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WO2025232830A1 - Staple cartridge status identification device and identification method, and surgical instrument - Google Patents

Staple cartridge status identification device and identification method, and surgical instrument

Info

Publication number
WO2025232830A1
WO2025232830A1 PCT/CN2025/093434 CN2025093434W WO2025232830A1 WO 2025232830 A1 WO2025232830 A1 WO 2025232830A1 CN 2025093434 W CN2025093434 W CN 2025093434W WO 2025232830 A1 WO2025232830 A1 WO 2025232830A1
Authority
WO
WIPO (PCT)
Prior art keywords
staple cartridge
staple
current threshold
current value
nail
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/CN2025/093434
Other languages
French (fr)
Chinese (zh)
Inventor
李大平
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Suzhou IntoCare Medical Technology Co Ltd
Original Assignee
Suzhou IntoCare Medical Technology Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Suzhou IntoCare Medical Technology Co Ltd filed Critical Suzhou IntoCare Medical Technology Co Ltd
Publication of WO2025232830A1 publication Critical patent/WO2025232830A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/11Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
    • A61B17/115Staplers for performing anastomosis, e.g. in a single operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/07257Stapler heads characterised by its anvil
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/068Surgical staplers, e.g. containing multiple staples or clamps
    • A61B17/072Surgical staplers, e.g. containing multiple staples or clamps for applying a row of staples in a single action, e.g. the staples being applied simultaneously
    • A61B2017/07214Stapler heads
    • A61B2017/07271Stapler heads characterised by its cartridge

