WO2017028362A1

WO2017028362A1 - Surgical instrument having single-handed-operation safety device, and operation method thereof

Info

Publication number: WO2017028362A1
Application number: PCT/CN2015/090210
Authority: WO
Inventors: 聂红林; 张析量; 李安华; 石秀凤; 江洋; 杨尧
Original assignee: 上海逸思医疗科技有限公司; 逸思（苏州）医疗科技有限公司
Priority date: 2015-08-14
Filing date: 2015-09-22
Publication date: 2017-02-23
Also published as: CN105167814A

Abstract

Provided are a surgical instrument having a single-handed-operation safety device, and an operation method thereof, comprising: an actuator (300), an intermediate connector (200), and a controller (100). The actuator (300), the intermediate connector (200) and the controller (100) are connected to one another in sequence. The actuator (300) comprises a staple cartridge component (3002), a staple anvil component (3001), and a driving component (3003). The controller (100) comprises a firing trigger mechanism and a firing safety mechanism. The surgical instrument can enable a stapler to be single-handedly operated to unlock a firing safety mechanism without sacrificing safety, thereby reducing a risk in a surgery process, and shortening a surgery time.

Description

Surgical device with one-hand operation of safety device and operation method thereof

Technical field

The present invention relates to surgical instruments, and more particularly to a surgical stapler, and more particularly to an improved surgical device safety device and method of operation thereof that can be operated with one hand to achieve a convenient and safe opening of the safety function.

Background technique

The principle of the surgical stapler is to close the tissue by two corresponding jaws (commonly referred to as the anvil assembly and the cartridge assembly), and then push the metal staples in the stapler cartridge to form the tissue. Together. In some staplers, a cutting knife is also provided for cutting the stitched tissue.

The stapler having the above functions includes an actuator, an intermediate connector, and a controller. The actuator consists of an anvil assembly, a cartridge assembly and a drive assembly. The anvil assembly includes a nail forming surface, the nail forming surface includes a plurality of rows of nail grooves, and the nail groove is used for forming a metal staple. The cartridge assembly generally includes a staple cartridge, a staple, a pusher block, and a pusher slider and a staple cartridge. The upper surface of the staple cartridge is a tissue contacting surface, and the staple cartridge is mounted in the staple cartridge holder. The anvil assembly is movably coupled proximally to the proximal end of the cartridge assembly and is switchable between an open state and a closed state. The drive assembly is coupled to the transmission mechanism for converting the firing trigger action into an actuator closing, firing, and opening action. Typically, the anvil assembly and the cartridge holder each also include a longitudinal slot for receiving the drive assembly. When the drive assembly is moved toward the distal end of the actuator through the longitudinal slot, the anvil assembly and the cartridge assembly are driven from the open state to the closed state, and the pusher slider and the pusher block are driven out of the staple and Formed in the staple groove of the nail forming surface of the anvil assembly. Typically, the drive assembly also includes a cutting knife for cutting tissue between rows of staple lines after the tissue is stitched by the staples. The controller is used for manually controlling the operating instrument, and generally includes a fixed handle, a firing trigger that is movably coupled to the fixed handle, a transmission mechanism that transmits the firing trigger to the actuator, and a manual reset assembly. Operating the manual reset assembly can urge the cartridge assembly and the anvil assembly to return to an open state when the cartridge assembly and the anvil assembly of the actuator are in a closed state. The intermediate connector is movably coupled to the distal end of the controller and coupled to the proximal end of the actuator, the intermediate connector forming a connecting passage for effecting the action of firing the trigger to the actuator.

For example, US Pat. No. 2014/0001233 A1 discloses a stapler that is capable of converting an anvil assembly and a cartridge assembly of an actuator from an open state to a closed state by operating a firing trigger. Pressing, firing, etc., the other hand needs to pull back the manual reset component with the other hand to drive the cartridge assembly and the anvil assembly to open. The technical solution does not fire the insurance mechanism, can not effectively prevent the false hitting, and the coherent process from pressing the tissue to firing the firing trigger for a continuous pressing operation cannot make the medical practitioner clearly perceive that the control performs the pressing and firing actions respectively.

Further, for example, a suturing device disclosed in the Chinese patent document CN202950702U, which has a firing safety device, but an operation button for controlling the firing safety device is located on the side of the suturing device, resulting in the operation button and the firing wrench The distance is too far, making it difficult to operate with one hand. To take a step back, even if the doctor's finger is long, the doctor still needs to operate the trigger button and the operation button of the safety device through the index finger and the thumb, in the process, Since the thumb and the other four fingers are on different sides of the stapler handle, the slack of the thumb tends to cause the gripper to be unstable. Moreover, the suturing device does not have an automatic resetting mechanism, and the medical practitioner needs to use another hand to pull the manual resetting structure back to the initial position of the proximal end after performing a pressing action, so as to drive the staple cartridge assembly and the anvil assembly to open. State, therefore, in fact, the stapler still requires two hands to operate when it is necessary to repeatedly press the tissue, and cannot achieve one-handed operation.

