WO2021243809A1 - 超声刀与换能器的连接机构及采用其的超声刀组件 - Google Patents

超声刀与换能器的连接机构及采用其的超声刀组件 Download PDF

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Publication number
WO2021243809A1
WO2021243809A1 PCT/CN2020/101666 CN2020101666W WO2021243809A1 WO 2021243809 A1 WO2021243809 A1 WO 2021243809A1 CN 2020101666 W CN2020101666 W CN 2020101666W WO 2021243809 A1 WO2021243809 A1 WO 2021243809A1
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Prior art keywords
ultrasonic knife
transducer
turntable
sleeve
rotating cap
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PCT/CN2020/101666
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English (en)
French (fr)
Inventor
黄文星
张苗
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赛诺微医疗科技（浙江）有限公司
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Application filed by 赛诺微医疗科技（浙江）有限公司 filed Critical 赛诺微医疗科技（浙江）有限公司
Priority to US18/000,793 priority Critical patent/US20230240700A1/en
Priority to EP20939202.6A priority patent/EP4111990A4/en
Publication of WO2021243809A1 publication Critical patent/WO2021243809A1/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
    • A61B17/3209—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
    • A61B17/28—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
    • 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
    • A61B2017/320072—Working tips with special features, e.g. extending parts
    • A61B2017/320074—Working tips with special features, e.g. extending parts blade
    • A61B2017/320075—Working tips with special features, e.g. extending parts blade single edge blade, e.g. for cutting
    • 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
    • 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
    • A61B90/03—Automatic limiting or abutting means, e.g. for safety
    • A61B2090/031—Automatic limiting or abutting means, e.g. for safety torque limiting
    • 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

Definitions

  • the invention relates to the technical field of medical equipment, in particular to a connecting mechanism of an ultrasonic knife and a transducer and an ultrasonic knife assembly using the same.
  • the commonly used tightening method is to add a set of plastic torque wrenches.
  • the torque wrench is composed of a knob body and a rotating shaft. During use, the knob body presses the plastic elastic deformation on the rotating shaft to control the tightening force. During the operation, the doctor needs to obliquely observe the selection of the large and small gears from the side of the ultrasonic scalpel.
  • the bag is directly placed on the ultrasonic knife and it is easy to slip off. It cannot safely and effectively isolate the contact between the doctor/user and the surface of the transducer.
  • the bag is directly attached to the ultrasonic knife and affects the operation of the doctor's handheld ultrasonic knife. Perform high temperature sterilization on the transducer connected with the ultrasonic knife.
  • Each ultrasonic knife is provided with a torque wrench, which increases the cost of equipment;
  • the torque wrench is provided by the elastic deformation of the plastic, and the torque value is unstable. The torque value will become smaller and smaller after repeated use, and the plastic shrapnel is easy to break;
  • the button position is in the cutting and coagulation positions. In actual doctors' operation, cutting is selected most of the time.
  • the symmetrical position design makes it feel more fatigued after long-term use;
  • the main purpose of the present invention is to provide a connecting mechanism of an ultrasonic knife and a transducer and an ultrasonic knife assembly using the same, in order to at least partially solve at least one of the above technical problems.
  • connection mechanism of an ultrasonic knife and a transducer which includes:
  • the tightening turntable is a rotating body structure taking the insertion direction of the ultrasonic knife as the axis, and the shaft is formed with a through hole to sleeve the ultrasonic knife, and the ultrasonic knife can be rotated synchronously with the rotating cap through a pin or a locking structure; one end of the tightening turntable is provided with It has a threaded or snap-fit structure to connect with the sleeve structure that contains the transducer; the other end is a limit plane with a number of grooves for matching with the torsion pin installed on the rotating cap , Or, there are a number of torsion pins which are supported by springs and protrude from the surface, which are used to cooperate with the grooves provided on the rotating cap;
  • the rotating cap is a rotating body structure taking the insertion direction of the ultrasonic knife as the axis, and the shaft center forms a through hole for the ultrasonic knife to pass through; Torsion pins or grooves that come out of the surface; when the rotating cap is subjected to rotating force, tightening the torsion pins on the turntable or the rotating cap can compress the spring to retract the surface, and extend into the corresponding groove when it is not under force;
  • the sleeve structure which is hollow inside, can accommodate transducers and cables, and its surface can be detachably sealed with the bag and/or protective film, so that the sleeve can be connected by the bag and/or protective film.
  • the structure is isolated from the outside world to protect the transducer from contamination.
  • an ultrasonic knife assembly adopting the above-mentioned connection mechanism of the ultrasonic knife and the transducer is also proposed.