Definitions

  • This disclosure relates to the field of medical devices, and more particularly to a staple cartridge status identification device and identification method for a surgical instrument, and a surgical instrument.
  • Anastomosing devices are medical devices used to replace manual sutures. Their main working principle is to use staples to cut or anastomose tissue, similar to a stapler. Electric anastomosing devices combine a motor, circuit board, and traditional mechanical components, achieving all the functions of a laparoscopic anastomosing device under electric control, making operation simpler.
  • This disclosure provides a device and method for identifying the status of a staple cartridge for surgical instruments, as well as the surgical instruments themselves.
  • a staple cartridge status recognition device for surgical instruments, comprising: an end effector, a closure assembly, a drive motor, a current monitoring circuit, and a processing circuit.
  • the end effector includes an anvil and a staple cartridge assembly operably connected to the anvil, the staple cartridge assembly being configured to receive a staple cartridge containing staples, the end effector including a proximal end and a distal end opposite to each other; a closure assembly configured to move along an axial direction from the proximal end to the distal end, the closure assembly including: a slidable closure member and a closure drive member actuating the closure member, the closure member having an initial position and a closed position, wherein the closure member, the staple cartridge assembly, and the staple cartridge are configured such that the staple cartridge assembly is moved closer to the anvil as the closure member moves from the initial position to the closed position; a drive motor configured to provide a driving force to the closure drive member under the action of a drive current; a current monitoring circuit configured to
  • the processing circuit is further configured to: set a first current threshold, wherein the first current threshold is greater than zero; and compare the maximum drive current value with the first current threshold; wherein, when the maximum drive current value is less than or equal to the first current threshold, it is determined that the nail cartridge does not exist in the nail cartridge assembly; and when the maximum drive current value is greater than the first current threshold, it is determined that the nail cartridge exists in the nail cartridge assembly.
  • the processing circuit is further configured to: after identifying the presence of the staple cartridge in the staple cartridge assembly, further identify whether the suture staples in the staple cartridge have been fired.
  • the processing circuit is further configured to: set a second current threshold, wherein the second current threshold is greater than the first current threshold; and compare the maximum drive current value with the second current threshold; wherein, when the maximum drive current value is greater than the first current threshold and less than or equal to the second current threshold, it is determined that the suture staple has been fired; and when the maximum drive current value is greater than the second current threshold, it is determined that the suture staple has not been fired.
  • the first current threshold is 0.95 to 1.05 A
  • the second current threshold is 1.15 to 1.25 A.
  • the closing member further has a closing start position located between the initial position and the closed position; the closing member, the staple cartridge assembly, and the staple cartridge are configured such that: when the closing member is in the initial position, there is a maximum distance between the staple cartridge assembly and the anvil; when the closing member is in the closed position, there is a minimum distance between the staple cartridge assembly and the anvil; when the closing member is in the closing start position, the staple cartridge assembly begins to move closer to the anvil; the current monitoring circuit is configured to monitor an initial maximum drive current value during the process of the closing member moving from the initial position to the closing start position; and the processing circuit is configured to identify whether the staple cartridge is present in the staple cartridge assembly based on the initial maximum drive current value.
  • the processing circuit is further configured to: set a first current threshold, wherein the first current threshold is greater than zero; and compare the initial maximum drive current value with the first current threshold; wherein, when the initial maximum drive current value is less than or equal to the first current threshold, it is determined that the nail cartridge does not exist in the nail cartridge assembly; and when the initial maximum drive current value is greater than the first current threshold, it is determined that the nail cartridge exists in the nail cartridge assembly.
  • the processing circuit is further configured to: after determining that the staple cartridge is present in the staple cartridge assembly, further determine whether the suture staples in the staple cartridge have been fired.
  • the processing circuit is further configured to: set a second current threshold, wherein the second current threshold is greater than the first current threshold; and compare the initial maximum drive current value with the second current threshold; wherein, when the initial maximum drive current value is greater than the first current threshold and less than or equal to the second current threshold, it is determined that the suture staple has been fired; and when the initial maximum drive current value is greater than the second current threshold, it is determined that the suture staple has not been fired.
  • the staple cartridge includes a staple ejection surface having a staple ejection area and a non-staple ejection area, the non-staple ejection area being located on the side of the staple ejection area closer to the proximal end;
  • the anvil includes an abutment surface and at least one spring piece disposed on the abutment surface, the spring piece extending toward the non-staple ejection area, such that when the staple cartridge assembly moves toward the anvil, the spring piece and the staple cartridge have the following positional relationship: when the staple cartridge is present in the staple cartridge assembly, the spring piece abuts against the non-staple ejection area of the staple cartridge; when the staple cartridge is not present in the staple cartridge assembly, the spring piece does not contact the non-staple ejection area of the staple cartridge.
  • the anvil surface has an anvil area and a non-anvil area, the non-anvil area being located on the side of the anvil area closer to the proximal end;
  • the at least one spring includes a head end and a tail end opposite to each other in its extending direction, the tail end being connected to the non-anvil area, the head end being a protruding end and extending toward the non-outlet area, such that when the staple cartridge assembly moves closer to the anvil and the staple cartridge is present in the staple cartridge assembly, the protruding end of the at least one spring abuts against the non-outlet area.
  • the staple cartridge assembly further includes: a bottom shell defining an elongated channel for receiving the staple cartridge, the staple cartridge being detachably mounted in the elongated channel; and a staple pusher assembly configured to push the staples out of the staple cartridge, the staple pusher assembly including a staple pusher member located between the staple cartridge and the bottom shell and configured to move between a proximal position near the proximal end and a distal position near the distal end; wherein the staple pusher assembly is configured such that when the staple pusher member moves to the distal position, a gap exists between the staple cartridge and the bottom shell at the proximal position, such that the staple cartridge has descent space when the spring abuts against the non-staple ejection area; and when the staple pusher member moves to the proximal position, the gap is occupied by the staple pusher member, such that the staple cartridge remains stationary when the spring abuts against the non-staple ejection area.
  • the anvil surface has a groove extending along the axial direction
  • the closing member includes a cutting portion configured to move within the groove
  • the anvil region includes a first anvil region and a second anvil region, the first anvil region and the second anvil region being located on opposite sides of the groove
  • the non-anvil region includes a first non-anvil region and a second non-anvil region, the first non-anvil region and the second non-anvil region being located on opposite sides of the groove
  • the at least one spring includes two springs, the two springs including a first spring and a second spring, the first spring being connected to the first non-anvil region, and the second spring being connected to the second non-anvil region.
  • the nail ejection surface has opposing grooves extending along the axial direction, and the cutting portion is configured to move simultaneously in the grooves and the opposing grooves;
  • the nail ejection area includes a first nail ejection area and a second nail ejection area, which are located on opposite sides of the groove;
  • the non-nail ejection area includes a first non-nail ejection area and a second non-nail ejection area, which are located on opposite sides of the groove;
  • the first spring is configured such that when the nail cartridge is present in the nail cartridge assembly, the first spring abuts against the first non-nail ejection area; when the nail cartridge is not present in the nail cartridge assembly, the first spring does not contact the first non-nail ejection area;
  • the second spring is configured such that when the nail cartridge is present in the nail cartridge assembly, the second spring abuts against the second non-nail ejection area; when the nail cartridge is not present in the nail cartridge assembly, the second spring
  • a surgical instrument including any of the staple cartridge status recognition devices described above.
  • a method for identifying the status of a staple cartridge in a surgical instrument comprising: driving a closure component to move from an initial position to a closed position; monitoring a maximum driving current value during the process of the closure component moving from the initial position to the closed position; and identifying whether the staple cartridge is present in the staple cartridge assembly based on the maximum driving current value.
  • identifying whether the nail cartridge exists in the nail cartridge assembly based on the maximum drive current value includes: setting a first current threshold, wherein the first current threshold is greater than zero; and comparing the maximum drive current value with the first current threshold; wherein, when the maximum drive current value is less than or equal to the first current threshold, it is determined that the nail cartridge does not exist in the nail cartridge assembly; and when the maximum drive current value is greater than the first current threshold, it is determined that the nail cartridge exists in the nail cartridge assembly.
  • the staple cartridge status identification method further includes: identifying whether the suture staples in the staple cartridge have been fired.
  • identifying whether the suture staples in the staple cartridge have been fired includes:
  • a second current threshold is set, wherein the second current threshold is greater than the first current threshold
  • the maximum driving current value is compared with the second current threshold; wherein, when the maximum driving current value is greater than the first current threshold and less than or equal to the second current threshold, it is determined that the suture staple has been fired; when the maximum driving current value is greater than the second current threshold, it is determined that the suture staple has not been fired.
  • a closing start position is provided between the initial position and the closed position, and the closing component moves from the initial position through the closing start position to the closing start position; monitoring the maximum drive current value during the process of the closing component moving from the initial position to the closed position includes: monitoring the initial maximum drive current value during the process of the closing component moving from the initial position to the closing start position; identifying whether the staple cartridge exists in the staple cartridge assembly based on the maximum drive current value includes: identifying whether the staple cartridge exists in the staple cartridge assembly based on the initial maximum drive current value.
  • Figure 1 is a schematic diagram of the structure of a surgical instrument according to an embodiment of this disclosure
  • FIG. 2 is a block diagram of a staple cartridge identification device according to an embodiment of the present disclosure
  • Figure 3A is a top view of a surgical instrument according to an embodiment of this disclosure.
  • Figure 3B is a schematic diagram of a cross section taken along line A-A in Figure 3A;
  • Figure 3C is a schematic diagram of another cross section taken along line A-A in Figure 3A;
  • Figure 4 is a schematic diagram of the structure of the closing component according to an embodiment of the present disclosure.
  • Figure 5A is a schematic diagram of the staple cartridge assembly according to an embodiment of this disclosure.
  • Figure 5B is a partially enlarged schematic diagram of Figure 5A;
  • Figure 6A is a schematic diagram of the structure of the anvil according to an embodiment of this disclosure.
  • Figure 6B is a partially enlarged schematic diagram of Figure 6A;
  • Figure 6C is a schematic diagram of the spring clip in Figure 6A;
  • Figure 7A is another top view of the surgical instruments according to an embodiment of this disclosure.
  • Figure 7B is a schematic diagram of a cross section taken along line B-B in Figure 7A;
  • Figure 7C is a schematic diagram of another cross section taken along line B-B in Figure 7A;
  • Figure 8A is a schematic diagram of the end effector in its initial state according to an embodiment of the present disclosure.
  • Figure 8B is a schematic diagram of the internal structure of the end effector in Figure 8A;
  • Figure 8C is a magnified view of a portion of region E in Figure 8B;
  • Figure 9A is a schematic diagram of the end effector in the closed start state according to an embodiment of the present disclosure.
  • Figure 9B is a schematic diagram of the internal structure of the end effector in Figure 9A;
  • Figure 9C is a magnified view of a portion of region F in Figure 9B;
  • Figure 9D is another internal structure diagram of the end effector in Figure 9A;
  • Figure 9E is a magnified view of a portion of region G in Figure 9D;
  • Figure 10 is another structural schematic diagram of the staple cartridge assembly according to an embodiment of this disclosure.
  • Figure 11 is a flowchart of the steps of the method for recognizing the status of the staple cartridge of a surgical instrument according to an embodiment of the present disclosure.
  • the electric stapler includes a shaft assembly and an end effector located at the distal end of the shaft assembly.
  • the end effector for example, has an openable structure similar to a clamp and includes an anvil and a staple cartridge assembly.
  • the staple cartridge assembly contains a replaceable staple cartridge to allow the end effector to be reused during operation.
  • various configurations of the staple cartridge assembly can be changed according to different properties of the tissue to be sutured, such as thickness and density. These different configurations of the staple cartridge assembly contain staples of different sizes, thereby improving the suturing effect.
  • this disclosure provides a device for identifying the status of a staple cartridge for a surgical instrument, including: an end effector, a closure assembly, a drive motor, a current monitoring circuit, and a processing circuit.
  • the end effector includes an anvil and a staple cartridge assembly operably connected to the anvil, the staple cartridge assembly being configured to receive a staple cartridge containing staples.
  • the end effector includes a proximal end and a distal end opposite to each other.
  • the closure assembly is configured to move along an axial direction from the proximal end to the distal end, and includes: a slidable closure member and a closure drive member for driving the closure member, the closure member having an initial position and a closed position, wherein the closure member, the staple cartridge assembly, and the staple cartridge are configured such that the staple cartridge assembly is moved closer to the anvil as the closure member moves from the initial position to the closed position.
  • the drive motor is configured to provide driving force to the closure drive member under the action of a drive current.
  • the current monitoring circuit is configured to monitor the maximum drive current value during the movement of the closure member from the initial position to the closed position.
  • the processing circuit is electrically connected to the current monitoring circuit and configured to identify the presence of a staple cartridge in the staple cartridge assembly based on the maximum drive current value.
  • This disclosure also provides a surgical instrument, including a staple cartridge status recognition device provided in this disclosure.
  • This disclosure also provides a method for identifying the status of a staple cartridge in a surgical instrument, including: driving a closure component to move from an initial position to a closed position; monitoring the maximum driving current value during the process of the closure component moving from the initial position to the closed position; and identifying whether a staple cartridge exists in the staple cartridge assembly based on the maximum driving current value.
  • the maximum driving current value during the process of the closing component moving from the initial position to the closed position is monitored, and the presence of a staple cartridge in the staple cartridge assembly is identified based on the maximum driving current value, so as to achieve the purpose of identifying the staple cartridge status. This not only improves the convenience of surgical instrument operation, but also reduces the risk of instrument misoperation.
  • Figure 1 is a structural schematic diagram of a surgical instrument according to an embodiment of the present disclosure.
  • Figure 2 is a block diagram of a staple cartridge identification device according to an embodiment of the present disclosure.
  • Figure 3A is a top view of a surgical instrument according to an embodiment of the present disclosure.
  • Figure 3B is a cross-sectional schematic diagram taken along line A-A of Figure 3A.
  • Figure 3C is another cross-sectional schematic diagram taken along line A-A of Figure 3A.
  • Figure 4 is a structural schematic diagram of a closure assembly according to an embodiment of the present disclosure.
  • the surgical instrument provided in this disclosure includes an end effector 1, a shaft assembly 2, and a handle assembly 3.
  • the end effector 1 includes an anvil 10 and a cartridge assembly 20 operably connected to the anvil 10, the cartridge assembly 20 being configured to accommodate a cartridge 22 containing suture staples.
  • the end effector 1 is in an open state.
  • the end effector 1 is in a closed state.
  • the end effector 1 is connected to the distal end of the shaft assembly 2, which is provided with drive components for performing closing and firing operations, such as a closing drive component 33 and a firing drive component (not shown).
  • the handle assembly 3 includes a housing, and the surgical instrument also includes a drive motor 40, a current monitoring circuit 50, a processing circuit 60, and a power supply circuit 70 disposed within the housing.
  • the power supply circuit 70 includes, for example, a reusable battery cell that can be inserted into the handle assembly 3 during use and removed from the handle assembly 3 after use.
  • the surgical instrument also includes a closure assembly 30 for closing the end effector 1, the closure assembly 30 performing linear reciprocating motion.
  • the end effector 1 includes a proximal end 1A and a distal end 1B opposite to each other.
  • the closure assembly 30 moves along an axis from the proximal end 1A to the distal end 1B (e.g., the +Z direction shown in the figure)
  • the cartridge assembly 20 and the anvil 10 move closer to each other, and the end effector 1 is closed
  • the closure assembly 30 moves in the opposite direction (e.g., the -Z direction shown in the figure)
  • the cartridge assembly 20 and the anvil 10 move away from each other, and the end effector 1 is opened.
  • the closing assembly 30 includes a closing member 31 and a closing drive member 33 that drives the closing member 33 to move linearly.
  • the closing member 31 includes a first connecting portion 311 and a second connecting portion 312.
  • the first connecting portion 311 is configured to slide with the anvil 10
  • the second connecting portion 312 is configured to slide with the staple cartridge assembly 20.
  • the anvil 10 and the staple cartridge assembly 20 can move closer to each other under the clamping action of the first connecting portion 311 and the second connecting portion 312, causing the end effector 1 to gradually close.
  • the closing member 31 moves in the -Z direction, the anvil 10 and the staple cartridge assembly 20 are no longer clamped, and they will move away from each other, and the end effector 1 will reopen.
  • the closing member 31 and the driving closing member 33 can be connected by interlocking or in other ways, which is not limited in this embodiment.
  • the pin cassette status recognition device includes an end effector 1, a closing component 30, a drive motor 40, a current monitoring circuit 50, and a processing circuit 60.
  • the closing member 31 has an initial position P0 and a closed position Py.
  • the end effector 1 is in the open state.
  • the closing member 31 is in the closed position Py, the end effector 1 is in the closed state.
  • the suture staple has been fired because the pusher member 35 is close to the distal end.
  • the closing member 31 returns to the initial position P0, and the end effector 1 returns to the open state.
  • Figure 5A is a structural schematic diagram of the staple cartridge assembly according to an embodiment of the present disclosure.
  • Figure 5B is a partially enlarged schematic diagram of Figure 5A.
  • Figure 6A is a structural schematic diagram of the anvil according to an embodiment of the present disclosure.
  • Figure 6B is a partially enlarged schematic diagram of Figure 6A.
  • Figure 6C is a structural schematic diagram of the spring in Figure 6A.
  • Figure 7A is another top view of the surgical instrument according to an embodiment of the present disclosure.
  • Figure 7B is a cross-sectional schematic diagram taken along line B-B of Figure 7A.
  • Figure 7C is another cross-sectional schematic diagram taken along line B-B of Figure 7A.
  • the staple cartridge 22 includes a staple ejection surface 220, which has a staple ejection area 222 and a non-staple ejection area 224, with the non-staple ejection area 224 located on the side of the staple ejection area 222 closer to the proximal end 1A.
  • the staple ejection area 222 has a plurality of staple ejection slots 232, each containing a staple. When a staple is fired, it moves upward, causing its legs to extend from the staple ejection slots 232 and move toward the anvil 10. The target tissue is trapped between the staple cartridge assembly 20 and the anvil 10; therefore, the staple ejection surface 220 is also referred to as a tissue contact surface.
  • the anvil 10 includes an anvil surface 110, which has an anvil area 112 and a non-anvil area 114.
  • the non-anvil area 114 is located on the side of the anvil area 112 near the proximal end 1A.
  • Multiple anvil seats 234 are provided in the anvil area 112, and each anvil seat 234 corresponds to a multiple staple exit groove 232.
  • the anvil seat 234 bends the leg of the staple into the tissue, achieving tissue suturing.
  • the anvil 10 also includes at least one spring (e.g., the first spring 12a and the second spring 12b shown in the figure) disposed on the nail abutment surface 110. Both the first spring 12a and the second spring 12b extend toward the non-nail ejection area 224, so that when the nail cartridge assembly 20 moves closer to the anvil 10, the first spring 12a and the second spring 12b have the following positional relationship with the nail cartridge 10: when the nail cartridge 22 is installed in the nail cartridge assembly 20, both the first spring 12a and the second spring 12b abut against the non-nail ejection area 224 of the nail cartridge 22; when the nail cartridge 22 is not installed in the nail cartridge assembly 20, neither the first spring 12a nor the second spring 12b contacts the non-nail ejection area 224 of the nail cartridge 22.
  • "at least one spring” can mean either the first spring 12a, the second spring 12b, or both the first spring 12a and the second spring 12b.
  • the closing drive member 33 needs to overcome the above-mentioned resistance force F to drive the closing member 31 to continue moving along the +Z direction. Therefore, by increasing the current value of the drive current I, the driving force of the closing drive member 33 can be increased.
  • This embodiment of the disclosure can identify whether there is a nail cartridge 22 in the nail cartridge assembly 20 by monitoring the maximum value of the driving current I, i.e., the maximum driving current value Imax.
  • the power supply circuit 70 is electrically connected to the drive motor 40 and is used to apply a drive current I to the drive motor 40. Under the action of the drive current I, the drive motor 40 provides driving force to the closing drive component 33. In some embodiments, the drive motor 40 transmits the driving force to the transmission assembly via the power output shaft, and the transmission assembly then transmits the driving force to the closing drive component 33, thereby realizing power transmission.
  • the current monitoring circuit 50 is connected to the drive motor 40 and is used to monitor the maximum drive current value Imax, i.e., the maximum value of current I, during the process of the closing component 31 moving from the initial position P0 to the closed position Py.
  • the processing circuit 60 is electrically connected to the current monitoring circuit 50 and identifies whether the staple cartridge 22 is present in the staple cartridge assembly 20 based on the maximum drive current value Imax.
  • the processing circuit 60 is further configured to: set a first current threshold I1, wherein the first current threshold I1 is greater than zero; and compare the maximum drive current value Imax with the first current threshold I1. When the maximum drive current value Imax is less than or equal to the first current threshold I1, it is determined that there is no nail cartridge 22 in the nail cartridge assembly 20; when the maximum drive current value Imax is greater than the first current threshold I1, it is determined that there is a nail cartridge 22 in the nail cartridge assembly 20.
  • the end effector is a replaceable component.
  • the distal assembly located to the left of the dotted line, including the end effector and part of the shaft assembly 2 can be completely disassembled.
  • the surgical instruments of this disclosure design the staple cartridge 22 as a replaceable component, while the shaft assembly 2, the anvil 10 in the end effector 1, and the base shell 24 are all reusable components. Because the staple cartridge 22 is made of plastic and is relatively small, it is difficult to design additional circuits or wires that can generate electrical connection signals within it.
  • a spring is provided on the anvil 10, and the resistance F generated by the spring causes a change in the driving current I.
  • the maximum driving current value Imax during the movement of the closing member 31 is monitored by the current monitoring circuit 50, and the processing circuit determines whether the staple cartridge 22 is installed based on the maximum driving current value.
  • the number of spring clips can be one or more, that is, two or more. This embodiment does not limit the number of spring clips.
  • This embodiment uses two spring clips as an example for illustration.
  • the material of the spring clips includes metal; in some embodiments, the spring clips can be metal spring clips.
  • the second spring 12b includes a head end E1 and a tail end E2 that are opposite to each other in its extending direction.
  • the tail end E2 is connected to the non-anchor region 114, and the head end E1 is a cantilever end that extends toward the non-outlet region 224.
  • the cantilever end of the second spring 12b abuts against the non-outlet region 224, thereby generating a resistance force F.
  • the tail end E2 By connecting the tail end E2 to the non-anchor region 224, interference of the second spring 12b with the anchor seat in the anchor region 112 can be further avoided.
  • the head end E1 By setting the head end E1 as a cantilever end, the second spring 12b can contact and abut against the non-outlet region 224 of the staple cartridge 22 as the staple cartridge assembly approaches the anvil, thereby generating a resistance force F.
  • the head end E1 is designed to have a curved shape, such as a hook shape, to avoid damaging the surface of the non-nail area 224.
  • the anvil surface 110 has a groove 116 extending in the +Z direction, and the closing member 31 includes a cutting portion 313 that moves within the groove 116 when the closing member 31 moves. This allows for the cutting of target tissue during the movement of the closing member 31.
  • the anvil region 112 includes a first anvil region 112a and a second anvil region 112b, located on opposite sides of the groove 116.
  • the non-anvil region 114 includes a first non-anvil region 114a and a second non-anvil region 114b, located on opposite sides of the groove 116.
  • a first spring tab 12a is connected to the first non-anvil region 114a, and a second spring tab 12b is connected to the second non-anvil region 114b. This configuration ensures that both shrapnel pieces can generate resistance while avoiding impact on the anvil in the anvil area.
  • the nail-exiting surface 220 has opposing grooves 226 extending along the +Z direction.
  • the nail-exiting area 222 includes a first nail-exiting area 222a and a second nail-exiting area 222b, which are located on opposite sides of the groove 116.
  • the non-nail-exiting area 224 includes a first non-nail-exiting area 224a and a second non-nail-exiting area 224b, which are located on opposite sides of the groove 116.
  • the first spring 12a abuts against the first non-staple ejection area 224a
  • the second spring 12b abuts against the second non-staple ejection area 224b
  • the first spring 12a does not contact the first non-staple ejection area 224a
  • the second spring 12b does not contact the second non-staple ejection area 224b, that is, neither the first spring 12a nor the second spring 12b contacts the surface of the staple cartridge.
  • the closing member 31 also has a closing start position Px located between the initial position P0 and the closing position Py.
  • a closing start position Px located between the initial position P0 and the closing position Py.
  • the current monitoring circuit 50 can be configured to monitor the initial maximum drive current value IOmax during the movement of the closing member 31 from the initial position P0 to the closed start position Px. Accordingly, the processing circuit 60 is configured to identify whether the staple cartridge 22 is present in the staple cartridge assembly 20 based on the initial maximum drive current value IOmax.
  • Figure 8A is a structural schematic diagram of the end effector of this embodiment in its initial state.
  • Figure 8B is a structural schematic diagram of the internal structure of the end effector of Figure 8A.
  • Figure 8C is a partially enlarged schematic diagram of region E in Figure 8B.
  • Figure 9A is a structural schematic diagram of the end effector of this embodiment in its closed initial state.
  • Figure 9B is a structural schematic diagram of the internal structure of the end effector of Figure 9A.
  • Figure 9C is a partially enlarged schematic diagram of region F in Figure 9B.
  • Figure 9D is another structural schematic diagram of the end effector of Figure 9A.
  • Figure 9E is a partially enlarged schematic diagram of region G in Figure 9D.
  • the closing member 31 is in the initial position P0, and the end effector 1 is in the open state.
  • the first spring 12a is not in contact with the first non-staple ejection area 224a
  • the second spring 12b is not in contact with the second non-staple ejection area 224b. Therefore, the driving current I driving the closing drive member 33 remains unchanged.
  • the driving current I increases to the initial maximum driving current value IOmax.
  • the processing circuit 60 is further configured to: set a first current threshold I1, which is greater than zero; and compare the initial maximum drive current value IOmax with the first current threshold I1.
  • a first current threshold I1 which is greater than zero
  • the processing circuit 60 compares the initial maximum drive current value IOmax with the first current threshold I1.
  • the monitoring current time can be further reduced, the power consumption of the device can be reduced, and the monitoring efficiency can be improved.
  • FIG 10 is another structural schematic diagram of the staple cartridge assembly according to an embodiment of the present disclosure.
  • the staple cartridge assembly 20 further includes a bottom shell 24 defining an elongated channel 240 for receiving the staple cartridge 22 (as shown in Figure 7B), in which the staple cartridge 22 is detachably mounted.
  • the staple cartridge assembly may also include a staple pusher assembly configured to eject staples from the staple cartridge 22.
  • the staple pusher assembly includes a staple pusher 35 located between the staple cartridge 22 and the bottom shell 24 and configured to move between a proximal position near the proximal end 1A of the end effector 1 (e.g., the position of the staple pusher 35 in Figure 10, also referred to as the non-firing position) and a distal position near the distal end 1B of the end effector 1 (e.g., the position of the staple pusher 35 in Figure 3B, also referred to as the firing position).
  • the staple pusher 35 includes an inclined surface configured to lift the staples in the staple cartridge 22 toward the anvil 10.
  • the pusher component 35 includes a plurality of inclined surfaces configured to slide beneath the pusher plate and lift the pusher plate and the suture staple supported on the pusher plate toward the anvil.
  • a gap G remains between the staple cartridge 22 and the base shell 24 at the proximal position, allowing the staple cartridge 22 to descend when the first spring 12a and the second spring 12b abut against the non-staple ejection area 224.
  • the aforementioned gap G is occupied by the pusher component 35 (as shown in Figure 10).
  • the staple cartridge 22 has no descent space and remains stationary. This descent space allows for further determination of whether the suture staple has been fired.
  • the force generated by each of the first spring 12a and the second spring 12b against the staple cartridge 22 is defined as the resistance force F1.
  • the force generated by each spring against the staple cartridge 22 is defined as the resistance force F2. Therefore, F1 is greater than F2. This is because if the pusher component 35 in Figure 10 is moved to the distal position, a gap will appear at its original position. This gap allows the staple cartridge some room to descend when compressed (e.g., by the springs), thus offsetting part of the resistance force.
  • the staple cartridge status identification device of this embodiment can further identify whether the suture staples in the staple cartridge 22 have been fired, that is, determine whether the staple cartridge in the staple cartridge assembly is a new staple cartridge.
  • the processing circuit 60 is further configured to: set a second current threshold I2, wherein the second current threshold I2 is greater than the first current threshold I1; and compare the maximum drive current value Imax and the second current threshold I2.
  • the maximum drive current value Imax is greater than or equal to the second current threshold I2
  • the maximum drive current value Imax is greater than the first current threshold I1 and less than or equal to the second current threshold I2, it is determined that the staple has been fired.
  • the processing circuit 60 is further configured to: set a second current threshold I2, wherein the second current threshold I2 is greater than the first current threshold I1; and compare the initial maximum drive current value IOmax and the second current threshold I2. If the initial maximum drive current value IOmax is greater than or equal to the second current threshold I2, it is determined that the staple has not been fired.
  • the current monitoring time can be further shortened while still determining whether the staple cartridge is new.
  • the first current threshold I1 ranges from 0.95 to 1.05 A
  • the second current threshold I2 ranges from 1.15 to 1.25 A.
  • the first current threshold I1 is set to approximately 1 A
  • the second current threshold I2 is set to approximately 1.1 A.
  • the following uses the initial maximum drive current value IOmax as the monitored current to illustrate the pin cartridge identification process.
  • the first current threshold I1 and the initial maximum drive current value IOmax are compared to determine whether a pin cartridge is installed. For example, when IOmax is less than or equal to 1 A, it is determined that there is no pin cartridge 22 in the pin cartridge assembly 20; when IOmax is greater than 1 A, it is determined that there is a pin cartridge 22 in the pin cartridge assembly 20.
  • the second current threshold I2 and the initial maximum drive current value IOmax are further compared to determine whether the suture pins in the pin cartridge 22 have been fired (i.e., whether it is a new pin cartridge). When IOmax is greater than 1 A and less than or equal to 1.1 A, it is determined that the suture pin has been fired; when IOmax is greater than 1.1 A, it is determined that the suture pin has not been fired.
  • the drive current of the motor when running under no-load is approximately 1A
  • the initial maximum drive current value IOmax when a new staple cartridge is installed is approximately 1.2A
  • the initial maximum drive current value IOmax when the staple cartridge is used is approximately 1.1A.
  • the initial maximum drive current value IOmax when running under no-load is also equal to the drive current when running under no-load.
  • Figure 11 is a flowchart illustrating the steps of a method for recognizing the status of a staple cartridge of a surgical instrument according to an embodiment of this disclosure.
  • the method for recognizing the status of a staple cartridge of a surgical instrument shown in Figures 1 to 10 includes:
  • S200 Monitors the maximum drive current value Imax during the process of the closed component 31 moving from the initial position P0 to the closed position Py;
  • S300 Based on the maximum drive current value Imax, identify whether there is a staple cartridge 22 in the staple cartridge assembly 20.
  • step S300 includes:
  • S302 Compare the maximum driving current value Imax with the first current threshold I1. If the maximum driving current value Imax is less than or equal to the first current threshold I1, it is determined that the staple cartridge 22 is not present in the staple cartridge assembly 20; if the maximum driving current value Imax is greater than the first current threshold I1, it is determined that the staple cartridge 22 is present in the staple cartridge assembly 20.
  • the above-described staple cartridge status identification method not only overcomes technical difficulties and achieves the purpose of identifying the staple cartridge status, but also requires minimal modification to existing surgical instruments and has low cost.
  • the staple cartridge status identification method of this disclosure may further include: identifying whether the suture staples in the staple cartridge 22 have been fired, that is, determining whether the staple cartridge in the staple cartridge assembly is a new staple cartridge.
  • the above-mentioned method for identifying the status of nail storage also includes:
  • S500 Compare the maximum drive current value Imax with the second current threshold I2. If the maximum drive current value Imax is greater than or equal to the second current threshold I2, it is determined that the suture staple has not been fired. If the maximum drive current value Imax is greater than the first current threshold I1 and less than or equal to the second current threshold I2, it is determined that the suture staple has been fired.
  • a closing start position Px is set between the initial position P0 and the closed position Py.
  • the closing component 33 moves from the initial position P0 to the closed position Py via the closing start position Px.
  • the closing component 31 begins to generate a clamping force on the end effector 1. If a staple cartridge exists in the staple cartridge assembly at this time, the spring will abut against the staple cartridge, generating a resistance force F. Therefore, by monitoring the change in the driving current from the initial position P0 to the closing start position Px, it can be determined whether a staple cartridge exists in the staple cartridge assembly. Compared to monitoring the change in the driving current from the initial position P0 to the closed position Py, the monitoring time can be further shortened.
  • step S200 above includes: monitoring the initial maximum drive current value IOmax during the process of the closing component 31 moving from the initial position P0 to the closing start position Px.
  • step S300 above includes: identifying whether there is an implantation cartridge 22 in the implantation cartridge assembly 20 based on the initial maximum drive current value IOmax. Further, for example, identifying whether there is an implantation cartridge 22 in the implantation cartridge assembly 20 based on the initial maximum drive current value IOmax includes:
  • the staple cartridge status identification method of this disclosure may further include: identifying whether the suture staples in the staple cartridge 22 have been fired, that is, determining whether the staple cartridge in the staple cartridge assembly is a new staple cartridge.
  • the above-mentioned method for identifying the status of nail storage devices further includes:
  • S500 Compare the initial maximum drive current value IOmax with the second current threshold I2; wherein, when the initial maximum drive current value IOmax is greater than the second current threshold I2, it is determined that the suture staple has not been fired; when the initial maximum drive current value IOmax is greater than the first current threshold I1 and less than or equal to the second current threshold I2, it is determined that the suture staple has been fired.
  • the first current threshold I1 ranges from 0.95 to 1.05 A
  • the second current threshold I2 ranges from 1.15 to 1.25 A.
  • the first current threshold I1 is set to approximately 1 A
  • the second current threshold I2 is set to approximately 1.1 A.
  • the following describes the staple cartridge identification process using the initial maximum drive current value IOmax as an example.
  • the first current threshold I1 and the initial maximum drive current value IOmax are compared to determine whether a staple cartridge is installed. For example, when IOmax is less than or equal to 1 A, it is determined that there is no staple cartridge 22 in the staple cartridge assembly 20; when IOmax is greater than 1 A, it is determined that there is a staple cartridge 22 in the staple cartridge assembly 20.
  • the second current threshold I2 and the initial maximum drive current value IOmax are further compared to determine whether the suture staples in the staple cartridge 22 have been fired (i.e., whether it is a new staple cartridge).
  • IOmax is greater than 1A and less than or equal to 1.1A, it is determined that the suture pin has been fired; when IOmax is greater than 1.1A, it is determined that the suture pin has not been fired.
  • the drive current of the motor when it is unloaded is approximately 1A
  • the initial maximum drive current value IOmax when a new suture cartridge is installed i.e., the suture pin has not been fired
  • the initial maximum drive current value IOmax after the suture cartridge has been used is approximately 1.1A.
  • the initial maximum drive current value IOmax when it is unloaded is also equal to the drive current when it is unloaded.
  • the maximum driving current value during the process of the closing component moving from the initial position to the closed position is monitored, and the presence of a staple cartridge in the staple cartridge assembly is identified based on the maximum driving current value, so as to achieve the purpose of identifying the staple cartridge status. This not only improves the convenience of surgical instrument operation, but also reduces the risk of instrument misoperation.

