WO2023116662A1 - Protective sleeve, surgical instrument, and surgical instrument assembly - Google Patents

Protective sleeve, surgical instrument, and surgical instrument assembly Download PDF

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Publication number
WO2023116662A1
WO2023116662A1 PCT/CN2022/140264 CN2022140264W WO2023116662A1 WO 2023116662 A1 WO2023116662 A1 WO 2023116662A1 CN 2022140264 W CN2022140264 W CN 2022140264W WO 2023116662 A1 WO2023116662 A1 WO 2023116662A1
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WO
WIPO (PCT)
Prior art keywords
surgical instrument
sleeve
area
protective cover
protective
Prior art date
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PCT/CN2022/140264
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French (fr)
Chinese (zh)
Inventor
陈晓
朱国征
张京田
蒋友坤
Original Assignee
上海微创医疗机器人(集团)股份有限公司
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Application filed by 上海微创医疗机器人(集团)股份有限公司 filed Critical 上海微创医疗机器人(集团)股份有限公司
Publication of WO2023116662A1 publication Critical patent/WO2023116662A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/30Surgical robots

Definitions

  • the present application relates to the technical field of medical devices, in particular to a protective cover, a surgical device and a surgical device assembly.
  • an insulating protective sheath is required to isolate the tissue and the surgical instrument to protect the tissue from electric injury.
  • the insulating protective sheath is a consumable, and medical personnel need to install it on the surgical instrument (such as an electric knife) before the operation. Due to the different proficiency and training effects of medical personnel, there is a risk of incorrect installation of the insulating protective sheath, which in turn causes the risk of falling off when passing through the trocar in the body.
  • the medical staff must remove the insulating protective sheath from the body to the outside, and need to pull out the surgical instrument and reinstall the insulating protective sheath, which reduces the safety of the operation and hinders the operation. The progress of the surgery.
  • the purpose of the present application is to provide a protective cover, a surgical instrument and a surgical instrument assembly, so as to solve the problem that the insulating protective cover of the existing surgical instrument is easily installed incorrectly and easily falls off.
  • the first aspect of the present application provides a protective sleeve, the protective sleeve has a first end and a second end opposite to the axial direction thereof, and the protective sleeve is used to be sleeved on a surgical instrument, and protruding the implementing portion at the distal end of the surgical instrument from the first end;
  • the outer periphery of the protective cover has a contiguous step area and a main body area, the step area is located at the second end of the protective cover, the step area and the main body area form a height in the radial direction of the protective cover Poor, wherein the stepped region is radially lower than the body region, at least a portion of the stepped region for insertion into a cannula of the surgical instrument.
  • the radially inner dimension of the opening of the protective sleeve at the first end is smaller than the radially inner dimension of the opening of the protective sleeve at the second end.
  • the protective cover at least the main body area is made of a first material, and the protective cover further includes a cylindrical reinforcing body, the reinforcing body is made of a second material, and the reinforcing body Constituting at least part of the step region; the second material having a modulus of elasticity greater than that of the first material.
  • a part of the reinforcing body also extends into the main body area toward the first end, and is connected to the inner side of the main body area.
  • the stepped area and/or the main body area corresponding to the reinforcing body forms a recessed area radially outward, and the reinforcing body is connected to the recessed area, And the thickness of the reinforcing body along the radial direction is adapted to the depth of the recessed area along the radial direction.
  • the protective cover includes a positioning hole, and the positioning hole is opened on the main body area along the radial direction of the protective cover; the positioning hole is used to fit the positioning protrusion of the surgical instrument With the snap.
  • the width of the positioning hole gradually increases along the direction from the first end toward the second end; wherein the width of the positioning hole is that the positioning hole is Set the inner dimension of the circumference.
  • the stepped area has an external thread, or the stepped area is extruded by the sleeve to form an external thread after being connected with the sleeve; the stepped area passes through the The external thread is connected with the internal thread of the casing.
  • the main body area includes a bevel section, and the bevel section is located on a side of the main body area close to the second end; the bevel section faces the second end Gradually shrinking, so that the main body area and the step area form a transition connection.
  • the outer surface of the main body area has a concave or convex anti-slip structure.
  • the second aspect of the present application provides a surgical instrument, which is used for mating connection with the above-mentioned protective sleeve;
  • the surgical instrument includes an executive part, an insulating A segment and an instrument shaft, the surgical instrument also includes a sleeve, the sleeve is arranged at the distal end of the instrument shaft; the execution part is used to protrude from the first end of the protective sleeve, the The sleeve is used to cover at least part of the step area.
  • the sleeve has an internal thread, and the sleeve is connected to the external thread of the step area through the internal thread.
  • the cannula is movable relative to the instrument shaft along the axial direction of the instrument shaft, and after the cannula moves and protrudes toward the distal end in the axial direction, it is sleeved on the At least part of the step area.
  • the surgical instrument further includes an outer tube, the outer tube is sheathed outside the instrument shaft and fixedly connected to the instrument shaft, at least part of the sleeve is passed through the outer tube, and The sleeve is movably connected to the outer tube.
  • the outer tube has a long hole radially penetrated, and the long axis of the long hole is arranged along the axial direction of the instrument shaft;
  • the sleeve has a A radially protruding slider, the width of the slider along the axis perpendicular to the instrument shaft is adapted to the width of the elongated hole perpendicular to the axis of the instrument shaft, and the slider along the axis of the instrument
  • the axial direction of the instrument rod is movably arranged in the elongated hole.
  • the surgical instrument includes a positioning protrusion, and the positioning protrusion is disposed on the insulating segment, and is adapted to engage with the positioning hole of the protective sheath.
  • a third aspect of the present application provides a surgical instrument assembly, which includes the above-mentioned protective sheath and the above-mentioned surgical instrument.
  • the protective sheath has opposite first and second ends along its own axial direction, and the protective sheath is used to be sleeved on the surgical instrument. on the instrument, and make the executive part of the distal end of the surgical instrument protrude from the first end;
  • the outer periphery of the protective cover has a contiguous step area and a main body area, and the step area is located on the protective cover At the second end, the step area and the main body area form a height difference in the radial direction of the protective sleeve, wherein the step area is lower than the main body area in the radial direction, and at least part of the step area is used for insertion Inside the cannula of the surgical instrument.
  • Fig. 1a is a schematic view before the surgical instrument and the protective cover of the embodiment of the present application are assembled;
  • Fig. 1b is a schematic diagram of the assembly of the surgical instrument and the protective cover according to the embodiment of the present application;
  • Fig. 1c is a schematic diagram of the assembled surgical instrument and protective cover according to the embodiment of the present application.
  • Fig. 2 is the schematic diagram of the surgical instrument of the embodiment of the present application.
  • Fig. 3a is a schematic diagram of the protective cover of the embodiment of the present application.
  • Fig. 3b is a schematic diagram of the axial section of the protective sleeve of the embodiment of the present application.
  • Fig. 4a is a schematic diagram of the surgical instrument assembly according to the embodiment of the present application before being installed into the trocar;
  • Fig. 4b is a schematic diagram of installing the surgical instrument assembly in the trocar according to the embodiment of the present application.
  • Fig. 4c is a schematic diagram of the surgical instrument assembly of the embodiment of the present application after being installed into the trocar;
  • Fig. 5 a is the installation flowchart of the surgical instrument of the embodiment of the present application.
  • Fig. 5b is a disassembly flowchart of the surgical instrument of the embodiment of the present application.
  • Fig. 6a is an axial cross-sectional view of the protective sleeve of the embodiment of the present application, which shows an exploded view of the reinforcing body and the recessed area;
  • Fig. 6b is a schematic diagram of the reinforcing body of the embodiment of the present application.
  • Fig. 6c is an axial cross-sectional view of the protective sleeve of the embodiment of the present application, which shows a schematic view of the reinforcement body and the recessed area after installation;
  • Fig. 6d is an axial cross-sectional view of the protective sleeve of the embodiment of the present application.
  • Fig. 7a is a schematic view before the protective sheath of the embodiment of the present application is screwed into the surgical instrument;
  • Fig. 7b is a schematic diagram of the protective sheath of the embodiment of the present application after being screwed into the surgical instrument;
  • Fig. 7c is a schematic diagram of the groove section of the protective sleeve of the embodiment of the present application.
  • Fig. 8a is a schematic diagram of the cannula according to the embodiment of the present application before extending to the distal end;
  • Fig. 8b is a schematic diagram of the cannula of the embodiment of the present application after it is stretched out to the distal end;
  • Fig. 8c is a schematic diagram of the casing and the outer tube of the embodiment of the present application.
  • Fig. 9a is a schematic diagram of a casing with a positioning hole according to an embodiment of the present application.
  • Fig. 9b is a schematic diagram of a surgical instrument with a positioning protrusion according to an embodiment of the present application.
  • Fig. 9c is a schematic diagram of the fit and engagement of the positioning hole and the positioning protrusion in the embodiment of the present application.
  • Fig. 10a is a schematic diagram of another example of a sleeve with a positioning hole according to an embodiment of the present application.
  • Fig. 10b is a schematic diagram of another example of a surgical instrument with a positioning protrusion according to an embodiment of the present application.
  • Fig. 10c is a schematic diagram of another example of the fit and engagement of the positioning hole and the positioning protrusion in the embodiment of the present application.
  • FIG. 11a to 11c are schematic diagrams of the anti-skid structure of the embodiment of the present application.
  • proximal and distal are defined herein with respect to a surgical robotic system having an interface configured to mechanically and electrically couple surgical instruments to a manipulator of the surgical robot.
  • proximal refers to the position of the element closer to the manipulator of the surgical robot
  • distal refers to the position of the element closer to the surgical instrument and thus further away from the manipulator of the surgical robot.
  • proximal and distal are defined herein with respect to an operator such as a surgeon or a clinician.
  • proximal refers to the position of the element closer to the operator
  • distal refers to the position of the element closer to the surgical instrument and thus farther from the operator.
  • connection, coupling, fitting, and one element being “disposed” on another element should be interpreted in a broad sense and usually only mean that there is connection, coupling, Fitting or transmission relationship, and the connection, coupling, cooperation or transmission between two elements may be direct or indirect through intermediate elements, but shall not be understood as indicating or implying a spatial positional relationship between two elements, that is, one element may be in another Any orientation of the inside, outside, top, bottom, or side of an element, unless the content clearly indicates otherwise.
  • directional terms such as above, below, up, down, up, down, left, right, etc. are used with respect to the exemplary embodiments as they are shown in the figures, with an upward or upward direction toward the top of the corresponding figure, The downward or downward direction is towards the bottom of the corresponding drawing.
  • the purpose of the present application is to provide a protective cover, a surgical instrument and a surgical instrument assembly, so as to solve the problem that the insulating protective cover of the existing surgical instrument is easily installed incorrectly and easily falls off.
  • This embodiment provides a surgical instrument combination, which is formed by assembling a protective sheath 10 and a surgical instrument 20 .
  • 1a to 1c show the process of assembling and connecting the protective sheath 10 and the surgical instrument 20 to form a surgical instrument combination.
  • the surgical instrument 20 includes an executing part 21, an insulating section 22 and an instrument shaft connected in sequence from the distal end (the right end in FIG. 2 ) to the proximal end (the left end in FIG. 2 ). twenty three.
  • the execution part 21 is mainly used to perform surgical operations, such as cutting, cutting, etc.
  • the execution part 21 communicates with The driving device (not shown) at the proximal end is connected, and driven by the driving device, the driving wire drives the actuator 21 to realize actions such as pitching, yaw, or opening and closing.
  • the executive part 21 can also be connected to the proximal energy supply end through the wires passing through the insulating section 22 and the instrument shaft 23, and then, for example, high-frequency discharge can be implemented to separate and coagulate the body tissue, thereby causing For the purpose of cutting and hemostasis. Since metal parts of the surgical instrument 20 other than the execution part 21 may cause unnecessary burns when in contact with the patient, or even cause additional danger, it is possible to use as few exposed metal parts as possible outside the execution part 21 .
  • the execution part 21 needs to realize functions such as pitching, yawing, opening and closing, and electric shearing, so its metal parts are exposed, and the insulating section 22 connected to the proximal end of the execution part 21 does not need to pitch or yaw (in some embodiments it can rotate around its axis), so it is preferable that the insulating segment 22 adopts a fixed structure and is made of insulating material.
