Surgical instrument

Abstract

A surgical instrument, comprising: an effector assembly, the effector assembly comprising a first jaw and a second jaw, which are configured to clamp and compress a tissue of a patient; a staple cartridge assembly, the staple cartridge assembly being arranged between the first jaw and the second jaw and comprising a plurality of suturing staples; a firing assembly, the firing assembly being configured to fire the plurality of suturing staples and / or cut the tissue of the patient; a driving system, the driving system comprising a driving source and a transmission mechanism, wherein the driving source is configured to provide a driving force so as to drive, by means of the transmission mechanism, the firing assembly to move to fire the plurality of suturing staples and / or cut the tissue of the patient; and a controller, the controller being configured to select, in response to a mode selection instruction input by a user, one of at least two modes to control the firing assembly to fire the plurality of suturing staples and / or cut the tissue of the patient, wherein in the at least two modes, at least one of the following is different: an initial firing speed at which the firing assembly starts firing, an adjustment range during firing of the firing assembly, a rate of change of the firing speed of the firing assembly during firing, a firing duration for the firing assembly to complete firing, and a compression prompt time for the completion of compression of the tissue of the patient. By means of the surgical instrument, the requirements of a user for operating on different tissues can be met by means of mode switching.

Description

A surgical instrument Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a surgical instrument. Background Technology

[0002] Currently, minimally invasive surgery occupies an important position in surgical procedures, and the stapler is a commonly used surgical instrument in minimally invasive surgery. The working principle of the stapler is to clamp the jaws of the distal actuator at a specific position near the lesion, cut the tissue with the cutting blade of the distal actuator, and simultaneously suture through the staple cartridge assembly of the distal actuator.

[0003] When handling tissues requiring special care, users need to control the speed of cutting and suturing to protect the tissue. Therefore, the cutting and suturing speeds vary depending on the type of tissue. Some existing staplers use intelligent control to adapt to different tissues; however, the speed of intelligent control in a single mode cannot meet all situations. For example, different users may have different desired speeds when handling the same tissue, or the same user may have different desired speeds when handling different tissues. Other existing staplers with mode switching control the firing process based on the firing mode after initial firing. For example, they might first fire a short distance, and based on the firing time of this short distance, determine the tissue thickness or type, and then allow the user to select a different firing mode based on the determination. This approach does not adequately provide comprehensive and consistent tissue protection throughout the entire process. Summary of the Invention

[0004] To address one or more of the aforementioned technical problems, this application provides a surgical instrument, including...

[0005] An actuator assembly, the actuator assembly including a first jaw and a second jaw for gripping and squeezing patient tissue;

[0006] A staple cartridge assembly disposed between a first jaw and a second jaw, the staple cartridge assembly including a plurality of suture staples;

[0007] A firing assembly for firing the plurality of suture staples and / or cutting the patient tissue;

[0008] A drive system, comprising a drive source and a transmission mechanism; the drive source provides driving force to drive the firing assembly to move via the transmission mechanism to fire the plurality of suture staples and / or cut the patient tissue;

[0009] A controller, configured to respond to a user-inputted mode selection command, selects one of at least two modes to control the firing assembly to fire the plurality of suture staples and / or cut the patient tissue, wherein the at least two modes are:

[0010] The firing assembly initiates an initial firing velocity at which it fires the suture staple and / or cuts the patient tissue.

[0011] The firing speed adjustment range of the firing assembly during the firing of the suture staples and / or cutting of the patient tissue.

[0012] The rate of change of firing speed of the firing assembly during the firing of the suture and / or cutting of the patient tissue.

[0013] The firing assembly completes the firing time for firing the suture and / or cutting the patient tissue.

[0014] The time when the patient tissue compression is completed.

[0015] At least one of them is different.

[0016] This application also provides a surgical instrument, comprising:

[0017] An actuator assembly, the actuator assembly including a first jaw and a second jaw for gripping and squeezing patient tissue;

[0018] A staple cartridge assembly disposed between a first jaw and a second jaw, the staple cartridge assembly including a plurality of suture staples;

[0019] A firing assembly for firing the plurality of suture staples and / or cutting the patient tissue;

[0020] A drive system, comprising a drive source and a transmission mechanism; the drive source provides driving force to drive the firing assembly to move via the transmission mechanism to fire the plurality of suture staples and / or cut the patient tissue;

[0021] Physical buttons, which are used to obtain a mode selection command by receiving a one-step operation from the user;

[0022] A controller, electrically connected to the physical button, is used to respond to the mode selection command and select one of at least two modes to control the firing assembly to fire the plurality of suture staples and / or cut the patient tissue.

[0023] This application also provides a surgical instrument, comprising:

[0024] An actuator assembly, the actuator assembly including a first jaw and a second jaw for gripping and squeezing patient tissue;

[0025] A staple cartridge assembly disposed between a first jaw and a second jaw, the staple cartridge assembly including a plurality of suture staples;

[0026] A firing assembly for firing the plurality of suture staples and / or cutting the patient tissue;

[0027] A drive system, comprising a drive source and a transmission mechanism; the drive source provides driving force to drive the firing assembly to move via the transmission mechanism to fire the plurality of suture staples and / or cut the patient tissue;

[0028] A controller, configured to respond to a user-inputted mode selection command, select one of at least two modes to control the firing assembly to fire the plurality of suture staples and / or cut the patient tissue;

[0029] The controller is also configured to:

[0030] The mode selection command input by the user is only responded to before the firing assembly is activated to fire the plurality of sutures and / or cut the patient tissue; the mode selection command input by the user is not responded to during the firing assembly firing the plurality of sutures.

[0031] And / or, during the process of the actuator component squeezing the patient tissue, it does not respond to the mode selection instruction input by the user, or responds to the mode selection instruction input by the user but does not modify the squeezing prompt time for the end of squeezing of the patient tissue in the current mode.