  • the connecting mechanism of the present invention has at least one of the following beneficial effects compared with the prior art:
  • the tightening device is integrated with the ultrasonic knife, eliminating the installation and removal steps, making the operation easier;
  • the tightening device is integrated with the ultrasonic knife, which eliminates the risk of omission during disinfection;
  • the tightening device serves as a rotating mechanism at the same time, without a separate torque wrench, which reduces product costs.
  • buttons are shaped differently, which is helpful for the operator to distinguish different gears while focusing on the operation.
  • the selection of the button position takes into account the ergonomics and the actual use of the doctor, which can be applied to more different hand operations and reduce the fatigue of the doctor;
  • the sleeve design at the tail of the ultrasonic knife facilitates the installation and disassembly of the instrument nurse, which can stably and effectively isolate the contact between the doctor and the outer surface of the transducer, and does not affect the use of the doctor's instrument;
  • the sleeve design reduces the damage of long-term high temperature sterilization to the transducer cable, prolongs the service life of the transducer, and improves the single-day use time of a single transducer.
  • Fig. 1 is a schematic diagram of the overall structure of an ultrasonic knife assembly according to an embodiment of the present invention
  • FIG. 2 is a schematic diagram of a semi-exploded structure of a connecting mechanism according to an embodiment of the present invention
  • Fig. 3 is a schematic side view of a semi-exploded structure of a connecting mechanism according to an embodiment of the present invention.
  • 4A and 4B are respectively a schematic diagram of the shape and position of the ultrasonic knife button of the sleeve structure of an embodiment of the present invention.
  • FIG. 5 is a schematic diagram of the overall structure of an ultrasonic knife assembly of a sleeve structure according to an embodiment of the present invention
  • Fig. 6 is a schematic diagram of a semi-exploded structure of an ultrasonic knife assembly of a fusion sleeve structure according to an embodiment of the present invention.
  • Knife head assembly 04. Tighten the turntable
  • the invention discloses a connecting mechanism of an ultrasonic knife and a transducer, including:
  • the tightening turntable is a rotating body structure taking the insertion direction of the ultrasonic knife as the axis, and the shaft is formed with a through hole to sleeve the ultrasonic knife, and the ultrasonic knife can be rotated synchronously with the rotating cap through a pin or a locking structure; one end of the tightening turntable is provided with It has a threaded or snap-fit structure to connect with the sleeve structure that contains the transducer; the other end is a limit plane with a number of grooves for matching with the torsion pin installed on the rotating cap Or, there are a number of torsion pins that are supported by springs and protrude from the surface to be matched with the grooves provided on the rotating cap. Among them, the torsion pin can be installed on either the tightening turntable and the rotating cap, as long as the two cooperate to limit rotation.
  • the rotating cap is a rotating body structure taking the insertion direction of the ultrasonic knife as the axis, and the shaft center forms a through hole for the ultrasonic knife to pass through; Torsion pins or grooves that come out of the surface; when the rotating cap is subjected to a rotating force, tightening the torsion pins on the turntable or the rotating cap can compress the spring to retract the surface, and extend into the corresponding groove when it is not under force.
  • the sleeve structure which is hollow inside, can accommodate transducers and cables, and its surface can be detachably sealed with the bag and/or protective film, so that the sleeve can be connected by the bag and/or protective film.
  • the structure is isolated from the outside world to protect the transducer from contamination.
  • the design of the sleeve structure can isolate the sterilization transducer from the user and the patient without direct contact.
  • fix the bag on the rear edge bulge of the sleeve structure in a sterile state pass the transducer through the bag and sleeve, and connect the transducer and the ultrasonic knife normally; remove the transducer first after use , And then unscrew the sleeve.
  • the next operation can be performed without high temperature disinfection.
  • the sleeve structure is a cylindrical hollow cylinder, the rear edge of which protrudes to form a ring of enlarged flange structure, which can be detachably sealed with the bag and/or protective film, thereby A bagging and/or protective film can be used to isolate the inside of the sleeve structure from the outside.
  • the sleeve structure completely isolates the outer surface of the transducer from the doctor, it can effectively avoid contamination of the outer surface of the transducer without affecting the operation and use of the doctor’s instruments, reducing the harm of long-term high temperature sterilization to the transducer cable and extending Transducer service life.
  • the side of the screwing turntable and/or the rotating cap can be formed with a number of ribs, which is convenient for hand holding and exerting force.
  • the material of the screwing turntable and/or the rotating cap can be engineering plastic or metal, such as polyethylene PE, polypropylene PP, ABS, PET, aluminum alloy, etc.
  • the torsion pin that is supported by the spring and protrudes from the surface can be a hemispherical or spherical ball arranged on a cube connected by a straight spring, or a ready-made spring clamp can be directly used.
  • the number of torsion pins can be 1, 2, 3, 4, 5, 6, 7, ..., and 2 or 3 is generally preferred.
  • Multiple torsion pins and grooves are set to cooperate to achieve multiple different angles of control, for example, the torsion pins slide into different grooves to lock in position.
