WO2022218422A1 - 一种超声外科手术器械及加工组装方法 - Google Patents

一种超声外科手术器械及加工组装方法 Download PDF

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Publication number
WO2022218422A1
WO2022218422A1 PCT/CN2022/087173 CN2022087173W WO2022218422A1 WO 2022218422 A1 WO2022218422 A1 WO 2022218422A1 CN 2022087173 W CN2022087173 W CN 2022087173W WO 2022218422 A1 WO2022218422 A1 WO 2022218422A1
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WIPO (PCT)
Prior art keywords
assembly
sleeve assembly
surgical instrument
ultrasonic surgical
outer ring
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PCT/CN2022/087173
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English (en)
French (fr)
Inventor
聂红林
廖梦辉
杨光
张永春
唐传刚
Original Assignee
上海逸思医疗科技股份有限公司
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Application filed by 上海逸思医疗科技股份有限公司 filed Critical 上海逸思医疗科技股份有限公司
Priority to EP22787644.8A priority Critical patent/EP4324411A1/en
Priority to JP2023562837A priority patent/JP2024514155A/ja
Priority to US18/555,700 priority patent/US20240197355A1/en
Publication of WO2022218422A1 publication Critical patent/WO2022218422A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367—Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00526—Methods of manufacturing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A61B2017/2927—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft
    • A61B2017/2929—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft with a head rotatable about the longitudinal axis of the shaft
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320072—Working tips with special features, e.g. extending parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A61B2017/320094—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw additional movable means performing clamping operation

Definitions

  • the present disclosure relates to the field of surgical medical instruments, is applied to surgical instruments, and in particular relates to an ultrasonic surgical instrument and a processing and assembling method.
  • the ultrasonic scalpel With the popularity of minimally invasive surgery, the ultrasonic scalpel has become a conventional surgical instrument.
  • the ultrasonic scalpel makes the blade mechanically oscillate at a certain ultrasonic frequency through the ultrasonic frequency generator, so that the water molecules in the tissue are vaporized, the protein hydrogen bonds are broken, and the cells are disintegrated, so that the tissue is incised or coagulated, and the blood vessels can also be closure.
  • the ultrasonic scalpel enables simultaneous tissue cutting and coagulation with less lateral thermal damage. Ultrasonic scalpels are gaining popularity because of their clinical use of this instrument, which can achieve lesion resection at lower temperatures and less bleeding, and can ensure minimal lateral thermal damage to the tissue.
  • Ultrasonic scalpel is mainly composed of ultrasonic frequency generator, transducer and surgical instruments.
  • the ultrasonic frequency generator sends out an oscillating electrical signal
  • the transducer converts the oscillating electrical signal into mechanical vibration
  • the surgical instrument uses the mechanical vibration of the transducer to cut and coagulate tissue.
  • Surgical instruments are usually composed of a knife bar, a clamp that forms a clamping structure with the knife bar, a sleeve assembly surrounding the outside of the knife bar, and a handle portion.
  • the cutter bar transmits the mechanical vibration of the transducer to the cutter bar; the cutter bar and the clamp cooperate with the clamp to hold the tissue to achieve cutting and coagulation functions;
  • the casing assembly is composed of an outer casing and an inner casing, and the cutter shaft is located in the inner casing,
  • the sleeve assembly isolates the knife rod from the outside to protect and support the knife rod; on the other hand, it forms a link mechanism with the clamp to drive the closing and opening of the clamp; the handle part is held by the doctor's hand,
  • the clamp can be operated to open and close, and a switch can control the ultrasonic frequency generator to start or stop outputting oscillating electrical signals.
  • the existing ultrasonic scalpel design has a relatively complex structure, high manufacturing cost, and inconvenient assembly.
  • the implementation and assembly of the inner/outer casing can only be realized by expanding the tube, rotating the groove, etc., so the cost remains high, and the internal / The structure of the outer casing is complex, the cost is high, and the processing efficiency is low.
  • the sealing between the inner sleeve and the outer sleeve of the existing ultrasonic scalpel is generally realized by making a bulging groove structure
  • the ultrasonic scalpel shown in FIG. 9 includes an outer sleeve assembly 21 ′ , inner casing assembly 22', dial outer ring 23' and sealing ring 24', dial outer ring 23', outer casing assembly 21', inner casing assembly 22' form a sequentially distributed structure from outside to inside
  • the sealing ring 24' is located between the outer sleeve body 211' of the outer sleeve assembly 21' and the inner sleeve body 221' of the inner sleeve assembly 22', wherein the outer sleeve body 211' of the outer sleeve assembly 21' and the inner sleeve assembly
  • the inner sleeve body 221' of 22' has a complex concave-convex structure, through which the sealing between the inner sleeve and
  • the present disclosure provides a reusable and simple-to-assemble ultrasonic surgical instrument, the overall structure of the instrument is more simplified, and the cost of the cannula assembly is greatly reduced.
  • the present disclosure can reduce the assembly process through the integral molding process, the integrality of the components produced by the integral molding process (co-injection) is strong, and the sealing between the inner and outer sleeves does not need to be designed through the complex configuration structure of the sleeve (such as bulging). It can be realized by matching with the groove structure), and the bulging groove structure of the sleeve part can be eliminated or simplified, which greatly improves the overall performance of the ultrasonic surgical instrument, so that the ultrasonic surgical instrument can be applied to the surgical scene with higher precision .
  • an ultrasonic surgical instrument comprising a cutter bar, a clamp, a sleeve assembly and a handle portion, the clamp and the distal end of the cutter bar constitute a clamping structure, and the cutter bar is used for transmitting ultrasonic waves energy ultrasonic cutter bar, the sleeve assembly is coaxially arranged with the cutter bar, the clamp is disposed at the distal end of the sleeve assembly, and the handle portion is disposed at the proximal end of the sleeve assembly part; wherein, the casing assembly includes an outer casing assembly, an inner casing assembly and an outer ring of the dial, and the outer casing assembly and the inner casing assembly are both integral structures (one-piece structures), and are connected through a connecting mechanism.
  • the ultrasonic surgical instrument further includes a dial outer ring, the dial outer ring is coaxially mounted on the outside of the outer sleeve assembly, and the dial outer ring and the outer sleeve assembly cannot be formed. relative rotation; the sleeve assembly is rotatably connected to the handle portion; the rotational connection between the outer sleeve assembly and the handle portion is non-detachable and restricts axial movement;
  • the connection structure of the coaxial rotation of the handle part is arranged on the outer casing assembly or on the outer ring of the dial; the outer casing assembly is provided with an anti-rotation boss along the axial direction, and the outer ring of the dial is provided with an anti-rotation boss.
  • the outer sleeve assembly is provided with an anti-rotation groove in the axial direction, and the outer ring of the dial is provided with an anti-rotation boss,
  • the anti-rotation boss is matched with the anti-rotation groove;
  • the outer sleeve assembly is provided with a first anti-drop boss along the axial direction, the outer ring of the dial is provided with a second anti-drop boss, and the outer sleeve is provided with a second anti-drop boss.
