WO2020125677A1 - 旋钮组件及圆管型吻合器 - Google Patents

旋钮组件及圆管型吻合器 Download PDF

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Publication number
WO2020125677A1
WO2020125677A1 PCT/CN2019/126299 CN2019126299W WO2020125677A1 WO 2020125677 A1 WO2020125677 A1 WO 2020125677A1 CN 2019126299 W CN2019126299 W CN 2019126299W WO 2020125677 A1 WO2020125677 A1 WO 2020125677A1
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WO
WIPO (PCT)
Prior art keywords
knob
orientation
stapler
clutch
mating
Prior art date
Application number
PCT/CN2019/126299
Other languages
English (en)
French (fr)
Inventor
陈志�
郭毅
林江
Original Assignee
天臣国际医疗科技股份有限公司
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
Priority claimed from CN201811549373.9A external-priority patent/CN111329545A/zh
Priority claimed from CN201822132546.9U external-priority patent/CN209529238U/zh
Application filed by 天臣国际医疗科技股份有限公司 filed Critical 天臣国际医疗科技股份有限公司
Publication of WO2020125677A1 publication Critical patent/WO2020125677A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/115—Staplers for performing anastomosis in a single operation

Definitions

  • the invention relates to the technical field of medical equipment, in particular to a knob assembly and a circular tube-type stapler.
  • Gastrointestinal diseases are one of the most common diseases in humans.
  • a circular tube-type stapler is often used to replace the doctor's manual operation to anastomize the digestive tract and other physiological tissues.
  • the round tube stapler is a common surgical instrument. Most of them use axial inward binding. During the operation, they form an end-to-end or end-to-side anastomosis of the esophagus, stomach, intestine and other physiological tissues.
  • the segmental tissues are contained and contained in the stapler, and after the firing is completed, a circular anastomosis is formed on the tissue to reconstruct the human body channel.
  • a round tube type stapler includes a stapler body, an operation handle movably connected to the stapler body, and a nail anvil assembly cooperating with the body.
  • the stapler body includes a staple cartridge assembly disposed at a distal end, the staple cartridge assembly includes a ring-shaped staple cartridge, a cutter; and a knob disposed at a proximal end of the body, the knob can rotate relative to the body, and the stapler
  • the interior of the body also includes a nail anvil shaft disposed from the proximal end to the distal end.
  • the distal end and the proximal end are relative to the operator.
  • the end closer to the operator is the proximal end, and the end farther from the operator, that is, the end closer to the operation position is the distal end.
  • the inside and the outside are relative to the axis of the stapler, the side near the axis is the inside, and the side away from the axis is the outside.
  • the nail anvil assembly includes a nail anvil, a nail anvil cap disposed at a distal end of the nail anvil, and a knife anvil disposed inside the nail anvil.
  • the nail anvil assembly may be directly connected to the distal end of the nail anvil shaft or connected through a nail anvil shaft connection .
  • the nail anvil shaft penetrates from the purse of the stump tissue and is located at the distal end of the stapler body. Rotate the knob to gradually reduce the distance between the nail anvil assembly and the nail cartridge After reaching a suitable distance, it can reach the firing state, and then the operating handle can be used to complete the anastomosis.
  • the round tube stapler is also more and more widely used in the treatment of diseases such as hemorrhoids.
  • the knob In the process of rotating the knob to make the anvil assembly approach the staple cartridge, sometimes the knob can be rotated after the tissue is closed in place, so that the staple anvil assembly and the staple cartridge will continue to approach and continue to compress the tissue, causing tissue Excessive squeezing may even crush the tissue, which is very detrimental to the surgical results.
  • the object of the present invention is to provide a knob assembly and a tube-shaped stapler.
  • the knob When the knob is rotated, when the resistance of the knob reaches the preset resistance value, the knob will not be able to transmit a larger Torque, the knob at this time enters the failure mode, the gap between the anvil assembly and the staple cartridge remains unchanged, without causing the tissue to be over-squeezed, and the preset resistance value is adjustable.
  • An embodiment of the present invention provides a knob assembly for a round tube-type stapler, and a screw rod is provided inside the stapler; the knob assembly includes:
  • a knob body the knob body is sleeved on the outside of the screw rod, a drive member is provided on the knob body, a first fitting member is provided on a proximal end surface of the drive member, and the wire is driven when the knob body rotates Rod axial movement;
  • the clutch member is located at the proximal end of the driving member, and the distal end surface of the clutch member has a second mating member corresponding to the first mating member.
  • the second mating member may be opposite to the first mating member. Axial movement, and when the second mating member is in contact with the first mating member, the rotation of the clutch member rotates the knob body;
  • An adjusting member is located at the proximal end of the clutch member, a compression spring is provided between the adjusting member and the clutch member, and the adjusting member can move relative to the clutch member in the axial direction of the stapler.
  • a second orientation portion is provided on the inner side of the adjustment member, the adjustment member is sleeved on the proximal end of the knob body, and a first orientation portion is provided on the proximal end of the knob body, the The second orientation portion cooperates with the first orientation portion, and the second orientation portion can only move axially relative to the first orientation portion.
  • a torsion adjustment cover is further included, and the distal end of the torsion adjustment cover cooperates with the proximal end of the adjustment member.
  • the mating surface of the distal end of the torque adjustment cover and the proximal end of the adjustment member is a spiral surface, or the mating surface of the distal end of the torque adjustment cover and the proximal end of the adjustment member is an inclined surface.
  • knob housing an inner side of the proximal end of the knob housing is provided with an arc-shaped limiting groove, and an outer side of the torque adjustment cover is provided with a limiting block, and the limiting block is embedded in the In the limit slot;
  • a limiting block is provided on the inner side of the proximal end of the knob housing, an arc-shaped limiting slot is provided on the outer side of the torsion adjustment cover, and the limiting block is embedded in the limiting slot.
  • the first orientation portion includes at least one first orientation groove extending in the axial direction of the stapler, and the second orientation portion is a first orientation corresponding to the first orientation groove Directional rib, the first directional rib extends into the first directional groove and is movable along the extending direction of the first directional groove; or
  • the first orientation part includes at least one first orientation rib extending in the axial direction of the stapler, and the second orientation part is a first orientation groove corresponding to the first orientation rib one by one, so The first orientation rib extends into the first orientation groove and can move along its extension direction.
  • the first matching piece is a first protrusion
  • the second matching piece is a second protrusion
  • the first matching piece is a first protrusion, and the second matching piece is a groove;
  • the first fitting piece is a groove
  • the second fitting piece is a protrusion
  • the first mating member includes a first side
  • the second mating member includes a third side.
  • the first side of the first mating member is The third side surface of the second mating member is contact-fitted, and the first side surface of the first mating member is inclined toward the first direction.
  • the first mating member further includes a second side surface
  • the second mating member further includes a fourth side surface.
  • the clutch member rotates in the second direction under external force, the second of the first mating member The side surface is in contact with and engaged with the fourth side surface of the second matching member;
  • the second side face of the first fitting piece is a right-angle face, or the second side face of the first fitting piece is inclined toward the second direction and the second side face of the first fitting piece is less inclined than the first side face Tilt.
  • first side of the first mating member and the third side of the second mating member are both flat or mating curved surfaces
  • the second side of the first mating member and the fourth side of the second mating member The sides are flat or matching curved surfaces.
  • the clutch member includes a clutch ring, and the clutch ring is sleeved on the outside of the knob body.
  • At least one second directional groove is provided on the side surface of the clutch member, and an inner surface of the knob housing of the knob assembly is provided with a second directional rib corresponding to the second directional groove, the first The two directional ribs extend along the axial direction of the stapler and extend into the second directional groove, and the second directional groove can move along the extending direction of the second directional rib; or
  • At least one second directional rib is provided on the side of the clutch member, and an inner surface of the knob housing of the knob assembly is provided with a second directional groove corresponding to the second directional rib, and the second directional rib The axial direction of the stapler extends into the second orientation groove.
  • the inner surface of the knob housing of the knob assembly is provided with a stepped portion, and the stepped portion is located on the distal end surface of the clutch.
  • a rear cover of the knob is also included.
  • the distal end of the knob back cover is provided with internal thread of the rear cover, and the proximal end of the knob body is provided with external thread matching with the internal thread of the rear cover.
