes a second rotation shaft hole 451b and a second tail hole 452b penetrating through it, and also includes a second reinforcing outer edge 453b protruding outwardly on the outer side of the proximal end of the second tail. The second jaw 41b includes a second jaw tip 411b, a second jaw slope 414b, and a second jaw piece 413b extending therebetween. One end of the second jaw handle 415b is integrally connected to the second jaw slope, and the other end is integrally connected to the second wrist.

[0070] The first clamp 30b includes a first anastomosis reference surface 38b, a first movement reference surface 39b, and a first clamp axis 37b. The second clamp 40b includes a second anastomosis reference surface 48b, a second movement reference surface 49b, and a second clamp axis 47b. As Figure 27 and Figure 29, measured along the axis of the first (second) clamp, the circumscribed circle radius of the first (second) clamp wrist is R1, the circumscribed circle radius of the first (second) claw is R2, and the maximum distance between the first convex reinforced outer edge and the first matching reference plane (between the second convex reinforced outer edge and the second matching reference plane) is X1. The thickness of the first (second) jaw is T2 (measured perpendicular to the matching reference plane); the width of the first (second) jaw is W2 (measured perpendicular to the motion reference plane).

[0071] The values ​​of R1 and X1 satisfy the relationship: When the ratio is less than 1.2, the strength enhancement effect of the reinforced outer edge is insufficient, and when the ratio is greater than 1.6, the size of the reinforced outer edge changes too much, which is not conducive to reducing the expansion damage to the microporous wound.

[0072] The values ​​of R1 and R2 satisfy the relationship: When the ratio is greater than 1.8, the size of the first (second) clamping jaw relative to the first (second) clamping wrist changes too much, which is not conducive to reducing the expansion damage to the micro-hole wound.

[0073] refer to Figure 27 , Figure 31 , Figure 33 , Figure 34 and Figure 35 The first reinforced outer edge and the second reinforced outer edge include smooth arc-shaped convex outer edge sides, and the corners of the intersection area between the first (second) reinforced outer edge and other structures of the first (second) clip tail include smooth rounded transitions without sharp edges or sharp corners. This arrangement is conducive to reducing friction damage to the patient's muscles and tissues when the first and second reinforced outer edges expand the microporous wound.

[0074] Figures 30 - 35 The assembly relationship of another inner core assembly 3b is depicted. The inner core assembly 3b comprises an outer tube 10, an inner tie rod 20, a first clamp 30b, a second clamp 40b, a first connecting piece 50, a second connecting piece 60 and a main pin 70. The structure and composition of the inner core assembly 3 are similar to those of the inner core assembly 3b, and their assembly relationship is basically the same. Figure 10 , Figure 11 , Figure 12 , Figure 30 and Figure 31 It is understood that: the first clamp and the second clamp are fixed between the first and second arms by the main pin, forming a main rotation pair; the first clamp tail and the first film head are connected to form a first transmission pair; the second clamp tail and the second film head are connected to form a second transmission pair; the pull rod head is connected to the first and second film tails and forms a main drive pair; move the pull rod, the main drive pair moves and rotates, driving the first transmission pair and the second transmission pair to move and rotate, and then driving the main rotation pair to rotate, so as to realize the closing or opening of the first and second clamps.

[0075] In one solution, its size design satisfies the relationship: as Figure 32 , the outer diameter of the fork base 11 is D2, where D2 ≥ 2R1. As Figures 33 - 34 , D1 and X1 satisfy the relationship: . As Figure 35 , the outer diameter of the extension tube is D1, . This design can not only endow the instrument with sufficient strength, but also reduce the degree of expansion of the fork base when passing through the micro-hole wound, and reduce the additional damage to the micro-hole wound. The settings of D1 and D2 are not only beneficial to the strength design and manufacturing of the fork base, but also beneficial to the gradual expansion of the micro-hole wound during the withdrawal of the instrument.

[0076] Figures 36 - 37 Illustrates an embodiment where R1 = R2, where: , , , . In a specific design case, take R1 = 1.48 mm, D1 = 2.96 mm, X1 = 1.8 mm, T2 = 1.1 mm.