  • the first anti-falling boss of the tube assembly is matched with the second anti-falling boss of the outer ring of the dial to assemble the outer sleeve assembly and the outer ring of the dial; the outer ring of the dial is connected to the outer ring of the dial
  • the outer sleeve assembly is assembled in a manner not limited to interference fitting or gluing, so that the outer ring of the dial wheel and the outer sleeve assembly cannot rotate relative to each other.
  • the ultrasonic surgical instrument of the present disclosure adopts an integral sleeve assembly, and the bulging structure is not provided (cancelled) in the sleeve assembly, so that the ultrasonic surgical instrument has a simple structure, simple assembly, and reduced cost.
  • a method for processing and assembling an ultrasonic surgical instrument includes a cutter bar, a clamp, a sleeve assembly and a handle portion, and the clamp and the distal end of the cutter bar constitute a clamping structure, so
  • the casing assembly includes an outer casing assembly and an inner casing assembly, and the processing and assembling method includes:
  • the outer sleeve assembly and the inner sleeve assembly are coaxially installed to obtain a sleeve assembly; and the sleeve assembly, the knife rod, the clamp, and the handle are assembled to obtain an ultrasonic surgical instrument.
  • the sealing between the inner and outer casings can be achieved without designing a complex configuration of the casing, and the bulging structure of the casing can be eliminated or Simplified, the overall structure is more simplified, and the performance is more optimized.
  • FIG. 1 is an overall schematic diagram of the ultrasonic surgical instrument of the present disclosure.
  • FIG. 2 is an exploded view of the casing assembly of the present disclosure.
  • FIG 3 is a schematic view of the installation of the sleeve assembly of the present disclosure.
  • FIG. 4 is a schematic structural diagram of the outer ring of the dial wheel of the present disclosure.
  • FIG. 5 is a schematic diagram of an outer sleeve assembly of the present disclosure.
  • FIG. 6 is a schematic diagram of an inner sleeve assembly of the present disclosure.
  • FIG. 7 is a schematic view of the sleeve assembly of the present disclosure installed in place.
  • FIG. 8 is an enlarged view of part A in FIG. 7 .
  • Figure 9 is a schematic diagram of the prior art.
  • the reference numerals involved are as follows: 1 cutter bar; 2 casing assembly; 3 clamp; 4 handle part; 21 outer casing assembly; 22 inner casing assembly; 23 dial outer ring; 24 sealing ring; 25 first installation 26 Second installation direction; 211 Outer casing body; 212 Outer casing base body; 213 First anti-fall off boss; 214 Anti-rotation boss; 215 Connection structure; Two anti-fall bosses; 232 anti-rotation grooves; 21' outer casing assembly; 22' inner casing assembly; 23' dial outer ring; 24' sealing ring; 211' outer casing body; 212' outer casing base.
  • the Chinese patent with the application number of CN201220588716.4 (announcement number of CN202908803U) discloses a disposable ultrasonic scalpel, which includes a cutter head and a cutter bar, and the cutter head includes an inner tube of the cutter head and an outer portion of the cutter head.
  • the cutter bar includes a cutter bar inner tube, a cutter bar outer tube and a cutter bar body;
  • the cutter head, the inner tube of the cutter bar, the outer tube and the body are respectively connected as a whole through disassembly and assembly.
  • the ultrasonic scalpel head of the utility model can only be used once and is disposable, and the use cost is high.
  • the Chinese patent with the application number CN201921215696.4 discloses a scissor-type integrated ultrasonic surgical knife and a surgical instrument.
  • the scissor-type integrated ultrasonic surgical tool includes an ultrasonic drive rod and a scissor handle, wherein the ultrasonic drive rod includes a knife rod and an ultrasonic transducer, the scissor handle includes a first handle and a second handle, and the ultrasonic drive rod is not detachable
  • the ultrasonic driving rod includes a limit structure, which is located inside the first handle and is used to limit the movement of the ultrasonic driving rod.
  • the ultrasonic surgical knife of the utility model is also made into a single-use sterile instrument as a whole, and cannot be used multiple times.
  • the Chinese patent application with the application number CN201810130712.3 discloses a reusable ultrasonic scalpel, the ultrasonic scalpel includes a cutter, a cutter bar assembly and a functional assembly; the cutter, the cutter bar assembly and the functional assembly connected in sequence; the cutter bar assembly includes a cutter bar, an inner sleeve and an outer sleeve that are sequentially sleeved on the cutter bar from the inside to the outside; the inner sleeve is divided into a pliers head end inner sleeve and a rotating shank end inner sleeve , the outer casing is divided into an outer casing at the pliers head end and an outer casing at the rotating handle end; the inner casing at the pliers head end and the inner casing at the rotating handle end are clamped by an L-shaped clamping structure.
  • An L-shaped clamping structure is used for clamping between the outer sleeve of the pliers head end and the outer sleeve of the rotating handle
  • the Chinese patent application with the application number CN201810871843.7 discloses an ultrasonic scalpel, comprising a casing, a knife rod assembly and a casing unit passing through the casing, a trigger assembly movably connected with the casing unit, and a knife rod
  • the assembly includes a core cutter rod unit and a handle unit
  • the casing unit includes an outer casing, an inner casing, two oppositely arranged inner casings, an outer casing, a rotating operating member and a fixing device, and a set between the inner casing and the inner casing is provided.
  • There is an axial limit device the fixing device is arranged between the outer sleeve and the rotating operating member, and the pin shaft unit is located in the first strip groove of the outer sleeve and the third strip groove of the inner sleeve.
  • the Chinese patent application with the application number of CN201811114966.2 discloses a reusable ultrasonic scalpel, including a casing, a handle, a knife bar assembly, a universal wheel and a moving mechanism, and the knife bar assembly passes through the shell,
  • the handle part is located in the outer casing and is connected with the cutter bar assembly.
  • the universal wheel is sleeved on the cutter bar assembly.
  • the cutter bar assembly includes a core cutter bar, an inner sleeve and an outer sleeve.
  • the core cutter bar passes through the inner sleeve, and the outer sleeve is sleeved Set on the outside of the inner casing, the core cutter rod is fixed to the handle in the axial direction, and is connected to the outer casing through the shaft pin in the radial direction.
  • the moving mechanism is located in the outer casing and connected to the inner casing.
  • the universal wheel faces one end of the outer casing. There is a gap, a silicone plug is arranged in the gap, a cleaning slot is opened on the connecting part, and the silicone plug is used to close the cleaning slot.
  • the Chinese patent application whose application number is CN201910752035.3 (publication number is CN110448357A) discloses a reusable ultrasonic scalpel, comprising a handle assembly and an ultrasonic tool bar extending at its distal end for transmitting ultrasonic mechanical energy.
  • the rod casing is provided with a sleeve assembly, and the sleeve assembly is detachably connected to the handle assembly through a quick-connect mechanism.
  • the existing ultrasonic scalpel design has a relatively complex structure, high manufacturing cost, and inconvenient assembly.