  • An embodiment of the present invention also provides a round tube type stapler including the knob assembly.
  • the invention provides a knob assembly for a round tube-type stapler.
  • the knob assembly is divided into a knob body and a clutch member. When the resistance of the knob body reaches the preset resistance value, rotating the clutch member can bring the knob body together Rotating, the knob body can drive the anvil assembly to move along the axial direction of the stapler and close to the staple cartridge.
  • the clutch cannot drive the knob body to rotate, and the knob assembly enters the failure mode ,
  • the gap between the anvil assembly and the staple cartridge remains unchanged, without causing the tissue to be over-squeezed;
  • the preset value is the pressure limit of the tissue clamped between the anvil assembly and the staple cartridge assembly, the resistance
  • the set value is related to the spring force of the compression spring at the proximal end of the clutch.
  • FIG. 1 is a schematic structural diagram of an anastomotic device according to an embodiment of the present invention.
  • FIG. 2 is a schematic diagram of the knob assembly and the screw rod according to an embodiment of the present invention.
  • FIG. 3 is a schematic structural view of a knob body according to an embodiment of the invention.
  • FIG. 4 is a schematic structural view of a clutch ring according to an embodiment of the invention.
  • FIG. 5 and 6 are schematic structural views of a knob housing according to an embodiment of the invention.
  • FIG. 7 is a schematic structural view of an adjusting member according to an embodiment of the invention.
  • FIG. 8 is a schematic structural view of a torque adjustment cover according to an embodiment of the invention.
  • FIG. 9 is a schematic structural diagram of a first knob back cover according to an embodiment of the present invention.
  • FIG. 10 is a schematic diagram of a clutch ring and a compression spring in an initial state according to an embodiment of the invention
  • FIG. 11 is a schematic diagram of a clutch ring and a compression spring in a failure state according to an embodiment of the present invention.
  • the present invention provides a knob assembly for a round tube-type stapler.
  • the round-tube type stapler includes a knob body, a clutch member, and an adjustment member.
  • the knob body is sleeved On the outside of the screw rod, a drive member is provided on the knob body, and a first fitting member is provided on the proximal end surface of the drive member.
  • the clutch member Located at the proximal end of the driving member, a second mating member is provided on the distal end surface of the clutch member, the second mating member can move axially relative to the first mating member, and the second mating member and the second mating member
  • the rotation of the clutch member drives the knob body to rotate
  • the second mating member has a first state that can drive the first mating member, and a second state that cannot drive the first mating member status.
  • the second fitting is in the first state
  • the rotation of the clutch drives the knob body to rotate.
  • the second fitting is in the second state, the rotation of the clutch does not drive the knob body to rotate.
  • the clutch member moves axially proximally relative to the knob body; the adjustment member is located at the proximal end of the clutch member, a compression spring is provided between the adjustment member and the clutch member, and the adjustment The member is movable in the axial direction of the stapler relative to the clutch member.
  • the knob assembly is divided into a knob body and a clutch member.
  • an adjustment member and a positioning compression spring are provided at the proximal end of the knob body.
  • the axial movement of the clutch member toward the distal end of the stapler will be hindered by the compression spring, that is, the axial movement of the clutch member needs to overcome the spring force of the compression spring.
  • the driving part and the clutch part of the knob body together constitute a clutch structure.
  • Rotating the clutch member can drive the knob body to rotate together.
  • the knob body can drive the nail anvil assembly Move along the axial direction of the stapler and approach the staple cartridge; when the resistance of the knob reaches the preset resistance value, the clutch mechanism cannot transmit torque greater than the resistance of the knob body, and the clutch moves toward the proximal end of the stapler and disengages from the drive And the compression spring is pressed. At this time, the clutch cannot drive the knob body to rotate, the knob assembly enters the failure mode, and the gap between the nail anvil assembly and the nail cartridge remains unchanged, without causing excessive tissue compression.
  • the magnitude of the preset resistance value is determined by the inclination of the contact surface between the driving member and the clutch member and the spring force of the compression spring. For the same compression spring, at different degrees of compression, its spring force is different, the spring force is equal to the spring stiffness multiplied by the amount of compression, therefore, the greater the amount of compression, the greater the spring force, the smaller the amount of compression, The smaller the spring force. Therefore, the present invention further adjusts the preset resistance value by adjusting the initial compression degree of the compression spring.
  • the magnitude of the preset resistance value corresponds to the magnitude of the maximum tissue squeezing force that compresses the tissue between the anvil assembly and the cartridge assembly.
  • the compression spring is disposed between the clutch member and the adjustment member, the adjustment member can move along the axial direction of the stapler, when the adjustment member approaches the clutch member, the preset resistance value further increases, and when the adjustment member moves away from the clutch member, the resistance The preset value is further reduced.
  • An embodiment of the present invention also provides a round tube-type stapler.
  • the knob assembly is located at a proximal end of the stapler.
  • a staple cartridge assembly and a nail anvil assembly are provided at the distal end of the stapler.
  • the nail anvil assembly It is connected to the distal end of the screw rod by a nail anvil shaft or directly connected to the distal end of the screw rod.
  • the knob body When the knob body is rotated, the nail anvil assembly can be driven to move along the axial direction of the stapler by the nail anvil shaft, so as to approach or move away from the nail cartridge assembly.
  • the clutch mechanism can transmit torque greater than the resistance of the knob body, the compression spring maintains the initial state, no deformation or a certain amount of initial deformation occurs, the clutch member drives the knob body to rotate in the first direction, that is, the second mating member is in In the first state, the first mating member is driven, and the anvil assembly is driven by the anvil shaft and the screw to gradually approach the nail cartridge assembly.
  • the knob body When the proper distance is reached between the anvil assembly and the cartridge assembly, and the squeezing force on the tissue reaches a suitable predetermined value, then turn the knob, the knob body will be subjected to resistance that hinders the rotation in the first direction, this resistance corresponds to the nail
  • the tissue squeezing force between the anvil assembly and the staple cartridge assembly at this time, only when a rotational torque greater than the resistance is applied to the knob body can the knob body be rotated in the first direction.
  • the stapler includes a stapler body and an anvil assembly 83, wherein the stapler body includes a stapler housing 81, a staple cartridge assembly 82 located at the distal end of the stapler housing 81, and a proximal end at the stapler housing 81
  • the knob assembly rotates, the nail anvil assembly 83 is driven to move axially through the screw rod and the anvil shaft sequentially, away from or near the nail cartridge assembly 82.
  • the nail anvil assembly 83 is directly connected to the stapler body, and the nail anvil assembly 83 cannot be anastomosed from The nail body is removed, and the nail anvil assembly 83 does not include a nail anvil shaft, and the nail anvil is directly fixedly connected to the distal end of the screw shaft 85.
  • the present invention will be described by taking an example of such a stapler.
  • the knob assembly includes a knob body 1, a clutch member, and an adjustment member 5.
  • the knob body 1 is sleeved on the outside of the screw 85, and the knob body 1 is provided with a driving member 14.
  • the proximal end surface of the driving member 14 is provided with a first matching member, and the internal body of the knob body 1 is provided with internal thread 13 which cooperates with the screw 85 of the stapler.
  • the clutch member is located at the proximal end of the driving member 14, a second mating member is provided on the distal end surface of the clutch member, and the second mating member can be opposite to The first mating member moves axially, and the second mating member has a first state that can drive the first mating member and a second state that cannot drive the first mating member.
  • the rotation of the clutch member drives the knob body 1 to rotate, and when the second mating member is in the second state, the rotation of the clutch member does not drive the knob body to rotate,
  • the clutch member moves axially proximally with respect to the knob body;
  • the adjustment member 5 is located at the proximal end of the stapler, and a compression spring 3 is provided between the adjustment member 5 and the clutch member, and the The adjusting member 5 can move relative to the clutch member in the axial direction of the stapler to move away from or close to the clutch member.
  • the clutch member includes a clutch ring 2, the clutch ring 2 is sleeved on the knob body 1, and the adjusting member 5 may use an adjusting washer.
  • the first fitting member is disposed on the proximal end surface of the driving member 14.
  • the first matching member may be a first protrusion 11, and the second matching member may be a second protrusion 21.