  • the head of the torsion pin has a smooth transition on the clockwise edge of the tangent to the outer circumference, and the counterclockwise edge forms a step, and the groove is also arranged, so that the turntable is tightened and/or rotated clockwise.
  • the pin of the turntable drives the ultrasonic knife to rotate, so that the ultrasonic knife and the sleeve structure are screwed together.
  • the torsion pin receives more and more tangential force and positive pressure, compressing the compression spring, and the torsion force. The value continues to increase as the compression amount of the compression spring increases.
  • the connecting mechanism of the ultrasonic knife and the transducer may also include a pistol-shaped handle, which is convenient for the operator to hold, especially for one-handed operation.
  • the rotating cap and the tightening turntable are located at the muzzle part of the pistol-shaped handle
  • the sleeve structure is located at the barrel part
  • at least two ultrasonic knife buttons are arranged on the trigger part of the pistol-shaped handle, and they are arranged in different shapes according to the frequency of use and habits.
  • the size and pressing angle are used for different gear selection.
  • there are two ultrasonic knife keys and the action stroke of the ultrasonic knife keys adopts an eccentric setting that deviates from the horizontal line of the center of the key. In this way, the special-shaped design at the button helps the operator to distinguish different gears while focusing on the operation; the special-shaped position at the button is suitable for operations with different hands, reducing the fatigue of the doctor.
  • a decorative decorative cover can be sleeved on the rotating cap to enhance the beauty of the connecting mechanism and play a role of waterproof and dustproof.
  • the invention also discloses an ultrasonic knife assembly adopting the above-mentioned connecting mechanism, which includes a transducer, an ultrasonic knife and the like.
  • Fig. 1 is a schematic diagram of the overall structure of an ultrasonic knife of a connecting mechanism according to an embodiment of the present invention.
  • 01 is an ultrasonic knife handle (with a built-in transducer)
  • 02 is a tightening device, including the tightening turntable and rotating cap mentioned above
  • 03 is a knife head assembly, which mainly includes an ultrasonic knife.
  • the tightening device 02 is fixed on the handle 01 of the ultrasonic knife through a bayonet, and is fixed by a pin and 03. By turning the tightening device 02 to rotate, it can also drive the 03 to rotate.
  • Fig. 2 is a schematic diagram of a semi-exploded structure of a connecting mechanism according to an embodiment of the present invention.
  • 04 is a tightening turntable, which is approximately hexagonal with six rounded corners.
  • On its side facing the rotating cap there are 6 semi-circular grooves;
  • 05 is a torsion pin with a half head. Round shape, used in conjunction with the groove on the turntable 04;
  • 06 is the compression spring;
  • 07 is the rotating cap, which can rotate independently, the torsion pin 05 and the compression spring 06 are assembled in the corresponding position in the rotating cap 07;
  • 08 is the decorative cover plate , Plays the role of decoration and support for the knife bar.
  • Fig. 3 is a schematic side view of a semi-exploded structure of a connecting mechanism according to an embodiment of the present invention.
  • 05 is a torsion pin with a semi-circular head. It is used in conjunction with the groove on the turntable 04.
  • 06 is a compression spring and 07 is a rotating cap. The torsion pin 05 and compression spring 06 are assembled on the rotating cap. The corresponding position in 07.
  • FIGS. 4A and 4B are schematic diagrams of the shape and position of the ultrasonic knife button of the ultrasonic knife handle part of an embodiment of the present invention. It can be seen from FIG. 4A that there are two ultrasonic knife buttons 09, and the outer contours of the two are not the same, and the hand touch feeling is obviously different. As shown in Figure 4B, the center line of the key positions of the two ultrasonic knife keys 09 is also set to the lower side, that is, the previous key is a commonly used key, which occupies a larger operating area and is easier to touch, and the operation of both The stroke is not set horizontally, but is appropriately eccentric, for example, the angle between the two is ⁇ , which is convenient for the operator to distinguish between the two when operating with one hand.
  • Fig. 5 is a schematic diagram of the overall structure of an ultrasonic knife assembly of a fusion sleeve structure according to an embodiment of the present invention.
  • 10 is the sleeve structure
  • 11 is the transducer
  • 12 is the standard bagging; before the operation, disassemble the sterile ultrasonic knife, the sleeve structure 10, and the standard bag 12, and fix the standard bag 11 on the sleeve structure 10.
  • the sleeve structure 10 is rotatably fixed to the handle 01 of the ultrasonic knife. Then, the sterilized transducer 11 is passed through the standard sleeve 12 and the sleeve structure 10 in order to connect the transducer to the ultrasonic knife.
  • the transducer 11 is first unscrewed to exit, and then the sleeve structure 10 is unscrewed.