  • the implementation and assembly of the inner/outer casing can only be realized by expanding the tube, rotating the groove, etc., so the cost remains high, and the internal / The structure of the outer casing is complex, the cost is high, and the processing efficiency is low.
  • the instrument operator when expressing the orientation, the instrument operator is generally used as a reference, and the position relatively close to the instrument operator is referred to as the "proximal end", and the position relatively far from the instrument operator is referred to as the "distal end”. Further, herein, the length direction of the ultrasonic scalpel may be referred to as the axial direction.
  • the surgical instrument generally includes a cutter bar 1 , a clamp 3 , a sleeve assembly 2 and a handle portion 4 , the clamp 3 and the distal end of the cutter bar 1 .
  • a clamping structure is formed, in which the sleeve assembly 2 is surrounded by the outside of the cutter shank 1 .
  • the cutter bar 1 is an ultrasonic cutter bar for transmitting ultrasonic energy
  • the sleeve assembly 2 is arranged coaxially with the cutter bar 1
  • the clamp 3 is arranged at the distal end of the sleeve assembly 2
  • the handle portion 4 is disposed at the proximal end portion of the sleeve assembly 2; wherein the sleeve assembly 2 is an integral structure and is connected to the handle portion 4 through a connecting mechanism.
  • the handle part 4 is held by the doctor's hand, and the clamp 3 can be operated to open and close, and a switch can control the ultrasonic frequency generator to start or stop outputting oscillating electrical signals.
  • the oscillating electrical signal is converted into mechanical vibration by the transducer, and the tool bar 1 transmits the mechanical vibration of the transducer to the tool bar.
  • the cutter bar cooperates with the clamp 3 to clamp the tissue and perform ultrasonic cutting and hemostasis on the clamped tissue.
  • the sleeve assembly 2 isolates the cutter bar 1 from the outside to protect the cutter bar, and on the other hand, it forms a link mechanism with the clamp 3 at its distal end to drive the clamp 3 to close and open.
  • FIG. 2 it is an exploded view of the cannula assembly 2 of the ultrasonic surgical instrument of the present disclosure, wherein the cannula assembly 2 includes an outer cannula assembly 21 , an inner cannula assembly 22 and a dial outer ring 23 .
  • the outer sleeve assembly 21 is coaxially arranged with the inner sleeve assembly 22 and the cutter bar 1, and the inner sleeve assembly 22 is located between the outer sleeve assembly 21 and the cutter bar 1, that is, the structural sequence from outside to inside is the outer sleeve assembly 21, The inner casing assembly 22 and the cutter bar 1 .
  • FIG. 3 further shows a schematic view of the installation of the sleeve assembly 2 of the ultrasonic surgical instrument of the present disclosure.
  • the ultrasonic surgical instrument further includes a dial outer ring 23, and the inner sleeve assembly 22 is coaxially installed with the outer sleeve assembly 21, that is, along the figure Installed in the first installation direction 25, the inner sleeve assembly 22 is inserted into the proximal end of the outer sleeve assembly 21 from the distal end; after that, the outer ring 23 of the dial is also installed coaxially with the outer sleeve assembly 21, that is, along the second installation direction 26 in the figure Installation, specifically: inserting the outer ring 23 of the dial wheel onto the outer sleeve assembly 21 from the distal end.
  • the outer ring 23 of the dial and the outer sleeve assembly 21 cannot rotate relative to each other.
  • the rotational connection between the outer sleeve assembly 2 and the handle portion 4 is non-detachable and restricts axial movement.
  • the outer sleeve assembly 21 is assembled by the outer sleeve body 211 and the outer sleeve base 212 through a co-injection integral molding process, a welding process or a gluing process;
  • the inner sleeve assembly 22 is integrally composed of the inner sleeve body 221 and the inner sleeve base 222 is assembled by co-injection integral molding process, welding process or gluing process.
  • the circumferential rotation of the outer ring 23 of the rotating dial drives the rotation of the casing assembly 2 , the cutter bar 1 and the clamp 3 , which is convenient for the doctor to adjust the appropriate cutting and coagulation angles.
  • the outer sleeve assembly 21 is composed of an outer sleeve body 211 and an outer sleeve base 212 , and the outer sleeve body 211 and the outer sleeve base 212 are provided as an integral structure.
  • An optional process is to integrally form the outer sleeve body 211 and the outer sleeve base body 212 through co-injection molding technology.
  • the integrated structure formed by the co-injection molding technology has no connection gaps, has strong integrity and is convenient to use.
  • a further optional process is to integrally form the outer sleeve body 211 and the outer sleeve base body 212 by welding or gluing.
  • the outer sleeve assembly 21 formed by these connection methods also has the advantages of strong integrity and convenient use.
  • the outer sleeve assembly 21 is provided with a first anti-falling boss 213 and an anti-rotation boss 214 .
  • the numbers of the first anti-falling bosses 213 and the anti-rotation bosses 214 may be the same or different.
  • Each of the first anti-falling bosses 213 and the anti-rotation bosses 214 may be distributed on the circumference one each, or a plurality of them may be evenly or unevenly distributed.
  • two first anti-fall off bosses 213 and two anti-rotation bosses 214 can be provided, and the two first anti-fall off bosses 213 are symmetrically distributed on the circumference, and the two anti-rotation bosses 214 are symmetrically distributed on the circumference , the advantage of this is that it can be installed regardless of whether it is positive or negative, which is easy to install.
  • the outer ring 23 of the dial wheel is provided with a second anti-falling boss 231 and an anti-rotation groove 232 .
  • the numbers of the second anti-falling bosses 231 and the anti-rotation grooves 232 may be the same or different.
  • Each of the second anti-falling bosses 231 and the anti-rotation grooves 232 may be distributed on the circumference one each, or a plurality of them may be evenly or unevenly distributed.
  • two second anti-fall off bosses 231 and two anti-rotation grooves 232 can be provided, and the two second anti-fall off bosses 231 are symmetrically distributed on the circumference, and the two anti-rotation grooves 232 are symmetrically distributed on the circumference , the advantage of this is that it can be installed regardless of whether it is positive or negative, which is easy to install.
  • the mutual positions of the outer ring 23 of the dial wheel and the outer sleeve assembly 21 are fixed by the mutual engagement of the first anti-separation boss 213 and the second anti-separation boss 232, so that the outer ring of the dial wheel 23 cannot be far away
  • the anti-rotation boss 214 on the outer casing assembly 21 first enters the anti-rotation groove 232 of the dial outer ring 23 to determine the assembly position, and then the outer casing assembly 21
  • the first anti-separation boss 213 on the upper part is then matched with the second anti-separation boss 231 of the outer ring 23 of the dial wheel, and is realized by the mutual engagement of the first anti-separation boss 213 and the second anti-separation boss 232 Fixing the mutual position of the outer ring 23 of the dial and the outer sleeve assembly 21 .
  • the anti-rotation boss 214 and the anti-rotation groove 232 are in an interference fit or fixed by gluing.