  • the structure of the insulating section 22 serves as the first barrier for the insulation protection of the electrosurgical instrument, and excellent insulating materials can resist a part of the voltage.
  • at least the outer surface of the instrument shaft 23 is also made of insulating material. In this way, the protective sheath 10 needs to protect the parts of the actuator 21 except the end that needs to be in direct contact with the patient, so as to form a complete electrical isolation protection.
  • the protective sheath 10 has a first end 101 and a second end 102 opposite to each other along its axial direction. Please refer to FIG. 1a to FIG. 1c , in use, the protective sheath 10 is sheathed to the distal end of the surgical instrument 20 along the direction from the second end 102 to the first end 101 , to the first end of the protective sheath 10 from the implementing part 21 101 is stretched out, and the assembly can be completed to form a surgical instrument assembly.
  • the next step in the surgical operation is to insert the surgical instrument assembly into the trocar 30, and then install the surgical instrument to the power box (not shown in the figure).
  • the power box is connected to the driving device.
  • the surgical instrument assembly can be withdrawn from the trocar 30, and then the protective cover 10 can be disassembled.
  • FIG. 5b for the specific disassembly process.
  • the trocar 30 , the power box and the driving device can all be configured according to the prior art, and those skilled in the art can understand its structure and principle based on the prior art, and the description of this embodiment will not be repeated here.
  • the protective cover 10 not only needs to have excellent insulation performance, but also needs to be soft enough to match the movement joints of the actuator 21. sports.
  • the soft protective sheath 10 will easily slip off axially toward the distal end during use, and fall out of the trocar 30 or fall into the patient's body during the operation.
  • the inventor found that when the protective sheath 10 moves in the trocar, the second end 102 of the protective sheath 10 tends to rub against the inner wall of the trocar 30 , which is a major cause of the protective sheath 10 falling off.
  • the protective cover 10 provided in this embodiment has an adjacent stepped area 11 and a main body area 12, the stepped area 11 is located at the second end 102, and the stepped area 11 and the main body area 12
  • the main body area 12 forms a height difference in the radial direction of the protective cover 10 , wherein the step area 11 is lower than the main body area 12 in the radial direction.
  • FIG. 3a and FIG. 3b the protective cover 10 provided in this embodiment has an adjacent stepped area 11 and a main body area 12, the stepped area 11 is located at the second end 102, and the stepped area 11 and the main body area 12
  • the main body area 12 forms a height difference in the radial direction of the protective cover 10 , wherein the step area 11 is lower than the main body area 12 in the radial direction.
  • the surgical instrument 20 also includes a sleeve 24, the sleeve 24 is arranged at the distal end of the instrument rod 23; the sleeve 24 is used to be sleeved on the step At least part of the zone 11 , ie at least part of the stepped zone 11 is intended to be inserted into the sleeve 24 of the surgical instrument 20 to be at least partially covered by the sleeve 24 .
  • the second end 102 of the protective sheath 10 is covered by the sleeve 24 of the surgical instrument 20, which can prevent the second end 102 of the protective sheath 10 from rubbing against the inner wall of the trocar 30, thereby reducing the protective sheath 10 to the trocar 30. Risk of falling off within 30.
  • the radial inner dimension of the opening of the protective sheath 10 at the first end 101 is smaller than that of the protective sheath 10 at the second end 102.
  • the protective cover 10 is substantially cylindrical, and both ends are opened to have openings.
  • the opening can be circular.
  • the opening may also be in the shape of a polygon, which is not limited in this embodiment.
  • the radial inner dimension of the opening of the protective cover 10 refers to the inner width of the opening along the radial direction. If the opening is circular, its radial inner dimension is the diameter of the circle.
  • the opening is polygonal, its radial inner dimension is the diameter of the inscribed circle of the polygon. Since the size of the implementing part 21 of the surgical instrument 20 generally narrows toward the distal end, the radially inner dimension of the opening at the first end 101 is set to be smaller, which is beneficial to adapt to the outer contour shape of the implementing part 21 .
  • the main body region 12 includes a straight section 121 and a constricted section 122 connected in sequence from the proximal end to the distal end. Constricted frustum.
  • At least the main body area 12 is made of a first material
  • the protective cover further includes a cylindrical reinforcing body 13, and the reinforcing body 13 is made of a second material,
  • the reinforcing body 13 constitutes at least part of the step region 11; the modulus of elasticity of the second material is greater than that of the first material.
  • the stepped area 11 is entirely composed of the reinforcing body 13 , and a part of the reinforcing body 13 also extends into the main body area 12 towards the direction of the first end 101 and connects with the inner side of the main body area 12 .
  • the outside of the reinforcing body 13 may also wrap part of the first material, that is, the reinforcing body 13 constitutes the inner part of the step area 11 , and the reinforcing body 13 is combined with the first material, for example, by encapsulation.
  • the reinforcing body 13 may only constitute a part of the axial section of the stepped region 11 instead of extending to form the entire stepped region 11 , and the rest of the stepped region 11 may be formed by filling the first material.
  • the material of the main body area 12 should have good insulation performance and tear resistance, such as silicone or For rubber, the modulus of elasticity is preferably less than 100 MPa.
  • the wall thickness of the side of the protective sheath 10 close to the first end 101 can be set larger to improve its insulation. Since the side of the protective sheath 10 close to the second end 102 is mainly sheathed on the insulating section 22 , the requirements for insulation performance and tear resistance are lower, and the wall thickness can be set smaller.
  • the protective sheath 10 is mainly connected to the surgical instrument 20 through the side near the second end 102 , so the side near the second end 102 needs to be able to resist deformation. Therefore, through the arrangement of the reinforcing body 13, the requirement of anti-deformation can be better met.
  • the reinforcement body 13 can be made of a material with a relatively high elastic modulus, such as hard plastic (such as nylon, polytetrafluoroethylene), and its elastic modulus is preferably greater than 1 GPa.
  • the area of the step area 11 and/or the main body area 12 corresponding to the reinforcing body 13 forms a recessed area 14 radially outward, the reinforcing body 13 is connected to the recessed area 14, and the reinforcing body 13 is connected to the recessed area 14, and the reinforcing body
  • the thickness of the body 13 along the radial direction is adapted to the depth of the recessed area 14 along the radial direction, so that after the reinforcing body 13 is installed in the recessed area 14, the inner wall of the reinforcing body 13 and the rest of the stepped area 11 and/or the main body area 12 Part of the inner wall remains flat, which is convenient for installation on the surgical instrument 20 .
  • the stepped area 11 is only composed of the reinforcing body 13, then the recessed area 14 is only formed in the main body area 12 at this time, and a part of the reinforcing body 13 is embedded in the recessed area 14 of the main body area 12, and the other part It protrudes towards the direction of the first end 101 to form a stepped area 11 .
  • the stepped area 11 also includes an inner and outer layer structure, the outer layer is the encapsulation of the first material, and a recessed area 14 is formed inside, and the reinforcing body 13 is disposed in the recessed area 14 .
  • the recessed area 14 may exist in the step area 11 and the main body area 12 at the same time.
  • the sleeve 24 is fixed on the instrument shaft 23 and stretches out to the insulating section 22 for a certain distance, and the protective cover 10 moves toward the proximal end of the surgical instrument 20 until the step area 11 is inserted into the sleeve 24.
  • the sleeve 24 has an internal thread
  • the stepped area 11 has an external thread 111, or, the stepped area 11 is in contact with the sleeve 24 After being connected, it is extruded by the sleeve 24 to form an external thread 111 ; the stepped area 11 is connected to the internal thread of the sleeve 24 through the external thread 111 .
  • the stepped area 11 can be formed by a reinforcing body 13 , and an external thread 111 can be directly provided on the outer surface thereof.
  • the step area 11 can be formed by encapsulating the first material on the outside of the reinforcing body 13, at this time, its outer surface is relatively soft, and the external thread can also be formed under the extrusion of the internal thread of the sleeve 24. 111 to realize the threaded connection of the two.
  • the sleeve 24 covers the end surface of the second end 102 of the protective sleeve 10 , so as to protect the end surface of the second end 102 of the protective sleeve 10 .
  • the protective cover 10 is installed on the insulating section 22 of the surgical instrument 24, the sleeve 24 is rotated, and the internal thread of the sleeve 24 is screwed on the internal thread of the step area 11, on the one hand, the second end 102 of the protective cover 10 is isolated from the The piercer 30 reduces friction, and on the other hand, fixes the axial position of the protective sheath 10 to avoid slipping, thus playing a double protective role.
  • the sleeve 24 is rotatably arranged relative to the instrument shaft 23 , so that the protective sheath 10 only needs to be inserted in the axial direction, and the sleeve 24 can be rotated to thread the two.
  • the sleeve 24 can also be fixedly connected to the instrument shaft 23, so that after inserting the protective sleeve 10 in the axial direction, and then rotating the protective sleeve 10, the connection between the sleeve 24 and the protective sleeve 10 can also be realized. threaded connection.
  • the main body area 12 includes a bevel section 123, and the bevel section 123 is located on a side of the main body area 12 close to the second end 102; the bevel section 123 faces The second end 102 shrinks gradually so that the main body area 12 forms a transition connection with the step area 11 .
  • the side of the groove section 123 close to the first end 101 can be flush with the rest of the main body region 12, and then the groove section 123 gradually shrinks inward along the direction toward the second end 102 (that is, the outer diameter gradually decreases),
  • the outer diameter of the bevel section 123 is substantially the same as the outer diameter of the stepped area 11 .
  • the transition connection here can be a straight slope connection, that is, the groove section 123 shrinks linearly, or a smooth transition connection (the groove section 123 shrinks nonlinearly). unlimited.
  • the stepped area 11 can completely enter the coverage of the casing 24 , but also a part of the bevel section 123 near the second end 102 can enter the coverage of the casing 24 .
  • the groove section 123 can be used as an indicator mark for the insertion depth. Specifically, in use, when the protective sheath 10 is inserted into the surgical instrument 20, there is a reasonable relative axial position with the surgical instrument 20 . For example, in the example shown in Fig. 1b and Fig.
  • the sheath of the protective sheath 10 when the side of the main body region 12 close to the second end 102 is flush with the proximal end of the insulating section 22, it can be considered that the sheath of the protective sheath 10 is in place, which is called protection at this time.
  • the position of the sleeve 10 is a predetermined position. If the protective sheath 10 is insufficiently inserted (meaning that the protective sheath 10 is closer to the distal end of the surgical instrument 20 relative to the predetermined position), the protective sheath 10 will easily fall off on the one hand, and on the other hand, the protective sheath 10 will over-shield the executive part 21, causing the executive part 21 does not work.
  • the protective sheath 10 If the protective sheath 10 is inserted too deeply (meaning that the protective sheath 10 is relatively close to the proximal end of the surgical instrument 20), the protective sheath 10 will not cover the executive part 21 enough, and it is easy to expose a part of the executive part 21 that should not be exposed. harm.
  • the arrangement of the bevel section 123 enables the operator to visually observe the relative positional relationship between the edge of the main body area 12 and the surgical instrument 20 , thereby avoiding insufficient or too deep insertion of the protective sheath 10 .
  • the arrangement of the bevel section 123 can also mechanically limit the relative positional relationship between the sleeve 24 and the protective sheath 10 .
  • the outer diameter of the groove section 123 near the second end 102 is smaller, and it is configured to be able to enter the distal end of the casing 24, while the outer diameter of the groove section 123 near the first end 101 is larger , which cannot enter the distal end of the cannula 24 .
  • the sleeve tube 24 (or protective cover 10) is continuously rotated to make the protective cover 10 move towards the proximal end of the surgical instrument 20, after a part of the groove section 123 enters the sleeve tube 24, the groove section 123 will be stuck in the sleeve tube. 24 is mechanically limited. This ensures that the protective sheath 10 cannot be inserted too deeply.
  • the sleeve 24 is movable relative to the instrument shaft 23 along the axial direction of the instrument shaft 23, and the sleeve 24 moves toward the distal end in the axial direction. After stretching out, it is sleeved on at least part of the step area 11 . Different from the previous example, the external thread 111 may not be provided on the step area 11.
  • the surgical instrument 20 also includes an outer tube 25, the outer tube 25 is sheathed outside the instrument shaft 23 and fixedly connected with the instrument shaft 23, at least part of the sleeve 24 is passed through the The outer tube 25 is inside, and the sleeve 24 is movably connected with the outer tube 25 .
