WO2016184300A1 - 一种超声玻切针头及其装置 - Google Patents

一种超声玻切针头及其装置 Download PDF

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Publication number
WO2016184300A1
WO2016184300A1 PCT/CN2016/080452 CN2016080452W WO2016184300A1 WO 2016184300 A1 WO2016184300 A1 WO 2016184300A1 CN 2016080452 W CN2016080452 W CN 2016080452W WO 2016184300 A1 WO2016184300 A1 WO 2016184300A1
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WO
WIPO (PCT)
Prior art keywords
ultrasonic
needle
needle tube
inner needle
cutting
Prior art date
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PCT/CN2016/080452
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English (en)
French (fr)
Inventor
颜忠余
骆威
Original Assignee
以诺康医疗科技(苏州)有限公司
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Publication date
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 US15/573,810 priority Critical patent/US10682255B2/en
Publication of WO2016184300A1 publication Critical patent/WO2016184300A1/zh

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    • A61B17/22004Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22025Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement applying a shock wave
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B2017/22027Features of transducers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B2017/22027Features of transducers
    • A61B2017/22028Features of transducers arrays, e.g. phased arrays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84Drainage tubes; Aspiration tips

Definitions

  • the invention relates to a medical device and a method thereof, in particular to an ultrasonic glass cutting method and a needle thereof.
  • the human eye can display images by transmitting light through the cornea and focusing the image through the lens, and then focusing on the posterior retina through the vitreous.
  • the quality of focus is determined by many factors, including the size and shape of the eye, as well as the transparency of the cornea, lens, and vitreous.
  • the vitreous is located in the gel-like transparent tissue at the back end of the eye.
  • diseases such as retinal hemorrhage and retinal detachment
  • glass-cut surgical instruments include glass-cut handles, illumination tubes, and injection tubes.
  • the glass cutting equipment commonly used in the prior art is pneumatic and also has a small amount of electric type. These complicated devices need to be driven by corresponding special driving devices.
  • the vitrectomy device is usually integrated with a phacoemulsification device on a single machine, which makes the device bulky, complicated in design, expensive, and inconvenient to operate; and the operating frequency of the pneumatic device is The audio range is loud, and the head movement is large.
  • the technical problem of the first aspect to be solved by the present invention is to provide an ultrasonic glass-cutting needle, which makes it possible to productize the ultrasonic cutting technology, and utilizes the noiseless, minute displacement, fluid repellent and viscosity-reducing effects of the ultrasonic vibration to provide a kind of Safe and applicable ultrasonic glass-cutting needles improve the safety of surgery.
  • the present invention provides an ultrasonic glass-cutting needle comprising a connecting body and an inner needle tube connected thereto, wherein an outer needle sleeve is further disposed on the outer circumference of the inner needle tube.
  • the outer needle cannula has a length at the distal end that is slightly longer than the inner inner needle tube, and the distal end of the outer needle cannula is a closed, non-sharp, gentle top surface, and the outer needle cannula is provided with a distal side wall of the inner needle tube. Open The mouth is inhaled into the vitreous.
  • a groove is provided on the outer circumference of the inner needle tube of the fastening portion, the proximal end of the outer needle sleeve is inserted into the groove, and the outer needle sleeve is in contact with the end surface of the fastening portion Sealed and cured with plastic materials.
  • the distal groove is used to receive, adjust, and stabilize the center position of the outer needle cannula.
  • a gap is left between the inner wall of the outer needle cannula and the outer wall of the inner needle tube.
  • a central tunnel is formed in the connecting body through the connecting body along the central axis, and the central tunnel has a shape adapted to the inner needle tube for accommodating the inner needle tube, and the connecting body and the inner tube The central axes of the needles coincide.
  • the distal end of the outer needle cannula is a closed plane or an outwardly convex curved surface. It is of course also possible to use other non-sharp, gentle top structures that are well known to those skilled in the art.
  • the connecting body includes a fastening portion, a threaded portion for connecting the ultrasonic driving handle and a tapered portion adjacent to the fastening portion for fixing the inner needle tube.