  • the sleeve assembly 2 and the handle portion 4 are provided with a coaxially rotating connection structure 215 that restricts axial movement, and the coaxially rotating connection structure 215 can be on the outer sleeve base 212 and coaxially connected with the handle; the same
  • the connection structure 215 for the shaft rotation may also be on the outer ring 23 of the dial wheel, coaxially connected with the handle.
  • the coaxially rotating connecting structure 215 is provided on the outer sleeve assembly 21 , and the connecting structure 215 is connected with the handle portion 4 .
  • the inner sleeve assembly 22 is composed of an inner sleeve body 221 and an inner sleeve base 222, and the inner sleeve body 221 and the base 222 are assembled into an integral structure.
  • An optional process is to integrally form the inner sleeve body 221 and the inner sleeve base body 222 through co-injection technology.
  • the integrated structure formed by the co-injection technology has no connection gaps, has strong integrity and is convenient to use.
  • a further optional process is to integrally form the inner sleeve body 221 and the inner sleeve base body 222 by welding or gluing.
  • the inner sleeve assembly 22 formed by these fixed connection methods also has the advantages of strong integrity and convenient use.
  • a sealing structure is provided between the base body 231 of the outer sleeve assembly 23 and the base body 221 of the inner sleeve assembly 22 to prevent the fine tissue or blood generated during the operation from entering the handle portion and contaminating the handle portion, so that it cannot be reused.
  • a sealing ring 24 can be provided between the base body 231 of the outer casing assembly 23 and the base body 221 of the inner casing assembly 22 , and the sealing ring 24 can realize the outer casing assembly base 231 and the inner casing assembly.
  • the sealing of the gaps between the base bodies 221 prevents fine tissue or blood from entering the cavity through capillary action, preventing the handle portion 4 from being polluted.
  • the inner sleeve assembly 22 is coaxially assembled with the outer sleeve assembly 21, and the outer ring of the dial 23 is coaxially installed outside the outer sleeve assembly 21.
  • the specific installation process includes:
  • Step A Assembling the outer sleeve body 211 and the outer sleeve base body 212 into an integral outer sleeve assembly 21 through a co-injection integral molding process, a welding process or a gluing process;
  • Step B Assemble the inner sleeve body 221 and the inner sleeve base 222 into an integral inner sleeve assembly 22 through a co-injection integral molding process, a welding process or a gluing process;
  • Step C coaxially install the outer sleeve assembly 21 and the inner sleeve assembly 22 to obtain the sleeve assembly 2;
  • Step D Assemble the casing assembly 2 , the cutter bar 1 , the clamp 3 , and the handle portion 4 to obtain an ultrasonic surgical instrument.
  • step B can be performed first and then step A can be performed.
  • step A includes: assembling the outer sleeve body 211 and the outer sleeve base body 212 into an integral outer sleeve assembly 21 through a co-injection integral molding process;
  • Step B includes: assembling the inner sleeve body 221 and the inner sleeve base body 222 into an integral inner sleeve assembly 22 through a co-injection integral molding process.
  • step C includes: coaxially installing the sealing ring 24 on the inner sleeve assembly 22 , and coaxially installing the outer sleeve assembly 21 on the inner sleeve assembly 22 . That is, the sealing ring 24 is installed between the outer sleeve base body 212 and the inner sleeve base body 222 .
  • the ultrasonic surgical instrument includes a dial outer ring 23, and step D includes: assembling the sleeve assembly 2, the knife rod 1, the clamp 3, the handle part 4, and the dial outer ring 23 to obtain the ultrasonic surgical instrument.
  • the cutter bar 1 is an ultrasonic cutter bar for transmitting ultrasonic energy
  • the sleeve assembly 2 is coaxially mounted on the outside of the cutter bar 1
  • the clamp 3 is arranged on the sleeve assembly 2.
  • the distal end portion of the handle portion 4 is arranged at the proximal end portion of the cannula assembly 2 .
  • outer sleeve assembly 21 is provided with a first anti-falling boss 213 and an anti-rotation boss 214
  • the outer ring 23 of the dial wheel is provided with a second anti-falling boss 231 and an anti-rotation groove 232 .
  • the anti-rotation bosses 214 and the first anti-falling bosses 213 on the outer casing assembly 21 respectively enter the outside of the dial.
  • the anti-rotation groove 232 of the ring 23 and the second anti-separation boss 231 make it impossible for the outer ring 23 of the dial wheel to escape from the outer sleeve assembly 21 to the distal end.
  • the inner sleeve assembly 22 is driven by the transmission assembly in the handle portion 4 to move, so as to open or close the clamp 3 , so that the clamp 3 is connected to the farthest end of the knife rod 1 . Form a separate state or a closed state.
  • the casing assembly 2 , the cutter bar 1 and the clamp 3 are driven to rotate by the circumferential rotation of the outer ring 23 of the rotating dial.
  • the sleeve assembly is formed by co-injection technology, welding process or gluing process, and further processing and assembly are used to obtain ultrasonic surgical instruments, which can reduce the assembly process.
  • the components made by co-injection, welding or gluing have strong integrity.
  • the sealing between the inner and outer casings can be achieved without designing the complex configuration of the casing.
  • the bulging structure of the casing can be eliminated or simplified.
  • the overall structure is more simplified and the performance is more optimized.
  • the ultrasonic surgical instrument of the present disclosure adopts an integral sleeve assembly, which reduces the manufacturing cost.
  • the surgical ultrasonic surgical instrument has simple structure, convenient assembly, easy disassembly and assembly, and easy cleaning and disinfection.
  • the ultrasonic surgical instrument of the present disclosure can be used in a surgical scene with higher precision.
  • Fig. 9 is a schematic diagram of the assembly of the prior art, showing that a complex bulging structure needs to be designed between the inner and outer casing parts, the structure is complex, and the performance is poor.