[0032] This application also provides a surgical instrument, comprising:

[0033] An actuator assembly, the actuator assembly including a first jaw and a second jaw for gripping and squeezing patient tissue;

[0034] A staple cartridge assembly disposed between a first jaw and a second jaw, the staple cartridge assembly including a plurality of suture staples;

[0035] A firing assembly for firing the plurality of suture staples and / or cutting the patient tissue;

[0036] A drive system, comprising a drive source and a transmission mechanism; the drive source provides driving force to drive the firing assembly to move via the transmission mechanism to fire the plurality of suture staples and / or cut the patient tissue;

[0037] A controller, configured to respond to a user-inputted mode selection command, select one of at least two modes to control the firing assembly to fire the plurality of suture staples and / or cut the patient tissue;

[0038] The controller is further configured to switch to a default mode after determining that the firing component has completed the firing process, the default mode being one of the at least two modes.

[0039] The surgical instruments according to the above embodiments can select different modes for different needs, or facilitate users to switch modes to better cope with various situations. Attached Figure Description

[0040] Figure 1 is a schematic diagram of the structure of a surgical instrument according to an embodiment;

[0041] Figure 2 is a schematic diagram of the structure of an actuator assembly according to an embodiment;

[0042] Figure 3 is a schematic diagram of the staple cartridge assembly according to one embodiment;

[0043] Figure 4 is a schematic diagram of the staple cartridge assembly according to one embodiment;

[0044] 100. Transmission mechanism;

[0045] 200, Actuator assembly; 210, First jaw; 220, Second jaw;

[0046] 300. Stamp cartridge assembly; 310. Mounting bracket;

[0047] 312. Tissue mating surface; 313. Movable cavity; 314. Supporting part; 315. Limiting part;

[0048] 320. Firing assembly; 330. Cutting blade;

[0049] 400. Handle assembly; 410. Fixed handle; 420. Movable trigger;

[0050] 500. Barrel assembly; 600. Physical buttons. Detailed Implementation

[0051] The present invention will now be described in further detail with reference to specific embodiments and accompanying drawings. Similar elements in different embodiments are referred to by associated similar element reference numerals. In the following embodiments, many details are described to facilitate a better understanding of this application. However, those skilled in the art will readily recognize that some features may be omitted in different situations, or may be replaced by other elements, materials, or methods. In some cases, certain operations related to this application are not shown or described in the specification. This is to avoid obscuring the core parts of this application with excessive description. For those skilled in the art, detailed description of these related operations is not necessary; they can fully understand the related operations based on the description in the specification and general technical knowledge in the art.

[0052] Furthermore, the features, operations, or characteristics described in the specification can be combined in any suitable manner to form various embodiments. At the same time, the steps or actions in the method description can be rearranged or adjusted in a manner obvious to those skilled in the art. Therefore, the various orders in the specification and drawings are only for the clear description of a particular embodiment and do not imply a necessary order, unless otherwise stated that a particular order must be followed.

[0053] The serial numbers assigned to components in this document, such as "first" and "second," are used only to distinguish the described objects and have no sequential or technical meaning. The terms "connection" and "linkage" used in this application, unless otherwise specified, include both direct and indirect connections (linkages).

[0054] In this application, "distal" refers to the end furthest from the operator when operating a surgical instrument, and "proximal" refers to the end closest to the operator when operating a surgical instrument. In this application, "axial" refers to the direction of the line connecting the center of the distal end and the center of the proximal end, and "radial" refers to the direction perpendicular to the axial direction.

[0055] The inventors discovered that when using a stapler to cut / suture tissue, the operation needs to be adjusted according to the tissue type. For example, when dealing with thick tissue, compression is required before firing to prevent tissue damage. Similarly, when dealing with tissues requiring special care, such as the pancreas, cirrhotic liver, or lung lobes, which are typically brittle or hard, the user needs to adjust the speed of the jaw closure process or the firing speed of the firing component to avoid tissue damage during closure and firing. Under the same conditions, single-mode intelligent control can only achieve one speed. Different users using the same instrument to treat the same type of tissue may arrive at different conclusions about the speed, such as whether it is appropriate, too fast, or too slow. Even the same user may find the speed appropriate for some tissues but too fast / too slow for others. Existing staplers with multiple modes switch modes after firing, resulting in insufficient control over firing. For example, when dealing with tissues requiring special care, the jaw pressure at the start of firing may be greater than the pressure used for compressing the tissue, leading to tissue damage during firing. Furthermore, the limited number of parameters controlling the entire firing process fails to effectively protect the tissue. While machines automatically determine tissue thickness or type, their assessment doesn't necessarily guarantee the optimal firing speed. For instance, in the case of a cirrhotic liver, the machine might classify the tissue as thin, potentially leading to a faster firing speed with the default intelligent firing strategy. However, for such specific tissue, a slower firing speed might be necessary. This application addresses these issues by offering at least two user-selectable modes, allowing for adjustments to various aspects such as the initial firing speed of the suture staples from the firing components, the range of firing speed adjustments during firing, firing duration, the rate of speed change during firing, and the pre-firing compression prompt time. This allows for better adaptation to clinical needs.

[0056] Please refer to the embodiments shown in Figures 1 to 4, which provide a surgical instrument including a transmission mechanism 100, an actuator assembly 200, a stapler cartridge assembly 300, a drive source, and a controller (the drive source and controller are not shown in the figures). For example, the surgical instrument may be a stapler.

[0057] In some embodiments, the device may further include a handle assembly 400 and a barrel assembly 500. The handle assembly 400 includes a fixed handle 410 and at least one movable trigger 420 for gripping and operation by an operator. The proximal end of the barrel assembly 100 is connected to the handle assembly 400, and the distal end of the barrel assembly 500 is connected to the actuator assembly 200. The barrel assembly 500 includes a closing drive chain and a firing drive chain. When operating the surgical instrument, the operator can grip the fixed handle 410 and insert the actuator assembly 200 into the lesion site within the body through the elongated barrel assembly 500. The closing drive chain is then triggered by the movable trigger 420 to close the jaws of the actuator assembly 200 and clamp it near the lesion site. The firing drive chain is then triggered by the firing button (not shown) to cause the cutting blade 330 within the actuator assembly 200 to cut the tissue, and simultaneously suture the tissue using the staples in the staple cartridge assembly 300.