  • the sleeve structure 10 and the standard bag 12 are treated in accordance with the medical waste standard. Protect the sterilized transducer 11 from contamination, continue the next operation, save sterilization time, and extend the service life of the transducer 11 cable;
  • 6 is a schematic diagram of a semi-exploded structure of an ultrasonic knife assembly of a fusion sleeve mechanism of an embodiment of the present invention
  • 10 is a sleeve structure
  • 01 is an ultrasonic knife handle
  • the doctor can adjust the angle of the knife head by rotating and tightening the turntable 04 or the rotating cap 07.
  • the mechanism design of the sleeve structure 10 on the handle of the ultrasonic knife isolates the sterilized transducer 11 from the user and patient without direct contact.
  • the standard bag 12 is fixed on the sleeve structure 10, and the sleeve structure 10 is rotated and fixed on the tail of the ultrasonic knife handle.
  • the transducer 11 passes through the standard bag 12 and the sleeve structure 10 in turn, and is connected normally Energy device 11 and ultrasonic knife; after use, first remove the energy device 11, and then unscrew the sleeve structure 10 in the opposite direction. After replacing the sterile sleeve structure 10 and the sterile standard bagging 12, the next operation can be performed.
  • the above definitions of various elements and methods are not limited to the various specific structures, shapes or methods mentioned in the embodiments, and those of ordinary skill in the art can simply modify or replace them, for example: the decorative cover can be omitted ; The number of pins and compression springs can be flexibly set according to the design needs; the tightening device can be replaced by other structural methods; the special shape of the button can be replaced by other structures; the structure of the sleeve can be flexibly designed and replaced according to the appearance requirements of the ultrasonic knife.