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Abstract

A staple cartridge status identification device and identification method, and a surgical instrument. The staple cartridge status identification device comprises: an end effector (1) comprising an anvil (10) and a staple cartridge assembly (20); a closure assembly (30) comprising a closure component (31) and a closure driving component (33) for driving the closure component (31) to slide; a driving electric motor (40) configured to provide a driving force to the closure driving component (33) under the action of a driving current; a current monitoring circuit (50) configured to monitor a maximum driving current value (Imax) during movement of the closure component (30) from an initial position (P0) to a closed position (Py); and a processing circuit (60) electrically connected to the current monitoring circuit (50) and configured to identify whether a staple cartridge (22) is present in the staple cartridge assembly (20) on the basis of the maximum driving current value (Imax). The staple cartridge status identification device and method not only improve the operational convenience of the surgical instrument, but also reduce the risk of incorrect operation of the instrument.

Description

钉仓状态识别装置及其识别方法和外科手术器械Staple cartridge status recognition device and its recognition method and surgical instruments

相关申请的交叉引用Cross-reference to related applications

本申请基于并且要求于2024年5月9日递交、名称为“钉仓状态识别装置及其识别方法和外科手术器械”的中国专利申请第202410566592.7号的优先权,在此全文引用上述中国专利申请公开的内容以作为本申请的一部分。This application is based on and claims priority to Chinese Patent Application No. 202410566592.7, filed on May 9, 2024, entitled “Device for recognizing staple cartridge status and method thereof and surgical instrument”, the disclosure of which is incorporated herein by reference in its entirety.

技术领域Technical Field

本公开涉及医疗器械领域,尤其涉及一种外科手术器械的钉仓状态识别装置及其识别方法和外科手术器械。This disclosure relates to the field of medical devices, and more particularly to a staple cartridge status identification device and identification method for a surgical instrument, and a surgical instrument.

背景技术Background Technology

吻合器是医学上使用的替代手工缝合的设备,主要工作原理是利用缝合钉对组织进行切割或吻合,类似于订书机。电动吻合器通过将电机、电路板和机械传统组件组合在一起,在电动控制下完全实现腔镜吻合器的所有动作功能,操作手法更简单。Anastomosing devices are medical devices used to replace manual sutures. Their main working principle is to use staples to cut or anastomose tissue, similar to a stapler. Electric anastomosing devices combine a motor, circuit board, and traditional mechanical components, achieving all the functions of a laparoscopic anastomosing device under electric control, making operation simpler.

发明内容Summary of the Invention

本公开实施例提供一种外科手术器械的钉仓状态识别装置及其识别方法和外科手术器械。This disclosure provides a device and method for identifying the status of a staple cartridge for surgical instruments, as well as the surgical instruments themselves.

根据本公开第一方面,提供一种外科手术器械的钉仓状态识别装置,包括:末端执行器、闭合组件、驱动电机、电流监测电路和处理电路。所述末端执行器包括钉砧和可操作地连接到所述钉砧的钉仓组件,所述钉仓组件构造为接收装有缝合钉的钉仓,所述末端执行器包括彼此相对的近端和远端;闭合组件,构造为沿从所述近端指向远端的轴向移动,所述闭合组件包括:可滑动的闭合部件和驱动所述闭合部件的闭合驱动部件,所述闭合部件具有初始位置和闭合位置,其中,所述闭合部件、所述钉仓组件和所述钉仓构造为:当所述闭合部件从所述初始位置移动到所述闭合位置过程中,所述钉仓组件被移动以靠近所述钉砧;驱动电机,配置为在驱动电流的作用下向所述闭合驱动部件提供驱动力;电流监测电路,配置为监测所述闭合部件从所述初始位置移动到所述闭合位置过程中的最大驱动电流值;和处理电路,与所述电流监测电路电连接,并且配置为根据所述最大驱动电流值识别所述钉仓组件中是否存在所述钉仓。According to a first aspect of this disclosure, a staple cartridge status recognition device for surgical instruments is provided, comprising: an end effector, a closure assembly, a drive motor, a current monitoring circuit, and a processing circuit. The end effector includes an anvil and a staple cartridge assembly operably connected to the anvil, the staple cartridge assembly being configured to receive a staple cartridge containing staples, the end effector including a proximal end and a distal end opposite to each other; a closure assembly configured to move along an axial direction from the proximal end to the distal end, the closure assembly including: a slidable closure member and a closure drive member actuating the closure member, the closure member having an initial position and a closed position, wherein the closure member, the staple cartridge assembly, and the staple cartridge are configured such that the staple cartridge assembly is moved closer to the anvil as the closure member moves from the initial position to the closed position; a drive motor configured to provide a driving force to the closure drive member under the action of a drive current; a current monitoring circuit configured to monitor a maximum drive current value during the movement of the closure member from the initial position to the closed position; and a processing circuit electrically connected to the current monitoring circuit and configured to identify the presence of the staple cartridge in the staple cartridge assembly based on the maximum drive current value.

至少一些实施例中,所述处理电路还配置为:设定第一电流阈值,其中所述第一电流阈值大于零;以及比较所述最大驱动电流值和所述第一电流阈值;其中,当所述最大驱动电流值小于或等于所述第一电流阈值时,则确定所述钉仓组件中不存在所述钉仓;当所述最大驱动电流值大于所述第一电流阈值时,则确定所述钉仓组件中存在所述钉仓。In at least some embodiments, the processing circuit is further configured to: set a first current threshold, wherein the first current threshold is greater than zero; and compare the maximum drive current value with the first current threshold; wherein, when the maximum drive current value is less than or equal to the first current threshold, it is determined that the nail cartridge does not exist in the nail cartridge assembly; and when the maximum drive current value is greater than the first current threshold, it is determined that the nail cartridge exists in the nail cartridge assembly.

至少一些实施例中,所述处理电路还配置为:当识别所述钉仓组件中存在所述钉仓后,进一步识别所述钉仓中的缝合钉是否被击发。In at least some embodiments, the processing circuit is further configured to: after identifying the presence of the staple cartridge in the staple cartridge assembly, further identify whether the suture staples in the staple cartridge have been fired.

至少一些实施例中,所述处理电路还配置为:设定第二电流阈值,其中所述第二电流阈值大于所述第一电流阈值;以及比较所述最大驱动电流值和所述第二电流阈值;其中,当所述最大驱动电流值大于所述第一电流阈值且小于或等于所述第二电流阈值时,则确定所述缝合钉被击发;当所述最大驱动电流值大于所述第二电流阈值时,则确定所述缝合钉没有被击发。In at least some embodiments, the processing circuit is further configured to: set a second current threshold, wherein the second current threshold is greater than the first current threshold; and compare the maximum drive current value with the second current threshold; wherein, when the maximum drive current value is greater than the first current threshold and less than or equal to the second current threshold, it is determined that the suture staple has been fired; and when the maximum drive current value is greater than the second current threshold, it is determined that the suture staple has not been fired.

至少一些实施例中,所述第一电流阈值为0.95~1.05A,所述第二电流阈值为1.15~1.25A。In at least some embodiments, the first current threshold is 0.95 to 1.05 A, and the second current threshold is 1.15 to 1.25 A.

至少一些实施例中,所述闭合部件还具有位于所述初始位置和所述闭合位置之间的闭合起始位置;所述闭合部件、所述钉仓组件和所述钉仓构造为:当所述闭合部件位于所述初始位置时,所述钉仓组件和所述钉砧之间具有最大间距;当所述闭合部件位于所述闭合位置时,所述钉仓组件和所述钉砧之间具有最小间距;当所述闭合部件位于所述闭合起始位置时,所述钉仓组件开始向所述钉砧靠近;所述电流监测电路配置为监测所述闭合部件从所述初始位置移动到所述闭合起始位置过程中的初始最大驱动电流值;所述处理电路配置为根据所述初始最大驱动电流值识别所述钉仓组件中是否存在所述钉仓。In at least some embodiments, the closing member further has a closing start position located between the initial position and the closed position; the closing member, the staple cartridge assembly, and the staple cartridge are configured such that: when the closing member is in the initial position, there is a maximum distance between the staple cartridge assembly and the anvil; when the closing member is in the closed position, there is a minimum distance between the staple cartridge assembly and the anvil; when the closing member is in the closing start position, the staple cartridge assembly begins to move closer to the anvil; the current monitoring circuit is configured to monitor an initial maximum drive current value during the process of the closing member moving from the initial position to the closing start position; and the processing circuit is configured to identify whether the staple cartridge is present in the staple cartridge assembly based on the initial maximum drive current value.

至少一些实施例中,所述处理电路还配置为:设定第一电流阈值,其中所述第一电流阈值大于零;以及比较所述初始最大驱动电流值和所述第一电流阈值;其中,当所述初始最大驱动电流值小于或等于所述第一电流阈值时,则确定所述钉仓组件中不存在所述钉仓;当所述初始最大驱动电流值大于所述第一电流阈值时,则确定所述钉仓组件中存在所述钉仓。In at least some embodiments, the processing circuit is further configured to: set a first current threshold, wherein the first current threshold is greater than zero; and compare the initial maximum drive current value with the first current threshold; wherein, when the initial maximum drive current value is less than or equal to the first current threshold, it is determined that the nail cartridge does not exist in the nail cartridge assembly; and when the initial maximum drive current value is greater than the first current threshold, it is determined that the nail cartridge exists in the nail cartridge assembly.

至少一些实施例中,所述处理电路还配置为:当确定所述钉仓组件中存在所述钉仓后,进一步确定所述钉仓中的缝合钉是否被击发。In at least some embodiments, the processing circuit is further configured to: after determining that the staple cartridge is present in the staple cartridge assembly, further determine whether the suture staples in the staple cartridge have been fired.

至少一些实施例中,所述处理电路还配置为:设定第二电流阈值,其中所述第二电流阈值大于所述第一电流阈值;以及比较所述初始最大驱动电流值和所述第二电流阈值;其中,当所述初始最大驱动电流值大于所述第一电流阈值且小于或等于所述第二电流阈值时,则确定所述缝合钉被击发;当所述初始最大驱动电流值大于所述第二电流阈值时,则确定所述缝合钉没有被击发。In at least some embodiments, the processing circuit is further configured to: set a second current threshold, wherein the second current threshold is greater than the first current threshold; and compare the initial maximum drive current value with the second current threshold; wherein, when the initial maximum drive current value is greater than the first current threshold and less than or equal to the second current threshold, it is determined that the suture staple has been fired; and when the initial maximum drive current value is greater than the second current threshold, it is determined that the suture staple has not been fired.

至少一些实施例中,所述钉仓包括出钉面,所述出钉面具有出钉区和非出钉区,所述非出钉区位于所述出钉区靠近所述近端的一侧;所述钉砧包括抵钉面和设置在所述抵钉面上的至少一个弹片,所述弹片朝所述非出钉区延伸,以使所述钉仓组件移动靠近所述钉砧时,所述弹片和所述钉仓具有如下位置关系:当所述钉仓组件中存在所述钉仓时,所述弹片抵靠于所述钉仓的非出钉区;当所述钉仓组件中不存在所述钉仓时,所述弹片与所述钉仓的非出钉区不接触。In at least some embodiments, the staple cartridge includes a staple ejection surface having a staple ejection area and a non-staple ejection area, the non-staple ejection area being located on the side of the staple ejection area closer to the proximal end; the anvil includes an abutment surface and at least one spring piece disposed on the abutment surface, the spring piece extending toward the non-staple ejection area, such that when the staple cartridge assembly moves toward the anvil, the spring piece and the staple cartridge have the following positional relationship: when the staple cartridge is present in the staple cartridge assembly, the spring piece abuts against the non-staple ejection area of the staple cartridge; when the staple cartridge is not present in the staple cartridge assembly, the spring piece does not contact the non-staple ejection area of the staple cartridge.

至少一些实施例中,所述抵钉面具有抵钉区和非抵钉区,所述非抵钉区位于所述抵钉区靠近所述近端的一侧;所述至少一个弹片包括在其延伸方向上彼此相对的头端和尾端,所述尾端连接于所述非抵钉区,所述头端为悬出端且朝所述非出钉区延伸,以使所述钉仓组件移动靠近所述钉砧且所述钉仓组件中存在所述钉仓时,所述至少一个弹片的悬出端抵靠于所述非出钉区。In at least some embodiments, the anvil surface has an anvil area and a non-anvil area, the non-anvil area being located on the side of the anvil area closer to the proximal end; the at least one spring includes a head end and a tail end opposite to each other in its extending direction, the tail end being connected to the non-anvil area, the head end being a protruding end and extending toward the non-outlet area, such that when the staple cartridge assembly moves closer to the anvil and the staple cartridge is present in the staple cartridge assembly, the protruding end of the at least one spring abuts against the non-outlet area.

至少一些实施例中,所述钉仓组件还包括:底壳,所述底壳限定用于接收所述钉仓的狭长通道,所述钉仓可拆卸地安装在所述狭长通道中;推钉组件,所述推钉组件配置为将所述缝合钉从所述钉仓中推出,所述推钉组件包括推钉部件,所述推钉部件位于所述钉仓和所述底壳之间并且构造为在靠近所述近端的近侧位置和靠近所述远端的远侧位置之间移动;其中,所述推钉组件构造为:当所述推钉部件移动到所述远侧位置时,所述钉仓和所述底壳在所述近侧位置处留有间隙,使得当所述弹片抵靠于所述非出钉区时,所述钉仓具有下降空间;当所述推钉部件移动到近侧位置时,所述间隙被推钉部件所占据,使得当所述弹片抵靠于所述非出钉区时,所述钉仓保持不动。In at least some embodiments, the staple cartridge assembly further includes: a bottom shell defining an elongated channel for receiving the staple cartridge, the staple cartridge being detachably mounted in the elongated channel; and a staple pusher assembly configured to push the staples out of the staple cartridge, the staple pusher assembly including a staple pusher member located between the staple cartridge and the bottom shell and configured to move between a proximal position near the proximal end and a distal position near the distal end; wherein the staple pusher assembly is configured such that when the staple pusher member moves to the distal position, a gap exists between the staple cartridge and the bottom shell at the proximal position, such that the staple cartridge has descent space when the spring abuts against the non-staple ejection area; and when the staple pusher member moves to the proximal position, the gap is occupied by the staple pusher member, such that the staple cartridge remains stationary when the spring abuts against the non-staple ejection area.

至少一些实施例中,所述抵钉面具有沿所述轴向延伸的刀槽,所述闭合部件包括切割部,所述切割部构造为在所述刀槽中移动;所述抵钉区包括第一抵钉子区和第二抵钉子区,所述第一抵钉子区和所述第二抵钉子区分别位于所述刀槽的相对两侧;所述非抵钉区包括第一非抵钉子区和第二非抵钉子区,所述第一非抵钉子区和所述第二非抵钉子区分别位于所述刀槽的相对两侧;所述至少一个弹片包括两个弹片,所述两个弹片包括第一弹片和第二弹片,所述第一弹片连接于所述第一非抵钉子区,所述第二弹片连接于所述第二非抵钉子区。In at least some embodiments, the anvil surface has a groove extending along the axial direction, the closing member includes a cutting portion configured to move within the groove; the anvil region includes a first anvil region and a second anvil region, the first anvil region and the second anvil region being located on opposite sides of the groove; the non-anvil region includes a first non-anvil region and a second non-anvil region, the first non-anvil region and the second non-anvil region being located on opposite sides of the groove; the at least one spring includes two springs, the two springs including a first spring and a second spring, the first spring being connected to the first non-anvil region, and the second spring being connected to the second non-anvil region.

至少一些实施例中,所述出钉面具有沿所述轴向延伸的对向刀槽,所述切割部构造为同时在所述刀槽和所述对向刀槽中移动;所述出钉区包括第一出钉子区和第二出钉子区,所述第一出钉子区和所述第二出钉子区分别位于所述刀槽的相对两侧;所述非出钉区包括第一非出钉子区和第二非出钉子区,所述第一非出钉子区和所述第二非出钉子区分别位于所述刀槽的相对两侧;所述第一弹片构造为:当所述钉仓组件中存在所述钉仓时,所述第一弹片抵靠所述第一非出钉子区;当所述钉仓组件中不存在所述钉仓时,所述第一弹片与所述第一非出钉子区不接触;所述第二弹片构造为:当所述钉仓组件中存在所述钉仓时,所述第二弹片抵靠所述第二非出钉子区;当所述钉仓组件中不存在所述钉仓时,所述第二弹片与所述第二非出钉子区不接触。In at least some embodiments, the nail ejection surface has opposing grooves extending along the axial direction, and the cutting portion is configured to move simultaneously in the grooves and the opposing grooves; the nail ejection area includes a first nail ejection area and a second nail ejection area, which are located on opposite sides of the groove; the non-nail ejection area includes a first non-nail ejection area and a second non-nail ejection area, which are located on opposite sides of the groove; the first spring is configured such that when the nail cartridge is present in the nail cartridge assembly, the first spring abuts against the first non-nail ejection area; when the nail cartridge is not present in the nail cartridge assembly, the first spring does not contact the first non-nail ejection area; the second spring is configured such that when the nail cartridge is present in the nail cartridge assembly, the second spring abuts against the second non-nail ejection area; when the nail cartridge is not present in the nail cartridge assembly, the second spring does not contact the second non-nail ejection area.