For example, the Endo GIA Universal cutting stapler from Tyco Healthcare (later renamed Covidien) and the Echelon cutting stapler from Ethicon Endo-Surgery in the United States are representative products for achieving the above functions. The above products have been sold for many years and have been proven by the market to have good clinical application effects. However, the design of these instruments still needs to be perfected. For example, during the operation of the device, the firing safety device of the device needs to be opened by two hands, which is not suitable for the surgeon to operate the device during the operation.

For example, in U.S. Patent No. 5,865,361, Tyco Healthcare describes the function and design of the Endo GIA Universal cutting stapler (hereafter referred to as the Endo GIA stapler). When the firing trigger of the Endo GIA stapler is operated, the anvil assembly and the cartridge assembly of the stapler will transition from the open state to the closed state, clamping the target tissue; after the tissue is properly clamped, the physician determines the anastomosis and cutting Before organizing, you first need to use the other hand to assist pressing the firing button of the stapler to open the firing safety device, and then can operate the firing trigger again to perform subsequent actions, which brings inconvenience to the operation of the instrument and brings additional risks to the operation. In minimally invasive surgery, doctors sometimes operate different instruments with two hands. If a device requires both hands to operate at the same time, the doctor needs to loosen the other device that is held. In minimally invasive surgery, the controller outside the device that is not under the control of the doctor may be displaced due to an accidental touch during the procedure. A small displacement of the instrument controller may cause a large amount of actuators at the distal end of the instrument. Controlled displacement; because the actuator at the distal end of the instrument is in close proximity to the tissue and organs within the target area of the instrument, uncontrolled displacement of the actuator may damage nearby tissues and organs. In Temporarily not operating the instrument room, some doctors will take the device out of the body to avoid the risk; in some cases, the device will be temporarily held by another doctor; sometimes, the doctor just releases the device and presses the distal end of the device Relying on certain tissues or in the interstitial spaces of the organization, these actions may either prolong the operation time or risk the damage to tissues and organs.

If the surgeon can open the firing safety mechanism with one hand without sacrificing safety, it will reduce the risk during the operation and shorten the operation time.

Summary of the invention

It is an object of the present invention to provide an improved surgical device that can be operated with one hand. In particular, it relates to a cutting stapler that can be applied under open surgery or laparoscopic surgery. The device according to the present invention (hereinafter referred to as an anastomat) can realize tissue clamping to realize the molding of at least one row of staples; under certain application conditions, tissue cutting can also be performed, and tissue is arranged between multiple rows of staple lines Cut open.

The surgical device according to the present invention can be operated by a single hand, including an actuator, an intermediate connector and a controller. The actuator, the intermediate connector and the controller are sequentially connected, and the controller includes a firing trigger and a firing insurance. Institution, first axis

The firing safety mechanism includes a firing trigger that is rotatable along a first axis of the controller;

The firing safety trigger is rotatable along a second axis disposed on the firing trigger;

The first axis is offset from the second axis, ie, a different axis;

Preferably, the second shaft is located in front of the distal end of the first shaft and above the first shaft; the firing trigger and the firing safety trigger are in the same direction of rotation after being operated.

Preferably, the rack of the controller is detachably engageable with a companion mechanism; the travel of the companion mechanism in the longitudinal direction is restricted by the blocking of the limit boss in the controller, the block restricting the rack in the engaging mechanism The maximum longitudinal stroke when engaged is L1;

When the firing trigger is in the operating position, the firing trigger can be rotated along the second axis after being operated to drive the engagement mechanism to disengage from the rack, thereby causing the accompanying mechanism to avoid the blocking of the limiting boss, so that the rack The maximum longitudinal stroke when disengaged from the accompanying mechanism is L2;

Wherein, the length of L2 is greater than the length of L1, and the distal position of L2 is located at the distal end of the distal position of L1.

Preferably, when the firing trigger is in the inoperative position, the firing trigger is outside the reach of the accompanying mechanism or the component driven by the accompanying structure, and is not driven by the firing trigger.

Preferably, the operating position is reached when the firing trigger is rotated from the initial position along the first axis to a maximum angle that can be rotated when the firing trigger is not operating.

Preferably, the companion mechanism is an automatic reset mechanism that is detachably engaged with the rack of the controller and applies a force to the rack that urges the rack back to the initial position upon engagement.

Preferably, the automatic reset mechanism comprises an automatic reset slider and an elastic energy storage assembly, the automatic reset slider is provided with a reset tooth and is movably mounted in a longitudinal rail of the controller housing, and the reset tooth of the automatic reset slider is The rack is detachably engaged; the elastic energy storage assembly is fixed at one end to the controller housing and at the other end to the automatic reset slider to provide an elastic force that urges the rack back to the original position.

Preferably, the rack is driven distally by the rotation of the firing trigger from the initial position, and the rack acts as a barrier to continued rotation of the firing trigger when the rack travels to the distal position of the stroke.