  • the fastening portion is an active surface of the wrench tool having a shape and a size adapted to the wrench tool, the threaded portion being an external thread disposed on an outer surface of the distal end of the connecting body, the tapered portion being disposed at the The proximal end of the threaded portion is a cone adapted to the inner cavity of the ultrasonically driven handle.
  • At least one slit is evenly distributed on the tapered portion for locking the inner needle tube.
  • the technical problem of the second aspect to be solved by the present invention is to provide an ultrasonic glass cutting device comprising an integrated phacoemulsification device, an ultrasonic driving handle and the ultrasonic glass-cutting needle according to any one of claims 1 to 6, ultrasonic
  • the glass-cutting needle is connected to the front end of the ultrasonic drive handle through a connector, and the ultrasonic drive handle is connected to the phacoemulsification device through a cable.
  • the inner end of the front end of the ultrasonic drive handle is provided with an internal thread and the threaded portion of the connecting body is engaged.
  • the front end of the internal thread portion of the front end of the ultrasonic drive handle is further provided with a tapered surface that cooperates with the tapered portion of the connecting body to further contract the slit of the tapered portion, thereby fixing the inner needle tube.
  • the technical problem of the third aspect to be solved by the present invention is to provide an ultrasonic glass cutting device
  • the method includes the following steps:
  • the ultrasonic glass-cutting needle comprises a connecting body and an inner needle tube connected thereto, and an outer needle sleeve is further disposed on the outer circumference of the inner needle tube, and the outer needle sleeve is The distal end is slightly longer than the inner inner needle tube, and the distal end is a closed, non-sharp, gentle top surface, and an opening is formed in the distal side wall of the outer needle sleeve that extends out of the inner needle tube.
  • the ultrasonic glass-cutting device of the invention Compared with the current pneumatic glass-cutting technology, the ultrasonic glass-cutting device of the invention has the characteristics of low noise, small moving distance, and the like, and is easily integrated into the commonly used ultrasonic emulsification equipment.
  • the beneficial effects of the present invention are embodied in:
  • the distal end of the outer needle cannula of the ultrasonic glass-cutting needle of the present invention is designed such that the distal end of the distal end of the outer needle cannula is a closed non-sharp, gentle top surface, and the outer needle cannula is provided with a distal end side of the inner needle tube.
  • the opening is for inhaling the vitreous; the flat top surface is closed to prevent ultrasonic vibration from being transmitted to the retina, and only an opening is provided on the distal side of the outer sleeve for the vitreous to enter.
  • 1 is a schematic view showing the connection structure of an ultrasonic glass-cutting needle and an ultrasonic driving handle at the front end according to an embodiment of the present invention.
  • FIG. 2 is a side view showing the structure of an embodiment of an ultrasonic glass-cutting needle according to the present invention.
  • FIG. 3 is a schematic cross-sectional view showing an embodiment of an ultrasonic glass-cutting needle according to an embodiment of the present invention.
  • Fig. 4 is a partially enlarged schematic view showing the fastening portion of the connector of Fig. 3;
  • FIG. 5A is a schematic cross-sectional view of the connector
  • FIG. 5B is a schematic view of the side structure of FIG. 4
  • FIG. 5C is a schematic cross-sectional view of the fastening portion of the connector.
  • the ultrasonic glass cutting needle shown in Figs. 5A, 5B, and 5C the ultrasonic glass cutting needle includes a connecting body 50 and an inner needle tube 60 connected thereto, and the connecting body is provided with a central portion of the connecting body 50 along the central axis.
  • the channel 55, the central channel 55 has a shape adapted to the inner needle tube 60 for receiving the inner needle tube 60, a portion of the inner needle tube 60 is inserted into the central opening 55 of the connector body 50, and the central axes of the two are coincident, the inner needle tube 60 The other portion extends distally outwardly of the connector body 50.
  • an outer needle cannula 70 is also disposed over the outer circumference of the needle tube 60.
  • the outer needle cannula 70 has a length at the distal end that is longer than the inner needle tube 60 therein. It is slightly longer, and its distal end 72 is a closed, non-sharp, flat plane, and an opening 71 is provided in the distal end wall of the outer needle cannula 70 that extends out of the inner needle 60 to draw the vitreous.