根据本公开第二方面,提供一种外科手术器械,包括以上任一所述的钉仓状态识别装置。According to a second aspect of this disclosure, a surgical instrument is provided, including any of the staple cartridge status recognition devices described above.

根据本公开第三方面,提供一种外科手术器械的钉仓状态识别方法,包括:驱动闭合部件从初始位置移动到闭合位置;监测所述闭合部件从所述初始位置移动到所述闭合位置过程中的最大驱动电流值;以及根据所述最大驱动电流值,识别所述钉仓组件中是否存在所述钉仓。According to a third aspect of this disclosure, a method for identifying the status of a staple cartridge in a surgical instrument is provided, comprising: driving a closure component to move from an initial position to a closed position; monitoring a maximum driving current value during the process of the closure component moving from the initial position to the closed position; and identifying whether the staple cartridge is present in the staple cartridge assembly based on the maximum driving current value.

至少一些实施例中,所述根据所述最大驱动电流值识别所述钉仓组件中是否存在所述钉仓,包括:设定第一电流阈值,其中所述第一电流阈值大于零;以及比较所述最大驱动电流值和所述第一电流阈值;其中,当所述最大驱动电流值小于或等于所述第一电流阈值时,则确定所述钉仓组件中不存在所述钉仓;当所述最大驱动电流值大于所述第一电流阈值时,则确定所述钉仓组件中存在所述钉仓。In at least some embodiments, identifying whether the nail cartridge exists in the nail cartridge assembly based on the maximum drive current value includes: setting a first current threshold, wherein the first current threshold is greater than zero; and comparing the maximum drive current value with the first current threshold; wherein, when the maximum drive current value is less than or equal to the first current threshold, it is determined that the nail cartridge does not exist in the nail cartridge assembly; and when the maximum drive current value is greater than the first current threshold, it is determined that the nail cartridge exists in the nail cartridge assembly.

至少一些实施例中,当识别所述钉仓组件中存在所述钉仓后,所述钉仓状态识别方法还包括:识别所述钉仓中的缝合钉是否被击发。In at least some embodiments, after identifying the presence of the staple cartridge in the staple cartridge assembly, the staple cartridge status identification method further includes: identifying whether the suture staples in the staple cartridge have been fired.

至少一些实施例中,所述识别所述钉仓中的缝合钉是否被击发,包括:In at least some embodiments, identifying whether the suture staples in the staple cartridge have been fired includes:

设定第二电流阈值,其中所述第二电流阈值大于所述第一电流阈值;以及A second current threshold is set, wherein the second current threshold is greater than the first current threshold; and

比较所述最大驱动电流值和所述第二电流阈值;其中,当所述最大驱动电流值大于所述第一电流阈值且小于或等于所述第二电流阈值时,则确定所述缝合钉被击发;当所述最大驱动电流值大于所述第二电流阈值时,则确定所述缝合钉没有被击发。The maximum driving current value is compared with the second current threshold; wherein, when the maximum driving current value is greater than the first current threshold and less than or equal to the second current threshold, it is determined that the suture staple has been fired; when the maximum driving current value is greater than the second current threshold, it is determined that the suture staple has not been fired.

至少一些实施例中,所述初始位置和所述闭合位置之间设置有闭合起始位置,所述闭合部件从所述初始位置经所述闭合起始位置移动到所述闭合起始位置;所述监测所述闭合部件从所述初始位置移动到所述闭合位置过程中的最大驱动电流值,包括:监测所述闭合部件从所述初始位置移动到所述闭合起始位置过程中的初始最大驱动电流值;所述根据所述最大驱动电流值识别所述钉仓组件中是否存在所述钉仓包括:根据初始最大驱动电流值,识别所述钉仓组件中是否存在所述钉仓。In at least some embodiments, a closing start position is provided between the initial position and the closed position, and the closing component moves from the initial position through the closing start position to the closing start position; monitoring the maximum drive current value during the process of the closing component moving from the initial position to the closed position includes: monitoring the initial maximum drive current value during the process of the closing component moving from the initial position to the closing start position; identifying whether the staple cartridge exists in the staple cartridge assembly based on the maximum drive current value includes: identifying whether the staple cartridge exists in the staple cartridge assembly based on the initial maximum drive current value.

附图说明Attached Figure Description

为了更清楚地说明本公开实施例的技术方案,下面将对实施例的附图作简单地介绍,显而易见地,下面描述中的附图仅仅涉及本公开的一些实施例,而非对本公开的限制。To more clearly illustrate the technical solutions of the embodiments of this disclosure, the accompanying drawings of the embodiments will be briefly described below. Obviously, the drawings described below only relate to some embodiments of this disclosure and are not intended to limit this disclosure.

图1为本公开实施例的外科手术器械的结构示意图;Figure 1 is a schematic diagram of the structure of a surgical instrument according to an embodiment of this disclosure;

图2为本公开实施例的钉仓识别装置的框图;Figure 2 is a block diagram of a staple cartridge identification device according to an embodiment of the present disclosure;

图3A为本公开实施例的外科手术器械的俯视图;Figure 3A is a top view of a surgical instrument according to an embodiment of this disclosure;

图3B为沿图3A的A-A线截取的截面示意图;Figure 3B is a schematic diagram of a cross section taken along line A-A in Figure 3A;

图3C为沿图3A的A-A线截取的另一截面示意图;Figure 3C is a schematic diagram of another cross section taken along line A-A in Figure 3A;

图4是本公开实施例的闭合组件的结构示意图;Figure 4 is a schematic diagram of the structure of the closing component according to an embodiment of the present disclosure;

图5A为本公开实施例的钉仓组件的结构示意图;Figure 5A is a schematic diagram of the staple cartridge assembly according to an embodiment of this disclosure;

图5B为图5A的局部放大示意图;Figure 5B is a partially enlarged schematic diagram of Figure 5A;

图6A为本公开实施例的钉砧的结构示意图;Figure 6A is a schematic diagram of the structure of the anvil according to an embodiment of this disclosure;

图6B为图6A的局部放大示意图;Figure 6B is a partially enlarged schematic diagram of Figure 6A;

图6C为图6A中弹片的结构示意图;Figure 6C is a schematic diagram of the spring clip in Figure 6A;

图7A为本公开实施例的外科手术器械的另一俯视图;Figure 7A is another top view of the surgical instruments according to an embodiment of this disclosure;

图7B为沿图7A的B-B线截取的截面示意图;Figure 7B is a schematic diagram of a cross section taken along line B-B in Figure 7A;

图7C为沿图7A的B-B线截取的另一截面示意图;Figure 7C is a schematic diagram of another cross section taken along line B-B in Figure 7A;

图8A为本公开实施例的末端执行器处于初始状态的结构示意图;Figure 8A is a schematic diagram of the end effector in its initial state according to an embodiment of the present disclosure;

图8B为图8A的末端执行器的内部结构示意图;Figure 8B is a schematic diagram of the internal structure of the end effector in Figure 8A;

图8C为图8B中区域E的局部放大示意图;Figure 8C is a magnified view of a portion of region E in Figure 8B;

图9A为本公开实施例的末端执行器处于闭合起始状态的结构示意图;Figure 9A is a schematic diagram of the end effector in the closed start state according to an embodiment of the present disclosure;

图9B为图9A的末端执行器的内部结构示意图;Figure 9B is a schematic diagram of the internal structure of the end effector in Figure 9A;

图9C为图9B中区域F的局部放大示意图;Figure 9C is a magnified view of a portion of region F in Figure 9B;

图9D为图9A的末端执行器的另一内部结构示意图;Figure 9D is another internal structure diagram of the end effector in Figure 9A;

图9E为图9D中区域G的局部放大示意图;Figure 9E is a magnified view of a portion of region G in Figure 9D;

图10为本公开实施例的钉仓组件的另一结构示意图;Figure 10 is another structural schematic diagram of the staple cartridge assembly according to an embodiment of this disclosure;

图11为本公开实施例的外科手术器械的钉仓状态识别方法的步骤流程图。Figure 11 is a flowchart of the steps of the method for recognizing the status of the staple cartridge of a surgical instrument according to an embodiment of the present disclosure.

具体实施方式Detailed Implementation

为使本公开实施例的目的、技术方案和优点更加清楚,下面将结合本公开实施例的附图,对本公开实施例的技术方案进行清楚、完整地描述。显然,所描述的实施例是本公开的一部分实施例,而不是全部的实施例。基于所描述的本公开的实施例,本领域普通技术人员在无需创造性劳动的前提下所获得的所有其他实施例,都属于本公开保护的范围。To make the objectives, technical solutions, and advantages of the embodiments of this disclosure clearer, the technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this disclosure. All other embodiments obtained by those skilled in the art based on the described embodiments of this disclosure without creative effort are within the scope of protection of this disclosure.

除非另作定义,此处使用的技术术语或者科学术语应当为本公开所属领域内具有一般技能的人士所理解的通常意义。本公开专利申请说明书以及权利要求书中使用的“第一”、“第二”以及类似的词语并不表示任何顺序、数量或者重要性,而只是用来区分不同的组成部分。“包括”或者“包含”等类似的词语意指出现在“包括”或者“包含”前面的元件或者物件涵盖出现在“包括”或者“包含”后面列举的元件或者物件及其等同,并不排除其他元件或者物件。“连接”或者“相连”等类似的词语并非限定于物理的或者机械的连接,而是可以包括电性的连接,不管是直接的还是间接的。“上”、“下”、“左”、“右”等仅用于表示相对位置关系,当被描述对象的绝对位置改变后,则所述相对位置关系也可能相应地改变。Unless otherwise defined, the technical or scientific terms used herein shall have the ordinary meaning understood by one of ordinary skill in the art to which this disclosure pertains. The terms “first,” “second,” and similar terms used in this patent application specification and claims do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Terms such as “comprising” or “including” indicate that the element or object preceding “comprising” or “including” encompasses the element or object listed following “comprising” or “including” and its equivalents, and do not exclude other elements or objects. Terms such as “connected” or “linked” are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. Terms such as “upper,” “lower,” “left,” and “right” are used only to indicate relative positional relationships, and these relative positional relationships may change accordingly when the absolute position of the described object changes.

电动吻合器包括轴组件和位于轴组件远端的末端执行器,末端执行器例如具有类似夹钳的可开合结构,其包含钉砧和钉仓组件。钉仓组件中安装有可更换的钉仓,以允许在操作过程中可重复使用末端执行器。例如,在操作过程中,可根据待缝合的组织的厚度、密度等不同性质,更换多种配置的钉仓组件,这些不同配置的钉仓组件具有不同尺寸的缝合钉,从而提高缝合效果。The electric stapler includes a shaft assembly and an end effector located at the distal end of the shaft assembly. The end effector, for example, has an openable structure similar to a clamp and includes an anvil and a staple cartridge assembly. The staple cartridge assembly contains a replaceable staple cartridge to allow the end effector to be reused during operation. For example, during operation, various configurations of the staple cartridge assembly can be changed according to different properties of the tissue to be sutured, such as thickness and density. These different configurations of the staple cartridge assembly contain staples of different sizes, thereby improving the suturing effect.

然而,现有电动吻合器不具备识别钉仓状态的功能,不仅降低电动吻合器操作的便利性,还存在误操作的风险。However, existing electric staplers do not have the function of recognizing the status of the staple cartridge, which not only reduces the convenience of operating the electric stapler, but also poses a risk of misoperation.

为此,本公开实施例提供一种外科手术器械的钉仓状态识别装置,包括:末端执行器、闭合组件、驱动电机、电流监测电路和处理电路。末端执行器包括钉砧和可操作地连接到钉砧的钉仓组件,钉仓组件构造为接收装有缝合钉的钉仓,末端执行器包括彼此相对的近端和远端。闭合组件,构造为沿从近端指向远端的轴向移动,闭合组件包括:可滑动的闭合部件和驱动闭合部件的闭合驱动部件,闭合部件具有初始位置和闭合位置,其中,闭合部件、钉仓组件和钉仓构造为:当闭合部件从初始位置移动到闭合位置过程中,钉仓组件被移动以靠近钉砧。驱动电机配置为在驱动电流的作用下闭合驱动部件提供驱动力。电流监测电路配置为监测闭合部件从初始位置移动到闭合位置过程中的最大驱动电流值。处理电路与电流监测电路电连接,并且配置为根据最大驱动电流值识别钉仓组件中是否存在钉仓。Therefore, this disclosure provides a device for identifying the status of a staple cartridge for a surgical instrument, including: an end effector, a closure assembly, a drive motor, a current monitoring circuit, and a processing circuit. The end effector includes an anvil and a staple cartridge assembly operably connected to the anvil, the staple cartridge assembly being configured to receive a staple cartridge containing staples. The end effector includes a proximal end and a distal end opposite to each other. The closure assembly is configured to move along an axial direction from the proximal end to the distal end, and includes: a slidable closure member and a closure drive member for driving the closure member, the closure member having an initial position and a closed position, wherein the closure member, the staple cartridge assembly, and the staple cartridge are configured such that the staple cartridge assembly is moved closer to the anvil as the closure member moves from the initial position to the closed position. The drive motor is configured to provide driving force to the closure drive member under the action of a drive current. The current monitoring circuit is configured to monitor the maximum drive current value during the movement of the closure member from the initial position to the closed position. The processing circuit is electrically connected to the current monitoring circuit and configured to identify the presence of a staple cartridge in the staple cartridge assembly based on the maximum drive current value.

本公开实施例还提供一种外科手术器械,包括本公开实施例提供的钉仓状态识别装置。This disclosure also provides a surgical instrument, including a staple cartridge status recognition device provided in this disclosure.

本公开实施例还提供一种外科手术器械的钉仓状态识别方法,包括:驱动闭合部件从初始位置移动到闭合位置;监测闭合部件从初始位置移动到闭合位置过程中的最大驱动电流值;以及根据最大驱动电流值,识别钉仓组件中是否存在钉仓。This disclosure also provides a method for identifying the status of a staple cartridge in a surgical instrument, including: driving a closure component to move from an initial position to a closed position; monitoring the maximum driving current value during the process of the closure component moving from the initial position to the closed position; and identifying whether a staple cartridge exists in the staple cartridge assembly based on the maximum driving current value.

上述本公开实施例提供的外科手术器械的钉仓识别装置和钉仓状态识别方法中,通过监测闭合部件从初始位置移动到闭合位置过程中的最大驱动电流值,并且根据该最大驱动电流值,识别钉仓组件中是否存在钉仓,以达到识别钉仓状态的目的,不仅提高外科手术器械操作上的便利性,还降低器械误操作的风险。In the surgical instrument staple cartridge identification device and staple cartridge status identification method provided in the above-described embodiments, the maximum driving current value during the process of the closing component moving from the initial position to the closed position is monitored, and the presence of a staple cartridge in the staple cartridge assembly is identified based on the maximum driving current value, so as to achieve the purpose of identifying the staple cartridge status. This not only improves the convenience of surgical instrument operation, but also reduces the risk of instrument misoperation.

下面通过具体实施例对本公开进行说明。为了保持本公开实施例以下的说明清楚且简明,可省略已知功能和已知部件的详细说明。当本公开实施例的任一部件在一个以上的附图中出现时,该部件在每个附图中可以由相同的参考标号表示。The present disclosure will now be described through specific embodiments. To keep the following description of the embodiments of the present disclosure clear and concise, detailed descriptions of known functions and components may be omitted. When any component of an embodiment of the present disclosure appears in more than one drawing, the component may be represented by the same reference numerals in each drawing.

图1为本公开实施例的外科手术器械的结构示意图。图2为本公开实施例的钉仓识别装置的框图。图3A为本公开实施例的外科手术器械的俯视图。图3B为沿图3A的A-A线截取的截面示意图。图3C为沿图3A的A-A线截取的另一截面示意图。图4是本公开实施例的闭合组件的结构示意图。Figure 1 is a structural schematic diagram of a surgical instrument according to an embodiment of the present disclosure. Figure 2 is a block diagram of a staple cartridge identification device according to an embodiment of the present disclosure. Figure 3A is a top view of a surgical instrument according to an embodiment of the present disclosure. Figure 3B is a cross-sectional schematic diagram taken along line A-A of Figure 3A. Figure 3C is another cross-sectional schematic diagram taken along line A-A of Figure 3A. Figure 4 is a structural schematic diagram of a closure assembly according to an embodiment of the present disclosure.