Preferably, the rack is driven by the intermediate connector to perform a first action during movement of the rack from the proximal position to the distal position of the stroke L1; the rack is moved from the distal position of the stroke L1 to the distal position of the stroke L2 During the process, the actuator is driven by the intermediate connector to perform the second action.

Preferably, the first action is:

- the cartridge assembly and the anvil assembly of the actuator are changed from an open state to a closed state; or

- the cartridge assembly and the anvil assembly of the actuator transition from an open state to a closed state and then from a closed state to an open state;

The second action is:

- The actuator assembly of the actuator pushes the staples directly or indirectly from the cartridge assembly of the actuator and drives the staples into the staple slots of the anvil assembly of the actuator.

Preferably, the firing safety mechanism includes a safety rotating block, wherein the safety rotating block is rotatably mounted on the controller housing;

When the firing trigger is in the operating position, the firing trigger can be rotated along the second axis of the firing trigger, and the safety rotating block is driven by the cooperation of the first driving boss of the firing trigger and the second driving boss of the safety rotating block The rotary motion, the rotary motion of the safety rotary block drives the third drive boss of the safety rotary block to push the automatic reset slider of the automatic reset mechanism to raise, so that the automatic reset slider is disengaged from the rack and avoids the limit boss Block restrictions.

According to the present invention, there is provided a method for operating a surgical instrument of the above-described safety device which can be operated by one hand, wherein, when the firing safety mechanism is not operated and is effective, after the firing trigger is operated, the firing trigger is operated to drive the firing insurance mechanism to be ineffective. .

Preferably, the firing trigger is rotated along the first axis, and the firing trigger and the firing trigger are relatively fixedly rotated along the first axis of the controller.

Preferably, when the firing trigger is operated, the firing trigger is operated by the first phase of rotation of the first axis of the controller, and the firing trigger is further operated to rotate along the second axis of the firing trigger. At this stage, the firing insurance fails, and the firing is released. After the trigger and the firing trigger are fired for the second time, in the second phase of the firing of the trigger along the first axis of the controller, the operating firing trigger and the firing trigger are relatively fixedly rotated along the first axis of the controller, The actuator is then driven by the firing trigger to complete the action. .

Preferably, when the firing safety mechanism is not operated and is effective, after the firing trigger is actuated and gripped, the firing trigger is operated to drive the firing insurance mechanism to fail.

Preferably, the firing trigger will automatically reset when the firing trigger is actuated and then the firing trigger is released.

Preferably, the firing safety mechanism is effective, and after the firing trigger is actuated, whether or not the firing trigger is actuated, the firing trigger is operated to defeat the firing insurance mechanism.

Preferably, after the firing trigger is actuated and then the firing trigger is released, the firing trigger remains in place, ie, cannot be automatically reset.

Preferably, the actuator is capable of performing a first action and a second action.

Preferably, when the firing safety mechanism is not in operation, the firing trigger triggers the actuator to always perform the first action.

Preferably, when the firing safety mechanism is effective, the actuator performs the first action when the firing trigger is first operated, and when the firing trigger is operated again, the actuator remains as it is, that is, no action is performed.

Preferably, when the firing safety mechanism is effective, the actuator performs the first action when the firing trigger is first operated, and the firing angle of the firing trigger along the first axis is completely before the failure of the firing safety mechanism or before the first action of the actuator is reset. That is, the trigger cannot be operated again or the trigger can not be fully operated again.

Preferably, the actuator comprises a cartridge assembly, an anvil assembly and a drive assembly; the cartridge assembly and the anvil assembly can be in an open state and a closed state, the staple cartridge assembly and the anvil assembly being in an open state in an initial state State; the drive assembly is moveable from a proximal end of the cartridge assembly to a distal end of the cartridge assembly.

Preferably, the first action performed by the actuator is that the cartridge assembly and the anvil assembly of the actuator transition from an open state to a closed state.

Preferably, the first action performed by the actuator comprises transitioning the cartridge assembly and the anvil assembly from an open state to a closed state and then from a closed state to an open state.

Preferably, when the firing safety mechanism fails, the actuator performs a second action when the firing trigger is operated.

Preferably, the second action performed by the actuator is that the actuator assembly of the actuator moves from the proximal end of the cartridge assembly of the actuator to its distal end.

Preferably, the cartridge assembly of the actuator comprises a staple cartridge and a staple, the staple being mounted in a staple cartridge, the staple The anvil assembly includes a staple slot; when the actuator performs the second action, the actuator assembly of the actuator directly or indirectly pushes the staple from the cartridge assembly and drives the staple into the staple groove of the anvil assembly.

Preferably, the drive assembly of the actuator comprises a cutting knife, and when the actuator performs the second action, the cutting knife cuts tissue clamped by the cartridge assembly and the anvil assembly of the actuator.

Preferably, the controller includes a manual reset mechanism, and after the actuator performs the first action or the second action, operating the manual reset mechanism will drive the cartridge assembly and the anvil assembly of the actuator from the closed state to the open state.

