WO2021027302A1 - 可重复利用的超声波手术刀 - Google Patents

可重复利用的超声波手术刀 Download PDF

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Publication number
WO2021027302A1
WO2021027302A1 PCT/CN2020/084408 CN2020084408W WO2021027302A1 WO 2021027302 A1 WO2021027302 A1 WO 2021027302A1 CN 2020084408 W CN2020084408 W CN 2020084408W WO 2021027302 A1 WO2021027302 A1 WO 2021027302A1
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WO
WIPO (PCT)
Prior art keywords
sleeve
assembly
ultrasonic scalpel
outer sleeve
inner sleeve
Prior art date
Application number
PCT/CN2020/084408
Other languages
English (en)
French (fr)
Inventor
刘柯
袁小鹤
刘振中
颜忠余
骆威
Original Assignee
以诺康医疗科技（苏州）有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Application filed by 以诺康医疗科技（苏州）有限公司 filed Critical 以诺康医疗科技（苏州）有限公司
Priority to KR1020227002158A priority Critical patent/KR20220024828A/ko
Priority to US17/635,195 priority patent/US20220287736A1/en
Priority to BR112022001682A priority patent/BR112022001682A2/pt
Priority to EP20852980.0A priority patent/EP4014899A4/en
Priority to JP2021576457A priority patent/JP7232941B2/ja
Publication of WO2021027302A1 publication Critical patent/WO2021027302A1/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
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • 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
    • A61B17/3209—Incision instruments
    • A61B17/3211—Surgical scalpels, knives; Accessories therefor
    • 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
    • A61B17/3209—Incision instruments
    • A61B17/3211—Surgical scalpels, knives; Accessories therefor
    • A61B17/3213—Surgical scalpels, knives; Accessories therefor with detachable blades
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0023—Surgical instruments, devices or methods, e.g. tourniquets disposable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
    • 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
    • A61B2017/320074—Working tips with special features, e.g. extending parts blade
    • 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
    • A61B2017/320082—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic for incising tissue
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0813—Accessories designed for easy sterilising, i.e. re-usable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/02—Operational features
    • A61B2560/0266—Operational features for monitoring or limiting apparatus function
    • A61B2560/028—Arrangements to prevent overuse, e.g. by counting the number of uses
    • A61B2560/0285—Apparatus for single use
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2560/00—Constructional details of operational features of apparatus; Accessories for medical measuring apparatus
    • A61B2560/04—Constructional details of apparatus
    • A61B2560/0443—Modular apparatus

Definitions

  • the invention relates to the field of medical equipment, in particular to an ultrasonic scalpel.
  • Ultrasonic scalpel means to further amplify the ultrasonic vibration obtained by the piezoelectric converter (the electric energy is transferred to the piezoelectric converter through the energy generator, and the electric energy is converted into ultrasonic mechanical energy by the piezoelectric converter), and the ultrasonic vibration is further amplified by the head of the scalpel.
  • the department uses the amplified ultrasonic vibration to cut and coagulate soft tissues. Clinical use of this device can achieve lesion resection under lower temperature and less bleeding, and can ensure minimal tissue lateral thermal damage. With the popularity of minimally invasive surgery, ultrasonic scalpel has become a conventional surgical instrument.
  • an ultrasonic scalpel includes a transducer, a handle, and a knife bar assembly arranged at the distal end of the handle.
  • the knife bar assembly of the existing ultrasonic scalpel has an ultrasonic knife bar, an inner sleeve and an outer sleeve.
  • the inner sleeve is located between the knife bar and the outer sleeve and can move a certain distance in the axial direction to open or close the movable clamp The forceps make the movable clamp contact or separate from the end of the knife bar to realize the clamping and cutting of the target biological tissue.
  • this kind of ultrasonic scalpel has a defect, that is, the handle housing and the blade assembly are non-detachable structures, and once they are disassembled, they cannot be restored. From the perspective of the structure of the cutter bar assembly, the inner tube and the outer tube are open at the cutter head, that is, the surgical site.
  • the liquid tissue of the surgical site will seep into the knife body from the opening of the tube end under the capillary action, that is, into the gap between the inner tube and the outer tube, and between the inner tube and the knife bar; the knife bar vibrates At this time, the silicone support ring on the knife bar becomes a piston that vibrates at the same frequency as the knife bar, and the liquid tissue is strongly sucked into the gap between the knife bar body and the inner tube.
  • solid fat samples and blood scabs were observed on the entire shank body and the outer wall of the inner tube near the blade head, especially on the entire shank body. The phenomenon is more serious.