[0058] In some embodiments, the surgical instrument may not include the handle assembly 400. In this case, the proximal end of the barrel assembly 500 may be connected to other components such as the robotic arm or robotic hand of the surgical robot, so that the actuator assembly 200 can be inserted into the lesion site in the human body through the barrel assembly 500, and then the jaw closure and tissue cutting and suturing can be completed through the mechanical / electric triggering closure transmission chain and the firing transmission chain.

[0059] In some embodiments, the firing drive chain includes a drive mechanism 100, which is used to fire the stitching staples under the action of a drive source, and / or to cut the cutting blade 330.

[0060] The actuator assembly 200 includes a first jaw 210 and a second jaw 220 for gripping tissue. The first jaw 210 and the second jaw 220 are movably connected and can move relative to each other to achieve closing and opening. A mounting cavity is formed between the first jaw 210 and the second jaw 220, and the staple cartridge assembly 300 is disposed in the mounting cavity. The distal end of the transmission mechanism 100 extends into the mounting cavity. When the first jaw 210 and the second jaw 220 are closed to a certain position, and no further closing / opening or only a very small range of closing / opening occurs, this is considered as the closure being completed and the squeezing process beginning. The squeezing process involves the first jaw 210 and the second jaw 220 applying a certain force to the tissue to compress it. During the closing process, the jaws also apply a certain force to the tissue. In this application, the squeezing stage after the closure is completed is mainly referred to as squeezing.

[0061] In some embodiments, the tissue gradually deforms over time under the squeezing force of the clamps until it reaches equilibrium, which is the tissue creep characteristic. When the external force is removed, the tissue tends to return to its original state, so the longer the squeezing time, the lower the internal stress of the tissue and the greater the deformation of the tissue.

[0062] Referring to Figures 3 and 4, the staple cartridge assembly 300 includes a mounting base 310 and a firing assembly; the firing assembly 320 includes a staple pusher slider 320 and a cutting blade 330. The mounting base 310 has multiple mounting positions for mounting staples and a tissue-contacting surface 312 for contacting tissue. The staple pusher slider 320 is movably mounted on the mounting base 310, and the cutting blade 330 is movably connected to the mounting base 310. The staple pusher slider 320 and the cutting blade 330 are movable between the proximal and distal ends of the mounting base 310. The transmission mechanism 100 can drive the staple pusher slider 320 and the cutting blade 330 to move between the proximal and distal ends of the mounting base 310. It should be noted that the tissue-contacting surface 312 of the mounting base 310 refers to the side of the mounting base 310 that contacts the tissue being clamped when holding the tissue. Understandably, during tissue suturing, the suture staples are pushed out from the tissue-joining surface 312 of the mounting base 310 to achieve tissue suturing. The pushing out of the suture staples is equivalent to being fired by the staple pusher slider 320. In some embodiments, the staple cartridge assembly 300 is a replaceable disposable unit, and the staple pusher slider 320 and the cutting blade 330 are structural components within the staple cartridge assembly 300, serving as disposable units. In other embodiments, the cutting blade 330, or the staple pusher slider 320 and the cutting blade 330, are disposed together within the actuator assembly and are not replaced with the staple cartridge assembly 300, serving as non-disposable units.

[0063] In some embodiments, the mounting base 310 has a movable cavity 313 disposed along its axial direction, within which the pusher slider 320 and the cutter 330 are movably disposed. The movable cavity 313 defines the direction of movement of the pusher slider 320 and the cutter 330, thereby ensuring that the pusher slider 320 and the cutter 330 can move between the proximal and distal ends of the mounting base 310 along its axial direction.

[0064] In some embodiments, the mounting base 310 has a support portion 314 located on the side of the movable cavity 313 opposite to the mounting position, for supporting the pusher slider 320 and the cutter 330. The support portion 314 prevents the pusher slider 320 and the cutter 330 from disengaging from the side of the mounting base 310 opposite to the mounting position from the movable cavity 313.

[0065] In some embodiments, the proximal end of the mounting base 310 has a limiting portion 315, which prevents the pusher slider 320 and the cutter 330 from disengaging from the proximal end of the mounting base 310 into the movable cavity 313. The limiting portion 315 prevents the pusher slider 320 and the cutter 330 from disengaging from the proximal end of the mounting base 310 into the movable cavity 313.

[0066] In some embodiments, the staple cartridge assembly 300 can be considered as part of the actuator assembly 200. For example, the staple cartridge assembly 300 can be fixedly connected to the first jaw 210 or the second jaw 220 or form an integral structure. The staple cartridge assembly 300 can also be considered as a component independent of the actuator assembly 200. For example, the staple cartridge assembly 300 can be detachably mounted to the first jaw 210 or the second jaw 220, thereby allowing the staple cartridge assembly 300 to be considered as a consumable used in the actuator assembly 200.

[0067] The drive source can drive the pusher slider 320 and the cutter 330 to move via the transmission mechanism 100. Specifically, the drive source can apply a force in the axial direction of the transmission mechanism 100 to move the transmission mechanism 100 distally, causing the transmission mechanism 100 to push the pusher slider 320 and the cutter 330 to move. During movement, the pusher slider 320 fires one or more suture staples to suture the tissue, and the cutter 330 cuts the tissue during movement. It can be understood that when the drive source drives the transmission mechanism 100 with different drive parameters, the speed of the transmission mechanism 100 will be different, thus causing the moving speed of the pusher slider 320 and the firing speed of the suture staples to differ. In some embodiments, the drive source is a motor, and the speed of the transmission mechanism 100 can be controlled by setting parameters such as the motor's current and speed.