  • the instrument shaft 23 is recessed inwardly at the section where the outer tube 25 is provided.
  • the outer wall of the outer tube 25 is preferably flush with the outer walls of the rest of the instrument shaft 23. , to reduce the resistance through the piercer 30.
  • the outer tube 25 has a long hole 251 extending radially, the long axis of the long hole 251 is arranged along the axial direction of the instrument shaft 23;
  • the raised slider 241, the width of the slider 241 along the axial direction perpendicular to the instrument shaft 23 is adapted to the width of the elongated hole 251 along the axial direction perpendicular to the instrument shaft 23, the slider
  • the block 241 is movably disposed in the elongated hole 251 along the axial direction of the instrument shaft 23 .
  • the outer surface of the stepped area 11 in some embodiments is made of a flexible first material with a relatively large surface friction coefficient, if the moving direction of the sleeve 24 is inclined relative to the outer surface of the stepped area 11, it is difficult to drive the sleeve 24 smoothly.
  • the ground is sleeved on the step area 11 and is easily stuck.
  • the arrangement of the elongated hole 251 and the slider 241 limits the movement of the slider 241 only along the long axis direction of the elongated hole 251 (that is, the axial direction of the instrument rod 23), thereby ensuring that the sleeve pipe 24 does not stretch out from the outer tube 25.
  • the slider 241 can also be toggled by the operator, which is convenient for operation.
  • the protective sheath 10 includes a positioning hole 15, and the positioning hole 15 is opened on the main body area 12 along the radial direction of the protective sheath 10; the surgical instrument 20 A positioning protrusion 26 is included, and the positioning protrusion 26 is arranged on the insulating segment 22 .
  • the positioning hole 15 fits and engages with the positioning protrusion 26 of the surgical instrument 20 , so as to limit the relative position of the protective cover 10 and the surgical instrument 20 and prevent the protective cover 10 from falling off.
  • the positioning holes 15 are disposed on the insulating section 22 , the positioning holes 15 provided in the corresponding positions of the protective sheath 10 will not affect the insulation of the operating part 21 at the distal end of the surgical instrument 20 . It should be noted that the present embodiment does not specifically limit the shape and quantity of the positioning holes 15.
  • the positioning holes 15 can be several oval, circular or special-shaped holes, and the shape and quantity of the positioning protrusions 26 are the same as those of the positioning holes 15. match.
  • the width of the positioning hole 15 gradually increases along the direction of the first end 101 toward the second end 102; wherein the width of the positioning hole 15 is the inner dimension of the positioning hole 15 along the circumference of the protective sleeve 10 .
  • the width of the positioning protrusion 26 gradually increases along the direction from the distal end to the proximal end, wherein the width of the positioning protrusion 26 is the outer dimension of the positioning protrusion 26 along the circumferential direction of the insulating tube 22 .
  • the outer surface of the main body area 120 has a concave or convex anti-slip structure 124 .
  • the anti-skid structure 124 can be oval, circular, square, rhombus, arc or wavy, etc., and can be recessed on the outer surface of the main body area 120 or protruded on the outer surface of the main body area 120 .
  • FIG. 11 a shows an oval anti-slip structure 124
  • FIG. 11 b shows a diamond-shaped anti-slip structure 124
  • FIG. 11 c shows a wave-shaped anti-slip structure 124 .
  • the concave and convex anti-slip structures 124 can also be provided at the same time, and in other embodiments, various shapes of anti-slip structures 124 can also be used in combination, which is not limited in this embodiment.
  • the setting of the anti-slip structure 124 is convenient for the operator to hold and install the protective cover 10, and can prevent the fingers or installation tools from slipping during the installation process, improve the installation efficiency of the protective cover 10, and reduce the risk of the hand poking into the end of the surgical instrument 20. risk.
  • the protective sheath has opposite first and second ends along its own axial direction, and the protective sheath is used to be sleeved on the surgical instrument. on the instrument, and make the executive part of the distal end of the surgical instrument protrude from the first end;
  • the outer periphery of the protective cover has a contiguous step area and a main body area, and the step area is located on the protective cover At the second end, the step area and the main body area form a height difference in the radial direction of the protective sleeve, wherein the step area is lower than the main body area in the radial direction, and at least part of the step area is used for insertion Inside the cannula of the surgical instrument.

Abstract

A protective sleeve (10), a surgical instrument (20), and a surgical instrument assembly. The protective sleeve (10) has a first end (101) and a second end (102) opposite to each other in the axial direction of the protective sleeve; the protective sleeve (10) is configured to be sleeved on the surgical instrument (20) and to enable an execution part (21) at a distal end of the surgical instrument (20) to extend out from the first end (101); the periphery of the protective sleeve (10) has a step area (11) and a main body area (12) adjacent to each other; the step area (11) is located at the second end (102) of the protective sleeve (10); a height difference is formed between the step area (11) and the main body area (12) in the radial direction of the protective sleeve (10), wherein the step area (11) is lower than the main body area (12) in the radial direction, and at least part of the step area (11) is configured to be inserted into a sleeve (24) of the surgical instrument (20). According to such a configuration, friction between the second end (102) of the protective sleeve (10) and the inner wall of a puncture device (30) can be avoided by inserting the step area (11) at the second end (102) of the protective sleeve (10) into the sleeve (24) of the surgical instrument (20), such that the risk of the protective sleeve (10) falling off from the puncture device (30) can be reduced.

Description

保护套、手术器械及手术器械组合体Protective sheath, surgical instrument and surgical instrument combination 技术领域technical field
本申请涉及医疗器械技术领域,特别涉及一种保护套、手术器械及手术器械组合体。The present application relates to the technical field of medical devices, in particular to a protective cover, a surgical device and a surgical device assembly.
背景技术Background technique
在手术机器人辅助腹腔镜手术系统中,通常使用高频交流电的各种电外科手术器械。这些高频交流电刀在体内使用时,需要绝缘保护套隔离组织与手术器械,以保护组织不被电伤。目前绝缘保护套属于耗材,需要医护人员在术前安装至手术器械(如电刀)上。由于医护人员的熟练程度、培训效果不同,绝缘保护套会有不正确安装的风险,进而产生在体内过穿刺器时脱落的风险。一旦绝缘保护套脱落在体内或穿刺器内,医护人员必须将绝缘保护套从体内捡出至体外,并需要将手术器械拔出,重新安装绝缘保护套,降低了手术的安全性,也阻碍了手术的进程。In the surgical robot-assisted laparoscopic surgery system, various electrosurgical instruments with high-frequency alternating current are usually used. When these high-frequency AC electrosurgical units are used in the body, an insulating protective sheath is required to isolate the tissue and the surgical instrument to protect the tissue from electric injury. At present, the insulating protective sheath is a consumable, and medical personnel need to install it on the surgical instrument (such as an electric knife) before the operation. Due to the different proficiency and training effects of medical personnel, there is a risk of incorrect installation of the insulating protective sheath, which in turn causes the risk of falling off when passing through the trocar in the body. Once the insulating protective sheath falls off in the body or in the puncture device, the medical staff must remove the insulating protective sheath from the body to the outside, and need to pull out the surgical instrument and reinstall the insulating protective sheath, which reduces the safety of the operation and hinders the operation. The progress of the surgery.
发明内容Contents of the invention
本申请的目的在于提供一种保护套、手术器械及手术器械组合体,以解决现有手术器械的绝缘保护套易产生不正确安装,而容易脱落的问题。The purpose of the present application is to provide a protective cover, a surgical instrument and a surgical instrument assembly, so as to solve the problem that the insulating protective cover of the existing surgical instrument is easily installed incorrectly and easily falls off.
为解决上述技术问题,本申请的第一个方面提供一种保护套,所述保护套沿自身轴向具有相对的第一端和第二端,所述保护套用于套设于手术器械上,并使所述手术器械远端的执行部自所述第一端伸出;In order to solve the above technical problems, the first aspect of the present application provides a protective sleeve, the protective sleeve has a first end and a second end opposite to the axial direction thereof, and the protective sleeve is used to be sleeved on a surgical instrument, and protruding the implementing portion at the distal end of the surgical instrument from the first end;
所述保护套的外周具有相邻接的台阶区和主体区,所述台阶区位于所述保护套的第二端,所述台阶区与所述主体区在所述保护套的径向上形成高低差,其中所述台阶区沿径向低于所述主体区,所述台阶区的至少部分用于插入所述手术器械的套管内。The outer periphery of the protective cover has a contiguous step area and a main body area, the step area is located at the second end of the protective cover, the step area and the main body area form a height in the radial direction of the protective cover Poor, wherein the stepped region is radially lower than the body region, at least a portion of the stepped region for insertion into a cannula of the surgical instrument.
可选的,在所述保护套中,所述保护套于所述第一端处的开口的径向内尺寸小于所述保护套于所述第二端处的开口的径向内尺寸。Optionally, in the protective sleeve, the radially inner dimension of the opening of the protective sleeve at the first end is smaller than the radially inner dimension of the opening of the protective sleeve at the second end.
可选的,在所述保护套中,至少所述主体区由第一材料制成,所述保护套还包括筒状的加强体,所述加强体由第二材料制成,所述加强体构成所述台阶区的至少部分;所述第二材料的弹性模量大于所述第一材料的弹性模量。Optionally, in the protective cover, at least the main body area is made of a first material, and the protective cover further includes a cylindrical reinforcing body, the reinforcing body is made of a second material, and the reinforcing body Constituting at least part of the step region; the second material having a modulus of elasticity greater than that of the first material.
可选的,在所述保护套中,所述加强体的一部分还朝向所述第一端的方向延伸入所述主体区,与所述主体区的内侧连接。Optionally, in the protective cover, a part of the reinforcing body also extends into the main body area toward the first end, and is connected to the inner side of the main body area.
可选的,在所述保护套中,所述台阶区和/或所述主体区对应于所述加强体的区域沿径向向外形成凹陷区,所述加强体与所述凹陷区连接,且所述加强体沿径向的厚度与所述凹陷区沿径向的深度相适配。Optionally, in the protective cover, the stepped area and/or the main body area corresponding to the reinforcing body forms a recessed area radially outward, and the reinforcing body is connected to the recessed area, And the thickness of the reinforcing body along the radial direction is adapted to the depth of the recessed area along the radial direction.
可选的,所述保护套包括定位孔,所述定位孔沿所述保护套的径向贯通开设于所述主体区上;所述定位孔用于与所述手术器械的定位凸起相适配卡合。Optionally, the protective cover includes a positioning hole, and the positioning hole is opened on the main body area along the radial direction of the protective cover; the positioning hole is used to fit the positioning protrusion of the surgical instrument With the snap.
可选的,在所述保护套中,所述定位孔的宽度沿所述第一端朝向所述第二端的方向逐渐增大;其中所述定位孔的宽度为所述定位孔沿所述保护套周向的内尺寸。Optionally, in the protective cover, the width of the positioning hole gradually increases along the direction from the first end toward the second end; wherein the width of the positioning hole is that the positioning hole is Set the inner dimension of the circumference.
可选的,在所述保护套中,所述台阶区具有外螺纹,或者,所述台阶区在与所述套管连接后被所述套管挤压形成外螺纹;所述台阶区通过所述外螺纹与所述套管的内螺纹连接。Optionally, in the protective sleeve, the stepped area has an external thread, or the stepped area is extruded by the sleeve to form an external thread after being connected with the sleeve; the stepped area passes through the The external thread is connected with the internal thread of the casing.
可选的,在所述保护套中,所述主体区包括坡口段,所述坡口段位于所述主体区靠近所述第二端的一侧;所述坡口段朝向所述第二端逐渐收缩,以使所述主体区与所述台阶区形成过渡连接。Optionally, in the protective cover, the main body area includes a bevel section, and the bevel section is located on a side of the main body area close to the second end; the bevel section faces the second end Gradually shrinking, so that the main body area and the step area form a transition connection.
可选的,在所述保护套中,所述主体区的外表面具有凹陷或凸起的防滑结构。Optionally, in the protective cover, the outer surface of the main body area has a concave or convex anti-slip structure.