  • the ultrasonic scalpel can only be used as a disposable surgical instrument in accordance with the regulations. It should be discarded after the operation is completed.
  • its high price and huge medical ethics risk lurks: in order to obtain economic benefits, privately use the ultrasonic scalpel. After incomplete cleaning and disinfection, before using it on the next patient, the risk of cross infection is inevitable.
  • the present invention provides a reusable ultrasonic scalpel.
  • the technical solution of the present invention is:
  • a reusable ultrasonic scalpel includes a handle assembly and an ultrasonic knife rod extended at its distal end for transmitting ultrasonic mechanical energy.
  • the ultrasonic knife rod is sheathed with a sleeve assembly, and the sleeve assembly passes quickly
  • the connecting mechanism is detachably connected to the handle assembly.
  • the sleeve assembly includes an inner sleeve assembly and an outer sleeve assembly that are sleeved with each other, the inner sleeve assembly includes an inner sleeve and an inner sleeve seat fixed at a proximal end thereof, and the outer sleeve assembly includes The outer sleeve and the outer sleeve holder fixed at the proximal end thereof, the inner sleeve is located between the ultrasonic cutter bar and the outer sleeve, and can move a certain distance in the axial direction, thereby opening or closing the movable clamp, so that the movable clamp
  • the pliers are in contact with or separated from the farthest end of the tool bar, the inner sleeve assembly and the outer sleeve assembly are circumferentially fixed, and the outer sleeve seat is connected to the tool rotating axle provided at the distal end of the handle assembly through the first quick-connect mechanism At the same time, the inner
  • the first quick-connect mechanism includes a first protrusion arranged on the outer peripheral surface of the proximal end of the outer sleeve socket, and an L-shaped groove axially arranged in the cutter rotating wheel, and the two are mated with each other .
  • the second quick-connect mechanism includes a second protrusion provided on the outer peripheral surface of the proximal end of the inner sleeve seat, and an L-shaped hook axially provided on the spring seat, and the two are matched with each other. Pick up.
  • the axial movement distance of the first protrusion in the L-shaped groove is greater than or equal to the axial movement distance of the second protrusion in the L-shaped hook.
  • a first plane is provided on the inner circumference of the outer sleeve seat
  • a second plane is provided on the outer circumference of the inner sleeve seat
  • the outer sleeve seat is sleeved on the outer circumference of the inner sleeve seat.
  • the interaction of the first plane and the second plane restricts the circumferential rotation of the inner sleeve assembly and the outer sleeve assembly.
  • the cutter rotating wheel includes an internal thread, and a sleeve installation knob with an external thread is threadedly connected to it, and the proximal end of the sleeve installation knob always applies force to the outer sleeve socket to fix it Between the sleeve installation knob and the cutter rotating wheel.
  • the distal end surface of the outer sleeve socket is a stepped plane, which fits with the protrusion of the proximal end of the sleeve mounting knob.
  • the inner sleeve and the inner sleeve seat are realized by an in-mold injection molding process or glue bonding.
  • the outer sleeve and the outer sleeve seat are realized by an in-mold injection molding process or glue bonding.
  • the handle assembly and the ultrasonic knife rod are respectively made of high temperature resistant materials.
  • the beneficial effects of the present invention are mainly reflected in: it has the advantages of reliable installation, easy disassembly, easy cleaning and disinfection, quick replacement of the sleeve assembly as a consumable, and the remaining parts can be reused, can be cleaned and sterilized in various ways, including High-temperature steam sterilization; greatly reduces the cost of surgical consumables, reduces the burden on patients, and also reduces the risk of cross-infection in the use of ultrasonic scalpel.
  • Figure 1 is a schematic diagram of the three-dimensional structure of the ultrasonic scalpel of the present invention
  • Figure 2 is an exploded schematic view of the sleeve assembly of the ultrasonic scalpel of the present invention
  • Figure 3 is a partial cross-sectional view of the ultrasonic scalpel of the present invention, used to show the connection between the sleeve assembly and the handle;
  • FIG. 4 is an exploded schematic diagram of the connection structure between the sleeve assembly and the handle of the ultrasonic scalpel of the present invention
  • Figure 5 is a schematic structural view of the inner sleeve assembly of the ultrasonic scalpel of the present invention.
  • Figure 6 is a schematic structural view of the outer sleeve assembly of the ultrasonic scalpel of the present invention.
  • FIG. 7 is a cross-sectional view of the overall structure of the sleeve assembly of the ultrasonic scalpel of the present invention.