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  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Animal Behavior & Ethology (AREA)
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  • Surgical Instruments (AREA)

Abstract

一种套管组件(2)装配简单的超声手术器械，包括用于传递超声机械能的超声波刀杆(1)，超声波刀杆(1)外同轴安装有套管组件(2)，套管组件(2)的远端设有夹钳(3)，近端设置有手柄部(4)。套管组件(2)为整体式结构，通过连接机构连接于手柄部(4)。该整体式的套管组件可以减少装配工序，简化安装结构，减少复杂结构，总体上降低制造器械的成本，减轻患者的负担。

Description

一种超声外科手术器械及加工组装方法 技术领域
本公开涉及外科医疗器械领域，应用于外科手术器械，尤其涉及一种超声手术器械及加工组装方法。
背景技术
随着微创外科手术的普及，超声手术刀已经成为一种常规的手术器械。超声手术刀通过超声频率发生器使刀杆以一定的超声频率进行机械振荡，使组织内的水分子汽化、蛋白质氢键断裂、细胞崩解，从而使得组织被切开或者凝固，还可以使血管闭合。超声手术刀使组织切割和凝血同时完成，并具有较小的侧向热损伤。临床用这种器械可在较低温度和较少出血的情况下实现病灶切除，并能确保最小的组织侧向热损伤，因此超声手术刀越来越受到欢迎。
超声手术刀主要由超声频率发生器、换能器和手术器械组成。其中，超声频率发生器发出振荡电信号，换能器将振荡电信号转换为机械振动，手术器械利用换能器的机械振动对组织进行切割和凝血。手术器械通常由刀杆、与刀杆构成夹持结构的夹钳、包围在刀杆外部的套管组件以及手柄部组成。刀杆将换能器的机械振动传递到刀杆；刀杆与夹钳配合夹持组织实现切割和凝血功能；套管组件由外套管和内套管组成，刀杆位于内套管之内，套管组件一方面将刀杆与外部隔离起到保护和支撑刀杆的作用，另一方面与夹钳构成连杆机构能带动夹钳的闭合与张开；手柄部由医生手部握持，能操作夹钳张开闭合，且有开关能控制超声频率发生器开始或停止输出振荡电信号。
现有的超声波手术刀设计的刀杆组件结构比较复杂、制造成本比较高、装配也不便，内/外套管的实施装配需要用胀管、旋槽等工艺才能实现，成本居高不下，且内/外套管的结构复杂，成本高昂，加工效率低下。
如图9所示：现有的超声波手术刀的内套管与外套管之间的密封一般通过做胀形凹槽结构来实现，其中，图9所示的超声波手术刀包括外套管组件21’、内套管组件22’、拨轮外圈23’以及密封圈24’，拨轮外圈23’、外套管组件21’、内套管组件22’形成由外到内的逐次分布的结构，密封圈24’位于外套管组件21’的外套管本体211’和内套管组件22’的内套管本体221’之间，其中外套管组件21’的外套管本体211’和内套管组件22’的内套管本体221’均具有复杂的凹凸结构，通过这种复杂的凹凸结构实现内套管与外套管之间的密封；也就是说套管必须成型为特殊的构型以实现通过做成胀形凹槽结构实现密封，如此套管的结构复杂，加工工艺复杂，成本高昂。
因此，本领域需要一种用于超声波手术器械(超声波手术刀)，其可消除或至少缓解 上述现有技术中的全部或部分缺陷。
发明内容
本公开为了解决上述现有技术的至少其中一个缺陷，提供了一种可重复使用且装配简单的超声波手术器械，该器械整体结构更加简化，套管组件的成本大幅度下降。
同时，本公开通过一体成型工艺可以减少装配工序，一体成型工艺(共注)出来的部件整体性强，并且内外套管之间的密封不需要通过设计套管的复杂构型结构(如胀形凹槽结构)进行配合就可以实现，套管部分的胀形凹槽结构可以取消或者简化，大大提高了超声波手术器械的整体性能，从而使该超声波手术器械能够应用于精细度更高的手术场景。
根据本公开的一个方面，提供一种超声手术器械，包括刀杆、夹钳、套管组件和手柄部，夹钳与刀杆的远端构成夹持结构，所述刀杆为用于传递超声能量的超声波刀杆，所述套管组件与所述刀杆同轴布置，所述夹钳设置于所述套管组件的远端部分，所述手柄部设置于所述套管组件的近端部分；其中，所述套管组件包括外套管组件、内套管组件以及拨轮外圈，所述外套管组件和所述内套管组件均为整体式结构(一体式结构)，通过连接机构连接于所述手柄部；超声手术器械还包括拨轮外圈，所述拨轮外圈同轴安装于所述外套管组件的外部，且所述拨轮外圈与所述外套管组件不能发生相对旋转；所述套管组件可旋转地连接于所述手柄部；所述外套管组件与所述手柄部的旋转连接是不可拆卸的且限制轴向移动的；所述套管组件上和所述手柄部同轴旋转的连接结构设置在外套管组件上或设置在拨轮外圈上；所述外套管组件上沿轴向设有防转凸台，所述拨轮外圈上设有防转凹槽，所述防转凸台与所述防转凹槽配合；或所述外套管组件上沿轴向设有防转凹槽，所述拨轮外圈上设有防转凸台，所述防转凸台与防转凹槽配合；所述外套管组件上沿轴向设有第一防脱凸台，所述拨轮外圈上设有第二防脱凸台，所述外套管组件的第一防脱凸台与所述拨轮外圈的第二防脱凸台配合，以将所述外套管组件与所述拨轮外圈装配；所述拨轮外圈与所述外套管组件通过不限于过盈装配或者胶粘的方式装配，使得所述拨轮外圈与所述外套管组件不能发生相对旋转。
本公开的超声手术器械采用整体式的套管组件，且套管组件内没有设置(取消)胀形结构，使得超声手术器械的结构简单、装配简便、成本降低。
根据本公开的另一个方面，提供一种超声手术器械的加工组装方法，超声手术器械包括刀杆、夹钳、套管组件和手柄部，夹钳与刀杆的远端构成夹持结构，所述套管组件包括外套管组件、内套管组件，所述加工组装方法包括：
将外套管本体和外套管基体通过共注一体成型工艺、焊接工艺或者胶合工艺组装成 一个整体的外套管组件；
将内套管本体和内套管基体通过共注一体成型工艺、焊接工艺或者胶合工艺组装成一个整体的内套管组件；
将所述外套管组件和所述内套管组件同轴安装，获得套管组件；以及将套管组件、刀杆、夹钳、手柄部进行组装，得到超声手术器械。
根据本公开实施例提供的超声外科手术器械及加工组装方法可具有如下有益效果：
由于所述外套管组件和所述内套管组件均为整体式结构，内外套管之间的密封无需通过设计套管的复杂构型结构就可以实现，套管部分的胀形结构可以取消或者简化，整体构造更加简化，性能更加优化。
附图说明
此处所说明的附图用来提供对本公开实施例的进一步理解，构成本公开的一部分，本公开的示意性实施例及其说明用于解释本公开，并不构成对本公开的不当限定。在附图中：
图1是本公开超声手术器械的整体示意图。
图2是本公开套管组件的***图。
图3是本公开套管组件的安装示意图。
图4是本公开拨轮外圈的结构示意图。
图5是本公开外套管组件的示意图。
图6是本公开内套管组件的示意图。
图7是本公开套管组件安装到位的示意图。