[0077] Figures 38 - 39 Illustrates an embodiment where R1 = R2 and D1 = D2, where: , , . In another specific design case, take D1 = 2.5 mm, R1 = 1.2 mm, X1 = 1.6 mm, T2 = 0.9 mm.

[0078] The above design can not only ensure that the instrument has sufficient strength, but also enable the first and second jaws to have a large enough contact area with the tissue or organ clamped therebetween, and can also ensure that the instrument has a good guiding effect when inserted into the patient's body through the micro-hole wound, reducing the additional damage to the micro-hole wound.

[0079] Figures 40 - 42 Illustrates the structure and composition of the outer tube 10b. The outer tube 10b includes a fork base 11b, a tube handle 17, and an extension tube 15 extending therebetween. The fork base 11b includes a first fork base 12b and a second fork base 13b. The first fork base 12b includes a fork base root 121b and a first arm 122b and a second arm 123b extending distally. The first arm 122b and the second arm 123b define a U-shaped fork 124b. Side holes 126b are provided at the distal end of the fork base and penetrate the first arm and the second arm transversely. An axial hole 127b penetrates the fork base and communicates with the U-shaped fork 124b. The fork base root 111b extends proximally to form a fork base tail tube 125b, and a first outer convex block 128b and a second outer convex block 129b extend laterally outward from the outer surface of the fork base tail tube 125b respectively.

[0080] The second fork base 13b includes a fork base root 131b and a sleeve 132b extending towards the distal end. A first cutting groove 133b cuts the distal end of the sleeve 132b to form a first L-shaped locking hook 135b; a second cutting groove 134b cuts the distal end of the sleeve 132b to form a second L-shaped locking hook 136b. The fork base root 131b extends towards the proximal end and its outer diameter gradually decreases to form a fork base ramp 139b.

[0081] Combined Figure 40 With reference to 41 and 42, it can be understood that the fork base tail pipe 125b is inserted into the sleeve 132b, wherein the first outer convex block 128b is snapped into the first L-shaped locking hook 135b through the first cutting groove 133b, and the second outer convex block 129b is snapped into the second L-shaped locking hook 136b through the second cutting groove 134b, thereby connecting the first fork base 12b and the second fork base 13b into an integral fork base 11b.

[0082] Figures 43 - 44 The structure and composition of the outer tube 10c are depicted. The outer tube 10c includes a distal fork base 11c, a proximal tube handle 17, and an extension tube 15 extending therebetween. The fork base 11c includes a first fork base 12c and a second fork base 13c. The first fork base 12c includes a fork base root 121c, a first arm 122c, and a second arm 123c extending towards the distal end. The first arm 122c and the second arm 123c define a U-shaped fork 124c. Side holes 126c are provided at the distal end of the fork base and penetrate the first arm and the second arm transversely. An axial hole 127c runs through the fork base and communicates with the U-shaped fork 124c. The fork base root 111c extends towards the proximal end to form a fork base tail pipe 125c, and the outer surface of the fork base tail pipe includes an external thread 128c.

[0083] The second fork base 13c includes a fork base root 131c and a sleeve 132c extending towards the distal end, and the sleeve includes an internal thread 133c. The 131c extends towards the proximal end and its outer diameter gradually decreases to form a fork base ramp 139c.

[0084] Combined Figure 43 With reference to 44, it can be understood that the fork base tail pipe 125c is inserted into the sleeve 132c, and the external thread 128c and the internal thread 133c are matched and locked with each other, thereby connecting the first fork base 12c and the second fork base 13c into an integral fork base 11c.