为解决上述技术问题,本申请的第二个方面提供一种手术器械,其用于与如上所述的 保护套配合连接;所述手术器械自远端向近端包括依次连接的执行部、绝缘段与器械杆,所述手术器械还包括套管,所述套管设置于所述器械杆的远端;所述执行部用于自所述保护套的所述第一端伸出,所述套管用于套设于所述台阶区的至少部分。In order to solve the above technical problems, the second aspect of the present application provides a surgical instrument, which is used for mating connection with the above-mentioned protective sleeve; the surgical instrument includes an executive part, an insulating A segment and an instrument shaft, the surgical instrument also includes a sleeve, the sleeve is arranged at the distal end of the instrument shaft; the execution part is used to protrude from the first end of the protective sleeve, the The sleeve is used to cover at least part of the step area.
可选的,在所述手术器械中,所述套管具有内螺纹,所述套管通过所述内螺纹与所述台阶区的外螺纹连接。Optionally, in the surgical instrument, the sleeve has an internal thread, and the sleeve is connected to the external thread of the step area through the internal thread.
可选的,在所述手术器械中,所述套管沿所述器械杆的轴向相对所述器械杆可移动,所述套管沿轴向朝向远端移动伸出后,套设于所述台阶区的至少部分。Optionally, in the surgical instrument, the cannula is movable relative to the instrument shaft along the axial direction of the instrument shaft, and after the cannula moves and protrudes toward the distal end in the axial direction, it is sleeved on the At least part of the step area.
可选的,所述手术器械还包括外管,所述外管套设于所述器械杆外并与所述器械杆固定连接,所述套管的至少部分穿设于所述外管内,且所述套管可移动地与所述外管连接。Optionally, the surgical instrument further includes an outer tube, the outer tube is sheathed outside the instrument shaft and fixedly connected to the instrument shaft, at least part of the sleeve is passed through the outer tube, and The sleeve is movably connected to the outer tube.
可选的,在所述手术器械中,所述外管具有沿径向贯通开设的长条孔,所述长条孔的长轴沿所述器械杆的轴向布置;所述套管具有沿径向凸起的滑块,所述滑块沿垂直于所述器械杆轴向的宽度与所述长条孔沿垂直于所述器械杆轴向的宽度相适配,所述滑块沿所述器械杆的轴向可移动地设置于所述长条孔中。Optionally, in the surgical instrument, the outer tube has a long hole radially penetrated, and the long axis of the long hole is arranged along the axial direction of the instrument shaft; the sleeve has a A radially protruding slider, the width of the slider along the axis perpendicular to the instrument shaft is adapted to the width of the elongated hole perpendicular to the axis of the instrument shaft, and the slider along the axis of the instrument The axial direction of the instrument rod is movably arranged in the elongated hole.
可选的,所述手术器械包括定位凸起,所述定位凸起设置于所述绝缘段上,用于与所述保护套的定位孔相适配卡合。Optionally, the surgical instrument includes a positioning protrusion, and the positioning protrusion is disposed on the insulating segment, and is adapted to engage with the positioning hole of the protective sheath.
为解决上述技术问题,本申请的第三个方面提供一种手术器械组合体,其包括如上所述的保护套以及如上所述的手术器械。In order to solve the above technical problems, a third aspect of the present application provides a surgical instrument assembly, which includes the above-mentioned protective sheath and the above-mentioned surgical instrument.
综上所述,在本申请提供的保护套、手术器械及手术器械组合体中,所述保护套沿自身轴向具有相对的第一端和第二端,所述保护套用于套设于手术器械上,并使所述手术器械远端的执行部自所述第一端伸出;所述保护套的外周具有相邻接的台阶区和主体区,所述台阶区位于所述保护套的第二端,所述台阶区与所述主体区在所述保护套的径向上形成高低差,其中所述台阶区沿径向低于所述主体区,所述台阶区的至少部分用于插入所述手术器械的套管内。To sum up, in the protective sheath, surgical instrument and surgical instrument combination provided by the present application, the protective sheath has opposite first and second ends along its own axial direction, and the protective sheath is used to be sleeved on the surgical instrument. on the instrument, and make the executive part of the distal end of the surgical instrument protrude from the first end; the outer periphery of the protective cover has a contiguous step area and a main body area, and the step area is located on the protective cover At the second end, the step area and the main body area form a height difference in the radial direction of the protective sleeve, wherein the step area is lower than the main body area in the radial direction, and at least part of the step area is used for insertion Inside the cannula of the surgical instrument.
如此配置,通过将保护套第二端处的台阶区插入手术器械的套管内,可避免保护套的第二端与穿刺器的内壁摩擦,从而可以降低保护套于穿刺器内脱落的风险。With such a configuration, by inserting the step region at the second end of the protective sheath into the cannula of the surgical instrument, friction between the second end of the protective sheath and the inner wall of the trocar can be avoided, thereby reducing the risk of the protective sheath falling off in the trocar.
附图说明Description of drawings
本领域的普通技术人员将会理解,提供的附图用于更好地理解本申请,而不对本申请的范围构成任何限定。其中:Those of ordinary skill in the art will understand that the provided drawings are for better understanding of the present application, and do not constitute any limitation to the scope of the present application. in:
图1a是本申请实施例的手术器械与保护套装配前的示意图;Fig. 1a is a schematic view before the surgical instrument and the protective cover of the embodiment of the present application are assembled;
图1b是本申请实施例的手术器械与保护套装配中的示意图;Fig. 1b is a schematic diagram of the assembly of the surgical instrument and the protective cover according to the embodiment of the present application;
图1c是本申请实施例的手术器械与保护套装配后的示意图;Fig. 1c is a schematic diagram of the assembled surgical instrument and protective cover according to the embodiment of the present application;
图2是本申请实施例的手术器械的示意图;Fig. 2 is the schematic diagram of the surgical instrument of the embodiment of the present application;
图3a是本申请实施例的保护套的示意图;Fig. 3a is a schematic diagram of the protective cover of the embodiment of the present application;
图3b是本申请实施例的保护套的轴向剖面的示意图;Fig. 3b is a schematic diagram of the axial section of the protective sleeve of the embodiment of the present application;
图4a是本申请实施例的手术器械组合体安装入穿刺器前的示意图;Fig. 4a is a schematic diagram of the surgical instrument assembly according to the embodiment of the present application before being installed into the trocar;
图4b是本申请实施例的手术器械组合体安装入穿刺器中的示意图;Fig. 4b is a schematic diagram of installing the surgical instrument assembly in the trocar according to the embodiment of the present application;
图4c是本申请实施例的手术器械组合体安装入穿刺器后的示意图;Fig. 4c is a schematic diagram of the surgical instrument assembly of the embodiment of the present application after being installed into the trocar;
图5a是本申请实施例的手术器械的安装流程图;Fig. 5 a is the installation flowchart of the surgical instrument of the embodiment of the present application;
图5b是本申请实施例的手术器械的拆卸流程图;Fig. 5b is a disassembly flowchart of the surgical instrument of the embodiment of the present application;
图6a是本申请实施例的保护套的轴向的剖视图,其示出了加强体与凹陷区的分解示意;Fig. 6a is an axial cross-sectional view of the protective sleeve of the embodiment of the present application, which shows an exploded view of the reinforcing body and the recessed area;
图6b是本申请实施例的加强体的示意图;Fig. 6b is a schematic diagram of the reinforcing body of the embodiment of the present application;
图6c是本申请实施例的保护套的轴向的剖视图,其示出了加强体与凹陷区的安装后 的示意;Fig. 6c is an axial cross-sectional view of the protective sleeve of the embodiment of the present application, which shows a schematic view of the reinforcement body and the recessed area after installation;
图6d是本申请实施例的保护套的轴向的剖面图;Fig. 6d is an axial cross-sectional view of the protective sleeve of the embodiment of the present application;
图7a是本申请实施例的保护套与手术器械螺纹连接前的示意图;Fig. 7a is a schematic view before the protective sheath of the embodiment of the present application is screwed into the surgical instrument;
图7b是本申请实施例的保护套与手术器械螺纹连接后的示意图;Fig. 7b is a schematic diagram of the protective sheath of the embodiment of the present application after being screwed into the surgical instrument;
图7c是本申请实施例的保护套的坡口段的示意图;Fig. 7c is a schematic diagram of the groove section of the protective sleeve of the embodiment of the present application;
图8a是本申请实施例的套管向远端伸出前的示意图;Fig. 8a is a schematic diagram of the cannula according to the embodiment of the present application before extending to the distal end;
图8b是本申请实施例的套管向远端伸出后的示意图;Fig. 8b is a schematic diagram of the cannula of the embodiment of the present application after it is stretched out to the distal end;
图8c是本申请实施例的套管与外管的示意图;Fig. 8c is a schematic diagram of the casing and the outer tube of the embodiment of the present application;
图9a是本申请实施例的带有定位孔的套管的示意图;Fig. 9a is a schematic diagram of a casing with a positioning hole according to an embodiment of the present application;
图9b是本申请实施例的带有定位凸起的手术器械的示意图;Fig. 9b is a schematic diagram of a surgical instrument with a positioning protrusion according to an embodiment of the present application;
图9c是本申请实施例的定位孔与定位凸起相适配卡合的示意图;Fig. 9c is a schematic diagram of the fit and engagement of the positioning hole and the positioning protrusion in the embodiment of the present application;
图10a是本申请实施例的带有定位孔的套管的另一示例的示意图;Fig. 10a is a schematic diagram of another example of a sleeve with a positioning hole according to an embodiment of the present application;
图10b是本申请实施例的带有定位凸起的手术器械的另一示例的示意图;Fig. 10b is a schematic diagram of another example of a surgical instrument with a positioning protrusion according to an embodiment of the present application;
图10c是本申请实施例的定位孔与定位凸起相适配卡合的另一示例的示意图;Fig. 10c is a schematic diagram of another example of the fit and engagement of the positioning hole and the positioning protrusion in the embodiment of the present application;
图11a~图11c是本申请实施例的防滑结构的示意图。11a to 11c are schematic diagrams of the anti-skid structure of the embodiment of the present application.
附图中:In the attached picture:
10-保护套;101-第一端;102-第二端;11-台阶区;111-外螺纹;12-主体区;121-平直段;122-缩口段;123-坡口段;124-防滑结构;13-加强体;14-凹陷区;15-定位孔;10-protective sleeve; 101-first end; 102-second end; 11-step area; 111-external thread; 12-main body area; 121-straight section; 124-anti-slip structure; 13-reinforcing body; 14-depressed area; 15-positioning hole;
20-手术器械;21-执行部;22-绝缘段;23-器械杆;24-套管;241-滑块;25-外管;251-长条孔;26-定位凸起;20-surgical instrument; 21-executive part; 22-insulation section; 23-instrument rod; 24-sleeve; 241-slider; 25-outer tube; 251-long hole;
30-穿刺器。30 - Trocar.
具体实施方式Detailed ways
为使本申请的目的、优点和特征更加清楚,以下结合附图和具体实施例对本申请作进一步详细说明。需说明的是,附图均采用非常简化的形式且未按比例绘制,仅用以方便、明晰地辅助说明本申请实施例的目的。此外,附图所展示的结构往往是实际结构的一部分。特别的,各附图需要展示的侧重点不同,有时会采用不同的比例。In order to make the purpose, advantages and features of the application clearer, the application will be further described in detail below in conjunction with the drawings and specific embodiments. It should be noted that the drawings are all in a very simplified form and not drawn to scale, and are only used to facilitate and clearly assist the purpose of illustrating the embodiments of the present application. In addition, the structures shown in the drawings are often a part of the actual structures. In particular, each drawing needs to display different emphases, and sometimes uses different scales.