例如,本公开实施例提供的外科手术器械包括末端执行器1、轴组件2和柄部组件3。末端执行器1包括钉砧10和可操作地连接到钉砧10的钉仓组件20,钉仓组件20构造为容纳装有缝合钉的钉仓22。当钉仓组件20和钉砧10彼此远离时,末端执行器1处于打开状态。当钉仓组件20和钉砧10相互靠近时,末端执行器1处于闭合状态。末端执行器1连接在轴组件2的远端,轴组件2中设置有用于实现闭合操作和击发操作的驱动部件,例如闭合驱动部件33、击发驱动部件(未示出)等。柄部组件3包括壳体,外科手术器械还包括设置在壳体中的驱动电机40、电流监测电路50、处理电路60和供电电路70等,该供电电路70例如包括可重复使用的电池芯体,该电池芯体可在使用时插入到柄部组件3中,在使用后从柄部组件3中拔出。For example, the surgical instrument provided in this disclosure includes an end effector 1, a shaft assembly 2, and a handle assembly 3. The end effector 1 includes an anvil 10 and a cartridge assembly 20 operably connected to the anvil 10, the cartridge assembly 20 being configured to accommodate a cartridge 22 containing suture staples. When the cartridge assembly 20 and the anvil 10 are far apart, the end effector 1 is in an open state. When the cartridge assembly 20 and the anvil 10 are close together, the end effector 1 is in a closed state. The end effector 1 is connected to the distal end of the shaft assembly 2, which is provided with drive components for performing closing and firing operations, such as a closing drive component 33 and a firing drive component (not shown). The handle assembly 3 includes a housing, and the surgical instrument also includes a drive motor 40, a current monitoring circuit 50, a processing circuit 60, and a power supply circuit 70 disposed within the housing. The power supply circuit 70 includes, for example, a reusable battery cell that can be inserted into the handle assembly 3 during use and removed from the handle assembly 3 after use.

例如,外科手术器械还包括用于闭合末端执行器1的闭合组件30,闭合组件30做直线往复运动。末端执行器1包括彼此相对的近端1A和远端1B,当闭合组件30沿从近端1A指向远端1B的轴向(例如图中所示+Z方向)移动,钉仓组件20和钉砧10相互靠近,末端执行器1被闭合;当闭合组件30沿反方向(例如图中所示-Z方向)移动,钉仓组件20和钉砧10彼此远离,末端执行器1被打开。For example, the surgical instrument also includes a closure assembly 30 for closing the end effector 1, the closure assembly 30 performing linear reciprocating motion. The end effector 1 includes a proximal end 1A and a distal end 1B opposite to each other. When the closure assembly 30 moves along an axis from the proximal end 1A to the distal end 1B (e.g., the +Z direction shown in the figure), the cartridge assembly 20 and the anvil 10 move closer to each other, and the end effector 1 is closed; when the closure assembly 30 moves in the opposite direction (e.g., the -Z direction shown in the figure), the cartridge assembly 20 and the anvil 10 move away from each other, and the end effector 1 is opened.

例如,闭合组件30包括闭合部件31和驱动闭合部件33沿直线运动的闭合驱动部件33。闭合部件31包括第一连接部311和第二连接部312,第一连接部311构造为与钉砧10滑动连接,第二连接部312构造为与钉仓组件20滑动连接。当闭合部件31沿+Z方向移动时,钉砧10和钉仓组件20可在第一连接部311和第二连接部312的夹持作用下相互靠近,使末端执行器1逐渐闭合。当闭合部件31沿-Z方向移动时,钉砧10和钉仓组件20不再受到夹持作用,二者将彼此远离,末端执行器1被重新打开。闭合部件31和驱动闭合部件33可通过相互卡合的方式连接,或以其他方式连接,本公开实施例对此不作限定。For example, the closing assembly 30 includes a closing member 31 and a closing drive member 33 that drives the closing member 33 to move linearly. The closing member 31 includes a first connecting portion 311 and a second connecting portion 312. The first connecting portion 311 is configured to slide with the anvil 10, and the second connecting portion 312 is configured to slide with the staple cartridge assembly 20. When the closing member 31 moves in the +Z direction, the anvil 10 and the staple cartridge assembly 20 can move closer to each other under the clamping action of the first connecting portion 311 and the second connecting portion 312, causing the end effector 1 to gradually close. When the closing member 31 moves in the -Z direction, the anvil 10 and the staple cartridge assembly 20 are no longer clamped, and they will move away from each other, and the end effector 1 will reopen. The closing member 31 and the driving closing member 33 can be connected by interlocking or in other ways, which is not limited in this embodiment.

例如,本公开实施例提供的钉仓状态识别装置包括末端执行器1、闭合组件30、驱动电机40、电流监测电路50和处理电路60。For example, the pin cassette status recognition device provided in this embodiment includes an end effector 1, a closing component 30, a drive motor 40, a current monitoring circuit 50, and a processing circuit 60.

参见图3A至图3C,闭合部件31具有初始位置P0和闭合位置Py。当闭合部件31处于初始位置P0时,末端执行器1处于打开状态。当闭合部件31处于闭合位置Py时,末端执行器1处于闭合状态。从图3B中可看出,由于推钉部件35靠近远端,此时缝合钉已被击发。如图3C所示,当缝合钉被击发后,闭合部件31退回到初始位置P0,末端执行器1重新回到打开状态。Referring to Figures 3A to 3C, the closing member 31 has an initial position P0 and a closed position Py. When the closing member 31 is in the initial position P0, the end effector 1 is in the open state. When the closing member 31 is in the closed position Py, the end effector 1 is in the closed state. As can be seen from Figure 3B, the suture staple has been fired because the pusher member 35 is close to the distal end. As shown in Figure 3C, after the suture staple is fired, the closing member 31 returns to the initial position P0, and the end effector 1 returns to the open state.

图5A为本公开实施例的钉仓组件的结构示意图。图5B为图5A的局部放大示意图。图6A为本公开实施例的钉砧的结构示意图。图6B为图6A的局部放大示意图。图6C为图6A中弹片的结构示意图。图7A为本公开实施例的外科手术器械的另一俯视图。图7B为沿图7A的B-B线截取的截面示意图。图7C为沿图7A的B-B线截取的另一截面示意图。Figure 5A is a structural schematic diagram of the staple cartridge assembly according to an embodiment of the present disclosure. Figure 5B is a partially enlarged schematic diagram of Figure 5A. Figure 6A is a structural schematic diagram of the anvil according to an embodiment of the present disclosure. Figure 6B is a partially enlarged schematic diagram of Figure 6A. Figure 6C is a structural schematic diagram of the spring in Figure 6A. Figure 7A is another top view of the surgical instrument according to an embodiment of the present disclosure. Figure 7B is a cross-sectional schematic diagram taken along line B-B of Figure 7A. Figure 7C is another cross-sectional schematic diagram taken along line B-B of Figure 7A.

例如,钉仓22包括出钉面220,出钉面220具有出钉区222和非出钉区224,非出钉区224位于出钉区222靠近近端1A的一侧。出钉区222中设置有多个出钉槽232,每个出钉槽232中设置有缝合钉。当缝合钉被击发时,缝合钉向上移动,以使腿部从出钉槽232中伸出并且朝向钉砧10移动。目标组织会被夹在钉仓组件20和钉砧10之间,因此出钉面220也称为组织接触表面。For example, the staple cartridge 22 includes a staple ejection surface 220, which has a staple ejection area 222 and a non-staple ejection area 224, with the non-staple ejection area 224 located on the side of the staple ejection area 222 closer to the proximal end 1A. The staple ejection area 222 has a plurality of staple ejection slots 232, each containing a staple. When a staple is fired, it moves upward, causing its legs to extend from the staple ejection slots 232 and move toward the anvil 10. The target tissue is trapped between the staple cartridge assembly 20 and the anvil 10; therefore, the staple ejection surface 220 is also referred to as a tissue contact surface.

例如,钉砧10包括抵钉面110,抵钉面110具有抵钉区112和非抵钉区114,非抵钉区114位于抵钉区112靠近近端1A的一侧。抵钉区112中设置有多个抵钉座234,多个抵钉座234和多个出钉槽232一一对应。如此,当缝合钉的腿部穿过目标组织达到抵钉座234时,抵钉座234将缝合钉的腿部向组织内弯折,实现组织缝合。For example, the anvil 10 includes an anvil surface 110, which has an anvil area 112 and a non-anvil area 114. The non-anvil area 114 is located on the side of the anvil area 112 near the proximal end 1A. Multiple anvil seats 234 are provided in the anvil area 112, and each anvil seat 234 corresponds to a multiple staple exit groove 232. Thus, when the leg of the staple passes through the target tissue and reaches the anvil seat 234, the anvil seat 234 bends the leg of the staple into the tissue, achieving tissue suturing.

例如,钉砧10还包括设置在抵钉面110上的至少一个弹片(例如图中所示的第一弹片12a和第二弹片12b),第一弹片12a和第二弹片12b均朝非出钉区224延伸,以使钉仓组件20移动靠近所述钉砧10时,第一弹片12a和第二弹片12b与钉仓10具有如下位置关系:当钉仓组件20中安装有钉仓22时,该第一弹片12a和第二弹片12b均均抵靠于钉仓22的非出钉区224;当钉仓组件20中没安装钉仓22时,则第一弹片12a和第二弹片12b与钉仓22的非出钉区224均不接触。本公开实施例中,“至少一个弹片”表示可以为第一弹片12a,或第二弹片12b,或第一弹片12a和第二弹片12b二者。For example, the anvil 10 also includes at least one spring (e.g., the first spring 12a and the second spring 12b shown in the figure) disposed on the nail abutment surface 110. Both the first spring 12a and the second spring 12b extend toward the non-nail ejection area 224, so that when the nail cartridge assembly 20 moves closer to the anvil 10, the first spring 12a and the second spring 12b have the following positional relationship with the nail cartridge 10: when the nail cartridge 22 is installed in the nail cartridge assembly 20, both the first spring 12a and the second spring 12b abut against the non-nail ejection area 224 of the nail cartridge 22; when the nail cartridge 22 is not installed in the nail cartridge assembly 20, neither the first spring 12a nor the second spring 12b contacts the non-nail ejection area 224 of the nail cartridge 22. In this embodiment, "at least one spring" can mean either the first spring 12a, the second spring 12b, or both the first spring 12a and the second spring 12b.

例如,如图7B所示,在钉仓组件20中未安装有钉仓22的情况下,当闭合部件31沿+Z方向移动时,钉仓组件20移动靠近钉砧10,但弹片(图中仅示出第一弹片12a)不会接触钉仓22的非出钉区224,这是因为此时钉仓22还未安装。如图7C所示,在钉仓组件20中安装有钉仓22的情况下,当闭合部件31沿+Z方向移动时,钉仓组件20移动靠近钉砧10,此时第一弹片12a会抵靠于钉仓22的非出钉区224上,从而产生阻止钉仓组件20和钉砧10相互靠近的力F。然而,为了最终使末端执行器1达到闭合状态,闭合驱动部件33需克服上述抵抗力F以驱动闭合部件31继续沿+Z方向移动。因此,通过提高驱动电流I的电流值,可增加闭合驱动部件33的驱动力。本公开实施例通过监测该驱动电流I的最大值,即最大驱动电流值Imax,即可识别钉仓组件20中是否存在钉仓22。For example, as shown in Figure 7B, when the staple cartridge 22 is not installed in the staple cartridge assembly 20, when the closing member 31 moves along the +Z direction, the staple cartridge assembly 20 moves closer to the anvil 10, but the spring (only the first spring 12a is shown in the figure) does not contact the non-discharge area 224 of the staple cartridge 22 because the staple cartridge 22 is not yet installed. As shown in Figure 7C, when the staple cartridge 22 is installed in the staple cartridge assembly 20, when the closing member 31 moves along the +Z direction, the staple cartridge assembly 20 moves closer to the anvil 10. At this time, the first spring 12a will abut against the non-discharge area 224 of the staple cartridge 22, thereby generating a force F that prevents the staple cartridge assembly 20 and the anvil 10 from moving closer to each other. However, in order to finally bring the end effector 1 to the closed state, the closing drive member 33 needs to overcome the above-mentioned resistance force F to drive the closing member 31 to continue moving along the +Z direction. Therefore, by increasing the current value of the drive current I, the driving force of the closing drive member 33 can be increased. This embodiment of the disclosure can identify whether there is a nail cartridge 22 in the nail cartridge assembly 20 by monitoring the maximum value of the driving current I, i.e., the maximum driving current value Imax.

返回图2,供电电路70与驱动电机40电连接,用于向驱动电机40施加驱动电流I。驱动电机40在驱动电流I的作用下通过向闭合驱动部件33提供驱动力。一些实施例中,驱动电机40经动力输出轴将驱动力传输到传动组件,传动组件再将驱动力传递给闭合驱动部件33,由此实现动力传输。电流监测电路50与驱动电机40连接,并且用于监测闭合部件31从初始位置P0移动到闭合位置Py过程中的最大驱动电流值Imax,即电流I的最大值。处理电路60与电流监测电路50电连接,并且根据最大驱动电流值Imax识别钉仓组件20中是否存在钉仓22。Referring back to Figure 2, the power supply circuit 70 is electrically connected to the drive motor 40 and is used to apply a drive current I to the drive motor 40. Under the action of the drive current I, the drive motor 40 provides driving force to the closing drive component 33. In some embodiments, the drive motor 40 transmits the driving force to the transmission assembly via the power output shaft, and the transmission assembly then transmits the driving force to the closing drive component 33, thereby realizing power transmission. The current monitoring circuit 50 is connected to the drive motor 40 and is used to monitor the maximum drive current value Imax, i.e., the maximum value of current I, during the process of the closing component 31 moving from the initial position P0 to the closed position Py. The processing circuit 60 is electrically connected to the current monitoring circuit 50 and identifies whether the staple cartridge 22 is present in the staple cartridge assembly 20 based on the maximum drive current value Imax.

例如,处理电路60还配置为:设定第一电流阈值I1,其中第一电流阈值I1大于零;以及比较最大驱动电流值Imax和第一电流阈值I1。当最大驱动电流值Imax小于或等于第一电流阈值I1时,则确定钉仓组件20中不存在钉仓22;当最大驱动电流值Imax大于第一电流阈值I1时,则确定钉仓组件20中存在钉仓22。For example, the processing circuit 60 is further configured to: set a first current threshold I1, wherein the first current threshold I1 is greater than zero; and compare the maximum drive current value Imax with the first current threshold I1. When the maximum drive current value Imax is less than or equal to the first current threshold I1, it is determined that there is no nail cartridge 22 in the nail cartridge assembly 20; when the maximum drive current value Imax is greater than the first current threshold I1, it is determined that there is a nail cartridge 22 in the nail cartridge assembly 20.

发明人发现,在相关的外科手术器械中,末端执行器整体为可更换部件。例如,参考图1,位于虚线左侧的、包括末端执行器和部分轴组件2在内的远侧组件可整体拆卸掉。通过在轴组件2和远侧组件中分别设置可产生电连接信号的电路或导线,并且监测该电连接信号,即可识别远侧组件是否更换,从而进一步确认是否安装新钉仓。The inventors discovered that in relevant surgical instruments, the end effector is a replaceable component. For example, referring to Figure 1, the distal assembly located to the left of the dotted line, including the end effector and part of the shaft assembly 2, can be completely disassembled. By providing circuits or wires that generate electrical connection signals in both the shaft assembly 2 and the distal assembly, and monitoring these electrical connection signals, it is possible to identify whether the distal assembly has been replaced, thereby further confirming whether a new staple cartridge needs to be installed.

然而,上述相关技术中的监测装置及方法无法应用到本公开实施例的外科手术器械中。出于降低使用成本的考虑,本公开实施例的外科手术器械将钉仓22设计为可更换部件,轴组件2和末端执行器1中的钉砧10以及底壳24等部件均为重复使用部件。由于钉仓22的材质为塑料且尺寸较小,很难在其中额外设计可产生电连接信号的电路或导线。However, the monitoring devices and methods described above cannot be applied to the surgical instruments of this disclosure. To reduce operating costs, the surgical instruments of this disclosure design the staple cartridge 22 as a replaceable component, while the shaft assembly 2, the anvil 10 in the end effector 1, and the base shell 24 are all reusable components. Because the staple cartridge 22 is made of plastic and is relatively small, it is difficult to design additional circuits or wires that can generate electrical connection signals within it.

本公开实施例的外科手术器械中,通过在钉砧10上设置弹片,利用弹片产生的抵抗力F引起驱动电流I的变化,利用电流监测电路50监测在闭合部件31移动过程中的最大驱动电流值Imax,利用处理电路根据该最大驱动电流值确认是否安装有钉仓22。和相关技术相比,不仅克服技术困难、达到识别钉仓状态的目的,而且对现有外科手术器械的改动小、成本低。In the surgical instrument of this embodiment, a spring is provided on the anvil 10, and the resistance F generated by the spring causes a change in the driving current I. The maximum driving current value Imax during the movement of the closing member 31 is monitored by the current monitoring circuit 50, and the processing circuit determines whether the staple cartridge 22 is installed based on the maximum driving current value. Compared with related technologies, this not only overcomes technical difficulties and achieves the purpose of identifying the status of the staple cartridge, but also requires minimal modification to existing surgical instruments and has low cost.

本公开实施例中,弹片的数量可以为一个,也可以为多个,即两个或两个以上,本公开实施例对此不作限定。本公开实施例以两个弹片为例进行说明。例如弹片的材料包括金属材料,一些实施例中,弹片可以为金属弹片。In this embodiment, the number of spring clips can be one or more, that is, two or more. This embodiment does not limit the number of spring clips. This embodiment uses two spring clips as an example for illustration. For example, the material of the spring clips includes metal; in some embodiments, the spring clips can be metal spring clips.

下面以第二弹片12b说明弹片的具体构造。例如,如图6A至6C所示,第二弹片12b包括在其延伸方向上彼此相对的头端E1和尾端E2,尾端E2连接于非抵钉区114,头端E1为悬出端且朝非出钉区224延伸,以使钉仓组件20移动靠近钉砧10且钉仓组件20中存在钉仓22时,第二弹片12b的悬出端抵靠于非出钉区224,从而产生抵抗力F。通过将尾端E2连接于非抵钉区224,可进一步避免第二弹片12b对抵钉区112中抵钉座的干扰。通过将头端E1设为悬出端,可使第二弹片12b随着钉仓组件与钉砧的靠近,接触并且抵靠于钉仓22的非出钉区224,以产生抵抗力F。一些实施例中,头端E1设计为具有弯曲形状,例如弯钩形,以避免损伤非出钉区224的表面。The specific structure of the second spring 12b is described below. For example, as shown in Figures 6A to 6C, the second spring 12b includes a head end E1 and a tail end E2 that are opposite to each other in its extending direction. The tail end E2 is connected to the non-anchor region 114, and the head end E1 is a cantilever end that extends toward the non-outlet region 224. When the staple cartridge assembly 20 moves closer to the anvil 10 and the staple cartridge 22 is present in the staple cartridge assembly 20, the cantilever end of the second spring 12b abuts against the non-outlet region 224, thereby generating a resistance force F. By connecting the tail end E2 to the non-anchor region 224, interference of the second spring 12b with the anchor seat in the anchor region 112 can be further avoided. By setting the head end E1 as a cantilever end, the second spring 12b can contact and abut against the non-outlet region 224 of the staple cartridge 22 as the staple cartridge assembly approaches the anvil, thereby generating a resistance force F. In some embodiments, the head end E1 is designed to have a curved shape, such as a hook shape, to avoid damaging the surface of the non-nail area 224.