  • the sleeve structure design of the present invention can avoid the number of repeated sterilization of the transducer while meeting the requirements of aseptic surgery, and shorten the damage to the device caused by repeated sterilization of the device; in addition, the sleeve design can be easily installed and disassembled , It is convenient for the operation of the equipment nurse. After installation, it does not affect the doctor’s hand feeling and operating comfort of the instrument at the same time; in addition, the connecting mechanism of the present invention is integrated with the ultrasonic knife, eliminating the installation and disassembly and disinfection steps, eliminating the risk of loss, the torque value is stable and reliable, and the service life is More long-term; the key design of the present invention accords with ergonomics and reduces the burden of the operator.

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Abstract

一种超声刀与换能器的连接机构及采用其的超声刀组件。本发明的连接机构包括：拧紧转盘、旋转帽和套筒结构；其中套筒结构内部中空，能够容纳换能器和线缆，其表面能够与套袋和/或保护膜形成可拆卸地密封连接，从而能够利用套袋和/或保护膜将所述套筒结构与外界隔离，保护换能器不受污染。本发明的套筒结构设计可以在满足无菌手术的同时，避免换能器重复灭菌的次数，缩短器械重复灭菌对器械的损害，方便操控人员的操作。

Description

超声刀与换能器的连接机构及采用其的超声刀组件 技术领域
本发明涉及医疗器械技术领域，具体涉及一种超声刀与换能器的连接机构及采用其的超声刀组件。
背景技术
在超声刀的应用技术中，因超声刀刀头和换能器为分体结构，两者通过螺纹接头连接，在连接时拧紧力需要控制在一定的范围内，否则超声刀不能正常工作，严重的会损毁刀头或换能器。常用的紧固方式为外加一套塑料扭力扳手，扭力扳手由旋钮体和旋转轴两个部件组成，使用过程中通过旋钮体压迫旋转轴上的塑料弹性变形来控制拧紧力的大小。术中医生在手术中需要倾斜从超声刀侧面去观察大小档位的选择。术中套袋直接套在超声刀上易滑落，不能安全有效地隔离医生/使用者与换能器表面的接触，套袋直接系在超声刀上影响医生的手持超声刀的操作，术后需要对与超声刀连接的换能器进行高温灭菌。
在实现本发明的过程中，发明人发现上述现有技术存在如下技术缺陷：
(1)每把超声刀都提供一个扭力扳手，造成器械成本的增加；
(2)扭力扳手经由器械前端安装和去除，操作不方便；
(3)扭力扳手在使用过程中需要妥善保管否则容易丢失，在使用中非常不方便；
(4)扭力扳手由塑料弹性变形提供扭力，扭力值不稳定，多次使用后扭力值将越来越小，且塑料弹片易折断；
(5)由于扭力扳手是单独配件，在超声刀消毒过程中可能会忘记将扳手消毒，使得超声刀无法按照设定要求连接工作而带来不便。
(6)医生在术中专心手术时，相同形状的按键操作时医生需要侧面观察选择档位；
(7)按键位置在切割、凝血两个档位，实际医生操作中，大部分时间选用为切割，对称的位置设计，长期使用后疲劳感强；
(8)套袋直接保护换能器与超声刀连接，固定不稳定易滑落；
(9)套袋直接安装在超声刀外表面上，密封性不稳定，严重影响医生手术使用超声刀；
(10)由于术中，医生/使用者与换能器外表面有接触会污染换能器，所以每一场手术后都需要对换能器重复高温灭菌。高温重复灭菌对换能器线缆与零部件、性能都有严重的损害。
发明内容
有鉴于此，本发明的主要目的在于提供一种超声刀与换能器的连接机构及采用其的超声刀组件，以期至少部分解决上述技术问题中的至少之一。
为了实现上述目的，作为本发明的一个方面，提出了一种超声刀与换能器的连接机构，包括：
拧紧转盘，为以超声刀插入方向为轴的旋转体结构，轴心形成通孔套设超声刀且通过销钉或卡合结构使所述超声刀能够随旋转帽同步转动；所述拧紧转盘一端设有螺纹或卡合结构，用于与容纳有换能器的套筒结构连接；另一端为一限位平面，其上设有若干凹槽，用于与安装在旋转帽上的扭力销钉相配合，或者，其上安装有若干通过弹簧支撑而伸出表面的扭力销钉，用于与设置在旋转帽上的凹槽相配合；