  • the distal end 72 of the outer needle cannula 70 can also be an outwardly convex curved surface. It is of course also possible to use other non-sharp, gentle top structures that are well known to those skilled in the art.
  • the central aperture 55 is sized slightly larger than the inner needle tube 60 for receiving the inner needle tube 60; the central aperture 55 has a shape that conforms to the inner needle tube 60, such as may be cylindrical , a polygon such as a pentagon, a hexagon, a heptagon, an octagon, etc., and the connecting body and the central axis of the inner needle are coincident.
  • FIG. 5A shows an embodiment of a connector 50 structure including a fastening portion 51, a threaded portion 52 for connecting the ultrasonic drive handle adjacent to the fastening portion 51, and a tapered end for fixing the inner needle tube Shape 53.
  • the fastening portion 51 is an active surface of the wrench tool and has a shape and a size corresponding to the wrench tool.
  • the threaded portion 52 is an external thread disposed on an outer surface of the connecting body 50, and the tapered portion 53 is disposed.
  • the tapered portion 53 has a tapered body adapted to ultrasonically drive the inner cavity of the handle, and the tapered portion 53 is evenly distributed with at least one slit 54 for locking the inner needle tube 60.
  • a groove 8 (Fig. 4, 5) is provided on the outer circumference of the inner needle tube 60 of the fastening portion 51, and the proximal end of the outer needle sleeve 70 is inserted into the groove 8, the outer needle sleeve The contact portion of the 70 and the end surface of the fastening portion 51 is sealed and solidified with a plastic material 4.
  • the groove 8 provided by the fastening portion 51 is used for receiving and adjusting The center position of the outer needle casing is stabilized.
  • the threaded portion 52 of the connecting body 50 is engaged with the distal end internal thread of the ultrasonic driving handle, that is, the connecting body 50 is screwed into the front end of the ultrasonic driving handle through the screwing engagement, and the guiding cone is used.
  • the shape 53 can be adapted to fit the tapered surface inside the ultrasonic drive handle.
  • the slit 54 is contracted by the squeeze extrusion during the screwing process, that is, the tapered end side of the tapered surface of the tapered portion 53 is gathered and abuts against the inner wall of the ultrasonic drive handle. Due to the deformation of the slit 54, the diameter of the central tunnel 55 also changes.
  • the inner needle tube 60 is rigidly coupled to the connector 50 and, in turn, to the distal end of the ultrasonically driven handle, and ultrasonic vibrations are thus efficiently transmitted to the front end of the ultrasonic surgical tool head.
  • the ultrasonic glass-cutting needle 100 is connected to the front end of the ultrasonic driving handle 200 through the connecting body 50, as described above, and the inner needle tube 60 is locked, and the ultrasonic driving handle cable is connected to
  • the ultrasonic vibration can be efficiently transmitted from the ultrasonic drive handle front end rod 201 to the distal end of the inner needle tube 60 when the power is turned on.
  • the vitreous energy can be broken by the ultrasonic vibration at the distal end of the inner tube 60, liquefaction, viscosity reduction, etc., and the vitreous body can be under a lower suction force. It is aspirated through the inner lumen 60 and the central suction conduit 202 of the handle.
  • the inner needle tube 60 of the present invention may be prepared by using a medical metal material, or may be made of a medical resin.
  • the length of the needle tube 60 needs to be designed within a certain range without attenuating the output of the ultrasonic vibration.
  • the inner needle tube is required to have a finer diameter range, usually below 500 ⁇ m, preferably between 200 ⁇ m and 500 ⁇ m.
  • the inner needle tube can be prepared by using materials such as metal, plastic, resin, etc., preferably by using a metal material.
  • An ultrasonic vitrectomy device as claimed in the present invention, comprising an integrated phacoemulsification device, an ultrasonic drive handle and the aforementioned ultrasonic glass-cutting needle, the ultrasonic glass-cutting needle passing through the external thread of the threaded portion 51 of the connecting body 50 and the ultrasonic driving handle
  • the internal thread inside the front end is engaged, connected, and in the ultrasonic drive
  • the front end of the internal thread portion of the front end of the movable handle is further provided with a tapered surface to cooperate with the tapered portion of the connecting body to further contract the slit of the tapered portion, thereby fixing the inner needle tube, and the ultrasonic driving handle is connected to the phacoemulsification device through a cable.
