WO2020249093A1 - 一种超声诱导定位型穿刺组件及套管式小针刀 - Google Patents

一种超声诱导定位型穿刺组件及套管式小针刀 Download PDF

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Publication number
WO2020249093A1
WO2020249093A1 PCT/CN2020/095853 CN2020095853W WO2020249093A1 WO 2020249093 A1 WO2020249093 A1 WO 2020249093A1 CN 2020095853 W CN2020095853 W CN 2020095853W WO 2020249093 A1 WO2020249093 A1 WO 2020249093A1
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WIPO (PCT)
Prior art keywords
cutting
puncture
sleeve
needle knife
cannula
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PCT/CN2020/095853
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English (en)
French (fr)
Inventor
王元利
王庆普
李永磊
卢艳丽
田志军
Original Assignee
北京市隆福医院
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Publication date
Priority claimed from CN201920896328.4U external-priority patent/CN210472185U/zh
Priority claimed from CN201920897676.3U external-priority patent/CN210749312U/zh
Application filed by 北京市隆福医院 filed Critical 北京市隆福医院
Priority to US17/596,591 priority Critical patent/US20220304648A1/en
Publication of WO2020249093A1 publication Critical patent/WO2020249093A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B10/0233—Pointed or sharp biopsy 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Detecting organic movements or changes, e.g. tumours, cysts, swellings
    • A61B8/0833—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Detecting organic movements or changes, e.g. tumours, cysts, swellings involving detecting or locating foreign bodies or organic structures for locating instruments
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B26—HAND CUTTING TOOLS; CUTTING; SEVERING
    • B26D—CUTTING; DETAILS COMMON TO MACHINES FOR PERFORATING, PUNCHING, CUTTING-OUT, STAMPING-OUT OR SEVERING
    • B26D1/00—Cutting through work characterised by the nature or movement of the cutting member or particular materials not otherwise provided for; Apparatus or machines therefor; Cutting members therefor
    • B26D1/56—Cutting through work characterised by the nature or movement of the cutting member or particular materials not otherwise provided for; Apparatus or machines therefor; Cutting members therefor involving a cutting member which travels with the work otherwise than in the direction of the cut, i.e. flying cutter
    • B26D1/62—Cutting through work characterised by the nature or movement of the cutting member or particular materials not otherwise provided for; Apparatus or machines therefor; Cutting members therefor involving a cutting member which travels with the work otherwise than in the direction of the cut, i.e. flying cutter and is rotating about an axis parallel to the line of cut, e.g. mounted on a rotary cylinder
    • B26D1/626—Cutting through work characterised by the nature or movement of the cutting member or particular materials not otherwise provided for; Apparatus or machines therefor; Cutting members therefor involving a cutting member which travels with the work otherwise than in the direction of the cut, i.e. flying cutter and is rotating about an axis parallel to the line of cut, e.g. mounted on a rotary cylinder for thin material, e.g. for sheets, strips or the like
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B26—HAND CUTTING TOOLS; CUTTING; SEVERING
    • B26D—CUTTING; DETAILS COMMON TO MACHINES FOR PERFORATING, PUNCHING, CUTTING-OUT, STAMPING-OUT OR SEVERING
    • B26D7/00—Details of apparatus for cutting, cutting-out, stamping-out, punching, perforating, or severing by means other than cutting
    • B26D7/26—Means for mounting or adjusting the cutting member; Means for adjusting the stroke of the cutting member

Definitions

  • This application relates to a traditional Chinese medicine minimally invasive surgical tool, in particular to an ultrasound-induced positioning type puncture assembly and a cannula-type small needle knife.
  • Small needle knife therapy is mainly used for soft tissue injury lesions and bone and joint lesions. It is a closed lysis procedure that is between surgical methods and non-surgical treatments. It is pierced deep into the treatment site to quantitatively release the lesion. Diseased tissues to achieve the purpose of relieving pain and eliminating diseases. In practical applications, the needle tip of the small needle knife is always located in the patient's body, and the operator can only observe the specific position of the needle tip through ultrasound imaging.