[0068] In some embodiments, a start position and an end position can be defined during the travel of the firing assembly from proximal to distal end, and the period between the start and end positions is defined as the firing process. The speed at which the firing assembly moves from the start position to the end position characterizes the firing speed. In some embodiments, the start position refers to the position where the firing assembly begins firing the suture staples during its movement, and the end position refers to the position where the firing assembly is located when the tissue suturing is complete. In other embodiments, the position where the firing assembly has fired some or all of the suture staples in the mounting base 310 is defined as the end position. In still other embodiments, the end position is defined by distance, with a preset distance between the end position and the start position. It is understood that the faster the firing assembly moves from the start position to the end position, the faster the firing process ends, the faster the overall firing speed, and the faster the tissue suturing speed. Conversely, the slower the firing assembly moves from the start position to the end position, the slower the firing process ends, the slower the overall firing speed, and the slower the tissue suturing speed. The most crucial concept in this embodiment lies in how to control the movement speed of the firing component from the starting position to the ending position. This can be understood as equivalent to how to control the firing speed of the suture staple, or how to control the driving parameters of the drive source, or how to control the suturing speed of the tissue.

[0069] In some embodiments, sensors or timers may be installed on certain components of the surgical instrument, enabling the controller to adjust the firing speed of the firing assembly in firing the suture and / or cutting the patient tissue, and the firing time of the firing assembly in intelligent control, based on at least one of the following parameters: jaw closure speed / time, squeezing time, jaw clamping force, firing resistance during firing, tissue thickness, or fluidity. The controller performs intelligent control based on the same control parameters in two modes, resulting in different firing speeds or firing times. The firing speed of the firing assembly in firing the suture refers to at least one of two aspects: the initial firing speed at which the firing assembly begins firing the suture, and the process speed during which the firing assembly fires the suture. For ease of reading, these parameters are referred to as control parameters in this embodiment. Furthermore, in this embodiment, the initial firing speed refers to the initial firing speed at which the firing assembly begins firing the suture and / or cutting the patient tissue, or the speed at which the firing assembly begins to move when fired; the process firing speed refers to the process speed during which the firing assembly fires the suture and / or cuts the patient tissue. Firing time refers to the time it takes for the firing assembly to complete firing the suture staple and / or cutting the patient tissue.

[0070] The controller responds to a user-inputted mode selection command and selects one of at least two modes to control the firing of the firing assembly. The two modes differ in at least one of the following: the initial firing speed at which the firing assembly begins firing the suture and / or cutting the patient tissue; the adjustment range of the firing speed during the firing of the suture and / or cutting of the patient tissue; the rate of change of the firing speed during the firing of the suture and / or cutting of the patient tissue; the firing time for the firing assembly to complete firing the suture and / or cutting of the patient tissue; and the compression indication time for the end of compression of the patient tissue. It is understood that the controller controls the movement speed of the transmission mechanism 100 by controlling the drive source, thereby controlling the firing speed of the firing assembly. Controlling the firing assembly in at least two modes adapts to the operational needs of different tissues or different users. The differences in control between different modes can be reflected in one of the following aspects:

[0071] On the one hand, the controller controls the firing assembly to fire the staples and / or cut the patient tissue at different initial firing speeds in different modes. When processing certain tissues, compression is required before firing to reduce internal tissue stress. During compression, the jaw pressure is usually lower than the firing pressure. For example, when processing tissues requiring special care, the initial firing speed needs to be reduced to decrease jaw pressure and firing resistance. The same user may consider different initial firing speeds for different tissues. By setting different initial firing speeds in different modes, different needs can be met when processing tissues requiring special care or ordinary tissues. However, if the stapler only allows the user to select different firing modes after firing, the selected firing mode cannot affect the initial firing. An unsuitable initial firing speed can cause tissue damage at the start of firing, and subsequent mode selection will no longer be able to protect the tissue.

[0072] On the one hand, the firing speed adjustment range of the firing component during the firing of the staples and / or cutting of the patient tissue varies in different modes. When handling tissues requiring special care, the firing speed is usually lower to reduce the impact on the tissue and firing resistance, thereby preventing tissue damage. A lower firing speed also allows for better control of jaw pressure. In practice, to protect the tissue, the controller sometimes needs to adjust the firing speed to near pause during firing. Conversely, when handling ordinary tissues or thick tissues requiring thorough compression, the firing speed is usually higher. Therefore, the difference in firing speed under different conditions is significant. Using only a single mode to match different tissues results in a large step size for adjusting the speed over a wide range. By setting different firing speed adjustment ranges in different modes, the stapler can better handle different tissues, and the intelligent control within each range is more precise. For example, in one mode, the firing speed adjustment range is 10-20 mm / s, while in another mode, it is 3-8 mm / s.

[0073] On the one hand, the rate of change of the firing assembly's speed during the firing of the suture staple and / or cutting of the patient tissue varies in different modes. This rate of change can be reflected in the speed change rate control of the surgical instrument's controller, based on control parameters such as compression time, jaw clamping force, and firing resistance. For example, under the same control parameters, the controller's intelligent control in different modes adjusts the firing speed differently, making it more suitable for various situations. For instance, a larger adjustment range is used when dealing with special tissues to reduce the speed more quickly to protect the tissue, or a smaller adjustment step is used when the control adjustment range is small to achieve more precise speed control.

[0074] On one hand, the firing time for the firing assembly to fire the suture staples and / or cut the patient's tissue varies depending on the firing mode. When dealing with tissues requiring special care, the firing time is typically longer, allowing for a longer compression period to reduce internal tissue stress and firing resistance. The completion time can be estimated using the remaining firing stroke during firing; if the completion time is not within a reasonable firing time, the firing speed is adjusted. For example, in one mode, the firing time is 50 seconds, which is the setting for routine tissues; in another mode, the firing time is 2 minutes, providing a much slower firing speed for tissues requiring special care compared to routine tissues, to fully protect the tissue during firing.