  • the ultrasonic vitrectomy device of the present invention inserts a glass-cutting needle into the vitreous of the eyeball during the vitrectomy, wherein the ultrasonic vitrectomy needle comprises a connecting body and an inner needle tube connected thereto, and an outer tube is further disposed outside the inner needle tube a needle cannula having a length at the distal end that is slightly longer than the inner needle tube, and a distal end of which is a closed, non-sharp, gentle top surface, and the outer needle cannula extends out of the inner needle tube
  • the end side wall is provided with an opening.
  • Ultrasonic vibration of the vitrectomy needle in the vitreous of the eyeball causes the vibration of the inner needle to emulsify the vitreous, and the suction chamber in fluid communication with the ultrasonic vitrectomy needle to pump the emulsified vitreous.
  • the invention provides a new idea and method for the vitrectomy, which is far superior to the vitrectomy performed by mechanical and pneumatic methods in the prior art. Ultrasonic vibration without noise, small displacement and viscosity reduction improve the safety of the operation.

Abstract

公开了一种用于眼睛玻璃体吸除的超声玻切针头及超声波切装置。超声玻切针头包括连接体(50)和与其连接的内针管(60),在内针管(60)外周还套有一外针套管(70),所述外针套管(70)在远端的长度比其内部的内针管(60)稍长,而其远端末端(72)是封闭的非尖锐的平缓顶面,且在外针套管(70)长出内针管(60)的远端侧壁设有一开口(71)以吸入玻璃体。超声振动的无噪音、微小位移、流体推斥性和降粘效果提高了手术的安全度。

Description

一种超声玻切针头及其装置 技术领域
本发明涉及一种医疗器材及其方法,具体涉及一种超声玻切方法及其针头。
背景技术
人眼可通过经由角膜使光透过并且通过晶状体进行图像汇聚聚焦,再经过玻璃体聚焦在后面的视网膜上显示图像。聚焦的质量由很多因素决定,包括眼睛的尺寸和形状,以及角膜,晶状体,玻璃体的透明度。
玻璃体位于眼睛后端的凝胶状透明组织,当眼睛发生疾病,如眼底出血、视网膜脱落等,需要用玻切手术将玻璃体吸除。常用的玻切手术器械包括有玻切手柄、照明管、注液管等。现有技术中常用的玻切设备是气动式的,也有少量电动式的,这些繁琐的装置都需要对应的专门驱动装置进行驱动。在常见的眼科手术设备中,玻切手术装置通常与超声白内障乳化装置集成在一台机器上,这样就使装置体积大、设计复杂、价格昂贵、且操作不便;而且气动装置的工作频率都在音频范围,噪音大,切头移动幅度大。