  • the first matching member and the second matching member can also be selected as other structures, for example, the first matching member is a protrusion, the second matching member is a groove that cooperates with the protrusion, or the first The mating member is a groove, the second mating member is a protrusion that cooperates with the groove, and the like, which all fall within the protection scope of the present invention.
  • the first protrusion 11 includes a first side 111
  • the second protrusion 21 includes a third side 211
  • the first protrusion when the clutch ring 2 rotates in a first direction 61 under external force, the first protrusion
  • the first side 111 of the first protrusion 11 is in contact with the third side 211 of the second protrusion 21, and the first side 111 of the first protrusion 11 is inclined toward the first direction 61.
  • the inclination direction of the third side surface 211 of the second protrusion 21 corresponds to the first side surface 111.
  • the first direction 61 is clockwise and the second direction 62 is counterclockwise.
  • the screw 85 moves toward the proximal end of the stapler and drives the anvil assembly 83 closer to the staple cartridge assembly 82 in a counterclockwise direction
  • the screw rod 85 moves toward the distal end of the stapler, and drives the nail anvil assembly 83 away from the nail cartridge assembly 82.
  • the first side surface 111 and the third side surface 211 are inclined surfaces.
  • the clutch ring 2 rotates in the first direction 61 under external force
  • the reaction force of the knob body 1 to the clutch ring 2 is decomposed by the inclined plane, and after the decomposition, the force along the axial direction of the stapler pushes the clutch ring 2 to move toward the proximal end of the stapler.
  • the compression spring 3 is deformed, so that the knob body 1 and the clutch ring 2 are gradually separated from each other.
  • the preset resistance value may be determined by the magnitude of the spring force of the compression spring 3 and the degree of inclination of the first side 111 and the third side 211.
  • the clutch ring 2 rotates clockwise and does not interlock with the knob body 1
  • the second protrusion 21 having a displacement at the end is more easily separated from the first protrusion 11.
  • the first protrusion 11 further includes a second side 112
  • the second protrusion 21 further includes a fourth side 212.
  • the second side surface 112 of the first protrusion 11 is a right angle surface, and correspondingly, the fourth side surface 212 of the second protrusion 21 is also a right angle surface.
  • the right-angle surface here refers to the surface of the second side 112 of the first protrusion 11 perpendicular to the driving member 14.
  • the second side surface 112 of the first protrusion 11 may also be inclined toward the second direction 62 and the second side surface 112 of the first protrusion 11 is less inclined than the first side of the first protrusion 11
  • the inclination degree of one side 111 corresponds to the inclination direction and angle of the fourth side 212 of the second protrusion 21 corresponding to the second side 112.
  • the first side 111 of the first protrusion 11 and the third side 211 of the second protrusion 21 are both flat or matching curved surfaces, and the second side 112 and the second protrusion 21 of the first protrusion 11
  • the fourth side 212 is a flat surface or a matching curved surface.
  • the magnitude of the preset resistance value is determined by the inclination of the contact surface between the driving member 14 and the clutch ring 2 and the spring force of the compression spring 3. For the same compression spring 3, at different degrees of compression, the spring force is different. Therefore, the present invention further adjusts the magnitude of the resistance preset value by adjusting the initial compression degree of the compression spring 3, that is, the initial deformation amount, that is, the magnitude of the maximum tissue pressing force.
  • the adjustment member 5 can move along the axial direction of the stapler. When the adjustment member approaches the clutch ring 2, the preset resistance value further increases, and the maximum tissue squeezing force increases. When the adjustment member moves away from the clutch ring 2, the resistance preset The value is further reduced and the maximum tissue pressing force is reduced.
  • the limit value of the pressing force can be changed by the movement of the adjusting member 5.
  • the inner side of the adjusting member 5 is provided with a second orientation portion
  • the adjusting member 5 is sleeved on the proximal end of the knob body 1
  • the proximal end of the knob body 1 is provided with a first An orientation portion
  • the second orientation portion cooperates with the first orientation portion
  • the second orientation portion can only move axially relative to the first orientation portion.
  • the first orientation portion includes at least one first orientation groove 15 extending in the axial direction of the stapler
  • the second orientation portion corresponds to the first orientation groove 15 in one-to-one correspondence
  • the first orientation rib 52 extends into the first orientation groove 15 and is movable along the extending direction of the first orientation groove 15.
  • the first orientation portion may also include at least one first orientation rib extending in the axial direction of the stapler, and the second orientation portion corresponds to the first orientation rib
  • the first directional groove, the directional rib extends into the groove and can move along its extension direction.
  • the knob assembly further includes a torque adjustment cover 6, the distal end of the torque adjustment cover 6 cooperates with the proximal end of the adjustment member 5, and the torque adjustment cover 6 is relative to the knob body 1 When rotating, the adjustment member 5 is driven to move in the axial direction of the stapler.
  • the mating surface of the distal end of the torque adjustment cover 6 and the proximal end of the adjustment member 5 is a spiral surface.
  • the distal end surface of the torque adjustment cover 6 is the second spiral surface 61
  • the proximal end surface of the adjustment member 5 is the first spiral surface 51. Since the spiral surfaces are in surface contact, the torque can be increased The degree of cooperation between the adjustment cover 6 and the adjustment member 5.
  • the mating surface of the distal end of the torque adjustment cover 6 and the proximal end of the adjustment member 5 can also adopt other matching methods, for example, the distal end of the torque adjustment cover 6 and the proximal end of the adjustment member The mating surface is inclined.
  • the fitting position between the torque adjusting cover 6 and the adjusting member 5 is also defined by the compression spring 3. That is, the compression spring 3 respectively defines the positions of the two mating structures at both ends: the distal end of the compression spring 3 defines the axial fit of the clutch ring 2 and the knob body 1, and the proximal end of the compression spring 3 defines the adjustment member 5 and the torque adjustment The axial fit of the cover 6.
  • one compression spring 3 is used to realize the positions of the two axial matching mechanisms, and the structure is simplified.
  • FIGS. 10 and 11 the structure in which the knob body 1 and the clutch ring 2 cooperate in the initial state and the failed state are respectively shown.
  • the knob assembly In the initial state where the anvil assembly 83 has just docked with the stapler body or the tissue has just been incorporated, the knob assembly is in the initial state, the operator rotates the clutch ring 2 in the first direction 61, and the clutch ring 2 rotates. The tissue has not been clamped, and the resistance of the knob body 1 has not reached the preset resistance value.
  • the clutch mechanism can cooperate with the first protrusion 11 and the second protrusion 21 to transfer torque greater than the resistance of the knob body 1 from the clutch ring. 2 is transmitted to the knob body 1, at this time, the reaction force of the knob body 1 to the clutch ring 2 is insufficient to overcome the elastic force of the compression spring 3. As shown in FIG.
  • the compression spring 3 maintains the initial state without deformation or a certain amount of initial deformation.
  • the second fitting is in the first state, that is, the second protrusion 21 of the clutch ring 2 and the knob body 1
  • the first protrusion 11 is fully contacted and engaged, the rotation of the clutch ring 2 drives the knob body 1 to rotate in the first direction 61, the nail anvil assembly 83 is driven by the screw 85 and the nail cartridge assembly 82 gradually approaches each other.
  • the knob body 1 After clamping the tissue between the anvil assembly 83 and the staple cartridge assembly 82, and then rotating the clutch ring 2 of the knob assembly in the first direction 61, the knob body 1 is subjected to resistance that prevents it from rotating in the first direction 61. At this time, only Only by applying a rotation torque greater than the resistance on the knob body 1 can the knob body 1 be turned in the first direction 61.
  • the clutch ring 2 will produce an axial movement toward the proximal end of the stapler, so that the second protrusion 21 of the clutch ring 2 disengages from the first protrusion 11 of the knob body 1, that is, the second fitting is in the first position.
  • the clutch ring 2 cannot transmit the rotational torque applied by the operator to the knob body 1, the knob body 1 does not rotate, the clutch ring 2 performs invalid idling, and can emit the first protrusion 11 and The click sound when the second protrusion 21 is tripped.
  • the knob assembly is in a failure state, the nail forming gap between the nail anvil assembly 83 and the nail cartridge assembly 82 remains unchanged, and the tissue will not be excessively pressed. If the operator hears a click or according to the feel of rotating the knob assembly in the failure state, it can determine that the current anvil assembly 83 has moved into place, and can perform the firing operation of the stapler.