  • the outer wall of the puncture assembly of the small needle knife is usually provided with a plurality of triangular pyramid grooves (CCR technology, cubic mirror technology) evenly arranged along the outer circumferential surface or semicircular annular grooves arranged along the outer circumferential surface to enhance Ultrasonic waves reflect, forming clear ultrasound images.
  • CCR technology cubic mirror technology
  • semicircular annular grooves arranged along the outer circumferential surface to enhance Ultrasonic waves reflect, forming clear ultrasound images.
  • a blade is formed at the front end of the small needle knife. During the travel of the knife body, the blade abuts the diseased tissue and further cuts.
  • the blade is exposed throughout the process before reaching the diseased tissue. Due to the deviation of the operation and the tissue variation, the blade can easily damage the surrounding nerves or blood vessels, causing irreparable damage to the patient; and By adopting the method of forward vertical cutting, it is easy to break away for the tough and strong tissue, and it is more difficult to cut.
  • this application aims to provide an ultrasonic-induced positioning puncture assembly and a sleeve-type small needle knife, which solves the difficulty in processing the triangular pyramid groove of the puncture assembly in the prior art and the annular semicircular concave
  • the side wall of the groove close to the ultrasonic imaging device will hinder the ultrasonic echo, the blade of the small needle knife is easy to damage the surrounding nerves or blood vessels, and it is difficult to cut by using a forward vertical cutting method.
  • the present application provides an ultrasound-induced positioning puncture assembly, which includes a puncture needle core and a puncture sleeve sleeved on the outside of the puncture needle core.
  • the outer wall of the puncture sleeve is provided with an annular recess facing the ultrasound probe along the circumference of the puncture sleeve.
  • the cross-sectional shape of the groove and the annular groove along the radial direction of the puncture sleeve is ear-shaped.
  • the cross section of the annular groove along the radial direction of the puncture sleeve includes a circular arc side and a straight side connected to the circular arc side, the straight side is close to the ultrasonic developing device, and the circular arc side is close to the puncture end of the puncture assembly.
  • the angle between the straight edge and the axis of the puncture sleeve is 45-60°.
  • the puncture end of the puncture needle core is formed with a cutting edge.
  • the cutting edge is a single bevel or double bevel.
  • the puncture end of the puncture sleeve is formed with a single inclined surface or a double inclined surface.
  • the application also provides a cannula-type small needle knife, which includes a cutting assembly and the above-mentioned puncture assembly.
  • the cutting assembly includes a cutting needle knife and a cutting sleeve sleeved on the outside of the cutting needle knife.
  • the side surface of the cutting end of the cutting needle knife is formed with a cutting edge
  • the shape of the cutting end of the cutting sleeve is arc
  • the side surface of the cutting sleeve is partially or completely opened with cutting slits.
  • the cutting blade is a hook or a side blade.
  • the operating end of the cutting sleeve is provided with a pointing mark for indicating the direction of the cutting seam.
  • the pointing mark is provided on the same side of the cutting seam and on the same straight line as the cutting seam.
  • a travel limit component is provided between the cutting end of the cutting needle knife and the cutting end of the cutting sleeve, which is used to limit the relative rotation between the cutting needle knife and the cutting sleeve during the travel of the cutting needle knife and the cutting sleeve.
  • the travel limit component includes a travel groove and a travel protrusion inserted into the travel groove.
  • a cutting limit component is provided between the cutting end of the cutting needle knife and the cutting end of the cutting sleeve, for limiting the relative rotation between the cutting needle knife and the cutting sleeve during the cutting process of the cutting needle knife.
  • the cutting limit component includes a cutting groove and a cutting protrusion inserted into the cutting groove.
  • the annular groove on the outer wall of the puncture sleeve faces the ultrasonic probe, and the cross-sectional shape of the annular groove along the radial direction of the puncture sleeve is ear-shaped, compared to a semicircular ring
  • the inclination angle of the side wall of the groove, which is close to the probe of the ultrasonic instrument, is small, which can reduce the obstruction of the ultrasonic wave by the side wall of the annular groove, ensure strong reflection of the ultrasonic wave, form a clear ultrasonic image, and obtain a satisfactory development effect.