旋转帽，为以超声刀插入方向为轴的旋转体结构，轴心形成供超声刀穿过的通孔；所述旋转帽朝向拧紧转盘的一面与拧紧转盘对应配合设置有若干通过弹簧支撑而伸出表面的扭力销钉或者凹槽；在旋转帽受旋转作用力时拧紧转盘或旋转帽上的扭力销钉能够压缩弹簧而缩回表面，在未受力时则伸入对应凹槽中；
套筒结构，其内部中空，能够容纳换能器和线缆，其表面能够与套袋和/或保护膜形成可拆卸地密封连接，从而能够利用套袋和/或保护膜将所述套筒结构与外界隔离，保护换能器不受污染。
作为本发明的另一个方面，还提出了一种采用如上所述的超声刀与换能器的连接机构的超声刀组件。
基于上述方案可知，本发明的连接机构相对于现有技术至少具有如下有益效果之一：
(1)拧紧装置与超声刀一体，省去安装和去除的操作步骤，使得操作更加简便；
(2)拧紧装置与超声刀一体，杜绝了丢失的风险，也无需专门保存，使用更加方便；
(3)拧紧装置与超声刀一体，杜绝了因消毒时遗漏带来的风险；
(4)使用压缩弹簧的方式调节扭力值，使得扭力值稳定可靠，使用寿命更加长久；
(5)拧紧装置同时作为旋转机构，无需配单独扭力扳手，降低产品成本。
(6)按键异形，有利于操作者专注手术时亦可分辨不同档位。
(7)按键位置选择考虑人体工学与医生的实际使用情况，可适用于更多不同手性的操作，减少医生的疲惫感；
(8)超声刀尾部的套筒设计，便于器械护士安装与拆卸，可稳定有效的隔离医生与换能器外表面的接触，并且不影响医生的器械使用；
(9)套筒设计减小长期高温灭菌对换能器线缆的危害，延长换能器使用寿命，提高单个换能器的单天使用时间。
附图说明
图1是本发明一实施例的超声刀组件的整体结构示意图；
图2是本发明一实施例的连接机构的半分解结构示意图；
图3是本发明一实施例的连接机构的侧面半分解结构示意图。
图4A、4B分别是本发明一实施例的套筒结构的超声刀按键的形状和位置示意图；
图5是本发明一实施例的套筒结构的超声刀组件的整体结构示意图；
图6是本发明一实施例的融合套筒结构的超声刀组件的半分解结构示意图。
上图中，附图标记含义如下：
01、超声刀手柄              02、拧紧装置
03、刀头组件                04、拧紧转盘
05、扭力销钉                06、压缩弹簧
07、旋转帽                  08、装饰盖板
09、超声刀按键              10、套筒结构
11、换能器                  12、标准套袋
具体实施方式
为使本发明的目的、技术方案和优点更加清楚明白，以下结合具体实施例，并参照附图，对本发明作进一步的详细说明。
本发明公开了一种超声刀与换能器的连接机构，包括：
拧紧转盘，为以超声刀插入方向为轴的旋转体结构，轴心形成通孔套设超声刀且通过销钉或卡合结构使所述超声刀能够随旋转帽同步转动；所述拧紧转盘一端设有螺纹或卡合结构，用于与容纳有换能器的套筒结构连接；另一端为一限位平面，其上设有若干凹槽，用于与安装在旋转帽上的扭力销钉相配合，或者，其上安装有若干通过弹簧支撑而伸出表面的扭力销钉，用于与设置在旋转帽上的凹槽相配合。其中，扭力销钉可以装在拧紧转盘和旋转帽中的任一上，只要两者配合能够限位旋转即可。
旋转帽，为以超声刀插入方向为轴的旋转体结构，轴心形成供超声刀穿过的通孔；所述旋转帽朝向拧紧转盘的一面与拧紧转盘对应配合设置有若干通过弹簧支撑而伸出表面的扭力销钉或者凹槽；在旋转帽受旋转作用力时拧紧转盘或旋转帽上的扭力销钉能够压缩弹簧而缩回表面，在未受力时则伸入对应凹槽中。
套筒结构，其内部中空，能够容纳换能器和线缆，其表面能够与套袋和/或保护膜形成可拆卸地密封连接，从而能够利用套袋和/或保护膜将所述套筒结构与外界隔离，保护换能器不受污染。
其中，套筒结构的设计，可以将灭菌换能器与使用者、患者隔离，无直接接触。操作时，在无菌状态下将套袋固定在套筒结构的后缘凸起上，换能器穿过套袋和套筒，正常连接换能器与超声刀；在使用后先撤离换能器，再拧下套筒即可。更换套筒、套袋后不需要再高温消毒即可进行下一场手术。
在一优选实施方式中，套筒结构为一圆柱形中空筒体，其后缘凸起形成一圈膨大凸缘结构，其上能够与套袋和/或保护膜形成可拆卸地密封连接， 从而能够利用套袋和/或保护膜将所述套筒结构内部与外界隔离。套筒结构上设有卡扣，在无菌状态将套袋旋转约30°固定在中间换能器套筒上，换能器依次穿过套袋和套筒，正常连接换能器与超声刀；在使用后撤离换能器，再反方向旋转拧下套筒退出与超声刀的连接即可。由于套筒结构将换能器外表面与医生完全隔离，可以有效避免换能器外表面污染，同时不影响医生的器械操作使用，减小长期高温灭菌对换能器线缆的危害，延长换能器使用寿命。
其中，拧紧转盘和/或旋转帽侧面可以形成若干凸棱，便于手握持和发力。该拧紧转盘和/或旋转帽的材质可以为工程塑料或金属，例如为聚乙烯PE、聚丙烯PP、ABS、PET、铝合金等。
其中，该弹簧支撑而伸出表面的扭力销钉可以是通过直弹簧连接的立方体上设置的半球状或球状的圆珠，也可以直接采用现成的弹簧卡珠。扭力销钉的数目可以是1、2、3、4、5、6、7、……，通常优选为2或3。通过设置多个扭力销钉和凹槽的配合来实现多个不同角度的控制，例如通过扭力销钉滑入不同的凹槽来卡位。