  • Fig. 8 is a schematic diagram of the three-dimensional structure of the outer sleeve holder of the ultrasonic scalpel of the present invention.
  • Fig. 9 is a schematic view of another direction of the three-dimensional structure of the overtube holder of the ultrasonic scalpel of the present invention.
  • Figure 10 is a three-dimensional schematic diagram of the inner sleeve holder of the ultrasonic scalpel of the present invention.
  • FIG. 11 is a schematic diagram of the three-dimensional structure of the knife rotating wheel of the ultrasonic scalpel of the present invention.
  • Figure 12 is a cross-sectional view of the knife rotating wheel of the ultrasonic scalpel of the present invention.
  • FIG. 13 is a schematic diagram of the installation of the sleeve installation knob and the outer sleeve seat of the ultrasonic scalpel of the present invention
  • 14a-14d are schematic diagrams of the connection between the sleeve assembly and the handle of the ultrasonic scalpel of the present invention.
  • 15a-15c are schematic diagrams of the connection between the inner sleeve seat and the spring seat of the ultrasonic scalpel of the present invention.
  • the present invention discloses a reusable ultrasonic scalpel, which includes a handle assembly and an ultrasonic scalpel 4 extending at its distal end for transmitting ultrasonic mechanical energy.
  • the handle assembly of the present invention includes a housing 12, a power touch module 11 arranged in the housing 12 for controlling the output of ultrasonic energy, a trigger 16 pivoted on the housing 12 and The manual button 17, the trigger 16 transmits force to the spring assembly 10 through the transmission structure 14 and 15, the manual button 17 is used to trigger the power touch module.
  • the housing 12 also includes a return spring 13 for resetting the transmission structure 14 and 15.
  • the specific structure and working principle of the handle assembly are roughly the same as those of the prior art, so it will not be repeated here.
  • the ultrasonic cutter bar 4 is sheathed with a sleeve assembly 1, and the sleeve assembly 1 is detachably connected to the handle assembly through a quick-connect mechanism.
  • the sleeve assembly 1 includes an inner sleeve assembly and an outer sleeve assembly that are sleeved with each other.
  • the inner sleeve assembly includes an inner sleeve 3 and an inner sleeve seat 7 fixed at its proximal end.
  • the outer sleeve assembly includes an outer sleeve 2 and an outer sleeve seat 6 fixed at its proximal end.
  • the inner sleeve 3 is located between the ultrasonic cutter bar 4 and the outer sleeve 2, and can move a certain distance in the axial direction to open Or close the movable clamp 20 so that the movable clamp 20 contacts or separates from the farthest end of the knife bar.
  • the quick connection mechanism includes a first quick connection mechanism and a second quick connection mechanism.
  • the outer sleeve seat 6 is axially fixed to the cutter rotating wheel 8 provided at the distal end of the handle assembly through a first quick-connect mechanism, while the inner sleeve seat 7 is connected to the handle set at the handle through a second quick-connect mechanism
  • the spring seat 9 as part of the drive mechanism in the assembly is axially fixed.
  • the first quick-connect mechanism includes a first protrusion 6b provided on the outer peripheral surface of the proximal end of the outer sleeve base 6, and an L-shaped groove 8a axially provided in the cutter rotating wheel 8, which are matched with each other.
  • the second quick-connect mechanism includes a second protrusion 7a provided on the outer peripheral surface of the proximal end of the inner sleeve seat 7 and an L-shaped hanging buckle 9a axially provided on the spring seat 9. Patched.
  • the axial movement distance of the first protrusion 6b in the L-shaped groove 8a is equal to the axial movement distance of the second protrusion 7a in the L-shaped buckle 9a, so that both It just can be patched.
  • the axial movement distance of the first protrusion 6b in the L-shaped groove 8a will be slightly larger than the axial movement distance of the second protrusion 7a in the L-shaped buckle 9a, so that the outer casing
  • the first protrusion 6b of the tube seat 6 can first slide into the L-shaped groove 8a to act as an axial movement guide; in this technical solution, it is only necessary to ensure that the first protrusion 6b and the second protrusion 7a respectively axis at the same time. Move to the flat-folded end of the L-shaped groove 8a and the L-shaped hook 9a.
  • a first flat surface 6c is provided on the inner peripheral surface of the outer sleeve seat 6, a second flat surface 7b is provided on the outer peripheral surface of the inner sleeve seat 7, and the outer sleeve seat 6 is sleeved on the inner sleeve seat
  • the outer circumference of 7 and the interaction of the first plane 6c and the second plane 7b restrict the circumferential rotation of the inner sleeve assembly and the outer sleeve assembly, that is, no relative rotation occurs between the two.