如在本申请中所使用的,单数形式“一”、“一个”以及“该”包括复数对象,术语“或”通常是以包括“和/或”的含义而进行使用的,术语“若干”通常是以包括“至少一个”的含义而进行使用的,术语“至少两个”通常是以包括“两个或两个以上”的含义而进行使用的,此外,术语“第一”、“第二”、“第三”仅用于描述目的,而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此,限定有“第一”、“第二”、“第三”的特征可以明示或者隐含地包括一个或者至少两个该特征,“一端”与“另一端”以及“近端”与“远端”通常是指相对应的两部分,其不仅包括端点。术语“近端”和“远端”在本文中相对于手术机器人系统定义,该手术机器人系统具有被构造成能够将手术器械以机械和电的方式联接到手术机器人之操纵器的接口。术语“近端”是指元件的更靠近手术机器人之操纵器的位置,术语“远端”是指元件的更靠近手术器械且因此更远离手术机器人之操纵器的位置。可选的,在手动或用手操作的应用场景中,术语“近端”和“远端”在本文中相对于操作者诸如外科医生或临床医生来定义。术语“近端”是指元件的更靠近操作者的位置,并且术语“远端”是指元件的更靠近手术器械并且因此更远离操作者的位置。此外,如在本申请中所使用的,“安装”、“相连”、“连接”,一元件“设置”于另一元件,应做广义理解,通常仅表示两元件之间存在连接、耦合、配合或传动关系,且两元件之间可以是直接的或通过中间元件间接的连接、耦合、配合或传动,而不能理解为指示或 暗示两元件之间的空间位置关系,即一元件可以在另一元件的内部、外部、上方、下方或一侧等任意方位,除非内容另外明确指出外。对于本领域的普通技术人员而言,可以根据具体情况理解上述术语在本申请中的具体含义。此外,诸如上方、下方、上、下、向上、向下、左、右等的方向术语相对于示例性实施方案如它们在图中所示进行使用,向上或上方向朝向对应附图的顶部,向下或下方向朝向对应附图的底部。As used in this application, the singular forms "a", "an" and "the" include plural objects, the term "or" is generally used in the sense of including "and/or", and the term "several" Usually, the term "at least one" is used in the meaning of "at least one", and the term "at least two" is usually used in the meaning of "two or more". In addition, the terms "first", "second "Two" and "third" are used for descriptive purposes only, and should not be understood as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features. Thus, the features defined as "first", "second", and "third" may expressly or implicitly include one or at least two of these features, "one end" and "another end" and "near end" and "near end" "Distal end" generally refers to the corresponding two parts, and it includes not only the endpoint. The terms "proximal" and "distal" are defined herein with respect to a surgical robotic system having an interface configured to mechanically and electrically couple surgical instruments to a manipulator of the surgical robot. The term "proximal" refers to the position of the element closer to the manipulator of the surgical robot, and the term "distal" refers to the position of the element closer to the surgical instrument and thus further away from the manipulator of the surgical robot. Optionally, in a manual or hand-operated application scenario, the terms "proximal" and "distal" are defined herein with respect to an operator such as a surgeon or a clinician. The term "proximal" refers to the position of the element closer to the operator, and the term "distal" refers to the position of the element closer to the surgical instrument and thus farther from the operator. In addition, as used in this application, "mounting", "connecting", "connecting", and one element being "disposed" on another element should be interpreted in a broad sense and usually only mean that there is connection, coupling, Fitting or transmission relationship, and the connection, coupling, cooperation or transmission between two elements may be direct or indirect through intermediate elements, but shall not be understood as indicating or implying a spatial positional relationship between two elements, that is, one element may be in another Any orientation of the inside, outside, top, bottom, or side of an element, unless the content clearly indicates otherwise. Those of ordinary skill in the art can understand the specific meanings of the above terms in this application according to specific situations. Furthermore, directional terms such as above, below, up, down, up, down, left, right, etc. are used with respect to the exemplary embodiments as they are shown in the figures, with an upward or upward direction toward the top of the corresponding figure, The downward or downward direction is towards the bottom of the corresponding drawing.
本申请的目的在于提供一种保护套、手术器械及手术器械组合体,以解决现有手术器械的绝缘保护套易产生不正确安装,而容易脱落的问题。The purpose of the present application is to provide a protective cover, a surgical instrument and a surgical instrument assembly, so as to solve the problem that the insulating protective cover of the existing surgical instrument is easily installed incorrectly and easily falls off.
以下参考附图进行描述。Description is made below with reference to the accompanying drawings.
本实施例提供一种手术器械组合体,其由保护套10与手术器械20装配形成。图1a至图1c示出了将保护套10与手术器械20装配连接,以形成手术器械组合体的过程。This embodiment provides a surgical instrument combination, which is formed by assembling a protective sheath 10 and a surgical instrument 20 . 1a to 1c show the process of assembling and connecting the protective sheath 10 and the surgical instrument 20 to form a surgical instrument combination.
请参考图2,在一个实施例中,所述手术器械20自远端(图2中为右端)向近端(图2中为左端)包括依次连接的执行部21、绝缘段22与器械杆23。执行部21主要用于执行手术操作,例如剪切、切割等,在一个可替代的实施例中,执行部21通过穿设于绝缘段22和器械杆23中的驱动丝(未图示)与近端的驱动装置(未图示)连接,在驱动装置的驱动下,驱动丝带动执行部21能够实现俯仰、偏摆或开合等动作。进一步的,执行部21还可以通过穿设于绝缘段22和器械杆23中的导线与近端的能源提供端连接,进而例如可实施高频放电,以对肌体组织进行分离和凝固,从而起到切割和止血的目的。由于手术器械20除了执行部21以外的金属部位在与患者接触时会产生不必要的灼伤,更甚者会产生额外的危险,因此可尽量在执行部21以外尽量少采用外露的金属部件。在一个示范例中,执行部21需要实现俯仰、偏摆、开合、电剪切等功能,因此其金属部件是外露的,而连接于执行部21近端的绝缘段22并不需要俯仰或偏摆(一些实施例中其可以绕轴自转),因此优选绝缘段22采用固定式的结构,采用绝缘材料制造。绝缘段22的结构是作为电外科手术器械绝缘保护的第一道屏障,优异的绝缘材料能抵抗一部分电压。进而器械杆23的至少外表面亦采用绝缘材料制造。这样,保护套10需要保护执行部21除需要直接与患者接触的末端以外的部位,从而即形成完整的电隔离保护。Please refer to FIG. 2 , in one embodiment, the surgical instrument 20 includes an executing part 21, an insulating section 22 and an instrument shaft connected in sequence from the distal end (the right end in FIG. 2 ) to the proximal end (the left end in FIG. 2 ). twenty three. The execution part 21 is mainly used to perform surgical operations, such as cutting, cutting, etc. In an alternative embodiment, the execution part 21 communicates with The driving device (not shown) at the proximal end is connected, and driven by the driving device, the driving wire drives the actuator 21 to realize actions such as pitching, yaw, or opening and closing. Further, the executive part 21 can also be connected to the proximal energy supply end through the wires passing through the insulating section 22 and the instrument shaft 23, and then, for example, high-frequency discharge can be implemented to separate and coagulate the body tissue, thereby causing For the purpose of cutting and hemostasis. Since metal parts of the surgical instrument 20 other than the execution part 21 may cause unnecessary burns when in contact with the patient, or even cause additional danger, it is possible to use as few exposed metal parts as possible outside the execution part 21 . In one example, the execution part 21 needs to realize functions such as pitching, yawing, opening and closing, and electric shearing, so its metal parts are exposed, and the insulating section 22 connected to the proximal end of the execution part 21 does not need to pitch or yaw (in some embodiments it can rotate around its axis), so it is preferable that the insulating segment 22 adopts a fixed structure and is made of insulating material. The structure of the insulating section 22 serves as the first barrier for the insulation protection of the electrosurgical instrument, and excellent insulating materials can resist a part of the voltage. Furthermore, at least the outer surface of the instrument shaft 23 is also made of insulating material. In this way, the protective sheath 10 needs to protect the parts of the actuator 21 except the end that needs to be in direct contact with the patient, so as to form a complete electrical isolation protection.
请参考图3a和图3b,在一个实施例中,所述保护套10沿自身轴向具有相对的第一端101和第二端102。请结合图1a至图1c,使用中,将保护套10沿第二端102向第一端101的方向套向手术器械20的远端,至执行部21自所述保护套10的第一端101伸出,即可完成装配,形成手术器械组合体。Please refer to FIG. 3 a and FIG. 3 b , in one embodiment, the protective sheath 10 has a first end 101 and a second end 102 opposite to each other along its axial direction. Please refer to FIG. 1a to FIG. 1c , in use, the protective sheath 10 is sheathed to the distal end of the surgical instrument 20 along the direction from the second end 102 to the first end 101 , to the first end of the protective sheath 10 from the implementing part 21 101 is stretched out, and the assembly can be completed to form a surgical instrument assembly.
进一步的,请参考图4a至图4c,在完成手术器械组合体的装配后,手术操作中的下一个步骤是将手术器械组合体插入穿刺器30,进而将手术器械安装至动力盒(未图示)上,使动力盒与驱动装置连接,具体的安装流程请参考图5a。与安装流程相反的,在术后,可将手术器械组合体从穿刺器30中退出,进而拆卸保护套10,具体的拆卸流程请参考图5b。需要说明的,穿刺器30、动力盒及驱动装置均可根据现有技术进行配置,本领域技术人员可根据现有技术对其结构和原理进行理解,本实施例在此不再展开说明。Further, referring to Fig. 4a to Fig. 4c, after completing the assembly of the surgical instrument assembly, the next step in the surgical operation is to insert the surgical instrument assembly into the trocar 30, and then install the surgical instrument to the power box (not shown in the figure). As shown), the power box is connected to the driving device. For the specific installation process, please refer to Figure 5a. Contrary to the installation process, after the operation, the surgical instrument assembly can be withdrawn from the trocar 30, and then the protective cover 10 can be disassembled. Please refer to FIG. 5b for the specific disassembly process. It should be noted that the trocar 30 , the power box and the driving device can all be configured according to the prior art, and those skilled in the art can understand its structure and principle based on the prior art, and the description of this embodiment will not be repeated here.
由于在一些实施例中,执行部21需要实现俯仰、偏摆、开合、电剪切等功能,因此保护套10不仅需要绝缘性能优良,还需要足够柔软以配合执行部21的各运动关节的运动。然而,如背景技术所述,柔软的保护套10若不采取特别的措施,其容易在使用中沿轴向朝向远端滑脱,在术中脱落于穿刺器30中或落至患者体内。特别的,发明人研究发现,保护套10在穿刺器中移动时,保护套10的第二端102容易与穿刺器30的内壁产生摩擦,是导致保护套10脱落的一大原因。Since in some embodiments, the actuator 21 needs to realize functions such as pitch, yaw, opening and closing, and electric shearing, the protective cover 10 not only needs to have excellent insulation performance, but also needs to be soft enough to match the movement joints of the actuator 21. sports. However, as described in the background art, if no special measures are taken, the soft protective sheath 10 will easily slip off axially toward the distal end during use, and fall out of the trocar 30 or fall into the patient's body during the operation. In particular, the inventor found that when the protective sheath 10 moves in the trocar, the second end 102 of the protective sheath 10 tends to rub against the inner wall of the trocar 30 , which is a major cause of the protective sheath 10 falling off.
基于此,请参考图3a和图3b,在本实施例提供的保护套10具有相邻接的台阶区11和主体区12,所述台阶区11位于第二端102,所述台阶区11与所述主体区12在所述保护 套10的径向上形成高低差,其中所述台阶区11沿径向低于所述主体区12。相适配的,请参考图2,所述手术器械20还包括套管24,所述套管24设置于所述器械杆23的远端;所述套管24用于套设于所述台阶区11的至少部分,亦即,所述台阶区11的至少部分用于插入手术器械20的套管24内,以至少部分地被所述套管24所覆盖。如此配置,保护套10的第二端102被手术器械20的套管24所包覆,可避免保护套10的第二端102与穿刺器30的内壁摩擦,从而可以降低保护套10于穿刺器30内脱落的风险。Based on this, please refer to FIG. 3a and FIG. 3b. The protective cover 10 provided in this embodiment has an adjacent stepped area 11 and a main body area 12, the stepped area 11 is located at the second end 102, and the stepped area 11 and the main body area 12 The main body area 12 forms a height difference in the radial direction of the protective cover 10 , wherein the step area 11 is lower than the main body area 12 in the radial direction. Compatible, please refer to FIG. 2, the surgical instrument 20 also includes a sleeve 24, the sleeve 24 is arranged at the distal end of the instrument rod 23; the sleeve 24 is used to be sleeved on the step At least part of the zone 11 , ie at least part of the stepped zone 11 is intended to be inserted into the sleeve 24 of the surgical instrument 20 to be at least partially covered by the sleeve 24 . In such a configuration, the second end 102 of the protective sheath 10 is covered by the sleeve 24 of the surgical instrument 20, which can prevent the second end 102 of the protective sheath 10 from rubbing against the inner wall of the trocar 30, thereby reducing the protective sheath 10 to the trocar 30. Risk of falling off within 30.