Preferably, the controller includes an automatic reset mechanism that, after operating the firing trigger to drive the cartridge assembly and the anvil assembly of the actuator from the open state to the closed state, releases the firing without operating the firing trigger Upon triggering, the automatic reset mechanism will automatically drive the cartridge assembly and anvil assembly of the actuator from a closed state to an open state.

Preferably, after the firing trigger triggers the cartridge assembly and the anvil assembly of the actuator to change from the open state to the closed state, the automatic reset mechanism remains intact when the firing trigger is operated and then the firing trigger is released. That is, the cartridge assembly and the anvil assembly of the actuator cannot be automatically driven from a closed state to an open state.

Compared with the prior art, the present invention has the advantages of:

1. The surgical instrument has a safe one-handed firing safety mechanism: when the firing trigger is operated to a specific position, the firing safety mechanism can be opened by operating the firing safety trigger, and the instrument enters a ready state for the next operation phase, and The doctor's action of firing the trigger and the safety trigger is performed by the same hand, freeing the doctor's other hand; and when the firing trigger is not operated or the firing trigger is not moved to a specific position, the firing cannot be turned on even if the firing trigger is operated. Insurance institutions, to the greatest extent possible, reduce the risk of mishandling of the device. This unique insurance mechanism of surgical instruments not only allows doctors to operate the instruments with one hand, but also simplifies the operation of the instruments, shortens the operation time, reduces the risk of accidents during the operation, and effectively ensures the ability to avoid misoperation of the instruments.

2. In the present invention, the second shaft is located in front of the distal end of the first shaft and above the first shaft, and the firing trigger and the firing safety trigger are rotated in the same direction after being operated, so that the safety trigger is located directly in front of the distal end of the firing trigger. So that the doctor can use the same index finger and simultaneously operate the safety trigger and the firing trigger.

3. The invention only needs one index finger operation in the process of performing repeated clamping and pressing, opening the firing trigger, preparing for firing, and firing, and realizes the purpose of one-hand operation, and realizes the operation of one-handed index finger. purpose.

DRAWINGS

Other features, objects, and advantages of the present invention will become apparent from the Detailed Description of Description

1 is a schematic structural view of a surgical instrument with an improved safety device that can be operated by one hand according to an embodiment of the present invention;

2 and 3 are schematic views showing an exploded structure of the surgical instrument shown in Fig. 1;

Figure 4 is a schematic view showing the structure of the surgical instrument shown in Figure 1 in an initial state;

Figure 5 is a schematic view showing the structure of the controller of the surgical instrument shown in Figure 1 after operating the firing trigger;

Figure 6 is a cross-sectional structural view of the controller shown in Figure 5 at A-A;

Figure 7 is a rear perspective view showing the state of the controller shown in Figure 5;

8 , FIG. 15( a ), FIG. 15( b ), and FIG. 16 together illustrate a structure in which the controller of the surgical instrument illustrated in FIG. 1 is disengaged from the moment when the safety trigger assembly is disengaged when the safety trigger is operated after the trigger is operated. Figure 16 is an enlarged view of a portion D of Figure 15;

Figure 9 is a rear perspective view showing the state of the controller shown in Figure 8;

10, FIG. 17(a), FIG. 17(b), and FIG. 18 are a schematic view showing the structure of the controller of the surgical instrument shown in FIG. 1 when the automatic reset mechanism fails after the trigger is operated after the trigger trigger is operated; Figure 18 is an enlarged view of a portion G of Figure 17;

Figure 11 is a rear perspective view showing the state of the controller shown in Figure 10;

12 is a schematic structural view of the controller of the surgical instrument shown in FIG. 1 when the safety trigger is operated but the firing trigger is not operated;

Figure 13 is a rear perspective view showing the state of the controller shown in Figure 12;

Figure 14 is a schematic view showing the structure of the controller of the surgical instrument shown in Figure 1 during manual reset after firing.

A1 denotes a central axis of the rotating shaft 1011 on the first fixed handle 101, and the firing trigger 111 can rotate along the axis;

A2 represents the central axis of the pin 1111 on the firing trigger 111 along which the firing safety trigger 116 can be rotated.

detailed description

The invention will now be described in detail in connection with specific embodiments. The following examples are intended to further understand the invention, but are not intended to limit the invention in any way. It should be noted that a number of variations and modifications may be made by those skilled in the art without departing from the inventive concept. These are all within the scope of protection of the present invention.

The invention is applied to a controller of a surgical instrument, and uses an innovative structural design scheme to operate the firing trigger and the firing trigger of the instrument through the same hand, and to ensure the safety of the firing insurance mechanism.

1 to 18 illustrate a surgical device with an improved safety device that can be operated by one hand according to an embodiment of the present invention. Schematic diagram of the machine.

Specifically, in the present embodiment, referring to FIG. 1 to FIG. 3, the surgical device capable of one-hand operation of the safety device includes a controller 100, an intermediate connector 200, and an actuator 300, wherein the controller 100 and the intermediate connector 200. The actuators 300 are sequentially connected. The actuator 300 includes a cartridge assembly 3002, an anvil assembly 3001, and a drive assembly 3003.