图8是图7中A部的放大图。
图9是现有技术的示意图。
其中涉及的附图标记如下：1刀杆；2套管组件；3夹钳；4手柄部；21外套管组件；22内套管组件；23拨轮外圈；24密封圈；25第一安装方向；26第二安装方向；211外套管本体；212外套管基体；213第一防脱凸台；214防转凸台；215连接结构；221内套管本体；222内套管基体；231第二防脱凸台；232防转凹槽；21’外套管组件；22’内套管组件；23’拨轮外圈；24’密封圈；211’外套管本体；212’外套管基体。
具体实施方式
为使本公开的目的、技术方案和优点更加清楚，下面将结合本公开具体实施例及相应的附图对本公开技术方案进行清楚、完整地描述。显然，所描述的实施例仅是本公开的一部分实施例，而不是全部的实施例。基于本公开的实施例，本领域普通技术人员在 没有做出创造性劳动前提下所获得的所有其他实施例，都属于本公开保护的范围。
现有技术中，申请号为CN201220588716.4(公告号为CN202908803U)的中国专利公开一种一次性超声手术刀，包括刀头和刀杆，所述刀头包括有刀头内管、刀头外管和刀头本体；所述刀杆包括有刀杆内管、刀杆外管和刀杆本体；该刀头、刀杆的内管、外管以及本体分别通过拆装式连接为一体。该实用新型的超声手术刀刀头只能一次性使用、即用即弃，使用成本高昂。
申请号为CN201921215696.4(公告号为CN211187447U)的中国专利公开了剪式一体式超声波手术刀具及手术器械。该剪式一体式超声波手术刀具包括超声波驱动杆和剪式手柄，其中，超声波驱动杆包括刀杆和超声波换能器，剪式手柄包括第一手把和第二手把，超声波驱动杆不可拆卸地设置在第一手把上，超声波驱动杆包括限位结构，限位结构位于第一手把的内部，用于限制超声波驱动杆的移动。该实用新型的超声波手术刀具同样是整体做成一次性使用的无菌器械，无法多次使用。
申请号为CN201810130712.3的中国专利申请公开一种可重复使用的超声手术刀，所述超声手术刀包括刀具、刀杆组件和功能组件；所述刀具、所述刀杆组件和所述功能组件依次连接；所述刀杆组件包括刀杆以及从内到外依次套在刀杆上的内套管和外套管；所述内套管分为钳头端内套管和旋转柄端内套管，所述外套管分为钳头端外套管和旋转柄端外套管；所述钳头端内套管和所述旋转柄端内套管之间采用一L形卡接结构卡接，所述钳头端外套管和所述旋转柄端外套管之间采用一L形卡接结构卡接。
申请号为CN201810871843.7(公开号为CN109009330A)的中国专利申请公开一种超声波手术刀，包括外壳、穿过外壳的刀杆组件及套管单元、与套管单元活动连接的扳机组件，刀杆组件包括芯刀杆单元及手柄单元，套管单元包括外套管、内套管、两个相对设置的内套壳、外套壳、旋转操作件及固定装置，内套壳与内套管之间设有轴向限位装置，固定装置设置于外套管与旋转操作件之间，销轴单元位于外套管的第一条形槽及内套管的第三条形槽中。
申请号为CN201811114966.2(公开号为CN108969058A)的中国专利申请公开一种可重复使用的超声波手术刀，包括外壳、手柄、刀杆组件、万向轮及移动机构，刀杆组件穿过外壳，手柄部分位于外壳中且与刀杆组件连接，万向轮套设于刀杆组件上，刀杆组件包括芯刀杆、内套管及外套管，芯刀杆穿过内套管，外套管套设于内套管的外部，芯刀杆轴向上与手柄固定，径向上通过轴销与外套管限位连接，移动机构位于外壳内且与内套管连接，万向轮朝向外套管的一端设有缺口，缺口内设有硅胶塞，连接部上开设有清理槽口，硅胶塞用于封闭清理槽口。
申请号为CN201910752035.3(公开号为CN110448357A)的中国专利申请公开一种可重复利用的超声波手术刀，包括手柄组件及延伸设置在其远端、用于传递超声机械能的超声波刀杆，超声波刀杆外套设有套管组件，套管组件通过快接机构可拆卸地连接于手柄组件。
现有的超声波手术刀设计的刀杆组件结构比较复杂、制造成本比较高、装配也不便，内/外套管的实施装配需要用胀管、旋槽等工艺才能实现，成本居高不下，且内/外套管的结构复杂，成本高昂，加工效率低下。
以下结合附图，详细说明根据本公开实施例提供的技术方案。
在此强调，除非另有说明，本文所用术语与本领域中各种科技术语的通常含义、各种技术词典、教科书等中定义的专业术语的含义一致。
在本文中，在表达方位时，一般是以器械操作者为参照，将相对靠近器械操作者的位置称为“近端”，相对远离器械操作者的位置称为“远端”。进一步地，在本文中，可将超声波手术刀的长度方向称为轴向。
参见图1，示出了根据本公开一实施例的超声手术器械，该手术器械通常包括刀杆1、夹钳3、套管组件2和手柄部4，夹钳3与刀杆1的远端构成夹持结构，其中套管组件2包围在刀杆1的外部。
所述刀杆1为用于传递超声能量的超声波刀杆，所述套管组件2与所述刀杆1同轴布置，所述夹钳3设置于所述套管组件2的远端部分，所述手柄部4设置于所述套管组件2的近端部分；其中所述套管组件2为整体式结构，通过连接机构连接于所述手柄部4。
手术时，手柄部4由医生手部握持，可操作夹钳3张开闭合，且有开关能控制超声频率发生器开始或停止输出振荡电信号。由换能器将震荡电信号转换为机械振动，所述刀杆1将换能器的机械振动传递到刀杆。刀杆与夹钳3配合夹持组织并对被夹持组织进行超声切割和止血。
套管组件2一方面将刀杆1与外部隔离起到保护刀杆的作用，另一方面在其远端与夹钳3构成连杆机构以带动夹钳3的闭合与张开。
如图2所示，是本公开超声外科手术器械的套管组件2的***图，其中，套管组件2包括外套管组件21和内套管组件22以及拨轮外圈23。
外套管组件21与内套管组件22及刀杆1同轴设置，内套管组件22位于外套管组件21和刀杆1之间，即形成由外至内的结构顺序为外套管组件21、内套管组件22、刀杆1。
图3进一步示出了本公开的超声外科手术器械的套管组件2安装示意图，超声手术器械还包括拨轮外圈23，内套管组件22与外套管组件21同轴安装，即沿图中第一安装方向25安装，内套管组件22从远端***外套管组件21的近端；之后，拨轮外圈23也与外套管组件21同轴安装，即沿图中第二安装方向26安装，具体的是：将拨轮外圈23从远端套入到外套管组件21上。
所述拨轮外圈23与所述外套管组件21不能发生相对旋转。
优选的，所述外套管组件2与所述手柄部4的旋转连接是不可拆卸的且限制轴向移动的。
其中，外套管组件21整体由外套管本体211和外套管基体212通过共注一体成型工艺、焊接工艺或者胶合工艺组装而成；内套管组件22整体由内套管本体221和内套管基体222通过共注一体成型工艺、焊接工艺或者胶合工艺组装而成。
将组装好的套管组件2安装到手柄部4上，然后通过手柄部4内传动组件带动套管组件2的内套管组件22运动，通过内套管组件22和外套管组件21之间的相对运动实现夹钳3与刀杆1的闭合或张开。
而转动拨轮外圈23的周向转动实现带动套管组件2、刀杆1、夹钳3的转动，方便医生调整合适的切割和凝血角度。