  • the cutter rotating wheel 8 includes an internal thread, and a sleeve installation knob 5 with an external thread is threadedly connected to it.
  • the proximal end of the sleeve installation knob 5 faces the outer sleeve socket 6 and always applies force to make it It is fixed between the sleeve installation knob 5 and the cutter rotating wheel 8.
  • the distal end surface of the outer sleeve socket 6 is a stepped flat surface 6 a, which is matched with the proximal protrusion 5 a of the sleeve installation knob 5.
  • the first protrusion 6b of the outer sleeve seat 6 is aligned with the L-shaped groove 8a of the cutter rotating wheel 8, and slides into the cutter rotating wheel 8 in the direction of the arrow in Figure 14a.
  • the first protrusion 6b and the L-shaped groove 8a of the cutter wheel 8 have a guiding effect, so that the second protrusion 7a of the inner sleeve seat 7 is also aligned with the L-shaped hook 9a of the spring seat 9 at the same time.
  • the sleeve installation knob 5 added in the present invention can install the outer sleeve to an accurate position and prevent reverse rotation, according to the direction shown in Figure 14c Screw in the cutter rotating wheel 8 and tighten the sleeve assembly to complete the assembly.
  • the specific principle of preventing reversal is as follows: When the disposable sleeve assembly is assembled, because the outer sleeve base 6 has a stepped plane 6a, when the sleeve installation knob 5 rotates in the direction shown in Figure 12, the end of the sleeve installation knob 5 The protrusion 5a contacts the stepped flat surface 6a and applies a certain force to the flat surface 6a, so that the outer sleeve socket 6 receives a certain torsion force.
  • This torsion has two functions: firstly, the unrotated sleeve assembly can be rotated to the end of the transverse groove of the L-shaped groove 8a of the tool rotating wheel 8, so as to ensure the accurate installation position of the sleeve assembly; secondly, the torque It can also play an anti-loose and anti-reverse effect.
  • the stepped plane 6a can also be a smoothly transitioned oblique end surface, that is, it is only necessary that the distal end surface of the outer sleeve 6 has a height difference.
  • the specific connection process of the inner sleeve seat 7 and the spring seat 9 is as follows: the second protrusion 7a of the inner sleeve seat 7 is moved along the spring seat 9 in the direction of the arrow shown in Figures 15a-15c The L-shaped hanging buckle 9a slides in. When it slides to the bottom, it rotates in the direction of the arrow in Figure 15b. The second protrusion 7a is stuck in the horizontal groove of the L-shaped hanging buckle. The inner sleeve seat 7 and the spring seat 9 are In this way, the inner sleeve seat 7 and the spring seat 9 are connected.
  • the inner sleeve 3 and the inner sleeve seat 7, the outer sleeve 2 and the outer sleeve seat 6 are all realized by in-mold injection molding process or glue bonding (Insert Molding), used to make the connection structure; general sleeve assembly
  • the flaring process is used to make the end connection structure, which will cause the size to be unstable and the production scrap rate is also high; and the present invention uses the in-mold injection molding process or glue bonding, which can reduce the scrap rate of the product, and can also make changes. More complicated structure to realize the function.
  • the handle assembly and the ultrasonic knife bar 4 of the present invention are respectively made of high temperature resistant materials (high temperature resistant plastics: PPA, PEI, etc.; high temperature resistant metals: titanium alloy, stainless steel, etc.), and can be cleaned and sterilized by high temperature steam.
  • high temperature resistant plastics PPA, PEI, etc.
  • high temperature resistant metals titanium alloy, stainless steel, etc.
  • the invention is convenient to disassemble and assemble, the user can realize the disassembly and assembly of the sleeve assembly and the reusable part in a short time, which is convenient for hospital use.