In the present embodiment, referring to FIGS. 1-6, the controller 100 includes a first fixed handle 101, a second fixed handle 102, a firing trigger 111, a rack 105, an automatic reset mechanism, and a firing insurance mechanism.

The first fixed handle 101 and the second fixed handle 102 are connected by welding or other secure means into an integral controller housing to form the inner cavity of the controller 100. The firing trigger 111 is movably mounted on the rotation axis A1 of the inner cavity of the controller 100. In the present embodiment, the spindle hole 1112 of the firing trigger 111 is concentrically mounted with the trigger return spring 112 on the rotating shaft 1011 of the first fixed handle 101, and the trigger return spring 112 always maintains the firing trigger 111 in a resilient tendency to return to the initial position. The extraction tooth 113 is rotatably coupled to the firing trigger 111 by the extraction pin 114. The extraction spring 115 is concentric with the extraction pin 114 and always maintains the firing tooth 1131 of the extraction tooth 113 toward the elastic tendency of the rack 105.

A rack (or toothed drive assembly) 105 is movably mounted in a longitudinal rail formed by the first fixed handle 101 and the second fixed handle 102. In the present embodiment, the rack 105 includes a first set of teeth 1051 and a second set of teeth 1052, wherein the first set of teeth 1051 is detachably engaged with the firing teeth 1131 of the extracted teeth 113, and the second set of teeth 1052 is automatically reset. The mechanism is detachably engaged. When the firing trigger 111 is operated, the rotational movement of the firing trigger 111 is transmitted to the rack 105 by the engagement of the firing teeth 1131 of the extraction teeth 113 with the first set of teeth 1051 of the rack 105, driving the rack 105 to move distally in the longitudinal direction. The first set of teeth 1051 and the second set of teeth 1052 can be teeth at different locations on one rack.

Typically, the controller 100 also includes a rack reset mechanism for returning the rack 105 after completion of the instrument function to the initial position. In this embodiment, as shown in FIG. 2 , the rack reset mechanism includes a first reset cap 103 , a second reset cap 104 , a tooth release trip piece 106 , a first positioning pin 107 , and a second positioning pin 108 . The reset pin 109 and the rack return spring 110. The tooth releasing trip piece 106 has two pin slots extending at an angle to the longitudinal direction. The first positioning pin 107 and the second positioning pin 108 pass through the two pin slots to move the tooth releasing trip piece 106. Attached to the rack 105, the lower end surface 1061 of the tooth take-off tab 106 will produce a downward movement as the tooth releasing tab 106 moves longitudinally proximally. When the rack 105 is not in the initial position, the operator pulls the first reset cap 103 and the second reset cap 104 to the proximal end, and firstly drives the tooth lift tripping piece 106 to move proximally and proximally through the reset pin 109. The lower end surface 1061 of the cleat 106 moves downward to drive the firing tooth 1131 of the extraction tooth 113 to disengage from the rack 105. When the first reset cap 103 and the second reset cap 104 are continuously pulled, the reset pin 109 continues to retreat until the rack is retracted. 105 rigid contact, then drive The racks 105 move together proximally until the initial position is restored.

In the present embodiment, referring to FIGS. 2 and 4, the automatic reset mechanism includes an automatic reset slider 120 and an automatic return spring 121. The automatic reset slider 120 is provided with a reset tooth 1201, two symmetrical first slide pins 1202, a second slide pin 1203, and a dislocation boss 1204. The reset tooth 1201 of the automatic reset slider 120 is detachably engaged with the second set of teeth 1052 of the rack 105, and the first slide pin 1202 and the second slide pin 1203 are movably mounted by the first fixed handle 101 and the second fixed The handle 102 is formed in a longitudinal rail. The one end of the automatic return spring 121 is fixed to the fixing pin 1012 of the first fixed handle 101, and the other end is connected to the automatic reset slider 120, so that the automatic reset slider 120 always maintains the elastic tendency of returning to the initial position.

In the present embodiment, referring to FIGS. 2 and 4, the firing safety mechanism includes a safety trigger 116, a safety trigger return spring 117, a safety rotating block 118, and a safety rotating block return spring 119. The safety trigger 116 is rotatably secured to the firing trigger 111, which always maintains the safety trigger 116 in a resilient tendency to return to the initial position. The safety rotary block 118 is rotatably fixed to the first fixed handle 101, and the safety rotary block return spring 119 always keeps the safety rotary block 118 in a resilient tendency to return to the initial position.