请继续参考图3a和图3b,在一个示范例中,所述保护套10于所述第一端101处的开口的径向内尺寸小于所述保护套10于所述第二端102处的开口的径向内尺寸。保护套10大致呈筒状,其两端均开放而具有开口。较佳的,开口可以呈圆形。当然在其它的一些实施例中,开口也可以是多边形等形状,本实施例对此不限。需要说明的,此处保护套10之开口的径向内尺寸是指开口沿径向的内宽度。若开口为圆形时,其径向内尺寸为该圆形的直径。若开口为多边形时,则其径向内尺寸为该多边形的内接圆的直径。由于手术器械20之执行部21的尺寸一般为朝向远端逐渐收窄,因此将第一端101处的开口的径向内尺寸设置得较小,有利适配执行部21的外轮廓形状。可选的,主体区12自近端朝向远端包括依次连接的平直段121和缩口段122,平直段121优选大致呈直筒的圆柱形,而缩口段122大致呈朝向远端逐渐收缩的圆台形。Please continue to refer to FIG. 3a and FIG. 3b. In an example, the radial inner dimension of the opening of the protective sheath 10 at the first end 101 is smaller than that of the protective sheath 10 at the second end 102. The radial inner dimension of the opening. The protective cover 10 is substantially cylindrical, and both ends are opened to have openings. Preferably, the opening can be circular. Of course, in some other embodiments, the opening may also be in the shape of a polygon, which is not limited in this embodiment. It should be noted that the radial inner dimension of the opening of the protective cover 10 refers to the inner width of the opening along the radial direction. If the opening is circular, its radial inner dimension is the diameter of the circle. If the opening is polygonal, its radial inner dimension is the diameter of the inscribed circle of the polygon. Since the size of the implementing part 21 of the surgical instrument 20 generally narrows toward the distal end, the radially inner dimension of the opening at the first end 101 is set to be smaller, which is beneficial to adapt to the outer contour shape of the implementing part 21 . Optionally, the main body region 12 includes a straight section 121 and a constricted section 122 connected in sequence from the proximal end to the distal end. Constricted frustum.
请参考图6a至图6d,可选的,至少所述主体区12由第一材料制成,所述保护套还包括筒状的加强体13,所述加强体13由第二材料制成,所述加强体13构成所述台阶区11的至少部分;所述第二材料的弹性模量大于所述第一材料的弹性模量。Please refer to FIG. 6a to FIG. 6d , optionally, at least the main body area 12 is made of a first material, and the protective cover further includes a cylindrical reinforcing body 13, and the reinforcing body 13 is made of a second material, The reinforcing body 13 constitutes at least part of the step region 11; the modulus of elasticity of the second material is greater than that of the first material.
一些实施例中,台阶区11完全由加强体13构成,加强体13的一部分还朝向第一端101的方向延伸入主体区12,与主体区12的内侧连接。另一些实施例中,加强体13的外侧还可以包裹部分的第一材料,即加强体13构成了台阶区11的内侧部分,加强体13与第一材料例如通过包胶等方式结合。在其它的一些实施例中,加强体13也可以仅构成台阶区11的一部分轴向区段,而不延伸构成整个台阶区11,台阶区11的其余部分可由第一材料填充形成。In some embodiments, the stepped area 11 is entirely composed of the reinforcing body 13 , and a part of the reinforcing body 13 also extends into the main body area 12 towards the direction of the first end 101 and connects with the inner side of the main body area 12 . In some other embodiments, the outside of the reinforcing body 13 may also wrap part of the first material, that is, the reinforcing body 13 constitutes the inner part of the step area 11 , and the reinforcing body 13 is combined with the first material, for example, by encapsulation. In some other embodiments, the reinforcing body 13 may only constitute a part of the axial section of the stepped region 11 instead of extending to form the entire stepped region 11 , and the rest of the stepped region 11 may be formed by filling the first material.
实际中,由于手术器械20靠近远端的执行部21是采用金属材料制成的导电体,且其需要运动,因此主体区12的材料应具有良好的绝缘性能及抗撕裂性能,例如硅胶或橡胶,其弹性模量优选小于100MPa。进一步的,请参考图6d,保护套10靠近第一端101的一侧可将壁厚设置得较大,以提高其绝缘性。而保护套10靠近第二端102的一侧由于主要套设在绝缘段22上,对绝缘性能及抗撕裂性能的需求较低,可将壁厚设置得较小。然而,保护套10主要是通过靠近第二端102的一侧与手术器械20形成连接,因此靠近第二端102的一侧需要能够抵抗形变。由此,通过加强体13的设置,能够较好地满足抗形变的需求。加强体13如可采用弹性模量较大的材料,如硬质的塑料(如尼龙、聚四氟乙烯),其弹性模量优选大于1GPa。In practice, since the executive part 21 near the distal end of the surgical instrument 20 is a conductor made of metal material and needs to move, the material of the main body area 12 should have good insulation performance and tear resistance, such as silicone or For rubber, the modulus of elasticity is preferably less than 100 MPa. Further, please refer to FIG. 6d , the wall thickness of the side of the protective sheath 10 close to the first end 101 can be set larger to improve its insulation. Since the side of the protective sheath 10 close to the second end 102 is mainly sheathed on the insulating section 22 , the requirements for insulation performance and tear resistance are lower, and the wall thickness can be set smaller. However, the protective sheath 10 is mainly connected to the surgical instrument 20 through the side near the second end 102 , so the side near the second end 102 needs to be able to resist deformation. Therefore, through the arrangement of the reinforcing body 13, the requirement of anti-deformation can be better met. For example, the reinforcement body 13 can be made of a material with a relatively high elastic modulus, such as hard plastic (such as nylon, polytetrafluoroethylene), and its elastic modulus is preferably greater than 1 GPa.
优选的,所述台阶区11和/或主体区12对应于所述加强体13的区域沿径向向外形成凹陷区14,所述加强体13与所述凹陷区14连接,且所述加强体13沿径向的厚度与所述凹陷区14沿径向的深度相适配,使得加强体13在安装于凹陷区14后,加强体13的内壁与台阶区11和/或主体区12其余部分的内壁保持平齐,便于安装于手术器械20上。可以理解的,在一些实施例中,若台阶区11仅由加强体13构成,则此时凹陷区14仅形成于主体区12,加强体13的一部分嵌入主体区12的凹陷区14,另一部分向第一端101的方向伸出,构成台阶区11。在另一些实施例中,台阶区11也包括内外两层的结构,外层为第一材料的包胶,其内部形成凹陷区14,加强体13则设置于该凹陷区14中。当然在其它的一些实施例中,凹陷区14可同时存在于台阶区11和主体区12。Preferably, the area of the step area 11 and/or the main body area 12 corresponding to the reinforcing body 13 forms a recessed area 14 radially outward, the reinforcing body 13 is connected to the recessed area 14, and the reinforcing body 13 is connected to the recessed area 14, and the reinforcing body The thickness of the body 13 along the radial direction is adapted to the depth of the recessed area 14 along the radial direction, so that after the reinforcing body 13 is installed in the recessed area 14, the inner wall of the reinforcing body 13 and the rest of the stepped area 11 and/or the main body area 12 Part of the inner wall remains flat, which is convenient for installation on the surgical instrument 20 . It can be understood that, in some embodiments, if the stepped area 11 is only composed of the reinforcing body 13, then the recessed area 14 is only formed in the main body area 12 at this time, and a part of the reinforcing body 13 is embedded in the recessed area 14 of the main body area 12, and the other part It protrudes towards the direction of the first end 101 to form a stepped area 11 . In some other embodiments, the stepped area 11 also includes an inner and outer layer structure, the outer layer is the encapsulation of the first material, and a recessed area 14 is formed inside, and the reinforcing body 13 is disposed in the recessed area 14 . Of course, in some other embodiments, the recessed area 14 may exist in the step area 11 and the main body area 12 at the same time.
在一个简易的实施例中,套管24固定于器械杆23上,并向绝缘段22伸出一段距离, 保护套10朝向手术器械20的近端移动,至台阶区11插入套管24内即可。请参考图7a和图7b,在一个可替代的示范例中,所述套管24具有内螺纹,所述台阶区11具有外螺纹111,或者,所述台阶区11在与所述套管24连接后被所述套管24挤压形成外螺纹111;所述台阶区11通过所述外螺纹111与所述套管24的内螺纹连接。在一些实施例中,台阶区11可由加强体13构成,其外表面可直接设置外螺纹111。在另一些实施例中,台阶区11可在加强体13的外侧用第一材料包胶形成,此时其外表面较为柔软,在套管24的内螺纹的挤压下,也可以形成外螺纹111而实现两者的螺纹连接。套管24和台阶区11螺纹连接后,套管24覆盖了保护套10第二端102的端面,从而能对保护套10第二端102的端面形成保护。当保护套10安装在手术器械24的绝缘段22上后,转动套管24,套管24的内螺纹旋压在台阶区11的内螺纹上,一方面隔离了保护套10第二端102与穿刺器30,减小了摩擦,另一方面固定了保护套10的轴向位置,避免滑脱,起到了双重保护作用。可选的,在一些实施例中,套管24相对器械杆23可转动地设置,这样只需沿轴向套入保护套10,转动套管24即可使两者螺纹连接。在另一些实施例中,套管24也可以是相对器械杆23固定连接的,这样在沿轴向套入保护套10后,再转动保护套10,亦可实现套管24与保护套10的螺纹连接。In a simple embodiment, the sleeve 24 is fixed on the instrument shaft 23 and stretches out to the insulating section 22 for a certain distance, and the protective cover 10 moves toward the proximal end of the surgical instrument 20 until the step area 11 is inserted into the sleeve 24. Can. Please refer to FIG. 7a and FIG. 7b. In an alternative example, the sleeve 24 has an internal thread, and the stepped area 11 has an external thread 111, or, the stepped area 11 is in contact with the sleeve 24 After being connected, it is extruded by the sleeve 24 to form an external thread 111 ; the stepped area 11 is connected to the internal thread of the sleeve 24 through the external thread 111 . In some embodiments, the stepped area 11 can be formed by a reinforcing body 13 , and an external thread 111 can be directly provided on the outer surface thereof. In some other embodiments, the step area 11 can be formed by encapsulating the first material on the outside of the reinforcing body 13, at this time, its outer surface is relatively soft, and the external thread can also be formed under the extrusion of the internal thread of the sleeve 24. 111 to realize the threaded connection of the two. After the sleeve 24 is screwed to the step area 11 , the sleeve 24 covers the end surface of the second end 102 of the protective sleeve 10 , so as to protect the end surface of the second end 102 of the protective sleeve 10 . After the protective cover 10 is installed on the insulating section 22 of the surgical instrument 24, the sleeve 24 is rotated, and the internal thread of the sleeve 24 is screwed on the internal thread of the step area 11, on the one hand, the second end 102 of the protective cover 10 is isolated from the The piercer 30 reduces friction, and on the other hand, fixes the axial position of the protective sheath 10 to avoid slipping, thus playing a double protective role. Optionally, in some embodiments, the sleeve 24 is rotatably arranged relative to the instrument shaft 23 , so that the protective sheath 10 only needs to be inserted in the axial direction, and the sleeve 24 can be rotated to thread the two. In other embodiments, the sleeve 24 can also be fixedly connected to the instrument shaft 23, so that after inserting the protective sleeve 10 in the axial direction, and then rotating the protective sleeve 10, the connection between the sleeve 24 and the protective sleeve 10 can also be realized. threaded connection.
请参考图7c,可选的,所述主体区12包括坡口段123,所述坡口段123位于所述主体区12靠近所述第二端102的一侧;所述坡口段123朝向所述第二端102逐渐收缩,以使所述主体区12与所述台阶区11形成过渡连接。坡口段123靠近第一端101的一侧可与主体区12其余的部分相平齐,进而坡口段123沿朝向第二端102的方向逐渐向内收缩(即外径逐渐减小),至与台阶区11连接处,坡口段123的外径与台阶区11的外径大致相同。由此即形成过渡连接。需要说明的,这里的过渡连接,如可以是直坡面连接,即坡口段123呈线性地收缩,或是圆滑地过渡连接(坡口段123呈非线性地收缩),本实施例对此不限。Please refer to FIG. 7c, optionally, the main body area 12 includes a bevel section 123, and the bevel section 123 is located on a side of the main body area 12 close to the second end 102; the bevel section 123 faces The second end 102 shrinks gradually so that the main body area 12 forms a transition connection with the step area 11 . The side of the groove section 123 close to the first end 101 can be flush with the rest of the main body region 12, and then the groove section 123 gradually shrinks inward along the direction toward the second end 102 (that is, the outer diameter gradually decreases), To the connection with the stepped area 11 , the outer diameter of the bevel section 123 is substantially the same as the outer diameter of the stepped area 11 . This forms the transition connection. It should be noted that the transition connection here can be a straight slope connection, that is, the groove section 123 shrinks linearly, or a smooth transition connection (the groove section 123 shrinks nonlinearly). unlimited.