例如,参考图4至图6C,抵钉面110具有沿+Z方向延伸的刀槽116,闭合部件31包括切割部313,当闭合部件31移动时,切割部313在刀槽116中移动。如此,可在闭合部件31移动过程中切割目标组织。抵钉区112包括第一抵钉子区112a和第二抵钉子区112b,第一抵钉子区112a和第二抵钉子区112b分别位于刀槽116的相对两侧。非抵钉区114包括第一非抵钉子区114a和第二非抵钉子区114b,第一非抵钉子区114a和第二非抵钉子区114b分别位于刀槽116的相对两侧。第一弹片12a连接于第一非抵钉子区114a,第二弹片12b连接于第二非抵钉子区114b。如此设置,可在保证两个弹片均能产生抵抗力的前提下,避免对抵钉区中抵钉座的影响。For example, referring to Figures 4 to 6C, the anvil surface 110 has a groove 116 extending in the +Z direction, and the closing member 31 includes a cutting portion 313 that moves within the groove 116 when the closing member 31 moves. This allows for the cutting of target tissue during the movement of the closing member 31. The anvil region 112 includes a first anvil region 112a and a second anvil region 112b, located on opposite sides of the groove 116. The non-anvil region 114 includes a first non-anvil region 114a and a second non-anvil region 114b, located on opposite sides of the groove 116. A first spring tab 12a is connected to the first non-anvil region 114a, and a second spring tab 12b is connected to the second non-anvil region 114b. This configuration ensures that both shrapnel pieces can generate resistance while avoiding impact on the anvil in the anvil area.

例如,出钉面220具有沿+Z方向延伸的对向刀槽226,当闭合部件31移动时,切割部313同时在刀槽116和对向刀槽226中移动。出钉区222包括第一出钉子区222a和第二出钉子区222b,第一出钉子区222a和第二出钉子区222b分别位于刀槽116的相对两侧。非出钉区224包括第一非出钉子区224a和第二非出钉子区224b,第一非出钉子区224a和第二非出钉子区224b分别位于刀槽116的相对两侧。当钉仓组件20中安装有钉仓22时,第一弹片12a抵靠于第一非出钉子区224a,第二弹片12b抵靠于第二非出钉子区224b;当钉仓组件20中没安装钉仓22时,第一弹片12a与第一非出钉子区224a不接触,第二弹片12b与第二非出钉子区224b也不接触,也就是,第一弹片12a和第二弹片12b与钉仓表面均不接触。For example, the nail-exiting surface 220 has opposing grooves 226 extending along the +Z direction. When the closing member 31 moves, the cutting part 313 moves simultaneously in both the groove 116 and the opposing groove 226. The nail-exiting area 222 includes a first nail-exiting area 222a and a second nail-exiting area 222b, which are located on opposite sides of the groove 116. The non-nail-exiting area 224 includes a first non-nail-exiting area 224a and a second non-nail-exiting area 224b, which are located on opposite sides of the groove 116. When the staple cartridge 22 is installed in the staple cartridge assembly 20, the first spring 12a abuts against the first non-staple ejection area 224a, and the second spring 12b abuts against the second non-staple ejection area 224b; when the staple cartridge 22 is not installed in the staple cartridge assembly 20, the first spring 12a does not contact the first non-staple ejection area 224a, and the second spring 12b does not contact the second non-staple ejection area 224b, that is, neither the first spring 12a nor the second spring 12b contacts the surface of the staple cartridge.

返回图3B,闭合部件31还具有位于初始位置P0和闭合位置Py之间的闭合起始位置Px。当闭合部件31位于初始位置P0时,钉仓组件20和钉砧10之间具有最大间距Dmax;当闭合部件31位于闭合位置Py时,钉仓组件20和钉砧10之间具有最小间距Dmin;当闭合部件31位于闭合起始位置Px时,钉仓组件20开始向钉砧10靠近,即开始从最大间距向最小间距Dmin缩小。换言之,在闭合起始位置Px,闭合部件31开始向末端执行器1产生夹持力,末端执行器1开始闭合。Referring back to Figure 3B, the closing member 31 also has a closing start position Px located between the initial position P0 and the closing position Py. When the closing member 31 is in the initial position P0, there is a maximum distance Dmax between the staple cartridge assembly 20 and the anvil 10; when the closing member 31 is in the closing position Py, there is a minimum distance Dmin between the staple cartridge assembly 20 and the anvil 10; when the closing member 31 is in the closing start position Px, the staple cartridge assembly 20 begins to move closer to the anvil 10, that is, it begins to shrink from the maximum distance to the minimum distance Dmin. In other words, at the closing start position Px, the closing member 31 begins to generate a clamping force on the end effector 1, and the end effector 1 begins to close.

例如,在闭合部件31从初始位置P0向闭合位置Py的移动过程中,通常在克服弹片的抵抗力F时出现瞬时驱动电流增大的情况。因此,为了进一步降低监测电流的时间,电流监测电路50可配置为监测闭合部件31从初始位置P0移动到闭合起始位置Px过程中的初始最大驱动电流值IOmax。相应地,处理电路60配置为根据初始最大驱动电流值IOmax识别钉仓组件20中是否存在钉仓22。For example, during the movement of the closing member 31 from the initial position P0 to the closed position Py, a momentary increase in drive current typically occurs when overcoming the resistance F of the spring. Therefore, to further reduce the monitoring time of the current, the current monitoring circuit 50 can be configured to monitor the initial maximum drive current value IOmax during the movement of the closing member 31 from the initial position P0 to the closed start position Px. Accordingly, the processing circuit 60 is configured to identify whether the staple cartridge 22 is present in the staple cartridge assembly 20 based on the initial maximum drive current value IOmax.

图8A为本公开实施例的末端执行器处于初始状态的结构示意图。图8B为图8A的末端执行器的内部结构示意图。图8C为图8B中区域E的局部放大示意图。图9A为本公开实施例的末端执行器处于闭合起始状态的结构示意图。图9B为图9A的末端执行器的内部结构示意图。图9C为图9B中区域F的局部放大示意图。图9D为图9A的末端执行器的另一内部结构示意图。图9E为图9D中区域G的局部放大示意图。Figure 8A is a structural schematic diagram of the end effector of this embodiment in its initial state. Figure 8B is a structural schematic diagram of the internal structure of the end effector of Figure 8A. Figure 8C is a partially enlarged schematic diagram of region E in Figure 8B. Figure 9A is a structural schematic diagram of the end effector of this embodiment in its closed initial state. Figure 9B is a structural schematic diagram of the internal structure of the end effector of Figure 9A. Figure 9C is a partially enlarged schematic diagram of region F in Figure 9B. Figure 9D is another structural schematic diagram of the end effector of Figure 9A. Figure 9E is a partially enlarged schematic diagram of region G in Figure 9D.

例如,在钉仓组件20中安装有钉仓22的情况下,闭合部件31处于初始位置P0,末端执行器1处于打开状态,此时,第一弹片12a与第一非出钉子区224a不接触,第二弹片12b与第二非出钉子区224b也不接触,所以驱动闭合驱动部件33的驱动电流I保持不变。当闭合部件31沿+Z方向移动到初始闭合位置Px时,第一弹片12a与第一非出钉子区224a接触并产生抵抗力,第二弹片12b与第二非出钉子区224b接触并产生抵抗力,此时,驱动电流I会增加至初始最大驱动电流值IOmax。For example, when the staple cartridge 22 is installed in the staple cartridge assembly 20, the closing member 31 is in the initial position P0, and the end effector 1 is in the open state. At this time, the first spring 12a is not in contact with the first non-staple ejection area 224a, and the second spring 12b is not in contact with the second non-staple ejection area 224b. Therefore, the driving current I driving the closing drive member 33 remains unchanged. When the closing member 31 moves to the initial closed position Px along the +Z direction, the first spring 12a contacts the first non-staple ejection area 224a and generates resistance, and the second spring 12b contacts the second non-staple ejection area 224b and generates resistance. At this time, the driving current I increases to the initial maximum driving current value IOmax.

例如,处理电路60还配置为:设定第一电流阈值I1,第一电流阈值I1大于零;以及比较初始最大驱动电流值IOmax和第一电流阈值I1。当初始最大驱动电流值IOmax小于或等于第一电流阈值I1时,则确定钉仓组件20中不存在钉仓22;当初始最大驱动电流值IOmax大于第一电流阈值I1时,则确定钉仓组件20中存在钉仓22。如此,可在能够识别钉仓组件20中是否存在钉仓22的前提下,进一步降低监测电流的时间,减少器械的电能损耗,提高监测效率。For example, the processing circuit 60 is further configured to: set a first current threshold I1, which is greater than zero; and compare the initial maximum drive current value IOmax with the first current threshold I1. When the initial maximum drive current value IOmax is less than or equal to the first current threshold I1, it is determined that there is no staple cartridge 22 in the staple cartridge assembly 20; when the initial maximum drive current value IOmax is greater than the first current threshold I1, it is determined that there is a staple cartridge 22 in the staple cartridge assembly 20. In this way, while being able to identify whether there is a staple cartridge 22 in the staple cartridge assembly 20, the monitoring current time can be further reduced, the power consumption of the device can be reduced, and the monitoring efficiency can be improved.

图10为本公开实施例的钉仓组件的另一结构示意图。例如,钉仓组件20还包括底壳24,底壳24限定用于接收钉仓22的狭长通道240(如图7B所示),钉仓22可拆卸地安装在狭长通道240中。钉仓组件还可包括推钉组件,推钉组件配置为将缝合钉从钉仓22中推出。例如,推钉组件包括推钉部件35,推钉部件35位于钉仓22和底壳24之间并且构造为在靠近末端执行器1的近端1A的近侧位置(例如图10中推钉部件35所在位置,也称非击发位置)和靠近末端执行器1的远端1B的远侧位置(例如图3B中推钉部件35所在位置,也称击发位置)之间移动。例如,推钉部件35包括倾斜表面,倾斜表面构造为朝向钉砧10提升钉仓22中的缝合钉。一些实施例中,推钉部件35包括多个倾斜表面,多个倾斜表面构造成能够在推钉片下方滑动并且朝向钉砧提升推钉片和支撑在推钉片上的缝合钉。Figure 10 is another structural schematic diagram of the staple cartridge assembly according to an embodiment of the present disclosure. For example, the staple cartridge assembly 20 further includes a bottom shell 24 defining an elongated channel 240 for receiving the staple cartridge 22 (as shown in Figure 7B), in which the staple cartridge 22 is detachably mounted. The staple cartridge assembly may also include a staple pusher assembly configured to eject staples from the staple cartridge 22. For example, the staple pusher assembly includes a staple pusher 35 located between the staple cartridge 22 and the bottom shell 24 and configured to move between a proximal position near the proximal end 1A of the end effector 1 (e.g., the position of the staple pusher 35 in Figure 10, also referred to as the non-firing position) and a distal position near the distal end 1B of the end effector 1 (e.g., the position of the staple pusher 35 in Figure 3B, also referred to as the firing position). For example, the staple pusher 35 includes an inclined surface configured to lift the staples in the staple cartridge 22 toward the anvil 10. In some embodiments, the pusher component 35 includes a plurality of inclined surfaces configured to slide beneath the pusher plate and lift the pusher plate and the suture staple supported on the pusher plate toward the anvil.

例如,当推钉部件35移动到远侧位置时,钉仓22和底壳24在近侧位置处留有间隙G,使得当第一弹片12a和第二弹片12b抵靠于非出钉区224时,钉仓22具有下降空间。当推钉部件35移动到近侧位置时,上述间隙G被推钉部件35所占据(如图10所示),这样,当第一弹片12a和第二弹片12b抵靠于非出钉区224时,钉仓22没有下降空间而保持原位不动。利用上述下降空间,可对是否缝合钉是否被击发进行进一步判断。For example, when the pusher component 35 moves to the distal position, a gap G remains between the staple cartridge 22 and the base shell 24 at the proximal position, allowing the staple cartridge 22 to descend when the first spring 12a and the second spring 12b abut against the non-staple ejection area 224. When the pusher component 35 moves to the proximal position, the aforementioned gap G is occupied by the pusher component 35 (as shown in Figure 10). Thus, when the first spring 12a and the second spring 12b abut against the non-staple ejection area 224, the staple cartridge 22 has no descent space and remains stationary. This descent space allows for further determination of whether the suture staple has been fired.

例如,设定当推钉部件35位于近侧位置(即缝合钉未被击发)时,第一弹片12a和第二弹片12b中的每个弹片抵靠在钉仓22产生的力为抵抗力为F1,当推钉部件35位于远侧位置(即缝合钉已被击发)时,每个弹片抵靠在钉仓22产生的力为抵抗力为F2,则F1大于F2。这是因为,如果图10中的推钉部件35被移动至远侧位置,则在原位置处会出现缝隙,该缝隙使钉仓受压(例如受到弹片的挤压)时有一定的下降空间,因此抵消了部分抵抗力。For example, when the pusher component 35 is in the proximal position (i.e., the suture staple has not been fired), the force generated by each of the first spring 12a and the second spring 12b against the staple cartridge 22 is defined as the resistance force F1. When the pusher component 35 is in the distal position (i.e., the suture staple has been fired), the force generated by each spring against the staple cartridge 22 is defined as the resistance force F2. Therefore, F1 is greater than F2. This is because if the pusher component 35 in Figure 10 is moved to the distal position, a gap will appear at its original position. This gap allows the staple cartridge some room to descend when compressed (e.g., by the springs), thus offsetting part of the resistance force.

基于以上原理,当识别钉仓组件20中存在钉仓22后,本公开实施例的钉仓状态识别装置可进一步识别钉仓22中的缝合钉是否被击发,即判断钉仓组件中的钉仓是否为新钉仓。Based on the above principles, after identifying the presence of a staple cartridge 22 in the staple cartridge assembly 20, the staple cartridge status identification device of this embodiment can further identify whether the suture staples in the staple cartridge 22 have been fired, that is, determine whether the staple cartridge in the staple cartridge assembly is a new staple cartridge.

例如,在电流监测电路50配置为监测闭合部件31从初始位置P0移动到闭合位置P2闭合位置Py过程中的最大驱动电流值Imax的情况下,处理电路60进一步配置为:设定第二电流阈值I2,其中第二电流阈值I2大于第一电流阈值I1;以及比较最大驱动电流值Imax和第二电流阈值I2。当最大驱动电流值Imax大于或等于第二电流阈值I2时,则确定缝合钉没有被击发。当最大驱动电流值Imax大于第一电流阈值I1且小于或等于第二电流阈值I2时,则确定缝合钉被击发。通过上述设置,可在不额外增加结构的基础上,不仅判断是否存在钉仓,还能进一步判断是否为新钉仓。再例如,在电流监测电路50配置为监测闭合部件31从初始位置P0移动到闭合起始位置Px过程中的初始最大驱动电流值IOmax的情况下,处理电路60进一步配置为:设定第二电流阈值I2,其中第二电流阈值I2大于第一电流阈值I1;以及比较初始最大驱动电流值IOmax和第二电流阈值I2。当初始最大驱动电流值IOmax大于或等于第二电流阈值I2时,则确定缝合钉没有被击发。当初始最大驱动电流值IOmax大于第一电流阈值I1且小于或等于第二电流阈值I2时,则确定缝合钉被击发。通过上述设置,可在判断是否为新钉仓的前提下,进一步缩短电流监测时间。For example, when the current monitoring circuit 50 is configured to monitor the maximum drive current value Imax during the process of the closing member 31 moving from the initial position P0 to the closed position P2/Py, the processing circuit 60 is further configured to: set a second current threshold I2, wherein the second current threshold I2 is greater than the first current threshold I1; and compare the maximum drive current value Imax and the second current threshold I2. When the maximum drive current value Imax is greater than or equal to the second current threshold I2, it is determined that the staple has not been fired. When the maximum drive current value Imax is greater than the first current threshold I1 and less than or equal to the second current threshold I2, it is determined that the staple has been fired. With the above settings, it is possible to determine not only whether a staple cartridge exists, but also whether it is a new staple cartridge, without adding any additional structure. As another example, when the current monitoring circuit 50 is configured to monitor the initial maximum drive current value IOmax during the process of the closing member 31 moving from the initial position P0 to the closed start position Px, the processing circuit 60 is further configured to: set a second current threshold I2, wherein the second current threshold I2 is greater than the first current threshold I1; and compare the initial maximum drive current value IOmax and the second current threshold I2. If the initial maximum drive current value IOmax is greater than or equal to the second current threshold I2, it is determined that the staple has not been fired. If the initial maximum drive current value IOmax is greater than the first current threshold I1 and less than or equal to the second current threshold I2, it is determined that the staple has been fired. With these settings, the current monitoring time can be further shortened while still determining whether the staple cartridge is new.