In the present embodiment, referring to FIGS. 1 and 3, the intermediate connector 200 is coupled to the distal end of the controller 100. The intermediate connecting body 200 includes: a first rotating joint 201, a second rotating joint 202, a gun casing 203, a barrel 204, a nail casing 205, a first nail inner tube 206, and a second nail inner tube 207. , transmission rod 208 and other components. The first rotary joint 201 and the second rotary joint 202 are integrally connected by welding or other safety means. The integral proximal end is connected to the distal end of the controller 100, and the distal end is fixedly coupled with the barrel 204. A gun sleeve 203 having a smooth and rustproof function is mounted on the outside of the tube 204, and the axis of the barrel 204 constitutes the longitudinal direction as described in this embodiment. The distal end of the barrel 204 is detachably coupled to the second inner tube 207, and at the same time, in order to avoid the surgical risk of the second inner tube 207 being detached from the distal end of the barrel 204 during surgery, The distal end of the barrel 204 is designed with a detachment prevention mechanism including a load limiting piece 209, a rotation stop block 210 and a loading spring 211. When the second magazine inner tube 207 is loaded at the distal end of the barrel 204, the loading limiting piece 209 prevents the second nail inner tube 207 from being detached from the barrel 204 by the biasing force exerted by the loading spring 211. Unless the load limiter 209 is manually removed from the home position.

After the first nail inner tube 206 and the second nail inner tube 207 are held together, the two nails are connected together by the nail sleeve 205, and the first nail inner tube 206 and the second nail inner tube 207 are combined. The axis of the lumen is coaxial with the longitudinal direction. The transmission rod 208 is disposed in the inner cavity formed by the barrel 204 and the first inner tube 206 and the second inner tube 207, and is reciprocally movable in the longitudinal direction. The proximal end of the drive rod 208 is coupled to the rack 105 and the distal end is coupled to the proximal end of the drive assembly 3003 of the actuator 300 for transmitting longitudinal motion of the rack 105 to the drive assembly 3003.

The actuator 300 can be designed as a plurality of application examples, and the embodiment cites a Chinese invention patent application. CN201210349356.7 The described surgical stapler actuator, as shown in Figures 1 and 3, the actuator 300 is primarily comprised of an anvil assembly 3001, a cartridge assembly 3002, and a drive assembly 3003. The anvil assembly 3001 is mainly formed by a back cover 301, a nail anvil 302 and a nail anvil 303. The lower surface of the anvil assembly 3001 is a staple molding surface. The cartridge assembly 3002 generally includes a staple cartridge 304, a plurality of staples 305, a plurality of pusher blocks 306, a staple cartridge holder 307, and a pusher slider 308. The upper surface of the staple cartridge 304 is a tissue contacting surface with a guide groove in the middle and is mounted in the cartridge holder 307. The anvil return spring 309 is mounted at the distal end of the intermediate connector 200, always maintaining the anvil assembly 3001 and the cartridge assembly 3002 in an elastic tendency to open. The driving assembly 3003 is disposed in the inner cavity formed by the guiding groove of the staple cartridge 304 and the first inner tube 206 and the second inner tube 207, and is reciprocally movable in the longitudinal direction. The distal end of the drive assembly 3003 further includes an upper beam 3101, a lower beam 3102, and a cutting edge 3103. When the drive assembly 3003 is moved distally, the upper beam 3101 and the lower beam 3102 of the drive assembly 3003 will drive the anvil assembly 3001 and the cartridge assembly 3002 from the open state to the closed state, thereby driving the pusher slider 308, pushing The staple block 306 creates motion that pushes the staple 305 from the staple cartridge 304 toward the staple forming surface of the anvil assembly 3001 and is shaped like a B-shape therein. During the driving of the staple forming process, the cutting edge 3103 of the driving assembly 3003 cuts the already stitched tissue to complete the stitching and cutting function of the instrument.

Referring to FIG. 1 and FIG. 4, when the controller of the surgical instrument according to the embodiment is in an initial state, the second set of teeth 1052 of the rack 105 is in mesh with the reset tooth 1201 of the automatic reset slider 120 of the automatic reset mechanism.

Referring to FIGS. 5-7, when the firing trigger 111 is operated, the firing trigger 111 drives the rack 105 through the pulling teeth 113, and the transmission rod 208 moves longitudinally to the distal end, thereby driving the driving assembly 3003 to move distally; the driving assembly 3003 is directed to Movement of the distal end drives the anvil assembly 3001 and the cartridge assembly 3002 from an open state to a closed state.

During the operation of firing the trigger 111, the second set of teeth 1052 of the rack 105 drives the automatic reset slider 120 to move distally by the engagement with the reset teeth 1201 of the automatic reset slider 120, at which time the automatic return spring 121 is pulled. Long and accumulate elastic energy.

In the event that the firing trigger 116 is not operated, the second set of teeth 1052 of the rack 105 remains in mesh with the reset teeth 1201 of the automatic reset slider 120. When the firing trigger 111 is released, the firing trigger 111 is driven back to the initial position by the trigger return spring 112, and the teeth 113 are disengaged from the first set of teeth 1051 of the rack 105. The rack 105, the transmission rod 208 and the drive assembly 3003 The proximal returning tension is generated only by the frictional resistance and the elastic return spring 121 accumulating the elastic energy in the longitudinal direction. When the return tension of the automatic return spring 121 is greater than the rack 105, the transmission rod 208 and the drive assembly 3003 are only subjected to frictional resistance in the longitudinal direction, the above-mentioned components including the drive assembly 3003 will move proximally until returning to the original position; The 3003 reverting to the proximal end of the motion causes the anvil assembly 3001 and the cartridge assembly 3002 to return to the open state from the closed state.