现有技术中,有较多的超声乳化装置,但较少有玻切装置。直到目前仍没有适合的超声玻切针头,以及与其配合的超声手术设备和超声手柄来安全地驱动细长的空心针头来传递一定幅度的超声振动且能安全伸入玻璃体内来达到液化、破碎的效果。为了解决上述的问题,本发明由此而来。
发明内容
本发明所要解决的第一方面技术问题是提供一种超声玻切针头,使超声波切技术产品化成为可能,利用超声振动的无噪音、微小位移、流体推斥性和降粘效果,提供一种安全适用的超声玻切针头,提高了手术的安全度。
为解决上述第一方面的技术问题,本发明提供一种超声玻切针头,其包括连接体和与其连接的内针管,其特点在于,在所述内针管外周还设有一外针套管,所述外针套管在远端的长度比其内部的内针管稍长,而其远端末端是封闭的非尖锐的平缓顶面,且在外针套管长出内针管的远端侧壁设有一开 口以吸入玻璃体。
在本发明的技术方案中,在所述紧固部的内针管外周设有凹槽,所述外针套管近端插入所述凹槽,外针套管与所述紧固部端面的接触处用塑胶类材料密封固化。远端的凹槽用于接受、调整、稳定外针套管的中心位置。
在本发明的技术方案中,外针套管内壁与内针管的外壁之间留有间隙。
在本发明的技术方案中,在所述的连接体内设有沿中轴贯通连接体的中央孔道,中央孔道具有与内针管相适应的形状,用于容纳所述内针管,且连接体和内针管的中心轴线重合。
在本发明的技术方案中,外针套管远端末端是封闭的平面,或者是向外凸起的弧面。当然还可以是本领域技术人员公知适用的其他非尖锐的平缓的顶面结构。
在本发明的技术方案中,所述连接体包括紧固部,与紧固部相邻的用于连接超声驱动手柄的螺纹部和末端用于固定内针管的锥形部。所述紧固部为扳手工具的作用面,具有与扳手工具相适应的形状和尺寸,所述螺纹部是设置于所述连接体远端外表面的外螺纹,所述锥形部设置在所述螺纹部的近端,所述锥形部是适配于超声驱动手柄内腔的锥形体。
在本发明的技术方案中,所述锥形部上平均分布有至少一个切口,用以锁紧内针管。
本发明所要解决的第二方面的技术问题,是提供一种超声玻切装置,其包括集成的超声乳化设备、超声驱动手柄和权利要求1-6任一项所述的超声玻切针头,超声玻切针头通过连接体与超声驱动手柄前端连接,超声驱动手柄通过电缆连接到超声乳化设备。
在本发明的技术方案中,超声驱动手柄前端内部设有内螺纹和连接体的螺纹部相啮合。
在本发明的技术方案中,且在超声驱动手柄前端的内螺纹部前端还设有锥形面与连接体的锥形部相配合,以进一步收缩锥形部的切口,从而固定内针管。
本发明所要解决的第三方面的技术问题,是提供一种超声玻切装置的使 用方法,其包括如下步骤:
(1)将玻切针头插入眼球的玻璃体中,其中,超声玻切针头包括连接体和与其连接的内针管,在所述内针管外周还设有一外针套管,所述外针套管在远端的长度比其内部的内针管稍长,而其远端末端是封闭的非尖锐的平缓顶面,且在外针套管长出内针管的远端侧壁设有一开口,
(2)打开超声振动开关,在眼球的玻璃体中超声振动超声玻切针头,该振动导致内针管的的振动以乳化玻璃体,和超声玻切针头流体连通的抽吸腔进行抽吸乳化的玻璃体。
本发明的超声玻切装置比起目前气动方式的玻切技术,超声玻切具有噪音小,移动距离小等特点,且很容易集成到目前常用的超声乳化设备上。本发明的有益效果体现在:
(1)针对超声系统的细长空心针头的设计,使超声波切技术产品化成为可能,超声振动的无噪音、微小位移、流体推斥性和降粘效果提高了手术的安全度;
(2)本发明超声玻切针头的外针套管远端设计:外针套管远端的末端是封闭的非尖锐的平缓顶面,外针套管长出内针管的远端侧面设有一开口以吸入玻璃体;封闭平缓的顶面是为了阻止超声振动传到视网膜而造成损伤,而只在外套管的远端侧面有一开口用以让玻璃体进入。解决了现有的超声针头远端尖部极其尖锐锋利,极易刺破组织器官的问题,降低了手术风险,提高了手术的安全性。
(3)超声玻切装置与超声白内障乳化装置的一体化大大简化了目前玻璃体切除系统的繁琐设计,为眼科手术提供了极大方便和节省了成本。