在一些实施例中,不仅台阶区11可以全部进入套管24的覆盖范围,靠近第二端102的一部分的坡口段123也可以进入套管24的覆盖范围内。在一些实施例中,坡口段123可作为插入深度指示标记,具体的,在使用中,保护套10在套入手术器械20的过程中,与手术器械20存在一个较合理的相对轴向位置。例如图1b和图1c示出的示范例中,主体区12靠近第二端102的一侧与绝缘段22的近端相平齐时,可认为保护套10的套设到位,此时称保护套10的位置为预定位置。若保护套10套入不足(指保护套10相对预定位置更靠近手术器械20的远端),则一方面保护套10容易脱落,另一方面保护套10对执行部21过度遮蔽,导致执行部21无法正常工作。若保护套10套入过深(指保护套10相对靠近手术器械20的近端),则保护套10对执行部21遮蔽不足,容易使执行部21的一部分不应当暴露的关节裸露出来而产生危害。坡口段123的设置,可以使操作者直观地观察到主体区12的边缘与手术器械20的相对位置关系,从而可避免保护套10套入不足或套入过深。特别的,在套管24与保护套10采用螺纹连接的方案中,由于套管24与保护套10相对转动时通过螺纹转换为轴向的相对运动量较小,不容易直观地获知套管24与保护套10的相对位置关系,而坡口段123的设置即对套管24与保护套10的相对位置关系进行指示。另一方面,坡口段123的设置还能够对套管24与保护套10的相对位置关系进行机械性地限制。具体的,坡口段123靠近第二端102的一侧外径较小,其被配置为能够进入套管24的远端,而坡口段123靠近第一端101的一侧外径较大,其无法进入套管24的远端。在不断旋动套管24(或保护套10)使保护套10不断向手术器械20的近端移动,至坡口段123的一部分进入套管24后,坡口段123将会卡在套管24的远端口部而被机械性地限位。由此可确保保护套10不会套入过深。In some embodiments, not only the stepped area 11 can completely enter the coverage of the casing 24 , but also a part of the bevel section 123 near the second end 102 can enter the coverage of the casing 24 . In some embodiments, the groove section 123 can be used as an indicator mark for the insertion depth. Specifically, in use, when the protective sheath 10 is inserted into the surgical instrument 20, there is a reasonable relative axial position with the surgical instrument 20 . For example, in the example shown in Fig. 1b and Fig. 1c, when the side of the main body region 12 close to the second end 102 is flush with the proximal end of the insulating section 22, it can be considered that the sheath of the protective sheath 10 is in place, which is called protection at this time. The position of the sleeve 10 is a predetermined position. If the protective sheath 10 is insufficiently inserted (meaning that the protective sheath 10 is closer to the distal end of the surgical instrument 20 relative to the predetermined position), the protective sheath 10 will easily fall off on the one hand, and on the other hand, the protective sheath 10 will over-shield the executive part 21, causing the executive part 21 does not work. If the protective sheath 10 is inserted too deeply (meaning that the protective sheath 10 is relatively close to the proximal end of the surgical instrument 20), the protective sheath 10 will not cover the executive part 21 enough, and it is easy to expose a part of the executive part 21 that should not be exposed. harm. The arrangement of the bevel section 123 enables the operator to visually observe the relative positional relationship between the edge of the main body area 12 and the surgical instrument 20 , thereby avoiding insufficient or too deep insertion of the protective sheath 10 . In particular, in the scheme where the sleeve pipe 24 and the protective sleeve 10 are threaded, since the relative movement of the sleeve pipe 24 and the protective sleeve 10 when the sleeve pipe 24 and the protective sleeve 10 are rotated relative to the axial direction is relatively small, it is not easy to intuitively know the connection between the sleeve pipe 24 and the protective sleeve 10. The relative positional relationship between the protective sheath 10 , and the setting of the bevel section 123 indicates the relative positional relationship between the sleeve 24 and the protective sheath 10 . On the other hand, the arrangement of the bevel section 123 can also mechanically limit the relative positional relationship between the sleeve 24 and the protective sheath 10 . Specifically, the outer diameter of the groove section 123 near the second end 102 is smaller, and it is configured to be able to enter the distal end of the casing 24, while the outer diameter of the groove section 123 near the first end 101 is larger , which cannot enter the distal end of the cannula 24 . When the sleeve tube 24 (or protective cover 10) is continuously rotated to make the protective cover 10 move towards the proximal end of the surgical instrument 20, after a part of the groove section 123 enters the sleeve tube 24, the groove section 123 will be stuck in the sleeve tube. 24 is mechanically limited. This ensures that the protective sheath 10 cannot be inserted too deeply.
请参考图8a至图8c,在另一个示范例中,所述套管24沿所述器械杆23的轴向相对所述器械杆23可移动,所述套管24沿轴向朝向远端移动伸出后,套设于所述台阶区11的 至少部分。与前一个示范例不同的,台阶区11上也可以不设置外螺纹111,通过对手术器械20上的套管24进行改进,具体将套管24配置为沿轴向可移动伸出,也可以实现隔离保护套10第二端102与穿刺器30的效果。Please refer to FIGS. 8a to 8c. In another example, the sleeve 24 is movable relative to the instrument shaft 23 along the axial direction of the instrument shaft 23, and the sleeve 24 moves toward the distal end in the axial direction. After stretching out, it is sleeved on at least part of the step area 11 . Different from the previous example, the external thread 111 may not be provided on the step area 11. By improving the sleeve 24 on the surgical instrument 20, specifically configuring the sleeve 24 to move and protrude in the axial direction, it is also possible to The effect of isolating the second end 102 of the protective sheath 10 from the trocar 30 is realized.
进一步的,所述手术器械20还包括外管25,所述外管25套设于所述器械杆23外并与所述器械杆23固定连接,所述套管24的至少部分穿设于所述外管25内,且所述套管24可移动地与所述外管25连接。较佳的,器械杆23于设置外管25的区段向内凹陷,外管25在套设安装于器械杆23上后,外管25的外壁优选与器械杆23其余部分的外壁相平齐,以减小穿过穿刺器30的阻力。Further, the surgical instrument 20 also includes an outer tube 25, the outer tube 25 is sheathed outside the instrument shaft 23 and fixedly connected with the instrument shaft 23, at least part of the sleeve 24 is passed through the The outer tube 25 is inside, and the sleeve 24 is movably connected with the outer tube 25 . Preferably, the instrument shaft 23 is recessed inwardly at the section where the outer tube 25 is provided. After the outer tube 25 is sleeved on the instrument shaft 23, the outer wall of the outer tube 25 is preferably flush with the outer walls of the rest of the instrument shaft 23. , to reduce the resistance through the piercer 30.
更进一步的,所述外管25具有沿径向贯通开设的长条孔251,所述长条孔251的长轴沿所述器械杆23的轴向布置;所述套管24具有沿径向凸起的滑块241,所述滑块241沿垂直于所述器械杆23轴向的宽度与所述长条孔251沿垂直于所述器械杆23轴向的宽度相适配,所述滑块241沿所述器械杆23的轴向可移动地设置于所述长条孔251中。由于一些实施例中台阶区11的外表面由柔性的第一材料构成,其表面摩擦系数较大,若套管24的移动方向相对台阶区11的外表面产生倾斜,则难以驱使套管24顺利地套在台阶区11上而容易被卡住。长条孔251和滑块241的设置限制了滑块241仅能沿长条孔251的长轴方向(亦即器械杆23的轴向)移动,由此保证套管24伸出外管25时不会产生倾斜、偏向等问题,从而保证套管24能够顺利地套设在台阶区11上。此外,滑块241也可供操作者拨动,方便操作。Furthermore, the outer tube 25 has a long hole 251 extending radially, the long axis of the long hole 251 is arranged along the axial direction of the instrument shaft 23; The raised slider 241, the width of the slider 241 along the axial direction perpendicular to the instrument shaft 23 is adapted to the width of the elongated hole 251 along the axial direction perpendicular to the instrument shaft 23, the slider The block 241 is movably disposed in the elongated hole 251 along the axial direction of the instrument shaft 23 . Since the outer surface of the stepped area 11 in some embodiments is made of a flexible first material with a relatively large surface friction coefficient, if the moving direction of the sleeve 24 is inclined relative to the outer surface of the stepped area 11, it is difficult to drive the sleeve 24 smoothly. The ground is sleeved on the step area 11 and is easily stuck. The arrangement of the elongated hole 251 and the slider 241 limits the movement of the slider 241 only along the long axis direction of the elongated hole 251 (that is, the axial direction of the instrument rod 23), thereby ensuring that the sleeve pipe 24 does not stretch out from the outer tube 25. There will be problems such as inclination and deflection, so as to ensure that the sleeve 24 can be smoothly sleeved on the step area 11 . In addition, the slider 241 can also be toggled by the operator, which is convenient for operation.
请参考图9a至图9c,优选的,所述保护套10包括定位孔15,所述定位孔15沿所述保护套10的径向贯通开设于所述主体区12上;所述手术器械20包括定位凸起26,所述定位凸起26设置于所述绝缘段22上。所述定位孔15与所述手术器械20的定位凸起26相适配卡合,从而限制保护套10与手术器械20的相对位置,避免保护套10脱落。由于定位凸起26设置于绝缘段22上,保护套10在对应的位置开设定位孔15不会对手术器械20远端的执行部21的绝缘产生影响。需要说明的,本实施例对定位孔15的形状和数量并不作特别的限定,定位孔15如可为若干个椭圆形、圆形或异形孔,定位凸起26的形状和数量与定位孔15相适配。Please refer to FIG. 9a to FIG. 9c, preferably, the protective sheath 10 includes a positioning hole 15, and the positioning hole 15 is opened on the main body area 12 along the radial direction of the protective sheath 10; the surgical instrument 20 A positioning protrusion 26 is included, and the positioning protrusion 26 is arranged on the insulating segment 22 . The positioning hole 15 fits and engages with the positioning protrusion 26 of the surgical instrument 20 , so as to limit the relative position of the protective cover 10 and the surgical instrument 20 and prevent the protective cover 10 from falling off. Since the positioning protrusions 26 are disposed on the insulating section 22 , the positioning holes 15 provided in the corresponding positions of the protective sheath 10 will not affect the insulation of the operating part 21 at the distal end of the surgical instrument 20 . It should be noted that the present embodiment does not specifically limit the shape and quantity of the positioning holes 15. The positioning holes 15 can be several oval, circular or special-shaped holes, and the shape and quantity of the positioning protrusions 26 are the same as those of the positioning holes 15. match.
请参考图10a至图10c,在另一个优选示例中,所述定位孔15的宽度沿所述第一端101朝向所述第二端102的方向逐渐增大;其中所述定位孔15的宽度为所述定位孔15沿所述保护套10周向的内尺寸。相适配的,所述定位凸起26的宽度沿远端朝向近端的方向逐渐增大,其中定位凸起26的宽度为所述定位凸起26沿绝缘管22周向的外尺寸。如此配置,一方面有利于减小保护套10的安装阻力,另一方面在保护套10安装在手术器械20上后,能有效防止保护套10脱落。Please refer to Fig. 10a to Fig. 10c, in another preferred example, the width of the positioning hole 15 gradually increases along the direction of the first end 101 toward the second end 102; wherein the width of the positioning hole 15 is the inner dimension of the positioning hole 15 along the circumference of the protective sleeve 10 . Adaptively, the width of the positioning protrusion 26 gradually increases along the direction from the distal end to the proximal end, wherein the width of the positioning protrusion 26 is the outer dimension of the positioning protrusion 26 along the circumferential direction of the insulating tube 22 . Such configuration, on the one hand, helps to reduce the installation resistance of the protective sheath 10 , and on the other hand, can effectively prevent the protective sheath 10 from falling off after the protective sheath 10 is installed on the surgical instrument 20 .