In the case where the firing trigger 116 is not operated, referring to Figures 5-7, the movement of the rack 105 distally is due to The movable reset slider 120 is obstructed by the first limiting boss 1014 of the first fixed handle 101 and the second limiting boss 1024 of the second fixed handle 102. When the trigger 111 is operated, only one full firing stroke can be fired. For a part of the stroke, the rack 105 can only travel a distance L1. At this time, referring to Fig. 16, the upper beam 3101 of the tool holder 310 is moved distally along the inclined curved surface of the inner rail at the proximal end of the nail anvil 302 until it approaches the inclined curved end point 3021.

At this time, when the firing trigger 116 is operated, the firing safety mechanism will be opened. At the moment of operating the firing trigger 116, referring to FIGS. 5, 8, and 9, the firing trigger 116 is rotated along the pin 1111 on the firing trigger 111. The first drive boss 1161 of the firing trigger 116 drives the safety rotary block 118 to perform a corresponding rotational movement along the half shaft 1013 of the first fixed handle 101. The rotation of the safety rotary block 118 causes the second drive boss of the safety rotary block 118. 1182 pushes the dislocation boss 1204 of the automatic reset slider 120 to drive the distal end of the automatic reset slider 120 to rotate along its symmetrical first sliding pin 1202 and the second sliding pin 1203, so that the reset tooth 1201 of the automatic reset slider 120 is The second set of teeth 1052 of the rack 105 are separated from the engaged state.

At this time, referring to FIG. 10 and FIG. 11, the elastic energy accumulated by the automatic return spring 121 pulls the automatic reset slider 120 back to the original position, and the automatic reset mechanism can no longer drive the drive assembly 3003 to return to the original position, thereby failing to drive the anvil assembly. The 3001 and cartridge assembly 3002 are returned from the closed state to the open state. Since the rack 105 is no longer limited by the automatic reset slider 120, the firing trigger 111 can operate a complete firing stroke to drive the rack 105 to travel L2. At this time, referring to Fig. 18, the upper beam 3101 of the tool holder 310 travels along the inner rail of the nail anvil 302 to over the inclined curved end point 3021.

Referring to Figures 12 and 13, in the case where the firing trigger 111 is not operated, when the firing trigger 116 is operated, since the pin 1111 of the firing trigger 116 is not in the set position, the first driving boss of the safety trigger 116 is fired. 1161 can not drive the safety rotating block 118 to perform corresponding rotational movement, nor can it drive the reset tooth 1201 of the automatic reset slider 120 and the second set of teeth 1052 of the rack 105 to be separated from the meshing state, that is, the firing safety mechanism cannot be opened, and the automatic reset mechanism is enabled. Invalid.

Referring to FIG. 10, after the firing trigger 111 is operated and the firing trigger 116 is operated to open the firing safety mechanism, the firing trigger 111 and the firing trigger 116 are released, and then the firing trigger 111 is repeatedly operated to drive the driving assembly 310 to continue moving distally. The staple 305, which is mounted in the staple cartridge 304, is then molded into the staple forming surface of the anvil assembly 3001. The blade 3103 of the drive assembly 3003 cuts the already stapled tissue to complete the suturing and cutting function of the instrument.

After opening the firing safety mechanism, whether or not the instrument has been operated to complete the suturing and cutting function, or if the instrument is not further operated, when the device is required to return to the original state, referring to FIG. 14, the first reset cap 103 and the second reset are manually pulled proximally. The cap 104 drives the firing teeth 1131 of the extraction teeth 113 out of engagement with the rack 105 to drive the rack 105 Move to the proximal end until the initial position is restored. During the movement of the rack 105 to return to the initial position, the reset tooth 1201 of the automatic reset slider 120 resumes meshing with the second set of teeth 1052 of the rack 105, causing the automatic reset mechanism to return to the initial state.

The specific embodiments of the present invention have been described above. It is to be understood that the invention is not limited to the specific embodiments described above, and various modifications and changes may be made by those skilled in the art without departing from the scope of the invention.