附图说明
图1为本发明一实施例的超声玻切针头和超声驱动手柄前端连接结构示意图。
图2为本发明超声玻切针头一实施例的侧面结构示意图。
图3为本发明超声玻切针头一实施例的剖面结构示意图。
图4为图3的连接体的紧固部局部放大示意图。
图5A为连接件剖面结构示意图,图5B为图4侧面结构示意图,图5C为连接体的紧固部处的横切面结构示意图。
具体实施方式
下面结合附图和实施例对本发明进行更详细地说明。
如图2-图4,图5A,5B,5C所示的超声玻切针头,超声玻切针头包括连接体50和与其连接的内针管60,连接体内设有沿中轴贯通连接体50的中央孔道55,中央孔道55具有与内针管60相适应的形状,用于容纳所述内针管60,内针管60的一部分插入连接体50的中央孔道55,且二者的中心轴线重合,内针管60的另一部分在连接体50外向远端延伸,在连结体外50的这一部分内针管60外周还套设有一外针套管70,外针套管70在远端的长度比其内部的内针管60稍长,而其远端末端72是封闭的非尖锐的平缓平面,且在外针套管70长出内针管60的远端侧壁设有一开口71以吸入玻璃体。
在本发明的一优选实施例中,外针套管70远端末端72还可以是向外凸起的弧面。当然还可以是本领域技术人员公知适用的其他非尖锐的平缓的顶面结构。
在本发明的一优选实施例中,中央孔道55的尺寸略大于内针管60的尺寸,用于容纳所述内针管60;中央孔道55具有与内针管60相适应的形状,如可以是圆柱形,多边形,如五边形,六边形,七边形,八边形等,且连接体和内针管的中心轴线重合。
如图4,图5A所示一实施例连接体50结构,其包括紧固部51,与紧固部51相邻的用于连接超声驱动手柄的螺纹部52和末端用于固定内针管的锥形部53。所述紧固部51为扳手工具的作用面,具有与扳手工具相适应的形状和尺寸,所述螺纹部52是设置于所述连接体50外表面的外螺纹,所述锥形部53设置在所述螺纹部52的近端,所述锥形部53具有适配于超声驱动手柄内腔的锥形体,所述锥形部53上平均分布有至少一个切口54,用以锁紧内针管60。
在本发明的技术方案中,在所述紧固部51的内针管60外周设有凹槽8(图4、5),外针套管70近端插入所述凹槽8,外针套管70与紧固部51端面的接触处用塑胶类材料4密封固化。紧固部51设的凹槽8用于接受、调 整、稳定外针套管的中心位置。外针套管70内壁与内针管60外壁之间留有间隙,这样在进行操作时,仅内针管60发生超声振动,而外针套管70不发生振动,不会消减超声振动的输出,两者之间的间隙大小可以根据具体临床需要进行调整。
应用本发明的超声玻切针头时,将连接体50的螺纹部52与超声驱动手柄的远端内螺纹啮合,即将连接体50通过该螺纹配合拧入超声驱动手柄的前端,起导向作用的锥形部53可与超声驱动手柄内部的锥形面相适应贴合。此时,切口54在被拧入的过程中因挤入挤压而收缩,即所述锥形部53的锥形面的锥端侧收拢并贴紧于所述超声驱动手柄的内壁。由于切口54的变形,所述中央孔道55的直径也会发生变化。这样,内针管60就被刚性地耦合到连接体50上,进而耦合到超声驱动手柄的远端上,超声振动因而也很有效地传到超声手术工具头前端。
应用本发明的超声玻切装置时,如图1所示,将超声玻切针头100通过连接体50,如前述与超声驱动手柄200的前端连接,锁紧内针管60,超声驱动手柄电缆连接到超声乳化设备,当打开电源时,超声振动就能有效地由超声驱动手柄前端杆201传到内针管60的远端。外针套管内壁与内针管60外壁之间留有间隙,因此,在操作时,仅内针管发生超声振动,而外针套管不动。当玻璃体组织由于真空和眼腔内液压作用通过外管70侧口71进入管内后,通过内管60远端的超声振动破碎、液化、降粘等作用,玻璃体能在较低的抽吸力下,通过内管腔60和手柄的中央抽吸管道202而被抽吸出来。
应当理解,虽然本说明书按照实施方式加以描述,但并非每个实施方式仅包含一个独立的技术方案,例如:本发明的内针管60可以选用医用金属材料制备,还可以采用医用树脂制成,内针管60的长度需设计在一定的范围内而不致衰减超声振动的输出,此外由于玻切技术的特殊性,内针管要求具有较细的直径范围,通常在500μm以下,优选为200μm-500μm。且该内针管,可以采用金属、塑料、树脂等材料制备,优选采用金属材料制备。