  • the stapler When the stapler is applied to different tissue cutting and suturing, the state of the tissue is different, and it is necessary to adjust the maximum tissue squeezing force between the anvil assembly 83 and the staple cartridge assembly 82, that is, to adjust the preset resistance value.
  • the torsion adjustment cover 6 needs to be rotated to make the adjustment member 5 move in the axial direction of the stapler, and the compression degree of the compression spring 3 in the initial state is adjusted, that is, the second protrusion 21 and the first protrusion 11 are changed
  • the second protrusion 21 moves to the proximal end of the stapler to overcome the magnitude of the elastic force.
  • the stapling device further includes a knob housing 4, and an inner surface of the knob housing 4 is provided with a fourth fitting portion; the clutch ring 2 is located inside the knob housing 4, and the clutch ring 2 A third engaging portion is provided on the side of the shaft, the third engaging portion cooperates with the fourth engaging portion, so that the knob housing 4 can drive the clutch ring 2 to rotate, and the clutch ring 2 can be relative to the knob housing 4 axis To move.
  • the third mating portion includes at least one second orientation groove 22 located on the axial side of the clutch ring 2, and the fourth mating portion includes a second one-to-one correspondence with the second orientation groove 22
  • Two directional ribs 41, the second directional ribs 41 extend along the axial direction of the stapler and extend into the second directional groove 22, and the second directional grooves 22 may be along the extending direction of the second directional ribs 41 It moves so that the clutch ring 2 can rotate together with the knob housing 4 and the clutch ring 2 moves axially relative to the knob housing 4.
  • the second directional rib 41 provides a guiding effect for the second directional groove 22.
  • two second directional grooves 22 and two second ribs 41 are provided and are symmetrically arranged to achieve structural balance and balance of forces, of course, there may be multiple or asymmetric Settings.
  • the third mating portion may also include at least one second directional rib located on the axial side of the clutch ring 2, and the fourth mating portion includes an directional groove corresponding to the second directional rib ,
  • the second directional rib extends along the axial direction of the stapler and extends into the directional groove, and the second directional rib can move along its extension direction.
  • the inner surface of the knob housing 4 is provided with an L-shaped step portion 42, and the step portion 42 is located on the distal end surface of the clutch ring 2.
  • the use of the step 42 can limit the movement of the clutch ring 2 toward the distal end of the stapler.
  • an arc-shaped limiting groove 43 is provided on the inner side of the proximal end of the knob housing 4, and a limiting block 62 is provided on the outer side of the torque adjusting cover 6
  • the block 62 is embedded in the limiting groove 43, and the limiting block 62 can rotate relative to the limiting groove 43 within the extending range of the limiting groove 43. This prevents the reciprocating phenomenon due to over-rotation when rotating the torque adjusting cover 6.
  • a limit stop may be provided on the inner side of the proximal end of the knob housing 4, and the outer side of the torque adjustment cover 6 is provided with an arc-shaped limit groove, and the limit block is embedded in In the limiting slot, the limiting block can rotate relative to the limiting slot within the extension of the limiting slot.
  • the knob assembly further includes a knob back cover.
  • the knob back cover includes a first knob back cover 7 and a second knob back cover 9.