[0075] On the one hand, the indication time for the end of tissue squeezing varies in different modes. In one mode, a default squeezing time, such as 15 seconds, will be indicated, while in another mode, a longer squeezing time, such as 30 seconds, will be displayed. When squeezing is complete, the user is alerted by sound and light to help them judge the degree of squeezing and thus protect the tissue. Of the above aspects, at least one aspect needs to be met based on the actual situation.

[0076] In some embodiments, at least two modes include a normal firing mode and a special firing mode. In normal firing mode, a default pressing time, such as 15 seconds, is indicated during the pressing process. In normal firing mode, the initial firing rate or the process firing rate can be a fixed value or adaptively adjusted based on a preset algorithm. Selecting the special firing mode overrides some settings from the normal firing mode, and the system operates using the control logic of the special firing mode.

[0077] In some embodiments, the initial firing speed of the firing assembly in the special firing mode when firing the suture staple and / or cutting the patient tissue is lower than that in the normal firing mode. By reducing the initial firing speed in the special firing mode, the controller reduces the clamping force of the jaws at the start of firing, allowing the special firing mode to better handle tissues requiring special care. Users can select a mode according to their needs before firing to prevent the intelligent adjustment from misjudging tissue type and generating an unreasonable initial firing speed. When the user selects the special firing mode, even if a misjudgment occurs, the relative speed is smaller, reducing the risk of misjudgment. In some embodiments, the initial firing speed of the firing assembly in the special firing mode is in the range of 4-8 mm / s, while the initial firing speed in the normal firing mode is in the range of 14-18 mm / s. It should be noted that the speed within this range can be a continuous or discrete value; that is, the speed within this range can be a continuously changing value, or one or more discrete speed values ​​can be preset within this range. For example, in normal mode, the initial firing speed is a preset value. In special firing mode, the controller adjusts the initial firing speed within the range of 4-8 mm / s based on control parameters such as closing time and squeezing time. In some embodiments, the initial firing speed of the firing assembly in special firing mode is less than a first preset speed. By controlling the initial firing speed in special firing mode to not exceed the preset value, a speed lower than this preset speed can effectively reduce firing resistance or jaw clamping force, thereby protecting tissue at the beginning of firing. The initial firing speed in normal firing mode is adjusted according to specific needs.

[0078] In some embodiments, the maximum value of the firing speed adjustment range in the special firing mode is less than the maximum or minimum value of the firing speed adjustment range in the normal firing mode. By limiting the maximum value of the process firing speed adjustment range in the special firing mode, excessive speed damage to tissue is prevented. In some embodiments, when both the maximum and minimum values ​​of the firing speed adjustment range in the special firing mode are between the maximum and minimum values ​​of the firing speed adjustment range in the normal firing mode, it is equivalent to the speed range of the special firing mode being within the speed range of the normal firing mode. In some embodiments, the minimum value of the firing speed adjustment range in the special firing mode is less than the minimum value of the firing speed adjustment range in the normal firing mode. When the maximum value of the firing speed in the special firing mode is within the range of the normal firing mode, the speed ranges of the two modes have some overlap. When the maximum value of the adjustment range in the special firing mode is less than the minimum value of the firing speed adjustment range in the normal firing mode, it is equivalent to the two modes having completely different ranges, allowing the user to quickly select the corresponding range as needed. Therefore, the speed adjustment ranges of the two modes can be set according to actual conditions, enabling the two modes to be applied to different tissues or different states of the same tissue. In some embodiments, the maximum value of the firing rate adjustment range in a special firing mode can be set to be less than a second preset speed, thus protecting tissue through the preset speed. It is understood that the process firing rate within the adjustment range can also be a discrete or continuous value.

[0079] The rate of change of firing speed of the firing assembly differs between the two modes during the firing of the suture staples and / or cutting of the patient tissue. The firing speed is not necessarily constant and can be adjusted by the controller based on control parameters. In some embodiments, the intelligent adjustment range differs between the special firing mode and the normal firing mode, or in other words, the controller adjusts the firing speed based on control parameters differently in the two modes. For example, under the same varying firing resistance, the rate of change of firing speed in the special firing mode is greater than that in the normal firing mode. That is, in the special firing mode, the firing assembly decreases in speed faster when subjected to firing resistance; this can also manifest as different values ​​of change in firing speed under the same conditions and resistance. When processing thick tissue that has not been adequately compressed, the internal stress is high, and a faster reduction in firing speed can achieve faster tissue protection. Similarly, when processing tissue requiring special care, a rapid reduction in firing speed is necessary; that is, changes in firing speed are more sensitive to changes in firing resistance. The firing resistance during the firing process is typically constantly changing. The following are examples of how the controller adjusts the firing speed of the process differently based on the control parameters in the two modes: when the pressing time is the same, the firing speed of the process is different in the two modes. When using the normal firing mode to process thick tissue after full pressing, the firing speed can usually be increased because the internal stress of the tissue is reduced after full pressing. However, when using the special firing mode to process tissue that requires special care, the firing speed is still relatively low after full pressing in order to prevent damage to the tissue.

[0080] In some embodiments, the firing time for the firing assembly to fire the suture staple and / or cut the patient tissue in the special firing mode is longer than that in the normal firing mode. When dealing with tissues requiring special care, the firing time is typically longer to provide more compression time and a slower firing speed. Making the firing time in the special firing mode longer than in the normal firing mode better suits tissues requiring special care. In some embodiments, the firing time in the special firing mode is in the range of 20-120 seconds, and the firing time in the normal firing mode is in the range of 4-12 seconds. Furthermore, an estimated firing time can be calculated during firing; if the estimated firing time is outside the range, the firing speed can be adjusted accordingly by the controller.