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Abstract

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(4)，超声波刀杆(4)外套设有套管组件(1)，套管组件(1)通过快接机构可拆卸地连接于手柄组件。该超声波手术刀具有安装可靠、易拆装、易清洗消毒的优点，可快速更换作为耗材的套管组件，其余部分可重复使用，可以经过清洗和高温蒸汽灭菌；使得手术的耗材成本大幅降低，减轻患者的负担，也降低了超声刀杆使用中交叉感染的风险。

Description

可重复利用的超声波手术刀 技术领域
本发明涉及一种医疗器械领域，尤其涉及一种超声波手术刀。
背景技术
超声波手术刀是指将通过压电转换器(通过能量发生器将电能传递至压电转换器，由压电转换器将电能转换为超声机械能)获得的超声振动进一步放大，并由手术刀的头部将放大后的超声振动用于对软组织的切割和凝闭的器械。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。随着微创外科手术的普及，超声波手术刀已经成为一种常规手术器械。
一般来讲，超声波手术刀包括换能器、手柄，及设置在手柄远端的刀杆组件。现有超声波手术刀的刀杆组件具有超声波刀杆、内套管及外套管，内套管位于该刀杆与外套管之间，且可沿轴向移动一定的距离，从而打开或闭合活动夹钳，使得活动夹钳与刀杆的末端接触或分开，实现目标生物组织的夹持及切割。
但是这种超声波手术刀有个缺陷，即手柄壳体与刀杆组件是不可拆卸结构，一旦拆开，则不可恢复。从刀杆组件结构上来看，内管和外管在刀头部位即手术部位是开放的。在刀杆静止时，手术部位的液态组织会在毛细作用下，从管端开口向刀身内部，即向内管与外管之间、内管与刀杆之间的间隙渗入；在刀杆振动时，刀杆上的硅胶支撑环就成为一个与刀杆同频振动的活塞，将液态组织强力吸入刀杆本体与内管之间的间隙内。在对废弃超声刀进行拆解后，在整个刀杆本体上、内管外壁靠近刀头一侧，都观察到凝固态的脂肪样和血液结痂，特别是在整个刀杆本体上，结痂现象更为严重。在完成一台甚至可能若干台手术后，超声刀的结构和性能仍是完好的，但无法对刀身内部进行彻底的清洗和消毒。所以，上述超声波手术刀按照规范只能作为一次性手术器械来使用，手术完成后即应丢弃，但其价格高昂，也潜伏着巨大的医德风险：为了牟取经济利益，私下对使用过的超声刀进行不彻底的清洗和消毒后，再用在下一个患者身上，交叉感染的风险增大是必然的。
鉴于此，中国专利CN201410023651.2、CN201810130712.3、CN201810871843.7、CN201811114966.2设计了一些可更换的刀杆组件，但是这些组件有的结构比较复杂、制造成本比较高、装配也不便，例如设置在刀杆外周的套管组件的基座采用金属件，这样内外套管的设置就需要用胀管、旋槽等工艺才能实现，加工效率和成本居高不下；有的没有防止反转的功能，有可能导致在超声振动时产生细微位移而影响手术的精准度。
发明内容
本发明为了解决上述现有技术的问题，提供了一种可重复使用的超声波手术刀。
为解决以上技术问题，本发明的技术方案为：
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，所述超声波刀杆外套设有套管组件，所述套管组件通过快接机构可拆卸地连接于所述手柄组件。
优选的，所述套管组件包括相互套接的内套管组件和外套管组件，所述内套管组件包括内套管和固定在其近端的内套管座，所述外套管组件包括外套管和固定在其近端的外套管座，所述内套管位于该超声波刀杆与外套管之间，且可沿轴向移动一定的距离，从而打开或闭合活动夹钳，使得活动夹钳与刀杆的最远末端接触或分开，所述内套管组件和外套管组件周向固定，所述外套管座通过第一快接机构与设置在所述手柄组件远端的刀具旋转轮轴向固定，同时所述内套管座通过第二快接机构与设置在所述手柄组件内的作为驱动机构一部分的弹簧座轴向固定。
优选的，所述第一快接机构包括设置在所述外套管座近端外周面上的第一凸起，以及轴向设置在所述刀具旋转轮内的L型槽，两者相互配接。
优选的，所述第二快接机构包括设置在所述内套管座近端外周面上的第二凸起，以及轴向设置在所述弹簧座上的L型挂扣，两者相互配接。
优选的，所述第一凸起在所述L型槽中的轴向移动距离大于等于所述第二凸起在所述L型挂扣中的轴向移动距离。