例如,第一电流阈值I1的取值范围为0.95~1.05A,第二电流阈值I2的取值范围为1.15~1.25A。一些实施例中,设定第一电流阈值I1为大约1A,第二电流阈值I2为大约1.1A。下面以初始最大驱动电流值IOmax作为被监测电流为例,具体说明钉仓的识别过程。首先,比较第一电流阈值I1和初始最大驱动电流值IOmax以确定是否安装有钉仓。例如,当IOmax小于或等于1A时,确定钉仓组件20中不存在钉仓22;当IOmax大于1A,则确定钉仓组件20中存在钉仓22。然后,进一步比较第二电流阈值I2和初始最大驱动电流值IOmax以确定该钉仓22中的缝合钉是否被击发(即确定是否为新钉仓)。当IOmax大于1A且小于或等于1.1A时,则确定缝合钉被击发;当IOmax大于1.1A时,则确定缝合钉未被击发。例如,本公开实施例中,电机空载时运行的驱动电流大约为1A,安装新钉仓(即缝合钉未被击发)的初始最大驱动电流值IOmax为大约1.2A,使用后的钉仓(即缝合钉已被击发)的初始最大驱动电流值IOmax为大约1.1A。需要说明的是,由于空载时运行的驱动电流保持不变,空载时初始最大驱动电流值IOmax也等于空载时的驱动电流。For example, the first current threshold I1 ranges from 0.95 to 1.05 A, and the second current threshold I2 ranges from 1.15 to 1.25 A. In some embodiments, the first current threshold I1 is set to approximately 1 A, and the second current threshold I2 is set to approximately 1.1 A. The following uses the initial maximum drive current value IOmax as the monitored current to illustrate the pin cartridge identification process. First, the first current threshold I1 and the initial maximum drive current value IOmax are compared to determine whether a pin cartridge is installed. For example, when IOmax is less than or equal to 1 A, it is determined that there is no pin cartridge 22 in the pin cartridge assembly 20; when IOmax is greater than 1 A, it is determined that there is a pin cartridge 22 in the pin cartridge assembly 20. Then, the second current threshold I2 and the initial maximum drive current value IOmax are further compared to determine whether the suture pins in the pin cartridge 22 have been fired (i.e., whether it is a new pin cartridge). When IOmax is greater than 1 A and less than or equal to 1.1 A, it is determined that the suture pin has been fired; when IOmax is greater than 1.1 A, it is determined that the suture pin has not been fired. For example, in this embodiment of the present disclosure, the drive current of the motor when running under no-load is approximately 1A, the initial maximum drive current value IOmax when a new staple cartridge is installed (i.e., the staple has not been fired) is approximately 1.2A, and the initial maximum drive current value IOmax when the staple cartridge is used (i.e., the staple has been fired) is approximately 1.1A. It should be noted that since the drive current when running under no-load remains unchanged, the initial maximum drive current value IOmax when running under no-load is also equal to the drive current when running under no-load.

图11为本公开实施例的外科手术器械的钉仓状态识别方法的步骤流程图。例如,参考图1至图11,图1至图10所示的外科手术器械的钉仓状态识别方法包括:Figure 11 is a flowchart illustrating the steps of a method for recognizing the status of a staple cartridge of a surgical instrument according to an embodiment of this disclosure. For example, referring to Figures 1 to 11, the method for recognizing the status of a staple cartridge of a surgical instrument shown in Figures 1 to 10 includes:

S100:驱动闭合部件33从初始位置P0移动到闭合位置Py;S100: Drive the closing component 33 from the initial position P0 to the closed position Py;

S200:监测闭合部件31从初始位置P0移动到闭合位置Py过程中的最大驱动电流值Imax;以及S200: Monitors the maximum drive current value Imax during the process of the closed component 31 moving from the initial position P0 to the closed position Py; and

S300:根据最大驱动电流值Imax,识别钉仓组件20中是否存在钉仓22。S300: Based on the maximum drive current value Imax, identify whether there is a staple cartridge 22 in the staple cartridge assembly 20.

例如,步骤S300包括:For example, step S300 includes:

S301:设定第一电流阈值I1,其中第一电流阈值I1大于零;以及S301: Set a first current threshold I1, wherein the first current threshold I1 is greater than zero; and

S302:比较最大驱动电流值Imax和第一电流阈值I1,其中,当最大驱动电流值Imax小于或等于第一电流阈值I1时,则确定钉仓组件20中不存在钉仓22;当最大驱动电流值Imax大于第一电流阈值I1时,则确定钉仓组件20中存在钉仓22。和相关技术相比,上述钉仓状态识别方法不仅克服技术困难、达到识别钉仓状态的目的,而且对现有外科手术器械的改动小、成本低。S302: Compare the maximum driving current value Imax with the first current threshold I1. If the maximum driving current value Imax is less than or equal to the first current threshold I1, it is determined that the staple cartridge 22 is not present in the staple cartridge assembly 20; if the maximum driving current value Imax is greater than the first current threshold I1, it is determined that the staple cartridge 22 is present in the staple cartridge assembly 20. Compared with related technologies, the above-described staple cartridge status identification method not only overcomes technical difficulties and achieves the purpose of identifying the staple cartridge status, but also requires minimal modification to existing surgical instruments and has low cost.

一些实施例中,当识别钉仓组件20中存在钉仓22后,本公开实施例的钉仓状态识别方法可进一步包括:识别钉仓22中的缝合钉是否被击发,即判断钉仓组件中的钉仓是否为新钉仓。In some embodiments, after identifying the presence of a staple cartridge 22 in the staple cartridge assembly 20, the staple cartridge status identification method of this disclosure may further include: identifying whether the suture staples in the staple cartridge 22 have been fired, that is, determining whether the staple cartridge in the staple cartridge assembly is a new staple cartridge.

例如,上述钉仓状态识别方法还包括:For example, the above-mentioned method for identifying the status of nail storage also includes:

S400:设定第二电流阈值I2,其中第二电流阈值I2大于第一电流阈值I1;以及S400: Set a second current threshold I2, wherein the second current threshold I2 is greater than the first current threshold I1; and

S500:比较最大驱动电流值Imax和第二电流阈值I2,其中,当最大驱动电流值Imax大于或等于第二电流阈值I2时,则确定缝合钉没有被击发。当最大驱动电流值Imax大于第一电流阈值I1且小于或等于第二电流阈值I2时,则确定缝合钉被击发。S500: Compare the maximum drive current value Imax with the second current threshold I2. If the maximum drive current value Imax is greater than or equal to the second current threshold I2, it is determined that the suture staple has not been fired. If the maximum drive current value Imax is greater than the first current threshold I1 and less than or equal to the second current threshold I2, it is determined that the suture staple has been fired.

通过上述步骤,可在不额外增加结构的基础上,不仅判断是否存在钉仓,还能进一步判断是否为新钉仓。例如,上述步骤S100中,在初始位置P0和闭合位置Py之间设置有闭合起始位置Px,闭合部件33从初始位置P0经闭合起始位置Px移动到闭合位置Py。在闭合起始位置Px,闭合部件31开始向末端执行器1产生夹持力,如果此时钉仓组件中存在钉仓,则弹片会抵靠钉仓上产生抵抗力F,因此通过监测从初始位置P0到闭合起始位置Px过程中的驱动电流的变化,即可判断出钉仓组件中是否存在钉仓。相比于监测从初始位置P0到闭合位置Py过程中的驱动电流的变化,能进一步缩短监测时间。Through the above steps, without adding any additional structure, it is possible to not only determine whether a staple cartridge exists, but also whether it is a new staple cartridge. For example, in step S100, a closing start position Px is set between the initial position P0 and the closed position Py. The closing component 33 moves from the initial position P0 to the closed position Py via the closing start position Px. At the closing start position Px, the closing component 31 begins to generate a clamping force on the end effector 1. If a staple cartridge exists in the staple cartridge assembly at this time, the spring will abut against the staple cartridge, generating a resistance force F. Therefore, by monitoring the change in the driving current from the initial position P0 to the closing start position Px, it can be determined whether a staple cartridge exists in the staple cartridge assembly. Compared to monitoring the change in the driving current from the initial position P0 to the closed position Py, the monitoring time can be further shortened.

例如,上述步骤S200包括:监测闭合部件31从初始位置P0移动到闭合起始位置Px过程中的初始最大驱动电流值IOmax。For example, step S200 above includes: monitoring the initial maximum drive current value IOmax during the process of the closing component 31 moving from the initial position P0 to the closing start position Px.

例如,上述步骤S300包括:根据初始最大驱动电流值IOmax,识别钉仓组件20中是否存在钉仓22。进一步地,例如,根据初始最大驱动电流值IOmax识别钉仓组件20中是否存在钉仓22,包括:For example, step S300 above includes: identifying whether there is an implantation cartridge 22 in the implantation cartridge assembly 20 based on the initial maximum drive current value IOmax. Further, for example, identifying whether there is an implantation cartridge 22 in the implantation cartridge assembly 20 based on the initial maximum drive current value IOmax includes:

S301’:设定第一电流阈值I1,其中第一电流阈值I1大于零;以及S301’: Set a first current threshold I1, wherein the first current threshold I1 is greater than zero; and

S302’:比较初始最大驱动电流值IOmax和第一电流阈值I1;其中,当初始最大驱动电流值IOmax小于或等于第一电流阈值I1时,则确定钉仓组件20中不存在钉仓22;当初始最大驱动电流值IOmax大于第一电流阈值I1时,则确定钉仓组件20中存在钉仓22。如此,可在能够识别钉仓组件20中是否存在钉仓22的前提下,进一步降低监测电流的时间,减少器械的电能损耗,提高监测效率。S302’: Compare the initial maximum drive current value IOmax with the first current threshold I1; wherein, when the initial maximum drive current value IOmax is less than or equal to the first current threshold I1, it is determined that there is no staple cartridge 22 in the staple cartridge assembly 20; when the initial maximum drive current value IOmax is greater than the first current threshold I1, it is determined that there is a staple cartridge 22 in the staple cartridge assembly 20. In this way, while being able to identify whether there is a staple cartridge 22 in the staple cartridge assembly 20, the monitoring current time can be further reduced, the power consumption of the device can be reduced, and the monitoring efficiency can be improved.

一些实施例中,当识别钉仓组件20中存在钉仓22后,本公开实施例的钉仓状态识别方法可进一步包括:识别钉仓22中的缝合钉是否被击发,即判断钉仓组件中的钉仓是否为新钉仓。In some embodiments, after identifying the presence of a staple cartridge 22 in the staple cartridge assembly 20, the staple cartridge status identification method of this disclosure may further include: identifying whether the suture staples in the staple cartridge 22 have been fired, that is, determining whether the staple cartridge in the staple cartridge assembly is a new staple cartridge.

例如,上述钉仓状态识别方法进一步包括:For example, the above-mentioned method for identifying the status of nail storage devices further includes:

S400’:设定第二电流阈值I2,其中第二电流阈值I2大于第一电流阈值I1;以及S400’: Set a second current threshold I2, wherein the second current threshold I2 is greater than the first current threshold I1; and

S500’:比较初始最大驱动电流值IOmax和第二电流阈值I2;其中,当初始最大驱动电流值IOmax大于第二电流阈值I2时,则确定缝合钉没有被击发;当初始最大驱动电流值IOmax大于第一电流阈值I1且小于或等于第二电流阈值I2时,则确定缝合钉被击发。S500’: Compare the initial maximum drive current value IOmax with the second current threshold I2; wherein, when the initial maximum drive current value IOmax is greater than the second current threshold I2, it is determined that the suture staple has not been fired; when the initial maximum drive current value IOmax is greater than the first current threshold I1 and less than or equal to the second current threshold I2, it is determined that the suture staple has been fired.

本公开实施例中,第一电流阈值I1的取值范围为0.95~1.05A,第二电流阈值I2的取值范围为1.15~1.25A。一些实施例中,设定第一电流阈值I1为大约1A,第二电流阈值I2为大约1.1A。下面以初始最大驱动电流值IOmax作为被监测电流为例,具体说明钉仓的识别过程。首先,比较第一电流阈值I1和初始最大驱动电流值IOmax以确定是否安装有钉仓。例如,当IOmax小于或等于1A时,确定钉仓组件20中不存在钉仓22;当IOmax大于1A,则确定钉仓组件20中存在钉仓22。然后,进一步比较第二电流阈值I2和初始最大驱动电流值IOmax以确定该钉仓22中的缝合钉是否被击发(即确定是否为新钉仓)。当IOmax大于1A且小于或等于1.1A时,则确定缝合钉被击发;当IOmax大于1.1A时,则确定缝合钉未被击发。例如,本公开实施例中,电机空载时运行的驱动电流大约为1A,安装新钉仓(即缝合钉未被击发)的初始最大驱动电流值IOmax为大约1.2A,使用后的钉仓(即缝合钉已被击发)的初始最大驱动电流值IOmax为大约1.1A。需要说明的是,由于空载时运行的驱动电流保持不变,空载时初始最大驱动电流值IOmax也等于空载时的驱动电流。In this embodiment, the first current threshold I1 ranges from 0.95 to 1.05 A, and the second current threshold I2 ranges from 1.15 to 1.25 A. In some embodiments, the first current threshold I1 is set to approximately 1 A, and the second current threshold I2 is set to approximately 1.1 A. The following describes the staple cartridge identification process using the initial maximum drive current value IOmax as an example. First, the first current threshold I1 and the initial maximum drive current value IOmax are compared to determine whether a staple cartridge is installed. For example, when IOmax is less than or equal to 1 A, it is determined that there is no staple cartridge 22 in the staple cartridge assembly 20; when IOmax is greater than 1 A, it is determined that there is a staple cartridge 22 in the staple cartridge assembly 20. Then, the second current threshold I2 and the initial maximum drive current value IOmax are further compared to determine whether the suture staples in the staple cartridge 22 have been fired (i.e., whether it is a new staple cartridge). When IOmax is greater than 1A and less than or equal to 1.1A, it is determined that the suture pin has been fired; when IOmax is greater than 1.1A, it is determined that the suture pin has not been fired. For example, in this embodiment of the present disclosure, the drive current of the motor when it is unloaded is approximately 1A, the initial maximum drive current value IOmax when a new suture cartridge is installed (i.e., the suture pin has not been fired) is approximately 1.2A, and the initial maximum drive current value IOmax after the suture cartridge has been used (i.e., the suture pin has been fired) is approximately 1.1A. It should be noted that since the drive current when it is unloaded remains unchanged, the initial maximum drive current value IOmax when it is unloaded is also equal to the drive current when it is unloaded.

上述本公开实施例提供的外科手术器械的钉仓识别装置和钉仓状态识别方法中,通过监测闭合部件从初始位置移动到闭合位置过程中的最大驱动电流值,并且根据该最大驱动电流值,识别钉仓组件中是否存在钉仓,以达到识别钉仓状态的目的,不仅提高外科手术器械操作上的便利性,还降低器械误操作的风险。In the surgical instrument staple cartridge identification device and staple cartridge status identification method provided in the above-described embodiments, the maximum driving current value during the process of the closing component moving from the initial position to the closed position is monitored, and the presence of a staple cartridge in the staple cartridge assembly is identified based on the maximum driving current value, so as to achieve the purpose of identifying the staple cartridge status. This not only improves the convenience of surgical instrument operation, but also reduces the risk of instrument misoperation.

本文中,有以下几点需要注意:The following points should be noted in this article:

(1)本公开实施例附图只涉及到与本公开实施例涉及到的结构,其他结构可参考通常设计。(1) The accompanying drawings of the embodiments of this disclosure only involve the structures involved in the embodiments of this disclosure. Other structures can be referred to the general design.

(2)在不冲突的情况下,本公开的实施例及实施例中的特征可以相互组合以得到新的实施例。(2) Where there is no conflict, the embodiments of this disclosure and the features in the embodiments can be combined with each other to obtain new embodiments.

(3)以上所述仅是本公开的示范性实施方式,而非用于限制本公开的保护范围,本公开的保护范围由所附的权利要求确定。(3) The above description is merely an exemplary embodiment of this disclosure and is not intended to limit the scope of protection of this disclosure. The scope of protection of this disclosure is determined by the appended claims.