  • the distal end of the first knob back cover 7 is provided with a back cover Internal thread 71
  • the proximal end of the knob body 1 is provided with a body external thread 12 that cooperates with the internal thread 71 of the back cover, the first knob back cover 7 can play a role of supporting and fixing the knob body 1, the second
  • the knob back cover 9 may be installed on the proximal end side of the first knob back cover 7.
  • the invention provides a knob assembly for a round tube-type stapler.
  • the knob assembly is divided into a knob body and a clutch member. When the resistance of the knob body reaches the preset resistance value, rotating the clutch member can bring the knob body together Rotating, the knob body can drive the anvil assembly to move along the axial direction of the stapler and close to the staple cartridge.
  • the clutch cannot drive the knob body to rotate, and the knob assembly enters the failure mode ,
  • the gap between the anvil assembly and the staple cartridge remains unchanged, without causing the tissue to be over-squeezed;
  • the preset resistance value is the pressure limit of the tissue clamped between the anvil assembly and the staple cartridge assembly, the resistance
  • the size of the preset value is related to the spring force of the compression spring at the proximal end of the clutch.

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Abstract

一种旋钮组件及圆管型吻合器，其中旋钮组件包括旋钮本体(1)、离合件和旋钮后盖，旋钮本体(1)上设置有第一配合件，旋钮本体(1)旋转时带动丝杆(85)沿吻合器的轴向移动，离合件上设置有第二配合件，调节件(5)和离合件之间设置有压簧(3)，调节件(5)可沿轴向移动以远离或靠近离合件，改变压簧(3)的压缩长度。通过将旋钮组件分为旋钮本体(1)和离合件，当旋钮所受的阻力达到阻力预设值之后，离合件无法驱使旋钮本体(1)转动，此时的旋钮组件进入失效模式，钉砧组件(83)和钉仓之间的间隙保持不变，而不会使得组织被过度压缩；其中阻力预设值的大小与离合件近端的压簧(3)的弹簧力有关，通过改变调节件(5)与离合件之间的距离，可以调节压簧(3)的弹簧力，从而可以调整阻力预设值的大小。

Description

旋钮组件及圆管型吻合器 技术领域
本发明涉及医疗器械技术领域，具体涉及一种旋钮组件及圆管型吻合器。
背景技术
消化道疾病是人类高发的疾病之一，在治疗过程中，常使用圆管型吻合器代替医生的手工操作对消化道等生理组织进行吻合。圆管型吻合器是一种常见的外科手术器械，大多采用轴向内装订方式，在手术时对食管、胃、肠道等生理组织形成端对端的、或者端对侧的吻合，吻合时两段组织内敛收容于吻合器内，击发完成后在组织上形成圆形吻合口，重建了人体通道。
现有技术中，圆管型吻合器包括吻合器本体、活动连接所述吻合器本体的操作把手以及与所述本体配合的钉砧组件。所述吻合器本体包括设于远端的钉仓组件，所述钉仓组件包括环形钉仓、切刀；以及设于本体近端的旋钮，所述旋钮可相对于本体旋转，所述吻合器本体的内部还包括从近端向远端设置的钉砧轴。此处远端和近端是相对于操作者来说的，距离操作者较近的一端为近端，距离操作者较远的一端，即更靠近手术位置的一端为远端。在吻合器中，内侧与外侧是相对与吻合器的轴心来说的，靠近轴心的一侧为内侧，远离轴心的一侧为外侧。所述钉砧组件包括钉砧、设置在钉砧远端的钉砧帽和设置在钉砧内部的刀砧，钉砧组件可以与钉砧轴的远端直接连接或通过钉砧轴连接件连接。在肿瘤手术过程中，离断去除肿瘤组织后，钉砧轴从残端组织的荷包穿出，配置于吻合器本体的远端，旋转旋钮，使钉砧组件和钉仓 之间的距离逐渐减小达到一个合适的距离后，达到可击发状态，才能握持操作把手击发器械完成吻合。随着医疗器械的不断发展，圆管型吻合器也越来越广泛地应用于痔疮等疾病的治疗。
在旋转旋钮，使钉砧组件向钉仓靠近的过程中，有时候组织闭合到位后，旋钮还是可以旋转的，这样钉砧组件与钉仓之间就会继续靠近，继续压缩组织，对组织造成过度压榨，甚至可能会压碎组织，对手术结果十分不利。
发明内容
针对现有技术中的问题，本发明的目的在于提供一种旋钮组件及圆管型吻合器，旋转旋钮时，当旋钮所受的阻力达到阻力预设值后，旋钮将无法再传递更大的扭矩，此时的旋钮进入失效模式，钉砧组件和钉仓之间的间隙保持不变，而不会使得组织被过度压榨，并且阻力预设值可调。
本发明实施例提供一种旋钮组件，用于圆管型吻合器，所述吻合器的内部设置有一丝杆；所述旋钮组件包括：
旋钮本体，所述旋钮本体套设于所述丝杆的外部，所述旋钮本体上设置有驱动件，所述驱动件的近端面设置有第一配合件，所述旋钮本体旋转时带动丝杆轴向移动；
离合件，位于所述驱动件的近端，所述离合件的远端面有与所述第一配合件对应设置的第二配合件，所述第二配合件可相对于第一配合件的轴向移动，且所述第二配合件与第一配合件接触配合时，所述离合件的旋转带动旋钮本体旋转；
调节件，位于所述离合件的近端，所述调节件与所述离合件之间设置有 一压簧，且所述调节件可相对于所述离合件沿吻合器的轴向移动。
可选地，所述调节件的内侧面设置有第二定向部，所述调节件套设于所述旋钮本体的近端，所述旋钮本体的近端设置有第一定向部，所述第二定向部与所述第一定向部配合，且所述第二定向部仅可相对于所述第一定向部的轴向移动。
可选地，还包括扭力调节罩，所述扭力调节罩的远端与所述调节件的近端相配合。
可选地，所述扭力调节罩的远端与所述调节件的近端的配合表面为螺旋面，或所述扭力调节罩的远端与所述调节件的近端的配合表面为斜面。
可选地，还包括旋钮外壳，所述旋钮外壳的近端内侧面设置有弧形的限位槽，所述扭力调节罩的外侧面设置有限位块，所述限位块嵌设于所述限位槽中；
或，所述旋钮外壳的近端内侧面设置有限位块，所述扭力调节罩的外侧面设置有弧形的限位槽，所述限位块嵌设于所述限位槽中。
可选地，所述第一定向部包括至少一个沿吻合器的轴向延伸的第一定向槽，所述第二定向部为与所述第一定向槽一一对应的第一定向筋，所述第一定向筋伸入所述第一定向槽中且可沿所述第一定向槽的延伸方向移动；或
所述第一定向部包括至少一个沿吻合器的轴向延伸的第一定向筋，所述第二定向部为与所述第一定向筋一一对应的第一定向槽，所述第一定向筋伸入所述第一定向槽中且可沿自身的延伸方向移动。
可选地，所述第一配合件为第一凸起，所述第二配合件为第二凸起；
或，所述第一配合件为第一凸起，所述第二配合件为凹槽；
或，所述第一配合件为凹槽，所述第二配合件为凸起。
可选地，所述第一配合件包括第一侧面，所述第二配合件包括第三侧面，所述离合件受外力沿第一方向旋转时，所述第一配合件的第一侧面与所述第二配合件的第三侧面接触配合，且所述第一配合件的第一侧面朝向第一方向倾斜。
可选地，所述第一配合件还包括第二侧面，所述第二配合件还包括第四侧面，所述离合件受外力沿第二方向旋转时，所述第一配合件的第二侧面与所述第二配合件的第四侧面接触配合；
所述第一配合件的第二侧面为直角面，或，所述第一配合件的第二侧面朝向第二方向倾斜且第一配合件的第二侧面的倾斜程度小于所述第一侧面的倾斜程度。