优选的，所述外套管座内周面上设有第一平面，所述内套管座的外周面上设有第二平面，所述外套管座套设在所述内套管座的外周且所述第一平面和第二平面相互作用限制所述内套管组件和外套管组件周向转动。
优选的，所述刀具旋转轮包括内螺纹，有一具有外螺纹的套管安装旋钮与之螺纹连接，所述套管安装旋钮的近端端面对所述外套管座始终施力，使其固定在所述套管安装旋钮与所述刀具旋转轮之间。
优选的，所述外套管座的远端端面为台阶式平面，与所述套管安装旋钮的近端的凸起配合。
优选的，所述内套管和内套管座采用模内注塑成型工艺或胶水粘接实现。
优选的，所述外套管和外套管座采用模内注塑成型工艺或胶水粘接实现。
优选的，所述手柄组件及超声波刀杆分别采用耐高温材料制成。
本发明的有益效果主要体现在：具有安装可靠、易拆装、易清洗消毒的优点，快速更换作为耗材的套管组件，其余部分可重复使用，可以经过清洗和采用多种方式灭菌，包括高温蒸汽灭菌；使得手术的耗材成本大幅降低，减轻患者的负担，也降低了超声刀使用中交叉感染的风险。
附图说明
图1是本发明超声波手术刀的立体结构示意图；
图2是本发明超声波手术刀的套管组件的爆炸示意图；
图3是本发明超声波手术刀的局部剖视图，用于显示套管组件与手柄之间的连接；
图4是本发明超声波手术刀的套管组件与手柄之间的连接结构的爆炸示意图；
图5是本发明超声波手术刀的内套管组件的结构示意图；
图6是本发明超声波手术刀的外套管组件的结构示意图；
图7是本发明超声波手术刀的套管组件的整体结构剖视图；
图8是本发明超声波手术刀的外套管座的立体结构示意图；
图9是本发明超声波手术刀的外套管座的另一方向的立体结构示意图；
图10是本发明超声波手术刀的内套管座的立体结构示意图；
图11是本发明超声波手术刀的刀具旋转轮的立体结构示意图；
图12是本发明超声波手术刀的刀具旋转轮的剖视图；
图13是本发明超声波手术刀的套管安装旋钮与外套管座的安装示意图；
图14a-14d是本发明超声波手术刀的套管组件与手柄之间的连接示意图；
图15a-15c是本发明超声波手术刀的内套管座与弹簧座之间的连接示意图。
具体实施方式
以下将结合附图所示的具体实施方式对本发明进行详细描述。但这些实施方式并不限于本发明，本领域的普通技术人员根据这些实施方式所做出的结构、方法、或功能上的变换均包含在本发明的保护范围内。
在方案的描述中，需要说明的是，术语“中心”、“上”、“下”、“左”、“右”、“前”、“后”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本发明的限制。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。并且，在方案的描述中，以操作人员为参照，靠近操作者的方向为近端，远离操作者的方向为远端。
如图1至3所示，本发明揭示了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4。与现有技术大致类似的，本发明的手柄组件包括外壳12，设置在外壳12内的功率触控模块11，用于超声能量输出的控制，枢轴设置在所述外壳12上的扳机16和手动按钮17，所述扳机16通过传动结构件14、15将力传递给弹簧组件10，所述手动按钮17用于触发功率触控模块。所述外壳12内还包括用于将所述传动结构件14、15进行复位的复位弹簧13。该手柄组件的具体结构与工作原理与现有技术大致相同，因此在此不再赘述。
所述超声波刀杆4外套设有套管组件1，所述套管组件1通过快接机构可拆卸地连接于所述手柄组件。具体来讲，所述套管组件1包括相互套接的内套管组件和外套管组件，所述内套管组件包括内套管3和固定在其近端的内套管座7，所述外套管组件包括外套管2和固定在其近端的外套管座6，所述内套管3位于该超声波刀杆4与外套管2之间，且可沿轴向移动一定的距离，从而打开或闭合活动夹钳20，使得活动夹钳20与刀杆的最远末端接触或分开。
结合图5-12所示，本发明中所述套管组件1与手柄组件之间有快接机构，所述快接机构包括第一快接机构和第二快接机构。所述外套管座6通过第一快接机构与设置在所述手柄组件远端的刀具旋转轮8轴向固定，同时所述内套管座7通过第二快接机构与设置在所述手柄组件内的作为驱动机构一部分的弹簧座9轴向固定。所述第一快接机构包括设置在所述外套管座6近端外周面上的第一凸起6b，以及轴向设置在所述刀具旋转轮8内的L型槽8a，两者相互配接。所述第二快接机构包括设置在所述内套管座7近端外周面上的第二凸起7a，以及轴向设置在所述弹簧座9上的L型挂扣9a，两者相互配接。