请参考图11a至图11c,可选的,所述主体区120的外表面具有凹陷或凸起的防滑结构124。防滑结构124如可为椭圆形、圆形、方块形、菱形、弧形或波浪形等,其可以凹陷于主体区120的外表面,也可以凸起于主体区120的外表面。图11a示出了椭圆形的防滑结构124,图11b示出了菱形的防滑结构124,图11c示出了波浪形的防滑结构124。一些实施例中,也可以同时设置凹陷和凸起的防滑结构124,另一些实施例中,也可以组合使用各种形状的防滑结构124,本实施例对此均不作限制。防滑结构124的设置,方便于操作者对保护套10的握持和安装,能防止安装过程中手指或者安装工具打滑,提高保护套10的安装效率、降低手部戳进手术器械20之末端的风险。Please refer to FIG. 11a to FIG. 11c , optionally, the outer surface of the main body area 120 has a concave or convex anti-slip structure 124 . The anti-skid structure 124 can be oval, circular, square, rhombus, arc or wavy, etc., and can be recessed on the outer surface of the main body area 120 or protruded on the outer surface of the main body area 120 . FIG. 11 a shows an oval anti-slip structure 124 , FIG. 11 b shows a diamond-shaped anti-slip structure 124 , and FIG. 11 c shows a wave-shaped anti-slip structure 124 . In some embodiments, the concave and convex anti-slip structures 124 can also be provided at the same time, and in other embodiments, various shapes of anti-slip structures 124 can also be used in combination, which is not limited in this embodiment. The setting of the anti-slip structure 124 is convenient for the operator to hold and install the protective cover 10, and can prevent the fingers or installation tools from slipping during the installation process, improve the installation efficiency of the protective cover 10, and reduce the risk of the hand poking into the end of the surgical instrument 20. risk.
综上所述,在本申请提供的保护套、手术器械及手术器械组合体中,所述保护套沿自身轴向具有相对的第一端和第二端,所述保护套用于套设于手术器械上,并使所述手术器械远端的执行部自所述第一端伸出;所述保护套的外周具有相邻接的台阶区和主体区,所述台阶区位于所述保护套的第二端,所述台阶区与所述主体区在所述保护套的径向上形成 高低差,其中所述台阶区沿径向低于所述主体区,所述台阶区的至少部分用于插入所述手术器械的套管内。如此配置,通过将保护套第二端处的台阶区插入手术器械的套管内,可避免保护套的第二端与穿刺器的内壁摩擦,从而可以降低保护套于穿刺器内脱落的风险。To sum up, in the protective sheath, surgical instrument and surgical instrument combination provided by the present application, the protective sheath has opposite first and second ends along its own axial direction, and the protective sheath is used to be sleeved on the surgical instrument. on the instrument, and make the executive part of the distal end of the surgical instrument protrude from the first end; the outer periphery of the protective cover has a contiguous step area and a main body area, and the step area is located on the protective cover At the second end, the step area and the main body area form a height difference in the radial direction of the protective sleeve, wherein the step area is lower than the main body area in the radial direction, and at least part of the step area is used for insertion Inside the cannula of the surgical instrument. With such a configuration, by inserting the step region at the second end of the protective sheath into the cannula of the surgical instrument, friction between the second end of the protective sheath and the inner wall of the trocar can be avoided, thereby reducing the risk of the protective sheath falling off in the trocar.
需要说明的,上述若干实施例之间可相互组合。上述描述仅是对本申请较佳实施例的描述,并非对本申请范围的任何限定,本申请领域的普通技术人员根据上述揭示内容做的任何变更、修饰,均属于权利要求书的保护范围。It should be noted that the above several embodiments can be combined with each other. The above description is only a description of the preferred embodiments of the present application, and does not limit the scope of the present application. Any changes and modifications made by those of ordinary skill in the field of the present application based on the above disclosure shall fall within the protection scope of the claims.

Claims (17)

  1. 一种保护套,其特征在于,所述保护套沿自身轴向具有相对的第一端和第二端,所述保护套用于套设于手术器械上,并使所述手术器械远端的执行部自所述第一端伸出;A protective sheath, characterized in that the protective sheath has opposite first ends and second ends along its axial direction, the protective sheath is used to be sleeved on the surgical instrument, and enables the execution of the distal end of the surgical instrument protruding from the first end;
    所述保护套的外周具有相邻接的台阶区和主体区,所述台阶区位于所述保护套的第二端,所述台阶区与所述主体区在所述保护套的径向上形成高低差,其中所述台阶区沿径向低于所述主体区,所述台阶区的至少部分用于插入所述手术器械的套管内。The outer periphery of the protective cover has a contiguous step area and a main body area, the step area is located at the second end of the protective cover, the step area and the main body area form a height in the radial direction of the protective cover Poor, wherein the stepped region is radially lower than the body region, at least a portion of the stepped region for insertion into a cannula of the surgical instrument.
  2. 根据权利要求1所述的保护套,其特征在于,所述保护套于所述第一端处的开口的径向内尺寸小于所述保护套于所述第二端处的开口的径向内尺寸。The protective cover according to claim 1, wherein the radial inner dimension of the opening of the protective cover at the first end is smaller than the radial inner dimension of the opening of the protective cover at the second end. size.
  3. 根据权利要求1所述的保护套,其特征在于,至少所述主体区由第一材料制成,所述保护套还包括筒状的加强体,所述加强体由第二材料制成,所述加强体构成所述台阶区的至少部分;所述第二材料的弹性模量大于所述第一材料的弹性模量。The protective case according to claim 1, wherein at least the main body area is made of a first material, and the protective case further comprises a cylindrical reinforcing body, and the reinforcing body is made of a second material, so that The reinforcing body constitutes at least part of the step region; the elastic modulus of the second material is greater than the elastic modulus of the first material.
  4. 根据权利要求3所述的保护套,其特征在于,所述加强体的一部分还朝向所述第一端的方向延伸入所述主体区,与所述主体区的内侧连接。The protective cover according to claim 3, wherein a part of the reinforcing body also extends into the main body area toward the direction of the first end, and is connected to the inner side of the main body area.
  5. 根据权利要求3所述的保护套,其特征在于,所述台阶区和/或所述主体区对应于所述加强体的区域沿径向向外形成凹陷区,所述加强体与所述凹陷区连接,且所述加强体沿径向的厚度与所述凹陷区沿径向的深度相适配。The protective cover according to claim 3, characterized in that, the stepped area and/or the main body area corresponding to the reinforcement body forms a concave area radially outward, and the reinforcement body and the depression The area is connected, and the thickness of the reinforcing body along the radial direction is adapted to the depth of the recessed area along the radial direction.
  6. 根据权利要求1所述的保护套,其特征在于,所述保护套包括定位孔,所述定位孔沿所述保护套的径向贯通开设于所述主体区上;所述定位孔用于与所述手术器械的定位凸起相适配卡合。The protective cover according to claim 1, wherein the protective cover includes a positioning hole, and the positioning hole is opened on the main body area along the radial direction of the protective cover; the positioning hole is used to communicate with The positioning protrusions of the surgical instruments are matched and engaged.
  7. 根据权利要求6所述的保护套,其特征在于,所述定位孔的宽度沿所述第一端朝向所述第二端的方向逐渐增大;其中所述定位孔的宽度为所述定位孔沿所述保护套周向的内尺寸。The protective cover according to claim 6, wherein the width of the positioning hole increases gradually along the direction from the first end toward the second end; wherein the width of the positioning hole is that along the direction of the positioning hole The inner dimension of the protective sleeve in the circumferential direction.
  8. 根据权利要求1所述的保护套,其特征在于,所述台阶区具有外螺纹,或者,所述台阶区在与所述套管连接后被所述套管挤压形成外螺纹;所述台阶区通过所述外螺纹与所述套管的内螺纹连接。The protective sleeve according to claim 1, characterized in that, the step area has an external thread, or the step area is extruded by the sleeve to form an external thread after being connected with the sleeve; the step The zone is connected with the inner thread of the sleeve through the outer thread.
  9. 根据权利要求8所述的保护套,其特征在于,所述主体区包括坡口段,所述坡口段位于所述主体区靠近所述第二端的一侧;所述坡口段朝向所述第二端逐渐收缩,以使所述主体区与所述台阶区形成过渡连接。The protective cover according to claim 8, wherein the main body area includes a bevel section, and the bevel section is located on a side of the main body area close to the second end; the bevel section faces the The second end tapers gradually so that the main body area and the step area form a transition connection.
  10. 根据权利要求1所述的保护套,其特征在于,所述主体区的外表面具有凹陷或凸起的防滑结构。The protective cover according to claim 1, wherein the outer surface of the main body area has a concave or convex anti-slip structure.
  11. 一种手术器械,其特征在于,用于与根据权利要求1~10中任一项所述的保护套配合连接;所述手术器械自远端向近端包括依次连接的执行部、绝缘段与器械杆,所述手术器械还包括套管,所述套管设置于所述器械杆的远端;所述执行部用于自所述保护套的所述第一端伸出,所述套管用于套设于所述台阶区的至少部分。A surgical instrument, characterized in that it is used for mating connection with the protective sheath according to any one of claims 1 to 10; the surgical instrument includes an executive part, an insulating section and an The instrument rod, the surgical instrument also includes a sleeve, the sleeve is arranged at the distal end of the instrument rod; the execution part is used to protrude from the first end of the protective sleeve, and the sleeve is used for It is sleeved on at least part of the step area.
  12. 根据权利要求11所述的手术器械,其特征在于,所述套管具有内螺纹,所述套管通过所述内螺纹与所述台阶区的外螺纹连接。The surgical instrument according to claim 11, wherein the sleeve has an internal thread, and the sleeve is connected to the external thread of the step area through the internal thread.
  13. 根据权利要求11所述的手术器械,其特征在于,所述套管沿所述器械杆的轴向相对所述器械杆可移动,所述套管沿轴向朝向远端移动伸出后,套设于所述台阶区的至少部分。The surgical instrument according to claim 11, wherein the sleeve is movable relative to the instrument shaft along the axial direction of the instrument shaft, and after the sleeve moves toward the distal end in the axial direction, the sleeve at least part of the step area.
  14. 根据权利要求13所述的手术器械,其特征在于,所述手术器械还包括外管,所述外管套设于所述器械杆外并与所述器械杆固定连接,所述套管的至少部分穿设于所述外管内,且所述套管可移动地与所述外管连接。The surgical instrument according to claim 13, characterized in that, the surgical instrument further comprises an outer tube, the outer tube is sheathed outside the instrument shaft and fixedly connected with the instrument shaft, at least A part is passed through the outer tube, and the sleeve is movably connected with the outer tube.
  15. 根据权利要求14所述的手术器械,其特征在于,所述外管具有沿径向贯通开设的长条孔,所述长条孔的长轴沿所述器械杆的轴向布置;所述套管具有沿径向凸起的滑块,所述滑块沿垂直于所述器械杆轴向的宽度与所述长条孔沿垂直于所述器械杆轴向的宽度相适配,所述滑块沿所述器械杆的轴向可移动地设置于所述长条孔中。The surgical instrument according to claim 14, characterized in that, the outer tube has a long hole radially penetrated, and the long axis of the long hole is arranged along the axial direction of the instrument shaft; the sleeve The tube has a slider protruding radially, the width of the slider along the axis perpendicular to the instrument shaft is adapted to the width of the elongated hole perpendicular to the axis of the instrument shaft, and the slider A block is movably disposed in the elongated hole along the axial direction of the instrument shaft.
  16. 根据权利要求11所述的手术器械,其特征在于,所述手术器械包括定位凸起,所述定位凸起设置于所述绝缘段上,用于与所述保护套的定位孔相适配卡合。The surgical instrument according to claim 11, characterized in that, the surgical instrument comprises a positioning protrusion, and the positioning protrusion is disposed on the insulating section, and is adapted to fit and engage with the positioning hole of the protective cover.
  17. 一种手术器械组合体,其特征在于,包括根据权利要求1~10中任一项所述的保护套以及根据权利要求11~16中任一项所述的手术器械。A surgical instrument assembly, characterized by comprising the protective sheath according to any one of claims 1-10 and the surgical instrument according to any one of claims 11-16.
PCT/CN2022/140264 2021-12-21 2022-12-20 Protective sleeve, surgical instrument, and surgical instrument assembly WO2023116662A1 (en)

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