可选地，所述第一配合件的第一侧面和第二配合件的第三侧面均为平面或相配合的曲面，所述第一配合件的第二侧面和第二配合件的第四侧面均为平面或相配合的曲面。
可选地，所述离合件包括离合环，所述离合环套设于所述旋钮本体的外部。
可选地，所述离合件的侧面设置有至少一个第二定向槽，所述旋钮组件的旋钮外壳的内表面设置有与所述第二定向槽一一对应的第二定向筋，所述第二定向筋沿吻合器的轴向方向延伸且伸入所述第二定向槽中，且所述第二定向槽可沿第二定向筋的延伸方向移动；或
所述离合件的侧面设置有至少一条第二定向筋，所述旋钮组件的旋钮外壳的内表面设置有与所述第二定向筋一一对应的第二定向槽，所述第二定向 筋沿吻合器的轴向方向延伸且伸入所述第二定向槽中。
可选地，所述旋钮组件的旋钮外壳的内表面设置有台阶部，所述台阶部位于所述离合件的远端面。
可选地，还包括一旋钮后盖，所述旋钮后盖的远端设置有后盖内螺纹，所述旋钮本体的近端设置有与所述后盖内螺纹相配合的本体外螺纹。
本发明实施例还提供一种圆管型吻合器，包括所述的旋钮组件。
本发明所提供的旋钮组件及圆管型吻合器具有下列优点：
本发明提供了一种用于圆管型吻合器的旋钮组件，将旋钮组件分为旋钮本体和离合件，当旋钮本体所受的阻力达到阻力预设值之前，旋转离合件可带动旋钮本体一起转动，旋钮本体可带动钉砧组件沿吻合器的轴向移动而靠近钉仓，当旋钮所受的阻力达到阻力预设值之后，离合件无法驱使旋钮本体转动，此时的旋钮组件进入失效模式，钉砧组件和钉仓之间的间隙保持不变，而不会使得组织被过度压榨；其中预设值即为钉砧组件和钉仓组件之间夹紧的组织的压力限值，阻力预设值的大小与离合件近端的压簧的弹簧力有关，通过改变调节件与离合件之间的距离，可以调节压簧的弹簧力，从而可以调整阻力预设值的大小，实现最大组织压榨力的调节。
附图说明
为了更清楚地说明本发明实施例中的技术方案，下面将对实施例描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1是本发明一实施例的吻合器的结构示意图；
图2是本发明一实施例的旋钮组件与丝杆配合的示意图；
图3是本发明一实施例的旋钮本体的结构示意图；
图4是本发明一实施例的离合环的结构示意图；
图5和图6是本发明一实施例的旋钮外壳的结构示意图；
图7是本发明一实施例的调节件的结构示意图；
图8是本发明一实施例的扭力调节罩的结构示意图；
图9是本发明一实施例的第一旋钮后盖的结构示意图；
图10是本发明一实施例的初始状态下离合环和压簧的示意图；
图11是本发明一实施例的失效状态下离合环和压簧的示意图。
具体实施方式
为使本发明实施例的目的、技术方案和优点更加清楚，下面将结合本发明实施例中的附图，对本发明实施例中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发明一部分实施例，而不是全部的实施例。
下面将参考附图并结合实施例，来详细说明本发明。
为了解决现有技术中的技术问题，本发明提供了一种旋钮组件，用于圆管型吻合器，所述圆管型吻合器包括旋钮本体、离合件和调节件，所述旋钮本体套设于所述丝杆的外部，所述旋钮本体上设置有驱动件，所述驱动件的近端面设置有第一配合件，所述旋钮本体旋转时带动丝杆轴向移动；所述离合件位于所述驱动件的近端，所述离合件的远端面设置有第二配合件，所述第二配合件可相对于第一配合件轴向移动，且所述第二配合件与第一配合件 接触配合时，所述离合件的旋转带动旋钮本体旋转，所述第二配合件具有可以驱动所述第一配合件的第一状态，及不能驱动所述第一配合件的第二状态。当所述第二配合件处于第一状态时，所述离合件的旋转带动旋钮本体旋转，当所述第二配合件处于第二状态时，所述离合件的旋转不带动旋钮本体旋转，所述离合件相对于所述旋钮本体向近端做轴向移动；所述调节件位于所述离合件的近端，所述调节件与所述离合件之间设置有一压簧，且所述调节件可相对于所述离合件沿吻合器的轴向移动。
因此，本发明将旋钮组件分为旋钮本体和离合件，另外在旋钮本体的近端设置调节件以及定位压簧。所述离合件朝向吻合器的远端的轴向移动会受到压簧的阻碍，即离合件的轴向运动需要克服压簧的弹簧力。旋钮本体的驱动件和离合件共同组成了离合结构。在操作者旋转旋钮组件时，首先受到操作者旋转力驱动而旋转的是离合件。当旋钮本体所受的阻力达到阻力预设值之前，离合机构可以传递大于旋钮本体的阻力的扭矩，旋钮本体和离合件联动，旋转离合件可带动旋钮本体一起转动，旋钮本体可带动钉砧组件沿吻合器的轴向移动而靠近钉仓；当旋钮所受的阻力达到阻力预设值之后，离合机构无法传递大于旋钮本体的阻力的扭矩，离合件向吻合器的近端移动与驱动件脱离，并且压迫压簧，此时离合件无法驱使旋钮本体转动，旋钮组件进入失效模式，钉砧组件和钉仓之间的间隙保持不变，而不会使得组织被过度压榨。
其中，阻力预设值的大小由驱动件和离合件之间接触面的倾角以及压簧的弹簧力所确定。对于同一个压簧来说，其在不同的压缩程度时，其弹簧力是不同的，弹簧力等于弹簧刚度乘以压缩量，因此，压缩量越大，弹簧力越 大，压缩量越小，弹簧力越小。因此，本发明进一步通过调节压簧的初始压缩程度来调节阻力预设值的大小。阻力预设值的大小即对应于钉砧组件和钉仓组件之间对组织压迫的最大组织压榨力的大小。具体地，压簧设置在离合件和调节件之间，调节件可以沿吻合器的轴向移动，在调节件靠近离合件时，阻力预设值进一步增大，调节件远离离合件时，阻力预设值进一步减小。
本发明实施例还提供一种圆管型吻合器，所述旋钮组件位于所述吻合器的近端，所述吻合器的远端设置有一钉仓组件和一钉砧组件，所述钉砧组件通过一钉砧轴连接至所述丝杆的远端或者直接连接至丝杆的远端。旋钮本体旋转时，可以通过钉砧轴带动钉砧组件沿吻合器的轴向移动，以靠近或远离钉仓组件。
在钉砧组件与具有钉仓组件的吻合器本体刚刚对接成功的初始状态，沿第一方向旋转旋钮，离合件旋转，此时由于组织尚未夹紧，旋钮本体所受的阻力未达到阻力预设值，离合机构可以传递大于旋钮本体的阻力的扭矩，压簧保持初始状态，未产生变形或产生一定量的初始变形量，离合件驱动旋钮本体也沿第一方向转动，即第二配合件处于第一状态而驱动第一配合件，钉砧组件被钉砧轴和丝杆带动与钉仓组件逐渐靠近。
当钉砧组件与钉仓组件之间到达合适的距离，同时对组织的压榨力达到合适的预定值时，再旋转旋钮，旋钮本体会受到阻碍第一方向旋转的阻力，此阻力即对应于钉砧组件和钉仓组件之间的组织压榨力，此时，只有在旋钮本体上施加大于该阻力的旋转扭矩才能沿第一方向转动旋钮本体。即，当该阻力大于阻力预设值时，如果施加更大的旋转力矩旋转离合件，旋钮本体受到的旋转力矩的反作用力给到离合件上，该反作用力会克服压簧的弹簧力而 压迫压簧产生变形，离合件会产生向吻合器近端的轴向运动，而使得离合件的第二配合件脱离旋钮本体的第一配合件，即第二配合件处于第二状态而不驱动第一配合件，此时，离合件无法将操作者施加的旋转力矩传递到旋钮本体上，旋钮本体不会转动，离合件进行的是无效的空转，并且可以发出第一配合件和第二配合件脱扣时的哒哒声，此时旋钮组件处于失效状态，钉砧组件和钉仓组件之间的钉成型间隙保持不变，组织不会被过度压榨。
下面结合附图对本发明一实施例提供的圆管型吻合器和其中的旋钮组件进行详细介绍。
如图1所示，示出了一实施例的吻合器的结构。其中，吻合器包括吻合器本体和钉砧组件83，其中，吻合器本体包括吻合器壳体81、位于吻合器壳体81的远端的钉仓组件82、位于吻合器壳体81的近端的旋钮组件以及从近端向远端设置的丝杆85，钉仓组件82包括环形钉仓和切刀，钉砧组件83包括钉砧和钉砧轴，钉砧通过钉砧轴连接至丝杆的远端。旋钮组件旋转时，依次通过所述丝杆和钉砧轴带动钉砧组件83轴向移动，远离或靠近钉仓组件82。
当然，在另一类的圆管型吻合器中，例如前文提到的做痔疮手术的圆管型吻合器，其钉砧组件83是直接与吻合器本体连接的，钉砧组件83不能从吻合器本体上取下来，此时即钉砧组件83不包含钉砧轴，钉砧直接与丝杆85的远端固定连接。本发明以此类吻合器为例进行说明。
如图2～9所示，所述旋钮组件包括旋钮本体1、离合件和调节件5，所述旋钮本体1套设于所述丝杆85的外部，所述旋钮本体1上设置有驱动件14，所述驱动件14的近端面设置有第一配合件，旋钮本体1的内部设置有本 体内螺纹13，本体内螺纹13与吻合器的丝杆85配合，所述旋钮本体1旋转时带动丝杆85沿吻合器的轴向移动；所述离合件位于所述驱动件14的近端，所述离合件的远端面设置有第二配合件，所述第二配合件可相对于第一配合件轴向移动，所述第二配合件具有可以驱动所述第一配合件的第一状态，及不能驱动所述第一配合件的第二状态。当所述第二配合件处于第一状态时，所述离合件的旋转带动旋钮本体1旋转，当所述第二配合件处于第二状态时，所述离合件的旋转不带动旋钮本体旋转，所述离合件相对于所述旋钮本体向近端做轴向移动；所述调节件5位于吻合器的近端，且调节件5与所述离合件之间设置有一压簧3，且所述调节件5可相对于所述离合件沿吻合器的轴向移动，以远离或靠近所述离合件。