一般来讲，所述第一凸起6b在所述L型槽8a中的轴向移动距离等于所述第二凸起7a在所述L型挂扣9a中的轴向移动距离，这样两者刚好可以配接。实际中，所述第一凸起6b在所述L型槽8a中的轴向移动距离会稍大于所述第二凸起7a在所述L型挂扣9a中的轴向移动距离，这样外套管座6的第一凸起6b可以先滑入L型槽8a中，起到轴向移动导向作用；在该技术方案中，只需保证第一凸起6b和第二凸起7a同时分别轴向移动到L型槽8a和L型挂扣9a的平折端部。
所述外套管座6内周面上设有第一平面6c，所述内套管座7的外周面上设有第二平面7b，所述外套管座6套设在所述内套管座7的外周且所述第一平面6c和第二平面7b相互作用限制所述内套管组件和外套管组件周向转动，即两者之间不会产生相对转动。
所述刀具旋转轮8包括内螺纹，有一具有外螺纹的套管安装旋钮5与之螺纹连接， 所述套管安装旋钮5的近端端面对所述外套管座6始终施力，使其固定在所述套管安装旋钮5与所述刀具旋转轮8之间。进一步的，所述外套管座6的远端端面为台阶式平面6a，与所述套管安装旋钮5的近端的凸起5a配合。
结合图4、图13、图14a-14d、图15a-15c具体解释本发明的超声波手术刀拆卸套管组件的过程。
一次性使用套管组件安装时，外套管座6的第一凸起6b对准刀具旋转轮8的L型槽8a，按图14a的箭头方向滑入刀具旋转轮8内，由于外套管座6的第一凸起6b与刀具转轮8的L型槽8a有导向作用，使内套管座7的第二凸起7a也同时对准了弹簧座9的L型挂扣9a。
一次性使用套管组件顺利滑到刀具旋转轮8底部时，按图14b所示箭头方向旋转套管组件，实现内套管座7与弹簧座9的连接以及外套管座6与刀具旋转轮8的连接。此时的套管组件有可能有未转到位或者按箭头反方向旋转的风险，因此本发明增加的套管安装旋钮5可以使外套管安装到准确位置并防止反转，按图14c所示方向旋进刀具旋转轮8，旋紧后套管组件组装完成。
防止反转的具体原理如下：一次性套管组件组装时，由于外套管座6有一段台阶式平面6a，当套管安装旋钮5按图12所示方向旋转时，套管安装旋钮5的端部凸起5a接触到该台阶式平面6a，并对该平面6a施加一定的力，使得外套管座6受到一定的扭力。这个扭力起到两个作用：首先，可以将未旋转到位的套管组件旋转到刀具旋转轮8的L型槽8a的横槽末端，这样可保证套管组件安装的位置准确；其次，这个扭力还可以起到防松防反转的效果。当然，台阶式平面6a也可以是平滑过渡的斜端面，即只需外套管座6的远端面具有高度差即可。
本发明中一次性套管组件组装时，内套管座7与弹簧座9的具体连接过程：按图15a-15c的箭头方向将内套管座7的第二凸起7a顺着弹簧座9的L型挂扣9a滑入，滑到底部时，按图15b的箭头方向旋转，第二凸起7a卡在L型挂扣的横槽内,所述内套管座7与弹簧座9之间就无法进行轴向相对运动，这样就实现了内套管座7与弹簧座9的连接。
本发明中，对于第一凸起6b和第二凸起7a的数量不做具体的要求。本领域的技术人员应该知道：1个、2个、或2个以上都是可以的。所述内套管3和内套管座7，所述外套管2和外套管座6均采用模内注塑成型工艺或胶水粘接(Insert Molding)实现，用于制作连接结构；一般套管组件都采用扩口工艺来制作端部连接结构，会造成尺寸不稳定，生产报废率也高；而本发明使用模内注塑成型工艺或胶水粘接，既可以减少产品报废率，同时也可以 做更复杂一些的结构去实现功能。
本发明所述手柄组件及超声波刀杆4分别采用耐高温材料(耐高温塑料：PPA、PEI等；耐高温金属：钛合金、不锈钢等)制成，可以经过清洗和高温蒸汽灭菌。本发明拆装便捷，使用者能在很短的时间内实现套管组件与可重复使用部分的拆装，方便医院使用。
以上仅是本发明的优选实施方式，应当指出的是，上述优选实施方式不应视为对本发明的限制，本发明的保护范围应当以权利要求所限定的范围为准。对于本技术领域的普通技术人员来说，在不脱离本发明的精神和范围内，还可以做出若干改进和润饰，这些改进和润饰也应视为本发明的保护范围。

Claims (13)

  1. 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(4)，其特征在于，所述超声波刀杆(4)外套设有套管组件(1)，所述套管组件(1)通过快接机构可拆卸地连接于所述手柄组件。