作为优选，扭力销钉的头部在外圆周切线的顺时钟方向的边沿设成平滑过渡，而逆时钟方向的边沿则形成阶梯，而凹槽也同样设置，从而在顺时钟旋转拧紧转盘和/或旋转帽时，拧紧转盘的销轴带动超声刀旋转，使超声刀和套筒结构螺纹连接，当螺纹全部拧进后再用力，扭力销钉受到切向力和正压力越来越大，压缩压缩弹簧，扭力值随着压缩弹簧压缩量加大而不断变大，当达到一定压缩量后，扭力销钉的顶部脱离拧紧转盘上的凹槽，限位作用消失，起到扭力过载保护作用；在拆卸换能器时，逆时针旋转旋转帽，拧紧转盘在扭力销钉顶部平面的带动下一起旋转，使得螺纹松开。
作为优选，该超声刀与换能器的连接机构还可以包括一手枪形手柄，以便于操作者握持，尤其是单手操作。旋转帽和拧紧转盘位于该手枪形手柄的枪口部位，套筒结构位于枪管部位，在手枪形手柄的扳机部位设置有至少两个超声刀按键，并按照使用频率和习惯设置成不同的形状大小和按压角度，用于不同档位选择。作为进一步优选，超声刀按键为两个，且超声刀按键的作用行程采用偏离按键中心水平线的偏心设置。如此，按键处 的异形设计，有利于操作者专注手术时亦可分辨不同档位；而按键处的异形位置，则适用于不同手性的操作，减少医生的疲惫感。
此外，旋转帽上还可以套设装饰性的装饰盖板，以增强连接机构的美观，且起到防水隔尘的作用。
本发明还公开了一种采用上述连接机构的超声刀组件，包括换能器和超声刀等。
下面通过具体实施例并结合附图对本发明的技术方案作进一步阐述说明。需要注意的是，下述实施例仅是为了举例说明，而不是用于对本发明进行限定。
图1是本发明一实施例的连接机构的超声刀的整体结构示意图。如图1所示，01为超声刀手柄(内设换能器)，02为拧紧装置，包括上文中提到的拧紧转盘和旋转帽，03为刀头组件，主要包括超声刀。拧紧装置02通过卡口固定在超声刀手柄01上，并通过销轴和03固定，通过拨动拧紧装置02旋转的同时又能带动03旋转。
图2是本发明一实施例的连接机构的半分解结构示意图。如图2所示，04为拧紧转盘，为具有六个圆角的近似六边形，在其朝向旋转帽的一面上设有6个半圆形凹槽；05为扭力销钉，头部为半圆形，同拧紧转盘04上的凹槽配合使用；06为压缩弹簧；07为旋转帽，可独立旋转，扭力销钉05和压缩弹簧06装配于旋转帽07中的相应位置；08为装饰盖板，起装饰和支撑刀杆作用。
图3是本发明一实施例的连接机构的侧面半分解结构示意图。如图3所示，05为扭力销钉，头部为半圆形，同拧紧转盘04上的凹槽配合使用，06为压缩弹簧，07为旋转帽，扭力销钉05和压缩弹簧06装配于旋转帽07中的相应位置。
图4A、4B是本发明一实施例的超声刀手柄部分的超声刀按键的形状和位置示意图。从图4A可以看出，超声刀按键09为两个，两者外部轮廓并不相同，手触摸感觉明显不同。如图4B所示，两个超声刀按键09的按键档位的中心线也为偏下设置，即上一按键为常用按键，占据更大的操作面积，更便于触摸到，且两者的操作行程也不是水平设置，而是适当偏心，例如分别与水平线夹角为α，便于操作者单手操作时更容易区分两者。
图5是本发明一实施例的融合套筒结构的超声刀组件的整体结构示意图。10为套筒结构，11为换能器，12为标准套袋；术前拆开无菌超声刀、套筒结构10、标准套袋12，将标准套袋11固定在套筒结构10上，套筒结构10旋转固定至超声刀手柄01。后将已经灭菌的换能器11依次穿过标准套袋12和套筒结构10，来连接换能器至超声刀。手术完成后先拧下换能器11退出，后拧下套筒结构10。将套筒结构10与标准套袋12按照医用废弃标准处理。保护灭菌的换能器11不受污染，继续下一场手术，节约灭菌时间，延长换能器11的线缆使用寿命；
图6是本发明一实施例的融合套筒机构的超声刀组件的半分解结构示意图；10为套筒结构，01为超声刀手柄；套筒结构10上存在两处凸起的楔形设计，顺时针固定更牢靠，逆时针拆卸更简单。
本发明的超声刀与换能器的连接机构及采用其的超声刀的工作原理如下：
1、在组装超声刀和换能器时，顺时针旋转旋转帽07，由于扭力销钉05在切向力的作用下起到限位作用，带动拧紧转盘04同时旋转，拧紧转盘04又通过销轴带动刀头组件03旋转，使超声刀和换能器螺纹连接，当螺纹全部拧进后再用力，扭力销钉05受到切向力和正压力越来越大，扭力销钉05向下压缩压缩弹簧06，扭力值随着压缩弹簧06压缩量加大而不断变大，当达到一定压缩量后，扭力销钉05顶部脱离拧紧转盘04上的凹槽，限位作用消失，起到扭力过载保护作用；在拆卸换能器时，逆时针旋转旋转帽07，拧紧转盘04在扭力销钉05顶部平面的带动下一起旋转，使得螺纹松开。
2、在超声刀使用过程中，医生可通过旋转拧紧转盘04或旋转帽07来调节刀头角度。
3、超声刀手柄上的套筒结构10的机构设计，将灭菌的换能器11与使用者、患者隔离，无直接接触。在无菌状态时将标准套袋12固定在套筒结构10上，套筒结构10旋转固定在超声刀手柄尾部，换能器11依次穿过标准套袋12和套筒结构10，正常连接换能器11与超声刀；在使用后先撤离换能器11，再反方向拧下套筒结构10即可。更换无菌的套筒结构10、无菌的标准套袋12后即可进行下一场手术。