  • the annular groove provided on the outer wall of the puncture sleeve is formed by continuous processing. Compared with the triangular pyramid groove, the processing is simple, which is beneficial to production, and it can be combined with a portable ultrasonic instrument. Meet the requirements of induced positioning and development, and facilitate the safe and effective promotion of technology.
  • the cannula-type needle knife provided by this application includes two components, namely a puncture component and a cutting component.
  • the puncture component is mainly used for puncturing and guiding
  • the cutting component is mainly used for cutting diseased tissue.
  • the shape of the cutting end of the cutting sleeve of the cutting assembly is arc, usually bluntly separating tissues or nerves, and only travel between the tissues; and, before reaching the diseased tissue, the cutting end of the cutting needle knife is always in the cutting sleeve , Will not come into contact with the tissues, which can reduce the damage of the cutting blade to the surrounding nerves or blood vessels, and provide an effective guarantee for patients.
  • the side cutting method is adopted, which is easier to complete the cutting of the diseased tissue than the forward vertical cutting method. Reduce the difficulty of small needle knife treatment.
  • FIG. 1 is a schematic structural diagram of an ultrasonic-induced positioning puncture assembly according to Embodiment 1 of the application, in which the puncture end of the puncture sleeve is formed with a single bevel;
  • FIG. 2 is a schematic structural diagram of the puncture end of the ultrasonic-induced positioning type puncture assembly according to the first embodiment of the application, which may be formed with a double inclined surface;
  • Figure 3 is a partial cross-sectional view of Figure 1;
  • FIG. 4 is a schematic diagram of the structure of the cutting assembly in the sleeve type needle knife according to the second embodiment of the application;
  • Fig. 5 is a schematic structural diagram of the sleeve-type small needle knife in the second embodiment of the application with cutting slits on the side of the cutting sleeve;
  • Fig. 6 is a schematic structural diagram of a needle knife with a side blade formed on the cutting end of the needle knife of the sleeve type in the second embodiment of the application.
  • 1- puncture needle core 2- puncture sleeve; 3- ring groove; 31- arc side; 32- straight side; 4- cutting needle knife; 5- cutting sleeve; 6-cutting seam; 7- hook ; 8-Lateral blade; 9-Pointing mark.
  • This embodiment provides an ultrasonic-induced positioning type puncture assembly, see Figures 1 to 3, comprising a puncture needle core 1 and a puncture sleeve 2 sheathed outside the puncture needle core 1, wherein the outer wall of the puncture sleeve 2
  • the puncture sleeve 2 is provided with an annular groove 3 facing the ultrasound probe in the circumferential direction, and the cross-sectional shape of the annular groove 3 along the radial direction of the puncture sleeve 2 is ear-shaped.
  • the annular groove 3 may be arranged near the puncture end of the puncture sleeve 2.
  • the puncture assembly punctures the patient's body surface, and makes the puncture end close to the location of the diseased tissue.
  • the annular groove 3 on the outer wall of the puncture sleeve 2 faces the ultrasound probe, and the cross-sectional shape of the annular groove 3 along the radial direction of the puncture sleeve 2 is Ear-shaped, compared to the semi-circular ring groove 3, the side wall close to the ultrasound probe has a smaller inclination angle, which can reduce the side wall of the ring groove 3 to the ultrasonic wave, ensure strong ultrasonic reflection, and form a clear Ultrasound image, obtain satisfactory development effect.
  • the annular groove 3 provided on the outer wall of the puncture sleeve 2 can be formed by continuous processing. Compared with the triangular pyramid groove, the processing is simple, which is beneficial to production, and the matching is simple.
  • the portable ultrasound system can meet the requirements of induced positioning and development, which is convenient for the safe and effective promotion of technology.
  • the cross section of the annular groove 3 along the radial direction of the puncture sleeve 2 may include a circular arc side 31 and a straight side 32 connected to the circular arc side 31.
  • the straight side 32 is close to the ultrasonic imaging device, and the circular arc side 31 is close to the puncture.
  • the piercing end of the component With the above-mentioned shapes, the circular arc shape and the straight shape are relatively simple and easier to realize in the processing and production process, thereby further reducing the processing difficulty of the small needle knife.