[0081] In some embodiments, the compression completion prompt time in the special firing mode is longer than that in the normal firing mode. Typically, the device displays the compression prompt time to remind the user whether compression is complete; for example, the preset compression prompt time is 15 seconds. However, different tissues require different compression times. For instance, when handling tissues requiring special care or thick tissues, users usually need to perform compression for a longer period. The longer compression prompt time in the special firing mode prompts the user to allow the currently treated tissue a longer compression time.

[0082] In some embodiments, the pressing reminder time can be further intelligently adjusted by controlling parameters. For example, when processing tissues requiring special care, the closure should be slow to avoid damaging the tissue, and such tissues typically require a longer pressing time. Therefore, the current level of tissue susceptibility can be determined by the closure time or clamping force, and the pressing reminder time can be further adjusted. In another example, sensors determine the current tissue thickness and fluidity. Thicker tissues typically require greater pressing force, so the tissue thickness can be determined by the pressing force, and thicker tissues often require a longer pressing time, thus adjusting the pressing reminder time based on the tissue thickness. Adjusting the pressing reminder time can occur only during the pressing process or at any time before the pressing ends.

[0083] In some embodiments, under a special firing mode, the firing assembly further includes a pause node during the firing of the suture staples and / or cutting of the patient tissue. During the pause node, information indicating that the firing assembly is firing normally is output. The controller controls the firing assembly to pause its movement based on control parameters meeting specific conditions, and outputs a prompt indicating that firing is normal during the pause node. For example, when the clamping force of the jaws or the firing resistance exceeds a certain threshold, the firing assembly is controlled to pause its movement to increase the compression time. After sufficient compression, firing continues to protect the tissue. If the user is not notified during the pause node that the instrument is still running, the user may mistakenly believe that the surgical instrument is malfunctioning or that the firing assembly is unable to cut the current tissue, leading to unnecessary operations. The prompt information clarifies to the user that no further operation is needed and that they should simply wait for the compression to complete.

[0084] In some embodiments, during the firing of the suture staples and / or cutting of the patient tissue in normal firing mode, a pause node is also included. However, the ease of triggering the pause node differs between the two modes; it is more difficult to trigger the pause node in normal firing mode compared to special firing mode. For example, a pause node may be triggered when the clamping force of the jaws or the firing resistance exceeds a larger threshold. Of course, a pause node may not be set in normal firing mode. During the pause node in the firing process, normal firing is still considered normal. To avoid the user perceiving a malfunction in the device during the pause node, a prompt message indicating that the firing component is firing normally is required.

[0085] In some embodiments, the surgical instrument also includes a mode prompting unit, such as a display screen or indicator light, to remind the user which mode is currently being used for firing.

[0086] Referring to Figures 1-4, this application also provides a surgical instrument, including a transmission mechanism 100, an actuator assembly 200, a stapler cartridge assembly 300, a drive source, and a controller. Exemplarily, the surgical instrument can be a stapler. The surgical instrument also includes a physical button 600 for receiving a mode selection command input by a user; and a controller electrically connected to the physical button 600 for responding to the mode selection command by selecting one of at least two modes to control a firing assembly to fire multiple staples.

[0087] In one embodiment, the physical button 600 is used to obtain a mode selection instruction by receiving a one-step operation from the user. A "one-step operation" means that the user only needs to perform one action to complete the mode selection.

[0088] This surgical instrument features a physical button for mode switching, offering at least the following advantages: Firstly, in terms of operational efficiency, surgical procedures typically don't require significant time or effort to control mode switching. During operation, if the initial or intermediate firing speed is too fast, or before firing just before the compression is complete, a quick mode switch is desirable. Switching modes via the display screen requires considerable effort. Therefore, placing the physical button 600 in an easily accessible location allows for one-step mode switching, improving efficiency. This one-step operation eliminates the need for the user to search for menu options or confirm actions. Furthermore, the physical button reduces the latency associated with the display screen, providing greater timeliness. Secondly, from a user experience perspective, while improving efficiency through one-step operation, the physical feedback from the button provides more intuitive and immediate feedback, allowing the surgeon to focus on observing the lesion rather than worrying about whether the switch is complete. The physical button also eliminates the need for a complex learning curve, enabling quick and intuitive mode switching. In terms of reliability, physical buttons are less susceptible to external interference and can reliably switch modes even when wearing gloves. More specifically, in surgical settings where blood or tissue fluid is present, switching modes via a display screen could lead to unresponsive touchscreens or accidental touches if the screen becomes smudged. In terms of application scenarios, physical buttons allow for mode switching even when visibility is limited, compared to a display screen.

[0089] In some embodiments, the two modes include a normal firing mode and a special firing mode; the controller is used to select one of the two modes, the normal firing mode and the special firing mode, to control the firing assembly to fire the suture staple. That is, when the physical button is pressed, only one of the two modes will be selected, rather than more modes. This means that the user can determine whether the tissue being processed is tissue that needs protection, and if so, switch to the special firing mode.

[0090] In some embodiments, the physical button 600 has multiple position states, each corresponding to a different mode among the at least two modes. Taking the normal firing mode and the special firing mode as examples, the physical button 600 has a position that can be tossed left and right; tossed to the left is the normal firing mode, and tossed to the right is the special firing mode; or, the physical button 600 has two position states: pressed and released; pressed is the special firing mode, and released is the normal firing mode. By distinguishing the position states of the physical button 600, users can easily switch between operating modes while clearly knowing the current mode type.

[0091] This application also provides a surgical instrument, including a transmission mechanism 100, an actuator assembly 200, a staple cartridge assembly 300, a drive source, and a controller. The controller is configured to respond to a user-inputted mode selection command, selecting one of at least two modes to control a firing assembly to fire multiple staples and / or cut patient tissue. In this embodiment, the controller is further configured to respond to the user-inputted mode selection command before initiating the firing assembly to fire multiple staples and / or cut patient tissue.