[0085] The outer tubes 10b and 10c replace the aforementioned outer tube 10, and the outer tube 10a can form a new inner core assembly. Those skilled in the art should be able to understand that high-strength stainless steel (such as 17-4PH, 17-7PH, 15-5PH) is used to manufacture the extension tube and the inner pull rod, and ultra-high-strength stainless steel (such as Custom465, F863) is used to manufacture the first and second clips and the first and second connecting pieces. Combining with the aforementioned design, the strength of the instrument can be made close to or equivalent to that of the existing instrument with a diameter of 5 mm. However, based on the existing processing technology, it will inevitably result in an expensive product price. The instrument should be repeatedly cleaned, sterilized, and reused to reduce the usage cost. The inner core assembly composed of the outer tubes 10b and 10c is convenient for disassembly, cleaning, and reuse. The relevant diameter size settings and length size ratios of the aforementioned fork seat and extension tube are beneficial not only to ensuring good guiding effect when the instrument is inserted into the patient's body through a micro-pore wound, reducing additional damage to the micro-pore wound, but also to the setting of the disassembly and connection structure and the structural strength during repeated use.

[0086] Those skilled in the art should be able to understand that some features described in the present invention can be combined and recombined with each other: for example, the first clip tail hole and the first transmission shaft are exchanged with each other, that is, the first clip tail contains the first rotating shaft, and the first clip head contains the first transmission hole, and the first rotating shaft is inserted into the first transmission hole to form a first transmission pair. For example, the first transmission shaft is replaced by the first transmission hole, and an additional transmission shaft is inserted into the first clip tail hole and the first transmission hole to connect the first clip tail and the first clip head together to form a rotatable first transmission pair. For example, the pull rod cross shaft is replaced by a drive hole, and an additional drive shaft is inserted into the drive hole, the first clip tail hole, and the second clip tail hole to connect the pull rod head with the first and second connecting pieces and enable relative rotation to form a main drive pair.

[0087] Those skilled in the art should easily think that, for the sake of simplicity of expression, in the examples shown, the first clip and the second clip adopt the same structure. However, different structures can also be adopted, such as different tooth shapes. Similarly, the first connecting piece and the second connecting piece can also adopt different structures. Those skilled in the art should be able to understand that the first, second, etc. do not have a strict order, only for the sake of simplicity and accuracy of description and convenience of understanding.

[0088] In addition, US patents US5489290, US5947996, US6340365, US7931667, US8551077, US8926599, etc. disclose various quick connection and disassembly mechanisms between the inner core assembly and the reusable handle. With slight adaptive modifications, these mechanisms can all be used for the connection between the inner core assembly of the present invention and the reusable handle. So far, many connection methods between the inner core assembly and the handle of minimally invasive surgical instruments have been disclosed in the field of minimally invasive surgical instruments. With slight adaptive modifications, they can all be used for the connection between the inner core assembly of the present invention and the handle, and will not be enumerated here.

Claims

1. A locally strengthened surgical instrument, comprising an inner core assembly and a handle assembly. The inner core assembly includes an outer tube, an inner pull rod, a first clamp, a second clamp, a first connecting piece, a second connecting piece and a main pin, characterized in that: 1) The outer tube includes a fork base and a tube handle and an extension tube therebetween. The fork base includes a fork base root and a first arm and a second arm. Side holes penetrate the first arm and the second arm transversely; the extension tube includes a tube head and a tube tail and a tube body therebetween; the tube head is integrally connected with the fork base, and the tube tail is integrally connected with the tube handle; 2) The first clamp includes a first clamping jaw, a first clamp tail and a first clamp wrist connecting them; the second clamp includes a second clamping jaw, a second clamp tail and a second clamp wrist connecting them; the first connecting piece includes a first piece head and a first piece tail and a first piece body connecting them, and the second connecting piece includes a second piece head and a second piece tail and a second piece body connecting them; the inner pull rod includes a pull rod head and a pull rod tail and a pull rod rod extending therebetween; 3) The first clamp and the second clamp are fixed between the first and second arms by the main pin to form a main rotating pair that can rotate around the main pin; the first clamp tail and the first piece head are connected to form a first transmission pair that can rotate relatively; the second clamp tail and the second piece head are connected to form a second transmission pair that can rotate relatively; the pull rod head is connected to the first and second piece tails and forms a main driving pair that can rotate relatively; moving the pull rod, the main driving pair moves and rotates, driving the first and second transmission pairs to move and rotate, and further driving the main rotating pair to rotate, realizing the closing or opening of the first and second clamping jaws.