  2. 根据权利要求1所述的可重复利用的超声波手术刀，其特征在于，所述套管组件(1)包括相互套接的内套管组件和外套管组件，所述内套管组件包括内套管(3)和固定在其近端的内套管座(7)，所述外套管组件包括外套管(2)和固定在其近端的外套管座(6)，所述内套管(3)位于该超声波刀杆(4)与外套管(2)之间，且可沿轴向移动一定的距离，从而打开或闭合活动夹钳(20)，使得活动夹钳(20)与刀杆的最远末端接触或分开，所述内套管组件和外套管组件周向固定，所述外套管座(6)通过第一快接机构与设置在所述手柄组件远端的刀具旋转轮(8)轴向固定，同时所述内套管座(7)通过第二快接机构与设置在所述手柄组件内的作为驱动机构一部分的弹簧座(9)轴向固定。
  3. 根据权利要求2所述的可重复利用的超声波手术刀，其特征在于，所述第一快接机构包括设置在所述外套管座(6)近端外周面上的第一凸起(6b)，以及轴向设置在所述刀具旋转轮(8)内的L型槽(8a)，两者相互配接。
  4. 根据权利要求3所述的可重复利用的超声波手术刀，其特征在于，所述第二快接机构包括设置在所述内套管座(7)近端外周面上的第二凸起(7a)，以及轴向设置在所述弹簧座(9)上的L型挂扣(9a)，两者相互配接。
  5. 根据权利要求4所述的可重复利用的超声波手术刀，其特征在于，所述第一凸起(6b)在所述L型槽(8a)中的轴向移动距离大于等于所述第二凸起(7a)在所述L型挂扣(9a)中的轴向移动距离。
  6. 根据权利要求2所述的可重复利用的超声波手术刀，其特征在于，所述外套管座(6)内周面上设有第一平面(6c)，所述内套管座(7)的外周面上设有第二平面(7b)，所述外套管座(6)套设在所述内套管座(7)的外周且所述第一平面(6c)和第二平面(7b)相互作用限制所述内套管组件和外套管组件周向转动。
  7. 根据权利要求2至6任一所述的可重复利用的超声波手术刀，其特征在于，所述刀具旋转轮(8)包括内螺纹，有一具有外螺纹的套管安装旋钮(5)与之螺纹连接，所述套管安装旋钮(5)的近端端面对所述外套管座(6)始终施力，使其固定在所述套管安装旋钮(5)与所述刀具旋转轮(8)之间。
  8. 根据权利要求7所述的可重复利用的超声波手术刀，其特征在于，所述外套管座(6)的远端端面为台阶式平面(6a)，与所述套管安装旋钮(5)的近端的凸起(5a)配合。
  9. 根据权利要求2至6任一所述的可重复利用的超声波手术刀，其特征在于，所述内套管(3)和内套管座(7)采用模内注塑成型工艺或胶水粘接实现。
  10. 根据权利要求2至6任一所述的可重复利用的超声波手术刀，其特征在于，所述外套管(2)和外套管座(6)采用模内注塑成型工艺或胶水粘接实现。
  11. 根据权利要求1所述的可重复利用的超声波手术刀，其特征在于，所述手柄组件及超声波刀杆(4)分别采用耐高温材料制成。
  12. 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(4)，其特征在于，所述超声波刀杆(4)外套设有套管组件(1)，所述套管组件(1)包括相互套接的内套管组件和外套管组件，所述内套管组件包括内套管(3)和设置在其近端的内套管座(7)，两者均为塑料材质并采用模内注塑成型工艺或胶水粘接固接；所述外套管组件包括外套管(2)和设置在其近端的外套管座(6)，两者均为塑料材质并采用模内注塑成型工艺或胶水粘接固接；所述套管组件(1)通过快接机构可拆卸地连接于所述手柄组件。
  13. 根据权利要求12所述的可重复利用的超声波手术刀，其特征在于，所述外套管座(6)通过第一快接机构与设置在所述手柄组件远端的刀具旋转轮(8)轴向固定，同时所述内套管座(7)通过第二快接机构与设置在所述手柄组件内的作为驱动机构一部分的弹簧座(9)轴向固定。
PCT/CN2020/084408 2019-08-15 2020-04-13 可重复利用的超声波手术刀 WO2021027302A1 (zh)

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BR112022001682A BR112022001682A2 (pt) 2019-08-15 2020-04-13 Bisturi ultrassônico reutilizável
EP20852980.0A EP4014899A4 (en) 2019-08-15 2020-04-13 REUSABLE ULTRASONIC SCALPEL
JP2021576457A JP7232941B2 (ja) 2019-08-15 2020-04-13 再使用可能な超音波メス

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