  • the angle between the ultrasonic wave emitted by the ultrasound probe and the axis of the puncture sleeve 2 is 45-60°.
  • the straight edge 32 and the puncture sleeve 2 The included angle of the axis can also be 45-60°, that is to say, the straight edge 32 is basically parallel to the direction of the ultrasonic wave emitted by the ultrasound probe, and it can simultaneously deal with the needs of superficial and deep tissues.
  • the puncture end of the puncture needle core 1 may be formed with a cutting edge, and the cutting edge is used as the puncture surface, so that the puncture end can more easily enter the patient's body, and from the perspective of processing,
  • the single inclined surface or the double inclined surface is easier to process, so that the production cost of the ultrasonic induced positioning type puncture assembly can be appropriately reduced.
  • the puncture end of the puncture sleeve 2 can also be formed with a single bevel or a double bevel.
  • the single bevel or double bevel is used as the puncture surface, so that the puncture end can enter the patient's body more easily, and from the perspective of processing, the single bevel Or the double inclined surface is easier to process, so that the production cost of the ultrasonic induced positioning type puncture assembly can be appropriately reduced.
  • This embodiment provides a cannula-type small needle knife, see Figures 4 to 6, including a cutting assembly and the puncture assembly provided in the first embodiment.
  • the cutting assembly is used to cut diseased tissue.
  • the cutting assembly includes a cutting needle knife 4 and a sleeve.
  • a cutting sleeve 5 arranged on the outside of the cutting needle knife 4.
  • the puncture assembly When performing small needle knife treatment, firstly, the puncture assembly is used to puncture the patient's body surface, and the puncture end of the puncture cannula 2 is close to the position of the diseased tissue, and the puncture cannula 2 is pulled out of the patient's body.
  • the puncture needle The core 1 is still in the patient's body; then, the end of the puncture needle core 1 outside the patient's body is inserted into the cutting sleeve 5, and the cutting sleeve 5 approaches the diseased tissue under the guidance of the puncture needle core 1.
  • the puncture needle core 1 Take out the cutting sleeve 5, and insert the cutting needle knife 4 into the cutting sleeve 5.
  • the cutting edge of the cutting end of the cutting needle knife 4 is not in the cutting seam 6; then, the cutting sleeve 5 and the cutting needle The knife 4 travels along the gap between the patient's tissues to the diseased tissue, and the cutting needle knife 4 is used to cut the diseased tissue; finally, the cutting sleeve 5 and the cutting needle knife 4 are pulled out to complete the small needle knife treatment.
  • the cannula-type needle knife provided in this embodiment includes two components, namely a puncture component and a cutting component.
  • the puncture component is mainly used for puncturing and guiding
  • the cutting component is mainly used for cutting diseased tissue, which is beneficial
  • the effect is basically the same as the beneficial effect of the ultrasonic-induced positioning puncture assembly provided in the first embodiment, and will not be repeated here.
  • a cutting edge is formed on the side of the cutting end of the cutting needle knife 4, and the shape of the cutting end of the cutting sleeve 5 is arc-shaped, and part or all of the side surface is provided with cutting Sew 6.
  • the cutting needle knife 4 When using the cutting assembly to cut the diseased tissue, first, the cutting needle knife 4 is inserted into the cutting sleeve 5, at this time, the cutting edge of the cutting end of the cutting needle knife 4 is not in the cutting seam 6; then, the cutting sleeve 5 and The cutting needle knife 4 travels along the gap between the patient’s tissues to the diseased tissue, and the cutting needle knife 4 is rotated so that the cutting end is inserted into the cutting slit 6, the cutting blade is in contact with the diseased tissue, and the cutting sleeve 5 and the cutting needle knife 4 are pulled outward , The diseased tissue can be cut; finally, the cutting needle knife 4 is rotated so that the cutting blade is separated from the cutting seam 6, and the cutting sleeve 5 and the cutting needle knife 4 are pulled out to complete the small needle knife treatment.