优选的实施例中，如图5所示，外套管组件21由外套管本体211和外套管基体212组成，外套管本体211和外套管基体212设置为整体式结构。
可选的工艺为，通过共注成型技术将外套管本体211和外套管基体212一体成型。共注成型技术形成的一体化结构没有连接缝隙，整体性强，使用便利。
进一步可选的工艺为焊接或胶合的方式将外套管本体211和外套管基体212一体成型。通过这些连接方式形成的外套管组件21也同样具有整体性强、使用便利的优点。
为便于与拨轮外圈23的装配，外套管组件21上设有第一防脱凸台213和防转凸台214。第一防脱凸台213和防转凸台214的数量可以相同、也可以不相同。第一防脱凸台213和防转凸台214可在圆周上各分布有1个、或者均匀或不均匀分布有多个。优选的，第一防脱凸台213和防转凸台214均可设置两个，且两个第一防脱凸台213在圆周上对称分布，两个防转凸台214在圆周上对称分布，这样的优点是使得安装时可不分正反，便于安装。
对应的，如图4所示，拨轮外圈23上设有第二防脱凸台231和防转凹槽232。第二防脱凸台231和防转凹槽232的数量可以相同、也可以不相同。第二防脱凸台231和防转凹槽232可在圆周上各分布有1个、或者均匀或不均匀分布有多个。优选的，第二防 脱凸台231和防转凹槽232均可设置两个，且两个第二防脱凸台231在圆周上对称分布，两个防转凹槽232在圆周上对称分布，这样的优点是使得安装时可不分正反，便于安装。
拨轮外圈23和外套管组件21安装时，外套管组件21上的防转凸台214和第一防脱凸台213分别进入拨轮外圈的防转凹槽232和第二防脱凸台231上。通过第一防脱凸台213和第二防脱凸台232的相互卡合的作用实现拨轮外圈23和外套管组件21的相互位置的固定，使得所述拨轮外圈23无法在远端脱出所述外套管组件21；通过防转凸台214与防转凹槽232的配合而限制拨轮外圈23与外套管组件21之间发生相对转动。
优选的，拨轮外圈23和外套管组件21安装时，外套管组件21上的防转凸台214先进入拨轮外圈23的防转凹槽232内确定装配位置，然后外套管组件21上的第一防脱凸台213再与拨轮外圈23的第二防脱凸台231发生配合，通过第一防脱凸台213和第二防脱凸台232的相互卡合的作用实现拨轮外圈23和外套管组件21的相互位置的固定。
优选的，所述防转凸台214与所述防转凹槽232为过盈配合或者通过胶粘固定。
优选的，所述套管组件2和手柄部4上有限制轴向移动的同轴旋转的连接结构215，同轴旋转的连接结构215可以在外套管基体212上，与手柄同轴连接；同轴旋转的连接结构215也可以在拨轮外圈23上，与手柄同轴连接。
优选的，所述同轴旋转的连接结构215设置在外套管组件21上，所述连接结构215与所述手柄部4连接。
优选的实施例中，如图6所示，内套管组件22由内套管本体221和内套管基体222组成，内套管本体221和基体222被组装为整体式结构。
可选的工艺为，通过共注技术将内套管本体221和内套管基体222一体成型。共注技术形成的一体化结构没有连接缝隙，整体性强，使用便利。
进一步可选的工艺为焊接或胶合的方式将内套管本体221和内套管基体222一体成型。通过这些固定的连接方式形成的内套管组件22也同样具有整体性强、使用便利的优点。
在一个优选实施例中，在外套管组件23的基体231和内套管组件22的基体221之间设置有密封结构，以防止手术中产生的细小组织或血液进入到手柄部，污染手柄部，使得其不能重复用。
具体的，参阅图2、图8，可在外套管组件23的基体231和内套管组件22的基体221之间设置密封圈24，密封圈24可实现外套管组件基体231与内套管组件基体221之间间隙的密封，阻挡了细小组织或血液通过毛细作用进入腔体内，防止手柄部4受到污染。
图7为本公开超声手术器械的安装完成示意图，内套管组件22与外套管组件21同轴装配，拨轮外圈23同轴安装在外套管组件21外，具体的安装过程包括：
步骤A：将外套管本体211和外套管基体212通过共注一体成型工艺、焊接工艺或者胶合工艺组装成一个整体的外套管组件21；
步骤B：将内套管本体221和内套管基体222通过共注一体成型工艺、焊接工艺或者胶合工艺组装成一个整体的内套管组件22；
步骤C：将所述外套管组件21和所述内套管组件22同轴安装，获得套管组件2；以及
步骤D：将套管组件2、刀杆1、夹钳3、手柄部4进行组装，得到超声手术器械。
需要说明的是，以上步骤A和步骤B的顺序可调换，即可先进行步骤B再进行步骤A。
进一步的，步骤A包括：将外套管本体211和外套管基体212通过共注一体成型工艺组装成一个整体的外套管组件21；
步骤B包括：将内套管本体221和内套管基体222通过共注一体成型工艺组装成一个整体的内套管组件22。
进一步的，步骤C包括：将所述密封圈24同轴安装到所述内套管组件22上，将所述外套管组件21同轴安装到所述内套管组件22上。即在外套管基体212和内套管基体222之间安装密封圈24。
进一步的，超声手术器械包括拨轮外圈23，步骤D包括：将套管组件2、刀杆1、夹钳3、手柄部4、拨轮外圈23进行组装，得到超声手术器械。
进一步的，所述拨轮外圈23与所述外套管组件21不能发生相对转动。
进一步的，所述刀杆1为用于传递超声能量的超声波刀杆，所述套管组件2同轴安装在所述刀杆1的外部，所述夹钳3设置于所述套管组件2的远端部分，所述手柄部4设置于所述套管组件2的近端部分。
进一步的，所述外套管组件21上设有第一防脱凸台213和防转凸台214，所述拨轮外圈23上设有第二防脱凸台231和防转凹槽232。
进一步的，在将所述拨轮外圈23和所述外套管组件21安装时，所述外套管组件21上的防转凸台214和第一防脱凸台213分别进入所述拨轮外圈23的所述防转凹槽232和所述第二防脱凸台231上，使得所述拨轮外圈23无法往远端脱出所述外套管组件21。
本公开的超声外科手术器械，在使用时，通过所述手柄部4内的传动组件带动内套管组件22运动，从而打开或闭合夹钳3，使得夹钳3与刀杆1的最远末端形成分开状态 或者闭合状态。
在使用过程中，通过转动拨轮外圈23的周向转动实现带动套管组件2、刀杆1、夹钳3的转动。
根据本公开实施例提供的超声外科手术器械可具有如下有益效果：
1、通过共注技术、焊接工艺或者胶合工艺形成套管组件，进一步加工组装得到超声外科手术器械，可以减少装配工序。
2、通过共注、焊接或者胶合出来的部件整体性强，内、外套管之间的密封无需通过设计套管的复杂构型结构就可以实现，套管部分的胀形结构可以取消或者简化，整体构造更加简化，性能更加优化。
3、本公开的超声手术器械采用整体式的套管组件，制造成本降低。
4、该外科超声手术器械结构简单，装配方便，易拆装，易清洗消毒。
5、内、外套管组件之间具有密封结构，能够防止手术中产生的细小组织或血液进入手柄部造成污染。
6、本公开的超声手术器械能够用于精细度更高的手术场景。
图9是现有技术装配示意图，显示内、外套管部分之间需要设计复杂的胀形结构，结构复杂，性能较差。