2. The surgical instrument according to claim 1, characterized in that, The fork base root extends towards the proximal end and its outer diameter gradually decreases to form a fork base slope. The fork base slope is integrally connected with the extension tube. The outer diameter of the extension tube is D1, and the maximum outer diameter of the fork base is D2. D1 and D2 satisfy the relationship: 。 3. The surgical instrument according to claim 2, characterized in that, The first clamping jaw includes a first jaw tip, the thickness T1 of the first jaw tip, the width W1 of the first jaw tip, and the maximum circumscribed circle diameter D4 of the first clamp wrist. Among them, T1, W1, and D4 satisfy: 。 4. The surgical instrument according to claim 2, characterized in that, The total length from the fork base to the distal ends of the first and second clips is Y1, and the total length Y2 of the fork base, the first clip, and the part of the second clip with a diameter greater than or equal to D2, where .

5. The surgical instrument according to claim 1, characterized in that: 1) The first clamp tail further includes a first reinforcing outer edge protruding outwardly on the outer side of the proximal end of the first clamp tail, and the second clamp tail further includes a second reinforcing outer edge protruding outwardly on the outer side of the proximal end of the second clamp tail; 2) The first clamp includes a first anastomosis reference surface, a first movement reference surface and a first clamp axis; the second clamp includes a second anastomosis reference surface, a second movement reference surface and a second clamp axis; measured along the first (second) clamp piece axis, the circumscribed circle radius of the first (second) clamp wrist is R1, and the maximum distance between the first reinforcing outer edge and the first anastomosis reference surface (between the second reinforcing outer edge and the second anastomosis reference surface) is X1; 3) The values of R1 and X1 satisfy the relational expression: .

6. The surgical instrument according to claim 5, wherein: The first clamping jaw includes a first jaw tip, a first jaw slope and a first jaw piece extending therebetween; the second clamping jaw includes a second jaw tip, a second jaw slope and a second jaw piece extending therebetween; the circumscribed circle radius of the first (second) jaw piece is R2. Among them, R1 and R2 satisfy the relationship: 。 7. The surgical instrument according to claim 5, characterized in that, The root of the fork base extends towards the proximal end and its outer diameter gradually decreases to form a fork base slope, which is integrally connected to the extension tube. The outer diameter of the extension tube is D1, and the maximum outer diameter of the fork base is D2. D1 and D2 satisfy the relationship: 。 8. The surgical instrument according to claim 7, wherein D1 and X1 satisfy the relationship: 。 9. A surgical instrument kit, characterized in that: 1) It includes one or more instruments as described in any one of claims 1-8; 2) It further includes an ultra-fine puncture needle, the puncture needle includes a proximal puncture handle and a distal puncture rod with a diameter of D0, and the puncture rod includes a distal needle tip, where 1.5mm ≤ D0 ≤ 2.5mm.

10. The usage method of the surgical instrument kit as described in claim 9: S1 Puncture: First, make an incision at the patient's navel and insert a channel, then access the endoscope through this channel for real-time observation, and use the micro-puncture needle to puncture the patient's body wall under the condition of real-time image monitoring; S2 Dilation: Remove the micro-puncture needle, keep the first clip and the second clip of the surgical instrument in a mutually clamped state, utilize the guiding effect of the first jaw and the second jaw, squeeze and dilate the micro-puncture wound created by the micro-puncture needle until the first and second clips and the fork base all pass through the patient's body wall; S3 Operation: Move the surgical instrument to perform the surgical operation, and do not switch the instruments in the same micro-puncture wound during the operation; S4 Withdrawal: Pull out the surgical instrument out of the body, utilize the guiding effect of the fork base slope, squeeze and dilate the micro-puncture wound until the fork base and the first and second clips all withdraw out of the body through the micro-puncture wound.

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