  • the cutting end of the cutting sleeve 5 of the cutting assembly has an arc shape, usually bluntly separating tissues or nerves, and only travels between the tissues; and, before reaching the diseased tissue, the cutting end of the cutting needle knife 4 is always in the cutting sleeve In the tube 5, there is no contact with the tissue, which can reduce the damage to the surrounding nerves or blood vessels by the cutting blade, and provide an effective guarantee for the patient.
  • the side of the cutting end of the cutting needle knife 4 forms a cutting edge, the side cutting method is used to cut the diseased tissue more easily than the forward vertical cutting method, which reduces the difficulty of small needle knife treatment.
  • a hook 7 or a lateral blade 8 may be formed on the side of the cutting end as the cutting edge.
  • the hook 7 structure is adopted.
  • the operating end of the cutting sleeve 5 can be provided with a pointing mark 9 (for example, straight lines or protrusions of different colors, etc.), it can be understood that the pointing mark 9 can be provided on the same side of the cutting seam 6 and on the same straight line as the cutting seam 6.
  • the operator can know the direction of the cutting seam 6 through the pointing mark 9 so that the cutting seam 6 can be aligned with the diseased tissue to perform accurate cutting.
  • cutting A travel limit component may be provided between the cutting end of the needle knife 4 and the cutting end of the cutting sleeve 5 to restrict relative rotation between the cutting needle 4 and the cutting sleeve 5 during the travel. Under the limit of the travel limit component, the relative rotation between the cutting needle knife 4 and the cutting sleeve 5 can be avoided, so that the cutting edge of the cutting end of the cutting needle knife 4 can always be ensured that the cutting edge is not in the cutting seam 6.
  • the travel limit component includes a travel groove and a travel protrusion inserted into the travel groove.