本发明要求保护的一种超声玻切装置,其包括集成的超声乳化装置、超声驱动手柄和前述的超声玻切针头,超声玻切针头通过连接体50的螺纹部51的外螺纹与超声驱动手柄前端内部的内螺纹啮合,进行连接,且在超声驱 动手柄前端的内螺纹部前端还设有锥形面与连接体的锥形部相配合,以进一步收缩锥形部的切口,从而固定内针管,超声驱动手柄通过电缆连接到超声乳化设备。
本发明的超声玻切装置在进行玻切手术时,将玻切针头插入眼球的玻璃体中,其中,超声玻切针头包括连接体和与其连接的内针管,在所述内针管外周还设有一外针套管,所述外针套管在远端的长度比其内部的内针管稍长,而其远端末端是封闭的非尖锐的平缓顶面,且在外针套管长出内针管的远端侧壁设有一开口,
在眼球的玻璃体中超声振动超声玻切针头,该振动导致内针管的的振动以乳化玻璃体,和超声玻切针头流体连通的抽吸腔来抽吸乳化的玻璃体。
本发明为玻切手术提供了一种新的思路和方法,远优越于现有技术中通过机械气动方式进行的玻切手术。超声振动无噪音、位移微小和降粘效果提高了手术的安全性。
以上显示和描述了本发明的基本原理、主要特征和本发明的优点。本行业的技术人员应该了解,本发明不受上述实例的限制,上述实例和说明书中描述的只是说明本发明的原理,在不脱离本发明精神和范围的前提下本发明还会有各种变化和改进,这些变化和改进都落入要求保护的本发明范围内。本发明要求保护范围由所附的权利要求书及其等同物界定。

Claims (10)

  1. 一种超声玻切针头,其包括连接体和与其连接的内针管,其特征在于,在所述内针管外周还套有一外针套管,所述外针套管在远端的长度比其内部的内针管稍长,其远端末端是封闭的非尖锐的平缓顶面,且在外针套管长出内针管的远端侧壁设有一开口以吸入玻璃体。
  2. 根据权利要求1所述的超声玻切针头,其特征在于,在所述连接体的内针管外周设有凹槽,所述外针套管近端插入所述凹槽,外针套管与所述连接体端面的接触处用塑胶类材料密封固化。
  3. 根据权利要求1所述的超声玻切针头,其特征在于,外针套管内壁与内针管的外壁之间留有间隙。
  4. 根据权利要求1所述的超声玻切针头,其特征在于,在所述的连接体内设有沿中轴贯通连接体的中央孔道,中央孔道具有与内针管相适应的形状,用于容纳所述内针管,且连接体和内针管的中心轴线重合。
  5. 根据权利要求1所述的超声玻切针头,其特征在于,外针套管远端末端是封闭的平面,或者是封闭的向外凸起的弧面。
  6. 根据权利要求1所述的超声玻切针头,其特征在于,所述金属连接体包括紧固部,与紧固部相邻的螺纹部和末端用于固定内针管的锥形部。
  7. 根据权利要求6所述的超声玻切针头,其特征在于,所述锥形部上平均分布有至少一个切口,用以锁紧内针管。
  8. 一种超声玻切装置,其包括集成的超声乳化设备、超声驱动手柄和权利要求1-7任一项所述的超声玻切针头,超声玻切针头通过连接体与超声驱动手柄前端连接,超声驱动手柄通过电缆连接到超声乳化设备。
  9. 根据权利要求8所述的超声玻切装置,其特征在于,超声驱动手柄前端内部设有内螺纹和连接体的螺纹部相啮合,且在超声驱动手柄前端的内螺纹部前端还设有锥形面与连接体的锥形部相配合,以进一步收缩锥形部的切口,从而固定内针管。
  10. 一种权利要求8所述的超声玻切装置的使用方法,其包括如下步骤:
    (1)将玻切针头插入眼球的玻璃体中,其中,超声玻切针头包括连接体和与其连接的内针管,在所述内针管外周还设有一外针套管,所述外针套管在远端的长度比其内部的内针管稍长,而其远端末端是封闭的非尖锐的平缓顶面,且在外针套管长出内针管的远端侧壁设有一开口,
    (2)打开超声振动开关,在眼球的玻璃体中超声振动超声玻切针头,该振动导致内针管的的振动以乳化玻璃体,和超声玻切针头流体连通的抽吸腔进行抽吸乳化的玻璃体。
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