[0092] In some embodiments, the controller is configured to respond to user-inputted mode selection commands only before the firing assembly is initiated to fire the plurality of sutures and / or cut patient tissue; and not to respond to user-inputted mode selection commands during the firing of the plurality of sutures by the firing assembly. Users can judge, based on experience, which mode is suitable for the tissue being operated on and whether special care is required. Some control parameters obtained through surgical instruments can assist users in judging whether the tissue requires special care, but users generally want to achieve mode switching as early as possible, i.e., determining whether the tissue needs protection as early as possible from closure, pre-compression, firing start, and firing process. Furthermore, it is crucial to prevent unexpected mode switching due to misoperation after firing begins, which could cause a sudden increase in firing speed, firing resistance, or clamping force, severely damaging the tissue.

[0093] In some embodiments, during the squeezing of patient tissue by the actuator component, the user-inputted mode selection command is not responded to, thereby further protecting the tissue during the squeezing phase. Alternatively, the controller can respond to the user-inputted mode selection command but does not modify the squeezing end prompt time in the current mode. For example, if the user selects a special mode to enter the tissue squeezing period, the corresponding squeezing duration in the special mode is 30 seconds, after which a squeezing end prompt is given; in one embodiment, the user cannot change the mode during squeezing, and even if the mode selection button is triggered, the device will not respond to the mode modification command; in another embodiment, the user can change the mode during squeezing. After the user triggers the mode selection button, the special mode is changed to the normal mode, and the subsequent firing process will be carried out using the firing strategy of the normal mode, but the squeezing duration is not modified at this time, and the squeezing end prompt is still given after 30 seconds as in the special mode.

[0094] This application also provides a surgical instrument, including a transmission mechanism 100, an actuator assembly 200, a staple cartridge assembly 300, a drive source, and a controller.

[0095] The controller responds to user input mode selection commands and selects one of at least two modes to control the firing assembly to fire multiple suture staples. After determining that the firing assembly has completed its firing process, the controller switches to a default mode, which is one of the at least two modes. For example, after a physician completes a firing using a special firing mode, the device automatically switches to the normal firing mode (default mode). The physician needs to select the special firing mode again for the next firing (e.g., after changing the staple cartridge) when dealing with tissue requiring special care. This prevents the physician from forgetting to switch back to the normal firing mode after completing a firing, even if the next firing does not actually require the special firing mode.

[0096] While the principles herein have been illustrated in various embodiments, numerous modifications to the structures, arrangements, proportions, elements, materials, and components, particularly suited to specific environments and operational requirements, may be used without departing from the principles and scope of this disclosure. These modifications and other alterations or alterations will be included within the scope of this document.

[0097] The foregoing specific descriptions have been described with reference to various embodiments. However, those skilled in the art will recognize that various modifications and changes can be made without departing from the scope of this disclosure. Therefore, considerations for this disclosure are to be illustrative rather than restrictive, and all such modifications are to be included within its scope. Similarly, advantages, other advantages, and solutions to problems with respect to various embodiments have been described above. However, benefits, advantages, solutions to problems, and any elements that produce these, or make them more explicit, should not be construed as critical, essential, or necessary. The term “comprising” and any other variations thereof as used herein are non-exclusive inclusion, meaning that a process, method, article, or apparatus that includes a list of elements includes not only those elements but also other elements not expressly listed or not part of the process, method, system, article, or apparatus. Furthermore, the term “coupled” and any other variations thereof as used herein refer to physical connections, electrical connections, magnetic connections, optical connections, communication connections, functional connections, and / or any other connections.

[0098] Those skilled in the art will recognize that many changes can be made to the details of the above embodiments without departing from the basic principles of the invention. Therefore, the scope of the invention should be determined according to the following claims.

Claims

1. A surgical instrument, characterized in that, include: An actuator assembly, the actuator assembly including a first jaw and a second jaw for gripping and squeezing patient tissue; A staple cartridge assembly disposed between a first jaw and a second jaw, the staple cartridge assembly including a plurality of suture staples; A firing assembly for firing the plurality of suture staples and / or cutting the patient tissue; A drive system, comprising a drive source and a transmission mechanism; the drive source provides driving force to drive the firing assembly to move via the transmission mechanism to fire the plurality of suture staples and / or cut the patient tissue; A controller, configured to respond to a user-inputted mode selection command, selects one of at least two modes to control the firing assembly to fire the plurality of suture staples and / or cut the patient tissue, wherein the at least two modes are: The firing assembly initiates an initial firing velocity at which it fires the suture staple and / or cuts the patient tissue. The firing speed adjustment range of the firing assembly during the firing of the suture staples and / or cutting of the patient tissue. The rate of change of firing speed of the firing assembly during the firing of the suture and / or cutting of the patient tissue. The firing assembly completes the firing time for firing the suture and / or cutting the patient tissue. The time when the patient tissue compression is completed. At least one of them is different.

2. The surgical instrument as described in claim 1, characterized in that, The at least two modes include a normal firing mode and a special firing mode.

3. The surgical instrument as described in claim 2, characterized in that, In the special firing mode, the initial firing speed at which the firing assembly begins firing the suture and / or cutting the patient tissue is lower than the initial firing speed at which the firing assembly begins firing the suture and / or cutting the patient tissue in the normal firing mode.

4. The surgical instrument as described in claim 3, characterized in that, In the specific firing mode, the initial firing velocity of the firing assembly when firing the suture staples and / or cutting the patient tissue is in the range of 4-8 mm / s. In the normal firing mode, the initial firing velocity of the firing assembly when firing the suture staple and / or cutting the patient tissue is in the range of 14-18 mm / s.

5. The surgical instrument as described in claim 3, characterized in that, In the special firing mode, the initial firing speed at which the firing assembly fires the suture staple and / or cuts the patient tissue is less than a first preset speed.

6. The surgical instrument as described in claim 2, characterized in that, The maximum value of the firing speed adjustment range in the special firing mode is less than the maximum or minimum value of the firing speed adjustment range in the normal firing mode.