Claims

A surgical device capable of one-hand operation, comprising an actuator, an intermediate connector and a controller, wherein the actuator, the intermediate connector and the controller are sequentially connected, and the controller comprises a firing trigger, a firing insurance mechanism, and a An axis, the firing trigger being rotatable along a first axis of the controller;

The firing insurance mechanism includes firing a safety trigger;

The firing safety trigger is rotatable along a second axis disposed on the firing trigger;

The first axis is offset from the second axis, ie, a different axis.
The surgical device of claim 1, wherein the second shaft is located forward of the distal end of the first shaft and above the first shaft; the firing trigger and the firing trigger The direction of rotation after the operation is the same.
The surgical instrument of claim 1 wherein the rack of the controller is separably engaged with a companion mechanism; the travel of the companion mechanism in the longitudinal direction is limited by the controller a blocking limit of the boss, the blocking limit such that the maximum longitudinal travel of the rack when engaged with the engaging mechanism is L1;

When the firing trigger is in the operating position, the firing trigger can be rotated along the second axis after being operated to drive the engagement mechanism to disengage from the rack, thereby causing the accompanying mechanism to avoid the blocking of the limiting boss, so that the rack The maximum longitudinal stroke when disengaged from the accompanying mechanism is L2;

Wherein, the length of L2 is greater than the length of L1, and the distal position of L2 is located at the distal end of the distal position of L1.
The surgical device of claim 3, wherein the firing trigger is outside the reach of the accompanying mechanism or the component driven by the accompanying structure, while the firing trigger is in the inoperative position. Not driven by the trigger trigger.
A surgical instrument as claimed in claim 3 wherein the firing trigger reaches the operational position when the firing trigger is rotated from the initial position along the first axis to a maximum angle at which the firing trigger is rotatable when not in operation.
The surgical instrument according to claim 3, wherein the companion mechanism is an automatic reset mechanism, and the automatic reset mechanism is detachably engaged with the rack of the controller and is meshed when engaged. The strip applies a force that drives the rack back to its original position.
A surgical instrument as claimed in claim 6 wherein the automatic reset mechanism comprises an automatic reset slider and an elastic energy storage assembly, the automatic reset slider with reset teeth and a movable mounting In the longitudinal rail of the controller housing, the resetting teeth of the automatic reset slider are detachably engaged with the rack; elastic energy storage One end of the assembly is attached to the controller housing and the other end is coupled to the auto-reset slider to provide an elastic force that urges the rack back to its original position.
A surgical instrument according to claim 3, wherein the rack is driven distally by the rotation of the firing trigger from the initial position, when the rack travels to the distal end of the stroke. At the time, the rack blocks the continued rotation of the firing trigger.
The surgical device of claim 3, wherein the rack is moved from the proximal position to the distal position of the stroke L1, and the actuator is urged to perform the first action by the intermediate connector. During the movement of the rack from the distal position of the stroke L1 to the distal position of the stroke L2, the actuator is urged to perform the second action by the intermediate connector.
A surgical instrument as claimed in claim 3, wherein said first action is:

- the cartridge assembly and the anvil assembly of the actuator are changed from an open state to a closed state; or

- the cartridge assembly and the anvil assembly of the actuator transition from an open state to a closed state and then from a closed state to an open state;

The second action is:

- The actuator assembly of the actuator pushes the staples directly or indirectly from the cartridge assembly of the actuator and drives the staples into the staple slots of the anvil assembly of the actuator.
The surgical device according to claim 7, wherein the firing safety mechanism comprises a safety rotating block, wherein the safety rotating block is rotatably mounted on the controller housing;

When the firing trigger is in the operating position, the firing trigger can be rotated along the second axis of the firing trigger, and the safety rotating block is driven by the cooperation of the first driving boss of the firing trigger and the second driving boss of the safety rotating block The rotary motion, the rotary motion of the safety rotary block drives the third drive boss of the safety rotary block to push the automatic reset slider of the automatic reset mechanism to raise, so that the automatic reset slider is disengaged from the rack and avoids the limit boss Block restrictions.
A method of operating a surgical instrument that can be operated by one hand according to any one of claims 1 to 11, characterized in that, when the firing safety mechanism is not operated and is effective, the firing trigger is operated after the firing trigger is operated. The trigger drives the firing insurance mechanism to fail.
The method of operating a surgical instrument according to claim 12, wherein the firing trigger is rotated along the first axis, and the firing trigger and the firing trigger are relatively fixed together along the first axis of the controller Rotate.
The method of operating a surgical instrument capable of single-handed operation according to claim 12, wherein when the firing trigger is operated, the firing trigger is operated by a first phase of rotation of the first axis of the controller, further operation The firing trigger pulls along the second axis of the firing trigger. At this stage, the firing insurance fails. After the firing trigger is released and the safety trigger is fired, the firing trigger is operated for the second time. In the second stage of firing the trigger along the first axis of the controller. The operation firing trigger and the firing trigger are relatively fixedly rotated along the first axis of the controller such that the actuator is driven by the firing trigger to complete the performing action.
The method of operating a surgical instrument according to claim 12, wherein the firing trigger triggers the trigger to cause the actuator to perform the first action; wherein:

- When the firing safety mechanism is effective, the actuator performs the first action when the trigger is triggered for the first time, and the actuator remains as it is when the firing trigger is operated again; and/or

- When the firing safety mechanism is active, the actuator performs the first action when the firing trigger is first operated, and the firing angle of the firing trigger along the first axis is completely completed before the firing of the safety mechanism or before the first action of the actuator is reset.
The method of operating a surgical instrument that can be operated by a single hand according to claim 12, wherein when the firing safety mechanism fails, the actuator performs a second action when the firing trigger is operated.