需要说明的是，附图中的实施方案仅为本公开比较有代表性的实施例，不利于技术人员容易理解，本公开的保护范围不仅仅限定在附图中实施方式所限定的范围内，对附图实施方式的组合、变形、变化均落在本公开的保护范围内。
需要说明的是，在本文中，术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含，从而使得包括一系列要素的过程、方法、物品或者设备不仅包括那些要素，而且还包括没有明确列出的其他要素，或者是还包括为这种过程、方法、物品或者设备所固有的要素。在没有更多限制的情况下，由语句“包括一个……”限定的要素，并不排除在包括所述要素的过程、方法、物品或者设备中还存在另外的相同要素。
最后应说明的是：以上实施例仅用于说明本公开的技术方案，而非对其限制；尽管参照前述实施例对本公开进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本公开各实施例技术方案的精神和范围。

Claims (15)

  1. 一种超声手术器械，包括刀杆、夹钳、套管组件和手柄部，所述刀杆为用于传递超声能量的超声波刀杆，所述套管组件与所述刀杆同轴布置，所述夹钳设置于所述套管组件的远端部分，所述手柄部设置于所述套管组件的近端部分；其特征在于，
    所述套管组件包括外套管组件、内套管组件及拨轮外圈，所述外套管组件和所述内套管组件均为整体式结构，所述套管组件可旋转地连接于所述手柄部；
    所述拨轮外圈同轴安装于所述外套管组件的外部，且所述拨轮外圈与所述外套管组件不能发生相对旋转。
  2. 如权利要求1所述的超声手术器械，其特征在于，所述外套管组件与所述手柄部的旋转连接是不可拆卸的且限制轴向移动的。
  3. 如权利要求1所述的超声手术器械，其特征在于，所述套管组件上和所述手柄部同轴旋转的连接结构设置在外套管组件上或设置在拨轮外圈上。
  4. 如权利要求1所述的超声手术器械，其特征在于，所述外套管组件上沿轴向设有防转凸台，所述拨轮外圈上设有防转凹槽，所述防转凸台与所述防转凹槽配合；或所述外套管组件上沿轴向设有防转凹槽，所述拨轮外圈上设有防转凸台，所述防转凸台与防转凹槽配合。
  5. 如权利要求1所述的超声手术器械，其特征在于，所述外套管组件上沿轴向设有第一防脱凸台，所述拨轮外圈上设有第二防脱凸台，所述外套管组件的第一防脱凸台与所述拨轮外圈的第二防脱凸台配合，以将所述外套管组件与所述拨轮外圈装配。
  6. 如权利要求5所述的超声手术器械，其特征在于，所述第一防脱凸台为1个或者多个；所述第一防脱凸台优选设置两个，且两个所述第一防脱凸台在圆周上对称分布。
  7. 如权利要求1所述的超声手术器械，其特征在于，所述拨轮外圈与所述外套管组件通过不限于过盈装配或者胶粘的方式装配，使得所述拨轮外圈与所述外套管组件不能发生相对旋转。
  8. 如权利要求1至7所述的超声手术器械，其特征在于，所述夹钳与所述刀杆的远端构成夹持结构，所述外套管组件和所述内套管组件同轴装配，所述内套管组件位于所述刀杆与所述外套管组件之间，通过所述手柄部的传动组件带动内套管组件运动，以打开或闭合夹钳，使得夹钳与刀杆的远端形成分开状态或者闭合状态。
  9. 如权利要求1至7任一项所述的超声手术器械，其特征在于，所述外套管组件包括外套管本体和外套管基体，所述外套管本体和所述外套管基体通过共注一体成型工艺、胶合工艺或者焊接工艺组装成一个整体。
  10. 如权利要求1至7任一项所述的超声手术器械，其特征在于，所述内套管组件包括内套管本体和内套管基体，所述内套管本体和所述内套管基体通过共注一体成型工艺、胶合工艺或者焊接工艺组装成一个整体。
  11. 如权利要求1至7任一项所述的超声手术器械，其特征在于，超声手术器械包括密封圈，所述密封圈位于所述外套管组件和所述内套管组件之间，所述密封圈优选位于所述外套管组件的外套管基体和所述内套管组件的内套管基体之间。
  12. 一种超声手术器械的加工组装方法，其中，超声手术器械包括刀杆、夹钳、套管组件和手柄部，夹钳与刀杆的远端构成夹持结构，所述套管组件包括外套管组件、内套管组件以及拨轮外圈，所述加工组装方法包括：
    将外套管本体和外套管基体通过共注一体成型工艺、焊接工艺或者胶合工艺组装成一个整体的外套管组件；
    将内套管本体和内套管基体通过共注一体成型工艺、焊接工艺或者胶合工艺组装成一个整体的内套管组件；
    将所述外套管组件和所述内套管组件同轴安装，获得套管组件；以及
    将套管组件、刀杆、夹钳以及手柄部进行组装，得到超声手术器械，其中，所述拨轮外圈与所述套管组件中的外套管组件不能发生相对转动。
  13. 如权利要求12所述的超声手术器械的加工组装方法，其特征在于，所述外套管组件与所述手柄部的旋转连接是不可拆卸的且限制轴向移动的，所述套管组件上和所述手柄部同轴旋转的连接结构设置在外套管组件上或设置在拨轮外圈上。
  14. 如权利要求12所述的超声手术器械的加工组装方法，其特征在于，所述外套管组件上沿轴向设有防转凸台，所述拨轮外圈上设有防转凹槽，所述加工组装方法包括：使所述外套管组件的防转凸台与所述拨轮外圈的防转凹槽配合。
  15. 如权利要求12所述的超声手术器械的加工组装方法，其特征在于所述外套管组件上沿轴向设有第一防脱凸台，所述拨轮外圈上设有第二防脱凸台，所述加工组装方法包括：使所述外套管组件的第一防脱凸台与所述拨轮外圈的第二防脱凸台配合，以将所述外套管组件与所述拨轮外圈装配。
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US20190262028A1 (en) * 2018-02-23 2019-08-29 Covidien Lp Ultrasonic surgical instrument with torque assist feature
CN109009330A (zh) 2018-08-02 2018-12-18 嘉善飞阔医疗科技有限公司 超声波手术刀及超声波手术刀***
CN108969058A (zh) 2018-09-25 2018-12-11 嘉善飞阔医疗科技有限公司 可重复使用的超声波手术刀
CN211187447U (zh) 2019-07-30 2020-08-07 泰惠（北京）医疗科技有限公司 剪式一体式超声波手术刀具及手术器械
CN110448357A (zh) 2019-08-15 2019-11-15 以诺康医疗科技（苏州）有限公司 可重复利用的超声波手术刀
CN211609975U (zh) * 2019-08-15 2020-10-02 以诺康医疗科技（苏州）有限公司 可重复利用的超声波手术刀
CN113057715A (zh) * 2020-01-02 2021-07-02 上海逸思医疗科技股份有限公司 一种可拆装器械

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