  • the rotation between the cutting needle knife 4 and the cutting sleeve 5 will also adversely affect the small needle knife treatment. Therefore, the cutting end of the cutting needle knife 4 and the cutting A cutting limit component can be arranged between the cutting ends of the sleeve 5 to limit the relative rotation between the cutting needle 4 and the cutting needle 4 during the cutting process.
  • the cutting limit component includes a cutting groove and a cutting protrusion inserted into the cutting groove.
  • a comprehensive limit protrusion and two can be set between the two Integrated limit grooves.
  • One of the two integrated limit grooves is used for travel limit and the other is used for cutting limit. They are distinguished by coating different colors, for example, red and blue.

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Abstract

一种超声诱导定位型穿刺组件及套管式小针刀，小针刀包括切割组件以及穿刺组件。穿刺组件包括穿刺针芯（1）和穿刺套管（2），穿刺套管（2）的外壁沿周向开设有朝向超声仪探头的环形凹槽（3），环形凹槽（3）的截面形状为耳状。解决了现有技术中穿刺组件的三棱锥凹槽的加工难度较大以及环形半圆形凹槽靠近超声显影设备一侧的侧壁会阻碍超声波回声、小针刀的刀刃容易伤害到周围的神经或血管以及采用向前垂直切割的方式较难切割的问题。

Description

一种超声诱导定位型穿刺组件及套管式小针刀 技术领域
本申请涉及一种中医微创手术用具，尤其涉及一种超声诱导定位型穿刺组件及套管式小针刀。
背景技术
小针刀治疗术主要用于软组织损伤性病变和骨关节病变，是一种介于手术方法和非手术疗法之间的闭合性松解术，在治疗部位刺入深部到病变处进行定量松解病变组织，以达到止痛祛病的目的。在实际应用中，小针刀的针尖始终位于患者体内，操作者仅能过通过超声显影观测针尖具体位置。
现有技术中，通常在小针刀的穿刺组件的外壁开设多个沿外周面均匀布置的三棱锥凹槽(CCR技术，立方镜技术)或者沿外周面设置的半圆形环形凹槽，增强超声波反射，形成清晰的超声图像。但是，由于穿刺组件的直径较小，在其外周面上加工三棱锥凹槽的加工难度较大；对于半圆形环形凹槽，由于半圆形环形凹槽靠近超声显影设备一侧的侧壁会阻碍超声波回声，不利于显影，对超声仪配置要求高价格昂贵、设备多为进口、仪器体积大、移动困难。
此外，现有技术中，小针刀前端形成刀刃，在刀体的行进过程中，刀刃抵在病变组织上并进一步进行切割。但是，采用上述结构的小针刀，在未到达病变组织的过程中刀刃全程暴露，由于操作的偏差以及组织变异，刀刃很容易伤害到周围的神经或血管，对患者造成不可挽回的损伤；并且采用向前垂直切割的方式，对于韧性和强度较大的组织容易发生脱离，较难切割。
发明内容
鉴于上述的分析，本申请旨在提供一种超声诱导定位型穿刺组件及套管式小针刀，解决了现有技术中穿刺组件的三棱锥凹槽的加工难度较大以及环形半圆形凹槽靠近超声显影设备一侧的侧壁会阻碍超声波回声、小针刀的刀刃容易伤害到周围的神经或血管以及采用向前垂直切割的方式较难切割的问题。
本申请的目的主要是通过以下技术方案实现的：
本申请提供了一种超声诱导定位型穿刺组件，包括穿刺针芯以及套设于穿刺针芯外侧的穿刺套管，穿刺套管的外壁沿穿刺套管周向开设有朝向超声仪探头的环形凹槽，环形凹槽沿穿刺套管径向的截面形状为耳状。
进一步地，环形凹槽沿穿刺套管径向的截面包括圆弧边以及与圆弧边连接的直边，直边靠近超声显影设备，圆弧边靠近穿刺组件的穿刺端。
进一步地，直边与穿刺套管轴线的夹角为45～60°。
进一步地，穿刺针芯的穿刺端形成有切割刃。
进一步地，切割刃为单斜面或双斜面。
进一步地，穿刺套管的穿刺端形成有单斜面或双斜面。
本申请还提供了一种套管式小针刀，包括切割组件以及上述穿刺组件，切割组件包括切割针刀以及套设于切割针刀外侧的切割套管。
进一步地，切割针刀切割端的侧面形成有切割刃，切割套管切割端的形状为弧形，切割套管的侧面部分或全部开设切割缝。
进一步地，切割刃为回钩或者侧向刃。
进一步地，切割套管的操作端设有用于指示切割缝朝向的指向标识。
进一步地，指向标识设于切割缝的同一侧面，且与切割缝位于同一 直线上。