在该实施例中，所述离合件包括离合环2，离合环2套设于旋钮本体1上，调节件5可以采用一个调节垫片。所述第一配合件设置于所述驱动件14的近端面。所述第一配合件可以为第一凸起11，所述第二配合件可以为第二凸起21。在其他的替代实施方式中，第一配合件和第二配合件也可以选择为其他结构，例如第一配合件为凸起，第二配合件为与凸起相配合的凹槽，或者第一配合件为凹槽，第二配合件为与凹槽相配合的凸起等等，均属于本发明的保护范围之内。进一步优选地，所述第一凸起11包括第一侧面111，所述第二凸起21包括第三侧面211，所述离合环2受外力沿第一方向61旋转时，所述第一凸起11的第一侧面111与所述第二凸起21的第三侧面211接触配合，且所述第一凸起11的第一侧面111朝向第一方向61倾斜。而第二凸起21的第三侧面211的倾斜方向与第一侧面111相适应。
在吻合器从近端朝向远端的视角中，第一方向61为顺时针方向，第二方 向62为逆时针方向。在沿顺时针方向旋转离合环2，并带动旋钮本体1沿顺时针方向旋转时，丝杆85向吻合器的近端移动，并带动钉砧组件83靠近钉仓组件82，在沿逆时针方向旋转离合环2，并带动旋钮本体1沿逆时针方向旋转时，丝杆85向吻合器的远端移动，并带动钉砧组件83远离钉仓组件82。
在该实施例中，第一侧面111和第三侧面211是斜面配合，通过斜面配合，在旋钮本体1受到的阻力大于阻力预设值时，所述离合环2受外力沿第一方向61旋转且对旋钮本体1施加一个较大的旋转力矩时，旋钮本体1给离合环2的反作用力通过斜面进行分解，分解后沿吻合器轴向方向的力推动离合环2向吻合器近端移动，以克服压簧3的弹性力而使得压簧3变形，从而使得旋钮本体1与离合环2逐渐相互脱离。阻力预设值可以由压簧3的弹簧力大小以及第一侧面111和第三侧面211的倾斜程度确定。此外，由于第一凸起11的第一侧面111和第二凸起21的第三侧面211的倾斜程度的设置，使得离合环2在顺时针方向旋转且不与旋钮本体1联动时，向近端有位移的第二凸起21更容易与第一凸起11脱离。
在该实施例中，所述第一凸起11还包括第二侧面112，所述第二凸起21还包括第四侧面212，所述离合环2受外力沿第二方向62旋转时，所述第一凸起11的第二侧面112与所述第二凸起21的第四侧面212接触配合，以利于当沿第二方向62旋转离合环2时，可以带动旋钮本体1沿第二方向62旋转增大钉砧83和钉仓组件82之间的距离。
在该实施例中，所述第一凸起11的第二侧面112为直角面，对应地，第二凸起21的第四侧面212也为直角面。此处直角面指的是第一凸起11的第二侧面112垂直于驱动件14的表面。在其他替代的实施方式中，所述第一凸 起11的第二侧面112也可以朝向第二方向62倾斜且第一凸起11的第二侧面112的倾斜程度小于第一凸起11的第一侧面111的倾斜程度，对应地，第二凸起21的第四侧面212的倾斜方向和角度与第二侧面112相适应。这样设置，可以使得离合环2在沿第二方向62旋转时，第二凸起21不容易与第一凸起11脱离，从而可以防止旋钮组件在沿第一方向61旋紧之后，当需要反向操作时，无法带动旋钮本体1沿第二方向62旋转增大钉砧组件83和钉仓组件82之间的距离。
所述第一凸起11的第一侧面111和第二凸起21的第三侧面211均为平面或相配合的曲面，所述第一凸起11的第二侧面112和第二凸起21的第四侧面212均为平面或相配合的曲面。
其中，阻力预设值的大小由驱动件14和离合环2之间接触面的倾角以及压簧3的弹簧力所确定。对于同一个压簧3来说，其在不同的压缩程度时，弹簧力是不同的。因此，本发明进一步通过调节压簧3的初始压缩程度即初始变形量来调节阻力预设值的大小，即调整最大组织压榨力的大小。具体地，调节件5可以沿吻合器的轴向移动，在调节件靠近离合环2时，阻力预设值进一步增大，最大组织压榨力增大，调节件远离离合环2时，阻力预设值进一步减小，最大组织压榨力减小。在将吻合器应用于不同厚度的组织或组织对于压榨力的承受能力不同时，可以通过调节件5的移动来改变压榨力的限值。
在该实施例中，所述调节件5的内侧面设置有第二定向部，所述调节件5套设于所述旋钮本体1的近端，所述旋钮本体1的近端设置有第一定向部，所述第二定向部与所述第一定向部配合，且所述第二定向部仅可相对于所述 第一定向部轴向移动。在该实施例中，所述第一定向部包括至少一个沿吻合器的轴向延伸的第一定向槽15，所述第二定向部为与所述第一定向槽15一一对应的第一定向筋52，所述第一定向筋52伸入所述第一定向槽15中且可沿所述第一定向槽15的延伸方向移动。在其他实施方式中，所述第一定向部也可以包括至少一个沿吻合器的轴向延伸的第一定向筋，所述第二定向部为与所述第一定向筋一一对应的第一定向槽，所述定向筋伸入所述凹槽中且可沿自身的延伸方向移动。
在该实施例中，所述旋钮组件还包括扭力调节罩6，所述扭力调节罩6的远端与所述调节件5的近端相配合，所述扭力调节罩6相对于所述旋钮本体1旋转时，带动所述调节件5沿吻合器的轴向移动。
在该实施例中，所述扭力调节罩6的远端与所述调节件5的近端的配合表面为螺旋面。如图7和图8所示，扭力调节罩6的远端面为第二螺旋面61，调节件5的近端面为第一螺旋面51，由于螺旋面之间是面接触，可以提高扭力调节罩6和调节件5之间的配合程度。在其他实施方式中，扭力调节罩6的远端与所述调节件5的近端的配合表面也可以采用其他配合方式，例如所述扭力调节罩6的远端与所述调节件的近端的配合表面为斜面。
在该实施例中，扭力调节罩6和调节件5之间的配合位置也采用压簧3进行限定。即，压簧3分别对两端的两个配合结构的位置进行限定：压簧3的远端限定离合环2和旋钮本体1的轴向配合，压簧3的近端限定调节件5与扭力调节罩6的轴向配合。该实施例中采用一个压簧3即实现了两个轴向配合机构的位置，结构精简。
如图10和11所示，分别示出了在初始状态下和失效状态下旋钮本体1 和离合环2配合的结构。
在钉砧组件83与吻合器本体刚刚对接成功的初始状态或者组织刚刚被纳入的初始状态，旋钮组件处于初始状态，操作者沿第一方向61旋转离合环2，离合环2旋转，此时由于组织尚未夹紧，旋钮本体1所受的阻力未达到阻力预设值，离合机构可以通过第一凸起11和第二凸起21之间的配合将大于旋钮本体1的阻力的扭矩从离合环2传递到旋钮本体1，此时旋钮本体1给离合环2的反作用力不足以克服压簧3的弹性力。如图10所示，此时压簧3保持初始状态，未产生变形或产生一定量的初始变形量，第二配合件处于第一状态，即离合环2的第二凸起21与旋钮本体1的第一凸起11充分接触配合，离合环2的旋转带动旋钮本体1沿第一方向61转动，钉砧组件83被丝杆85带动与钉仓组件82逐渐相互靠近。
钉砧组件83与钉仓组件82之间夹紧组织之后，再沿第一方向61旋转旋钮组件的离合环2，旋钮本体1会受到阻碍其沿第一方向61旋转的阻力，此时，只有在旋钮本体1上施加大于该阻力的旋转扭矩才能沿第一方向61转动旋钮本体1。当该阻力大于阻力预设值时，如果操作者施加小于该阻力的旋转扭矩给离合环2，离合环2受到旋钮本体1的阻碍而无法旋转，如果操作者施加大于该阻力的旋转力矩旋转离合环2，旋钮本体1受到的旋转力矩的反作用力通过第一凸起11和第二凸起21之间的配合传递到离合环2上，该反作用力沿轴向方向的分力会克服压簧3的弹簧力而压迫压簧3产生变形。如图11所示，离合环2会产生向吻合器近端的轴向运动，而使得离合环2的第二凸起21脱离旋钮本体1的第一凸起11，即第二配合件处于第二状态，此时，离合环2无法将操作者施加的旋转力矩传递到旋钮本体1上，旋钮本 体1不会转动，离合环2进行的是无效的空转，并且可以发出第一凸起11和第二凸起21脱扣时的哒哒声，此时旋钮组件处于失效状态，钉砧组件83和钉仓组件82之间的钉成型间隙保持不变，组织不会被过度压榨。操作者如果听到哒哒声或者根据失效状态时旋转旋钮组件的手感可以判定出当前钉砧组件83已经移动到位，可以执行吻合器的击发操作。
当将吻合器应用于不同的组织切割和缝合时，组织的状态不同，需要调整钉砧组件83和钉仓组件82之间的最大组织压榨力的大小，即调节阻力预设值的大小。此时，需要通过旋转扭力调节罩6，使得调节件5沿吻合器的轴向方向移动，而调整初始状态下压簧3的压缩程度，即改变了第二凸起21与第一凸起11脱离时，第二凸起21向吻合器近端移动需要克服的弹性力的大小。调节件5靠近离合环2时，压簧3初始压缩程度增加，离合环2需要克服的弹性力也增大，进而增大了最大组织压榨力，相反地，调节件5远离离合环2时，减小了最大组织压榨力。
在该实施例中，所述吻合器还包括旋钮外壳4，所述旋钮外壳4的内表面设置有第四配合部；所述离合环2位于所述旋钮外壳4的内部，所述离合环2的侧面设置有第三配合部，所述第三配合部与第四配合部相配合，以使得所述旋钮外壳4可带动离合环2旋转，且所述离合环2可相对于旋钮外壳4轴向移动。在该实施例中，所述第三配合部包括位于离合环2的轴向侧面的至少一个第二定向槽22，所述第四配合部包括与所述第二定向槽22一一对应的第二定向筋41，所述第二定向筋41沿吻合器的轴向方向延伸且伸入所述第二定向槽22中，且所述第二定向槽22可沿第二定向筋41的延伸方向移动，从而实现离合环2可与旋钮外壳4一起转动，且离合环2相对于旋钮 外壳4轴向移动，所述第二定向筋41为所述第二定向槽22提供导向作用。优选地，所述第二定向槽22与所述第二定向筋41分别设有两个，且为对称设置，以实现结构的平衡及受力的平衡，当然也可以是多个，或者非对称设置。