Claims (20)

一种外科手术器械的钉仓状态识别装置,包括:A staple cartridge status recognition device for surgical instruments includes: 末端执行器,包括钉砧和可操作地连接到所述钉砧的钉仓组件,所述钉仓组件构造为接收装有缝合钉的钉仓,所述末端执行器包括彼此相对的近端和远端;An end effector includes an anvil and a staple cartridge assembly operably connected to the anvil, the staple cartridge assembly being configured to receive a staple cartridge containing suture staples, the end effector including a proximal end and a distal end opposite to each other; 闭合组件,构造为沿从所述近端指向远端的轴向移动,所述闭合组件包括:可滑动的闭合部件和驱动所述闭合部件的闭合驱动部件,所述闭合部件具有初始位置和闭合位置,其中,所述闭合部件、所述钉仓组件和所述钉仓构造为:当所述闭合部件从所述初始位置移动到所述闭合位置过程中,所述钉仓组件被移动以靠近所述钉砧;A closure assembly configured to move along an axial direction from the proximal end to the distal end, the closure assembly comprising: a slidable closure member and a closure drive member for driving the closure member, the closure member having an initial position and a closed position, wherein the closure member, the staple cartridge assembly, and the staple cartridge are configured such that, as the closure member moves from the initial position to the closed position, the staple cartridge assembly is moved closer to the anvil; 驱动电机,配置为在驱动电流的作用下向所述闭合驱动部件提供驱动力;A drive motor is configured to provide driving force to the closed drive component under the action of a drive current; 电流监测电路,配置为监测所述闭合部件从所述初始位置移动到所述闭合位置过程中的最大驱动电流值;和A current monitoring circuit is configured to monitor the maximum drive current value during the process of the closed component moving from the initial position to the closed position; and 处理电路,与所述电流监测电路电连接并且配置为根据所述最大驱动电流值识别所述钉仓组件中是否存在所述钉仓。The processing circuit is electrically connected to the current monitoring circuit and configured to identify whether the staple cartridge is present in the staple cartridge assembly based on the maximum drive current value. 根据权利要求1所述的钉仓状态识别装置,其中,所述处理电路还配置为:According to claim 1, the staple cartridge status identification device, wherein the processing circuit is further configured as follows: 设定第一电流阈值,其中所述第一电流阈值大于零;以及A first current threshold is set, wherein the first current threshold is greater than zero; and 比较所述最大驱动电流值和所述第一电流阈值;其中,当所述最大驱动电流值小于或等于所述第一电流阈值时,则确定所述钉仓组件中不存在所述钉仓;当所述最大驱动电流值大于所述第一电流阈值时,则确定所述钉仓组件中存在所述钉仓。The maximum driving current value is compared with the first current threshold; wherein, when the maximum driving current value is less than or equal to the first current threshold, it is determined that the nail cartridge does not exist in the nail cartridge assembly; when the maximum driving current value is greater than the first current threshold, it is determined that the nail cartridge exists in the nail cartridge assembly. 根据权利要求2所述的钉仓状态识别装置,其中,所述处理电路还配置为:当识别所述钉仓组件中存在所述钉仓后,进一步识别所述钉仓中的缝合钉是否被击发。According to the staple cartridge status recognition device of claim 2, the processing circuit is further configured to: after recognizing the presence of the staple cartridge in the staple cartridge assembly, further recognize whether the suture staples in the staple cartridge have been fired. 根据权利要求3所述的钉仓状态识别装置,其中,所述处理电路还配置为:According to claim 3, the staple cartridge status identification device, wherein the processing circuit is further configured as follows: 设定第二电流阈值,其中所述第二电流阈值大于所述第一电流阈值;以及A second current threshold is set, wherein the second current threshold is greater than the first current threshold; and 比较所述最大驱动电流值和所述第二电流阈值;其中,当所述最大驱动电流值大于所述第一电流阈值且小于或等于所述第二电流阈值时,则确定所述缝合钉被击发;当所述最大驱动电流值大于所述第二电流阈值时,则确定所述缝合钉没有被击发。The maximum driving current value is compared with the second current threshold; wherein, when the maximum driving current value is greater than the first current threshold and less than or equal to the second current threshold, it is determined that the suture staple has been fired; when the maximum driving current value is greater than the second current threshold, it is determined that the suture staple has not been fired. 根据权利要求4所述的钉仓状态识别装置,其中,所述第一电流阈值为0.95~1.05A,所述第二电流阈值为1.15~1.25A。According to claim 4, the staple cartridge status identification device, wherein the first current threshold is 0.95 to 1.05 A, and the second current threshold is 1.15 to 1.25 A. 根据权利要求1至4任一项所述的钉仓状态识别装置,其中,The staple cartridge status identification device according to any one of claims 1 to 4, wherein, 所述闭合部件还具有位于所述初始位置和所述闭合位置之间的闭合起始位置;The closing component also has a closing start position located between the initial position and the closing position; 所述闭合部件、所述钉仓组件和所述钉仓构造为:当所述闭合部件位于所述初始位置时,所述钉仓组件和所述钉砧之间具有最大间距;当所述闭合部件位于所述闭合位置时,所述钉仓组件和所述钉砧之间具有最小间距;当所述闭合部件位于所述闭合起始位置时,所述钉仓组件开始向所述钉砧靠近;The closing member, the staple cartridge assembly, and the staple cartridge are configured such that: when the closing member is in the initial position, there is a maximum distance between the staple cartridge assembly and the anvil; when the closing member is in the closed position, there is a minimum distance between the staple cartridge assembly and the anvil; and when the closing member is in the closing start position, the staple cartridge assembly begins to move closer to the anvil. 所述电流监测电路配置为监测所述闭合部件从所述初始位置移动到所述闭合起始位置过程中的初始最大驱动电流值;The current monitoring circuit is configured to monitor the initial maximum drive current value during the process of the closing component moving from the initial position to the closing start position; 所述处理电路配置为根据所述初始最大驱动电流值识别所述钉仓组件中是否存在所述钉仓。The processing circuit is configured to identify whether the staple cartridge exists in the staple cartridge assembly based on the initial maximum drive current value. 根据权利要求6所述的钉仓状态识别装置,其中,所述处理电路还配置为:According to the staple cartridge status identification device of claim 6, the processing circuit is further configured to: 设定第一电流阈值,其中所述第一电流阈值大于零;以及A first current threshold is set, wherein the first current threshold is greater than zero; and 比较所述初始最大驱动电流值和所述第一电流阈值;其中,当所述初始最大驱动电流值小于或等于所述第一电流阈值时,则确定所述钉仓组件中不存在所述钉仓;当所述初始最大驱动电流值大于所述第一电流阈值时,则确定所述钉仓组件中存在所述钉仓。The initial maximum drive current value is compared with the first current threshold; wherein, when the initial maximum drive current value is less than or equal to the first current threshold, it is determined that the nail cartridge does not exist in the nail cartridge assembly; when the initial maximum drive current value is greater than the first current threshold, it is determined that the nail cartridge exists in the nail cartridge assembly. 根据权利要求7所述的钉仓状态识别装置,其中,所述处理电路还配置为:当确定所述钉仓组件中存在所述钉仓后,进一步确定所述钉仓中的缝合钉是否被击发。According to the staple cartridge status recognition device of claim 7, the processing circuit is further configured to: after determining that the staple cartridge exists in the staple cartridge assembly, further determine whether the suture staples in the staple cartridge have been fired. 根据权利要求8所述的钉仓状态识别装置,其中,所述处理电路还配置为:According to claim 8, the staple cartridge status identification device, wherein the processing circuit is further configured to: 设定第二电流阈值,其中所述第二电流阈值大于所述第一电流阈值;以及A second current threshold is set, wherein the second current threshold is greater than the first current threshold; and 比较所述初始最大驱动电流值和所述第二电流阈值;其中,当所述初始最大驱动电流值大于所述第一电流阈值且小于或等于所述第二电流阈值时,则确定所述缝合钉被击发;当所述初始最大驱动电流值大于所述第二电流阈值时,则确定所述缝合钉没有被击发。The initial maximum drive current value is compared with the second current threshold; wherein, when the initial maximum drive current value is greater than the first current threshold and less than or equal to the second current threshold, it is determined that the suture pin has been fired; when the initial maximum drive current value is greater than the second current threshold, it is determined that the suture pin has not been fired. 根据权利要求1至9任一项所述的钉仓状态识别装置,其中,The staple cartridge status identification device according to any one of claims 1 to 9, wherein, 所述钉仓包括出钉面,所述出钉面具有出钉区和非出钉区,所述非出钉区位于所述出钉区靠近所述近端的一侧;The staple cartridge includes a staple ejection surface, which has a staple ejection area and a non-staple ejection area, wherein the non-staple ejection area is located on the side of the staple ejection area closer to the proximal end; 所述钉砧包括抵钉面和设置在所述抵钉面上的至少一个弹片,所述弹片朝所述非出钉区延伸,以使所述钉仓组件移动靠近所述钉砧时,所述弹片和所述钉仓具有如下位置关系:当所述钉仓组件中存在所述钉仓时,所述弹片抵靠于所述钉仓的非出钉区;当所述钉仓组件中不存在所述钉仓时,所述弹片与所述钉仓的非出钉区不接触。The anvil includes an abutment surface and at least one spring piece disposed on the abutment surface. The spring piece extends toward the non-discharge area so that when the staple cartridge assembly moves closer to the anvil, the spring piece and the staple cartridge have the following positional relationship: when the staple cartridge is present in the staple cartridge assembly, the spring piece abuts against the non-discharge area of the staple cartridge; when the staple cartridge is not present in the staple cartridge assembly, the spring piece does not contact the non-discharge area of the staple cartridge. 根据权利要求10所述的钉仓状态识别装置,其中,According to the staple cartridge status identification device of claim 10, wherein, 所述抵钉面具有抵钉区和非抵钉区,所述非抵钉区位于所述抵钉区靠近所述近端的一侧;The anvil surface has an anvil area and a non-anvil area, the non-anvil area being located on the side of the anvil area closer to the proximal end; 所述至少一个弹片包括在其延伸方向上彼此相对的头端和尾端,所述尾端连接于所述非抵钉区,所述头端为悬出端且朝所述非出钉区延伸,以使所述钉仓组件移动靠近所述钉砧且所述钉仓组件中存在所述钉仓时,所述至少一个弹片的悬出端抵靠于所述非出钉区。The at least one spring includes a head end and a tail end opposite to each other in its extending direction, the tail end being connected to the non-anchored area, and the head end being a protruding end extending toward the non-outlet area, such that when the staple cartridge assembly moves close to the anvil and the staple cartridge is present in the staple cartridge assembly, the protruding end of the at least one spring abuts against the non-outlet area. 根据权利要求11所述的钉仓状态识别装置,其中,所述钉仓组件还包括:According to the staple cartridge status recognition device of claim 11, the staple cartridge assembly further includes: 底壳,所述底壳限定用于接收所述钉仓的狭长通道,所述钉仓可拆卸地安装在所述狭长通道中;A bottom shell defining an elongated channel for receiving the staple cartridge, the staple cartridge being detachably mounted in the elongated channel; 推钉组件,所述推钉组件配置为将所述缝合钉从所述钉仓中推出,所述推钉组件包括推钉部件,所述推钉部件位于所述钉仓和所述底壳之间并且构造为在靠近所述近端的近侧位置和靠近所述远端的远侧位置之间移动;A staple pusher assembly configured to push the staples out of the staple cartridge, the staple pusher assembly including a staple pusher component located between the staple cartridge and the bottom shell and configured to move between a proximal position near the proximal end and a distal position near the distal end; 其中,所述推钉组件构造为:当所述推钉部件移动到所述远侧位置时,所述钉仓和所述底壳在所述近侧位置处留有间隙,使得当所述弹片抵靠于所述非出钉区时,所述钉仓具有下降空间;当所述推钉部件移动到近侧位置时,所述间隙被推钉部件所占据,使得当所述弹片抵靠于所述非出钉区时,所述钉仓保持不动。The pusher assembly is configured such that when the pusher component moves to the distal position, a gap is left between the nail cartridge and the bottom shell at the proximal position, so that the nail cartridge has room to descend when the spring abuts against the non-nail ejection area; when the pusher component moves to the proximal position, the gap is occupied by the pusher component, so that the nail cartridge remains stationary when the spring abuts against the non-nail ejection area. 根据权利要求11或12所述的钉仓状态识别装置,其中,According to the staple cartridge status identification device of claim 11 or 12, wherein, 所述抵钉面具有沿所述轴向延伸的刀槽,所述闭合部件包括切割部,所述切割部构造为在所述刀槽中移动;The anvil surface has a groove extending along the axial direction, and the closing member includes a cutting portion configured to move within the groove; 所述抵钉区包括第一抵钉子区和第二抵钉子区,所述第一抵钉子区和所述第二抵钉子区分别位于所述刀槽的相对两侧;The anvil area includes a first anvil area and a second anvil area, which are located on opposite sides of the cutter groove, respectively. 所述非抵钉区包括第一非抵钉子区和第二非抵钉子区,所述第一非抵钉子区和所述第二非抵钉子区分别位于所述刀槽的相对两侧;The non-anchored area includes a first non-anchored area and a second non-anchored area, which are located on opposite sides of the cutter groove, respectively. 所述至少一个弹片包括两个弹片,所述两个弹片包括第一弹片和第二弹片,所述第一弹片连接于所述第一非抵钉子区,所述第二弹片连接于所述第二非抵钉子区。The at least one spring includes two springs, the two springs being a first spring and a second spring, the first spring being connected to the first non-nail area, and the second spring being connected to the second non-nail area. 根据权利要求13所述的钉仓状态识别装置,其中,According to the staple cartridge status identification device of claim 13, wherein, 所述出钉面具有沿所述轴向延伸的对向刀槽,所述切割部构造为同时在所述刀槽和所述对向刀槽中移动;The nail-out surface has opposing blade grooves extending along the axial direction, and the cutting part is configured to move simultaneously in the blade groove and the opposing blade groove; 所述出钉区包括第一出钉子区和第二出钉子区,所述第一出钉子区和所述第二出钉子区分别位于所述刀槽的相对两侧;The nail ejection area includes a first nail ejection area and a second nail ejection area, which are located on opposite sides of the blade groove, respectively. 所述非出钉区包括第一非出钉子区和第二非出钉子区,所述第一非出钉子区和所述第二非出钉子区分别位于所述刀槽的相对两侧;The non-nail-out area includes a first non-nail-out area and a second non-nail-out area, which are located on opposite sides of the cutter groove, respectively. 所述第一弹片构造为:当所述钉仓组件中存在所述钉仓时,所述第一弹片抵靠所述第一非出钉子区;当所述钉仓组件中不存在所述钉仓时,所述第一弹片与所述第一非出钉子区不接触;The first spring is configured such that when the staple cartridge is present in the staple cartridge assembly, the first spring abuts against the first non-staple ejection area; when the staple cartridge is not present in the staple cartridge assembly, the first spring does not contact the first non-staple ejection area. 所述第二弹片构造为:当所述钉仓组件中存在所述钉仓时,所述第二弹片抵靠所述第二非出钉子区;当所述钉仓组件中不存在所述钉仓时,所述第二弹片与所述第二非出钉子区不接触。The second spring is configured such that when the staple cartridge is present in the staple cartridge assembly, the second spring abuts against the second non-staple ejection area; when the staple cartridge is not present in the staple cartridge assembly, the second spring does not contact the second non-staple ejection area. 一种外科手术器械,包括权利要求1至14中任一项所述的钉仓状态识别装置。A surgical instrument comprising the staple cartridge status recognition device as described in any one of claims 1 to 14. 一种外科手术器械的钉仓状态识别方法,包括:A method for recognizing the status of a staple cartridge in a surgical instrument includes: 驱动闭合部件从初始位置移动到闭合位置;Drive the closing component to move from the initial position to the closed position; 监测所述闭合部件从所述初始位置移动到所述闭合位置过程中的最大驱动电流值;以及Monitor the maximum drive current value during the process of the closing component moving from the initial position to the closed position; and 根据所述最大驱动电流值,识别所述钉仓组件中是否存在所述钉仓。Based on the maximum drive current value, identify whether the staple cartridge exists in the staple cartridge assembly. 根据权利要求16所述的钉仓状态识别方法,其中,所述根据所述最大驱动电流值识别所述钉仓组件中是否存在所述钉仓,包括:According to the method for identifying the status of the nail cartridge according to claim 16, the step of identifying whether the nail cartridge exists in the nail cartridge assembly based on the maximum drive current value includes: 设定第一电流阈值,其中所述第一电流阈值大于零;以及A first current threshold is set, wherein the first current threshold is greater than zero; and 比较所述最大驱动电流值和所述第一电流阈值;其中,当所述最大驱动电流值小于或等于所述第一电流阈值时,则确定所述钉仓组件中不存在所述钉仓;当所述最大驱动电流值大于所述第一电流阈值时,则确定所述钉仓组件中存在所述钉仓。The maximum driving current value is compared with the first current threshold; wherein, when the maximum driving current value is less than or equal to the first current threshold, it is determined that the nail cartridge does not exist in the nail cartridge assembly; when the maximum driving current value is greater than the first current threshold, it is determined that the nail cartridge exists in the nail cartridge assembly. 根据权利要求17所述的钉仓状态识别方法,其中,当识别所述钉仓组件中存在所述钉仓后,所述钉仓状态识别方法还包括:识别所述钉仓中的缝合钉是否被击发。According to the staple cartridge status identification method of claim 17, when the presence of the staple cartridge in the staple cartridge assembly is identified, the staple cartridge status identification method further includes: identifying whether the suture staples in the staple cartridge have been fired. 根据权利要求18所述的钉仓状态识别方法,其中,所述识别所述钉仓中的缝合钉是否被击发,包括:According to the staple cartridge status recognition method of claim 18, the step of recognizing whether the suture staples in the staple cartridge have been fired includes: 设定第二电流阈值,其中所述第二电流阈值大于所述第一电流阈值;以及A second current threshold is set, wherein the second current threshold is greater than the first current threshold; and 比较所述最大驱动电流值和所述第二电流阈值;其中,当所述最大驱动电流值大于所述第一电流阈值且小于或等于所述第二电流阈值时,则确定所述缝合钉被击发;当所述最大驱动电流值大于所述第二电流阈值时,则确定所述缝合钉没有被击发。The maximum driving current value is compared with the second current threshold; wherein, when the maximum driving current value is greater than the first current threshold and less than or equal to the second current threshold, it is determined that the suture staple has been fired; when the maximum driving current value is greater than the second current threshold, it is determined that the suture staple has not been fired. 根据权利要求16至19任一项所述的钉仓状态识别方法,其中,所述初始位置和所述闭合位置之间设置有闭合起始位置,所述闭合部件从所述初始位置经所述闭合起始位置移动到所述闭合起始位置;According to any one of claims 16 to 19, the method for recognizing the status of a staple cartridge is wherein a closing start position is provided between the initial position and the closed position, and the closing component moves from the initial position through the closing start position to the closing start position; 所述监测所述闭合部件从所述初始位置移动到所述闭合位置过程中的最大驱动电流值,包括:The monitoring of the maximum drive current value during the process of the closing component moving from the initial position to the closed position includes: 监测所述闭合部件从所述初始位置移动到所述闭合起始位置过程中的初始最大驱动电流值;Monitor the initial maximum drive current value during the process of the closing component moving from the initial position to the closing start position; 所述根据所述最大驱动电流值识别所述钉仓组件中是否存在所述钉仓包括:根据初始最大驱动电流值,识别所述钉仓组件中是否存在所述钉仓。The step of identifying whether the stapler is present in the stapler assembly based on the maximum drive current value includes: identifying whether the stapler is present in the stapler assembly based on the initial maximum drive current value.
PCT/CN2025/093434 2024-05-09 2025-05-08 Staple cartridge status identification device and identification method, and surgical instrument Pending WO2025232830A1 (en)

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