此外，上述对各元件和方法的定义并不仅限于实施例中提到的各种具体结构、形状或方式，本领域普通技术人员可对其进行简单地更改或替换，例如：装饰盖板可以省略；销钉和压缩弹簧的数量可以根据设计需要进行灵活设置；拧紧装置可以用其他结构方式来代替；按键的异形用其他结构代替；套筒的结构根据超声刀外观需求进行灵活设计代替。
经过实验验证，本发明的套筒结构设计可以在满足无菌手术的同时，避免换能器重复灭菌的次数，缩短器械重复灭菌对器械的损害；此外，套筒设计能够便捷安装与拆卸，方便器械护士的操作。安装后同时不影响医生使用器械的手感和操作舒适性；此外，本发明的连接机构与超声刀一体，省去安装和拆卸消毒的操作步骤，杜绝了丢失的风险，扭力值稳定可靠，使用寿命更加长久；本发明的按键设计符合人体工学，减轻了操作者的负累。
以上所述的具体实施例，对本发明的目的、技术方案和有益效果进行了进一步详细说明，应理解的是，以上所述仅为本发明的具体实施例而已，并不用于限制本发明，凡在本发明的精神和原则之内，所做的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (11)

  1. 一种超声刀与换能器的连接机构，其特征在于，包括：
    拧紧转盘，为以超声刀插入方向为轴的旋转体结构，轴心形成通孔套设超声刀且通过销钉或卡合结构使所述超声刀能够随旋转帽同步转动；所述拧紧转盘一端设有螺纹或卡合结构，用于与容纳有换能器的套筒结构连接；另一端为一限位平面，其上设有若干凹槽，用于与安装在旋转帽上的扭力销钉相配合，或者，其上安装有若干通过弹簧支撑而伸出表面的扭力销钉，用于与设置在旋转帽上的凹槽相配合；
    旋转帽，为以超声刀插入方向为轴的旋转体结构，轴心形成供超声刀穿过的通孔；所述旋转帽朝向拧紧转盘的一面与拧紧转盘对应配合设置有若干通过弹簧支撑而伸出表面的扭力销钉或者凹槽；在旋转帽受旋转作用力时拧紧转盘或旋转帽上的扭力销钉能够压缩弹簧而缩回表面，在未受力时则伸入对应凹槽中；
    套筒结构，其内部中空，能够容纳换能器和线缆，其表面能够与套袋和/或保护膜形成可拆卸地密封连接，从而能够利用套袋和/或保护膜将所述套筒结构与外界隔离，保护换能器不受污染。
  2. 根据权利要求1所述的超声刀与换能器的连接机构，其特征在于，拧紧转盘和/或旋转帽侧面形成若干凸棱，便于握持和发力。
  3. 根据权利要求1所述的超声刀与换能器的连接机构，其特征在于，所述拧紧转盘和/或旋转帽的材质为工程塑料或金属；优选为聚乙烯PE、聚丙烯PP、ABS、POM或铝合金。
  4. 根据权利要求1所述的超声刀与换能器的连接机构，其特征在于，所述弹簧支撑而伸出表面的扭力销钉是通过直弹簧连接的立方体上设置的半球状或球状的圆珠，或直接采用弹簧卡珠。
  5. 根据权利要求1所述的超声刀与换能器的连接机构，其特征在于，所述扭力销钉的数目是1、2、3、4、5、6或7。
  6. 根据权利要求1所述的超声刀与换能器的连接机构，其特征在于，扭力销钉的头部在外圆周切线的顺时钟方向的边沿设成平滑过渡，而逆时钟方向的边沿则形成阶梯，而凹槽也同样设置，从而在顺时钟旋转拧紧转 盘和/或旋转帽时，拧紧转盘的销轴带动超声刀旋转，使超声刀和套筒结构螺纹连接，当螺纹全部拧进后再用力，扭力销钉受到切向力和正压力越来越大，压缩压缩弹簧，扭力值随着压缩弹簧压缩量加大而不断变大，当达到一定压缩量后，扭力销钉的顶部脱离拧紧转盘上的凹槽，限位作用消失，起到扭力过载保护作用；在拆卸换能器时，逆时针旋转旋转帽，拧紧转盘在扭力销钉顶部平面的带动下一起旋转，使得螺纹松开。
  7. 根据权利要求1所述的超声刀与换能器的连接机构，其特征在于，所述超声刀与换能器的连接机构还包括一手枪形手柄，所述旋转帽和拧紧转盘位于所述手枪形手柄的枪口部位，所述套筒结构位于枪管部位，在所述手枪形手柄的扳机部位设置有至少两个超声刀按键，其中所述超声刀按键按照使用频率和习惯设置成不同的形状大小和按压角度，用于不同档位选择。
  8. 根据权利要求7所述的超声刀与换能器的连接机构，其特征在于，所述超声刀按键为两个，且所述超声刀按键的作用行程采用偏离按键中心水平线的偏心设置。
  9. 根据权利要求1所述的超声刀与换能器的连接机构，其特征在于，所述旋转帽上还套设有装饰性的装饰盖板，以增强连接机构的美观，且起到防水隔尘的作用。
  10. 根据权利要求1所述的超声刀与换能器的连接机构，其特征在于，所述套筒结构在与拧紧转盘相对的一端形成凸缘结构，用于密封固定套袋。
  11. 一种采用如权利要求1至10任一项所述的超声刀与换能器的连接机构的超声刀组件。
PCT/CN2020/101666 2020-06-04 2020-07-13 超声刀与换能器的连接机构及采用其的超声刀组件 WO2021243809A1 (zh)

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