在其他实施方式，所述第三配合部也可以包括位于离合环2的轴向侧面的至少一条第二定向筋，所述第四配合部包括与所述第二定向筋一一对应的定向槽，所述第二定向筋沿吻合器的轴向方向延伸且伸入所述定向槽中，且所述第二定向筋可沿自身的延伸方向移动。
进一步地，所述旋钮外壳4的内表面设置有L形的台阶部42，所述台阶部42位于所述离合环2的远端面。台阶部42的使用可以对离合环2朝向吻合器远端方向的移动进行限位。
为了限制扭力调节罩6的旋转角度，在所述旋钮外壳4的近端内侧面设置有弧形的限位槽43，所述扭力调节罩6的外侧面设置有限位块62，所述限位块62嵌设于所述限位槽43中，且所述限位块62可相对于所述限位槽43在所述限位槽43的延伸范围内旋转。由此防止旋转扭力调节罩6时，由于过旋，出现往复现象。
在其他实施方式中，也可以在所述旋钮外壳4的近端内侧面设置有限位块，所述扭力调节罩6的外侧面设置有弧形的限位槽，所述限位块嵌设于所述限位槽中，且所述限位块可相对于所述限位槽在所述限位槽的延伸范围内旋转。
在该实施例中，所述旋钮组件还包括一旋钮后盖，所述旋钮后盖包括第一旋钮后盖7和第二旋钮后盖9，第一旋钮后盖7的远端设置有后盖内螺纹 71，所述旋钮本体1的近端设置有与所述后盖内螺纹71相配合的本体外螺纹12，第一旋钮后盖7可以起到支撑和固定旋钮本体1的作用，第二旋钮后盖9可以安装于第一旋钮后盖7的近端侧。
本发明所提供的圆管型吻合器具有下列优点：
本发明提供了一种用于圆管型吻合器的旋钮组件，将旋钮组件分为旋钮本体和离合件，当旋钮本体所受的阻力达到阻力预设值之前，旋转离合件可带动旋钮本体一起转动，旋钮本体可带动钉砧组件沿吻合器的轴向移动而靠近钉仓，当旋钮所受的阻力达到阻力预设值之后，离合件无法驱使旋钮本体转动，此时的旋钮组件进入失效模式，钉砧组件和钉仓之间的间隙保持不变，而不会使得组织被过度压榨；其中阻力预设值即为钉砧组件和钉仓组件之间夹紧的组织的压力限值，阻力预设值的大小与离合件近端的压簧的弹簧力有关，通过改变调节件与离合件之间的距离，可以调节压簧的弹簧力，从而可以调整阻力预设值的大小，实现组织压力限值的调节。
以上内容是结合具体的优选实施方式对本发明所作的进一步详细说明，不能认定本发明的具体实施只局限于这些说明。对于本发明所属技术领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干简单推演或替换，都应当视为属于本发明的保护范围。

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  1. 一种旋钮组件，其特征在于，用于圆管型吻合器，所述吻合器的内部设置有一丝杆；所述旋钮组件包括：
    旋钮本体，所述旋钮本体套设于所述丝杆的外部，所述旋钮本体上设置有驱动件，所述驱动件的近端面设置有第一配合件，所述旋钮本体旋转时带动丝杆轴向移动；
    离合件，位于所述驱动件的近端，所述离合件的远端面有与所述第一配合件对应设置的第二配合件，所述第二配合件可相对于第一配合件的轴向移动，且所述第二配合件与第一配合件接触配合时，所述离合件的旋转带动旋钮本体旋转；
    调节件，位于所述离合件的近端，所述调节件与所述离合件之间设置有一压簧，且所述调节件可相对于所述离合件沿吻合器的轴向移动。
  2. 根据权利要求1所述的旋钮组件，其特征在于，所述调节件的内侧面设置有第二定向部，所述调节件套设于所述旋钮本体的近端，所述旋钮本体的近端设置有第一定向部，所述第二定向部与所述第一定向部配合，且所述第二定向部仅可相对于所述第一定向部的轴向移动。
  3. 根据权利要求2所述的旋钮组件，其特征在于，还包括扭力调节罩，所述扭力调节罩的远端与所述调节件的近端相配合。
  4. 根据权利要求3所述的旋钮组件，其特征在于，所述扭力调节罩的远端与所述调节件的近端的配合表面为螺旋面，或所述扭力调节罩的远端与所述调节件的近端的配合表面为斜面。
  5. 根据权利要求3所述的旋钮组件，其特征在于，还包括旋钮外壳，所述旋钮外壳的近端内侧面设置有弧形的限位槽，所述扭力调节罩的外侧面设置有限位块，所述限位块嵌设于所述限位槽中；
    或，所述旋钮外壳的近端内侧面设置有限位块，所述扭力调节罩的外侧面设置有弧形的限位槽，所述限位块嵌设于所述限位槽中。
  6. 根据权利要求2所述的旋钮组件，其特征在于，所述第一定向部包括至少一个沿吻合器的轴向延伸的第一定向槽，所述第二定向部为与所述第一定向槽一一对应的第一定向筋，所述第一定向筋伸入所述第一定向槽中且可沿所述第一定向槽的延伸方向移动；或
    所述第一定向部包括至少一个沿吻合器的轴向延伸的第一定向筋，所述第二定向部为与所述第一定向筋一一对应的第一定向槽，所述第一定向筋伸入所述第一定向槽中且可沿自身的延伸方向移动。
  7. 根据权利要求1所述的旋钮组件，其特征在于，所述第一配合件为第一凸起，所述第二配合件为第二凸起；
    或，所述第一配合件为第一凸起，所述第二配合件为凹槽；
    或，所述第一配合件为凹槽，所述第二配合件为凸起。
  8. 根据权利要求1或7所述的旋钮组件，其特征在于，所述第一配合件包括第一侧面，所述第二配合件包括第三侧面，所述离合件受外力沿第一方向旋转时，所述第一配合件的第一侧面与所述第二配合件的第三侧面接触配合，且所述第一配合件的第一侧面朝向第一方向倾斜。
  9. 根据权利要求8所述的旋钮组件，其特征在于，所述第一配合件还包括第二侧面，所述第二配合件还包括第四侧面，所述离合件受外力沿第二方 向旋转时，所述第一配合件的第二侧面与所述第二配合件的第四侧面接触配合；
    所述第一配合件的第二侧面为直角面，或，所述第一配合件的第二侧面朝向第二方向倾斜且第一配合件的第二侧面的倾斜程度小于所述第一侧面的倾斜程度。
  10. 根据权利要求9所述的旋钮组件，其特征在于，所述第一配合件的第一侧面和第二配合件的第三侧面均为平面或相配合的曲面，所述第一配合件的第二侧面和第二配合件的第四侧面均为平面或相配合的曲面。
  11. 根据权利要求1所述的旋钮组件，其特征在于，所述离合件包括离合环，所述离合环套设于所述旋钮本体的外部。
  12. 根据权利要求1所述的旋钮组件，其特征在于，所述离合件的侧面设置有至少一个第二定向槽，所述旋钮组件的旋钮外壳的内表面设置有与所述第二定向槽一一对应的第二定向筋，所述第二定向筋沿吻合器的轴向方向延伸且伸入所述第二定向槽中；或
    所述离合件的侧面设置有至少一条第二定向筋，所述旋钮组件的旋钮外壳的内表面设置有与所述定向筋一一对应的第二定向槽，所述第二定向筋沿吻合器的轴向方向延伸且伸入所述第二定向槽中。
  13. 根据权利要求1所述的旋钮组件，其特征在于，所述旋钮组件的旋钮外壳的内表面设置有台阶部，所述台阶部位于所述离合件的远端面。
  14. 根据权利要求1所述的旋钮组件，其特征在于，还包括一旋钮后盖，所述旋钮后盖的远端设置有后盖内螺纹，所述旋钮本体的近端设置有与所述后盖内螺纹相配合的本体外螺纹。
  15. 一种圆管型吻合器，其特征在于，包括权利要求1至14中任一项所述的旋钮组件。
PCT/CN2019/126299 2018-12-18 2019-12-18 旋钮组件及圆管型吻合器 WO2020125677A1 (zh)

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US20050145402A1 (en) * 2001-08-23 2005-07-07 Markus Hehli Device for limiting a torque to be transferred
CN1849200A (zh) * 2003-09-10 2006-10-18 费洛工具厂霍兰莱茨有限公司 具有限制传递扭矩的可调装置的螺丝刀
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* Cited by examiner, † Cited by third party
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US20050145402A1 (en) * 2001-08-23 2005-07-07 Markus Hehli Device for limiting a torque to be transferred
CN1849200A (zh) * 2003-09-10 2006-10-18 费洛工具厂霍兰莱茨有限公司 具有限制传递扭矩的可调装置的螺丝刀
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CN102755180A (zh) * 2011-04-29 2012-10-31 Tyco医疗健康集团 组织压缩可控的圆形吻合器
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