7. The surgical instrument as described in claim 6, characterized in that, The minimum value of the firing speed adjustment range in the special firing mode is smaller than the minimum value of the firing speed adjustment range in the normal firing mode.

8. The surgical instrument as described in claim 6, characterized in that, The maximum value of the firing speed adjustment range in the special firing mode is less than the second preset speed.

9. The surgical instrument as described in claim 2, characterized in that, Under the same varying firing resistance, the rate of change of firing speed of the firing assembly in the special firing mode during the firing of the suture and / or cutting of the patient tissue is greater than that in the normal firing mode.

10. The surgical instrument as described in claim 2, characterized in that, In the special firing mode, the time for the indication that the patient tissue compression has ended is longer than that in the normal firing mode.

11. The surgical instrument as described in claim 2, characterized in that, In the special firing mode, the firing time for the firing assembly to fire the suture and / or cut the patient tissue is greater than that in the normal firing mode.

12. The surgical instrument as claimed in claim 11, characterized in that, In the special firing mode, the firing time for the firing assembly to fire the suture staple and / or cut the patient tissue is in the range of 20-120 seconds. In the normal firing mode, the firing time for the firing assembly to fire the suture staple and / or cut the patient tissue is in the range of 4-12 seconds.

13. The surgical instrument as described in claim 2, characterized in that, In the special firing mode, the firing assembly includes a pause node during the firing of the suture staple and / or cutting of the patient tissue, and during the pause node, outputs a prompt message indicating that the firing assembly is firing normally.

14. The surgical instrument as described in any one of claims 2-13, characterized in that, It also includes physical buttons electrically connected to the controller, which switches to the normal firing mode or the special firing mode based on the mode selection command input by the user through the physical buttons.

15. The surgical instrument as described in any one of claims 1-14, characterized in that, The controller is configured to: The mode selection command input by the user is responded to only before the firing assembly is activated to fire the plurality of sutures and / or cut the patient tissue; the mode selection command input by the user is not responded to during the firing assembly firing the plurality of sutures and / or cutting the patient tissue. And / or, during the process of the actuator component squeezing the patient tissue, it does not respond to the mode selection instruction input by the user, or responds to the mode selection instruction input by the user but does not modify the squeezing prompt time for the end of squeezing of the patient tissue in the current mode.

16. The surgical instrument according to any one of claims 1-15, characterized in that, The controller is configured to, after determining that the firing component has completed the firing process, either maintain the mode currently selected by the user or switch to a default mode, wherein the default mode is one of the at least two modes.

17. A surgical instrument, characterized in that, include: An actuator assembly, the actuator assembly including a first jaw and a second jaw for gripping patient tissue; A staple cartridge assembly disposed between a first jaw and a second jaw, the staple cartridge assembly including a plurality of suture staples; A firing assembly for firing the plurality of suture staples and / or cutting the patient tissue; A drive system, comprising a drive source and a transmission mechanism; the drive source provides driving force to drive the firing assembly to move via the transmission mechanism to fire the plurality of suture staples and / or cut the patient tissue; The physical button has multiple position states. The physical button is used to be placed in different position states according to the user's operation. The different position states of the physical button correspond to different firing modes of the firing component. A controller is configured to select a corresponding firing mode based on the position of the physical button to control the firing assembly to fire the plurality of suture staples and / or cut the patient tissue.

18. The surgical instrument as claimed in claim 17, characterized in that, The multiple position states include a normal firing mode position state and a special firing mode position state; the controller is used to select one of the normal firing mode and the special firing mode in a two-choice manner according to the position state of the physical button to control the firing assembly to fire the multiple suture staples and / or cut the patient tissue.

19. A surgical instrument, characterized in that, include: An actuator assembly, the actuator assembly including a first jaw and a second jaw for gripping and squeezing patient tissue; A staple cartridge assembly disposed between a first jaw and a second jaw, the staple cartridge assembly including a plurality of suture staples; A firing assembly for firing the plurality of suture staples and / or cutting the patient tissue; A drive system, comprising a drive source and a transmission mechanism; the drive source provides driving force to drive the firing assembly to move via the transmission mechanism to fire the plurality of suture staples and / or cut the patient tissue; A controller, configured to respond to a user-inputted mode selection command, select one of at least two modes to control the firing assembly to fire the plurality of suture staples and / or cut the patient tissue; The controller is also configured to: Before activating the firing assembly to fire the plurality of suture staples and / or cut the patient tissue, the mode selection command input by the user is invoked.

20. The surgical instrument as claimed in claim 19, characterized in that, The controller is also configured to: The mode selection command input by the user is only responded to before the firing assembly is activated to fire the plurality of sutures and / or cut the patient tissue; the mode selection command input by the user is not responded to during the firing assembly firing the plurality of sutures.

21. The surgical instrument as claimed in claim 19 or 20, characterized in that, The controller is also configured to: During the process of the actuator assembly squeezing the patient's tissue, the mode selection command input by the user is not responded to. or, During the squeezing of patient tissue by the actuator component, the mode selection instruction input by the user is responded to, but the squeezing prompt time for the end of squeezing of patient tissue in the current mode is not modified.

22. A surgical instrument, characterized in that, include: An actuator assembly, the actuator assembly including a first jaw and a second jaw for gripping and squeezing patient tissue; A staple cartridge assembly disposed between a first jaw and a second jaw, the staple cartridge assembly including a plurality of suture staples; A firing assembly for firing the plurality of suture staples and / or cutting the patient tissue; A drive system, comprising a drive source and a transmission mechanism; the drive source provides driving force to drive the firing assembly to move via the transmission mechanism to fire the plurality of suture staples and / or cut the patient tissue; A controller, configured to respond to a user-inputted mode selection command, select one of at least two modes to control the firing assembly to fire the plurality of suture staples and / or cut the patient tissue; The controller is further configured to switch to a default mode after determining that the firing component has completed the firing process, the default mode being one of the at least two modes.

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