进一步地，切割针刀的切割端和切割套管的切割端之间设有行进限位组件，用于在切割针刀和切割套管行进过程中限定切割针刀和切割套管之间相对转动。
进一步地，行进限位组件包括行进凹槽以及插入行进凹槽内的行进凸起。
进一步地，切割针刀的切割端和切割套管的切割端之间设有切割限位组件，用于在切割针刀切割过程中限定切割针刀和切割套管之间相对转动。
进一步地，切割限位组件包括切割凹槽以及插入切割凹槽内的切割凸起。
与现有技术相比，本申请至少可实现如下有益效果之一：
a)本申请提供的超声诱导定位型穿刺组件，穿刺套管外壁的环形凹槽朝向超声仪探头，且环形凹槽沿穿刺套管径向的截面形状为耳状，相比于半圆形环形凹槽，靠近超声仪探头的侧壁倾斜角度较小，从而能够减少环形凹槽侧壁对超声波的阻挡，保证超声波的较强反射，形成清晰的超声影像，获得满意的显影效果。
a)本申请提供的超声诱导定位型穿刺组件，穿刺套管外壁设置的环形凹槽以采用连续加工形成，相比于三棱锥凹槽，加工简单，利于生产，配合简配便携式超声仪即可满足诱导定位显影要求，便于技术安全有效推广。
c)本申请提供的套管式小针刀包括两个组件，即穿刺组件和切割组件，穿刺组件主要用于穿刺和引导，切割组件主要用于切割病变组织。其中，切割组件的切割套管切割端的形状为弧形，通常钝性分离组织或神经，仅会在组织间行进；并且，在到达病变组织之前，切割针刀的切 割端一直处于切割套管中，不会与组织相接触，从而能够减少切割刃伤害到周围的神经或血管，对患者提供有效的保证。
d)本申请提供的套管式小针刀，由于切割针刀切割端的侧面形成切割刃，采用侧向切割的方式，相比于向前垂直切割的方式，更容易完成对病变组织的切割，降低了小针刀治疗的难度。
本申请的其他特征和优点将在随后的说明书中阐述，并且，部分的从说明书中变得显而易见，或者通过实施本申请而了解。本申请的目的和其他优点可通过在所写的说明书以及附图中所特别指出的结构来实现和获得。
附图说明
附图仅用于示出具体实施例的目的，而并不认为是对本申请的限制，在整个附图中，相同的参考符号表示相同的部件。
图1为本申请实施例一的超声诱导定位型穿刺组件的结构示意图，其中，穿刺套管的穿刺端形成有单斜面；
图2为本申请实施例一的超声诱导定位型穿刺组件的穿刺端可以形成有双斜面的结构示意图；
图3为图1的局部剖视图；
图4为本申请实施例二的套管式小针刀中切割组件的结构示意图；
图5为本申请实施例二的套管式小针刀中切割套管侧向全部开有切割缝的结构示意图；
图6为本申请实施例二的套管式小针刀中切割针刀切割端形成有侧向刃的结构示意图。
附图标记：
1-穿刺针芯；2-穿刺套管；3-环形凹槽；31-圆弧边；32-直边；4-切 割针刀；5-切割套管；6-切割缝；7-回钩；8-侧向刃；9-指向标识。
具体实施方式
下面结合附图来具体描述本申请的优选实施例，其中，附图构成本申请的一部分，并与本申请的实施例一起用于阐释本申请的原理。
实施例一
本实施例提供了一种超声诱导定位型穿刺组件，参见图1至图3，包括穿刺针芯1以及套设于穿刺针芯1外侧的穿刺套管2，其中，穿刺套管2的外壁沿穿刺套管2周向开设有朝向超声仪探头的环形凹槽3，环形凹槽3沿穿刺套管2径向的截面形状为耳状。示例性地，环形凹槽3可以设置于靠近穿刺套管2穿刺端。
进行小针刀治疗时，首先，穿刺组件从患者的体表进行穿刺，并使得穿刺端接近病变组织位置。
与现有技术相比，本实施例提供的超声诱导定位型穿刺组件，穿刺套管2外壁的环形凹槽3朝向超声仪探头，且环形凹槽3沿穿刺套管2径向的截面形状为耳状，相比于半圆形环形凹槽3，靠近超声仪探头的侧壁倾斜角度较小，从而能够减少环形凹槽3侧壁对超声波的阻挡，保证超声波的较强反射，形成清晰的超声影像，获得满意的显影效果。
此外，由于本实施例提供的超声诱导定位型穿刺组件中，穿刺套管2外壁设置的环形凹槽3可以采用连续加工形成，相比于三棱锥凹槽，加工简单，利于生产，配合简配便携式超声仪即可满足诱导定位显影要求，便于技术安全有效推广。
示例性地，上述环形凹槽3沿穿刺套管2径向的截面可以包括圆弧边31以及与圆弧边31连接的直边32，直边32靠近超声显影设备，圆弧边31靠近穿刺组件的穿刺端。采用上述形状，圆弧形和直线形较为简单， 在加工生产过程中更容易实现，从而进一步降低上述小针刀的加工难度。
考虑到通常情况下，超声仪探头发射的超声波与穿刺套管2轴线的夹角为45～60°，为了进一步减小环形凹槽3侧壁对超声波的阻挡，直边32与穿刺套管2轴线的夹角也可以为45～60°，也就是说，直边32与超声仪探头发射的超声波的方向基本平行，同时可兼顾处理浅表和深部组织的需求。
对于穿刺针芯1的结构，具体来说，穿刺针芯1的穿刺端可以形成有切割刃，采用切割刃作为穿刺面，使得穿刺端更容易进入患者的体内，并且，从加工的角度考虑，单斜面或双斜面较容易加工，从而能够适当降低上述超声诱导定位型穿刺组件的生产成本。
同样地，穿刺套管2的穿刺端也可以形成有单斜面或双斜面，采用单斜面或双斜面作为穿刺面，使得穿刺端更容易进入患者的体内，并且，从加工的角度考虑，单斜面或双斜面较容易加工，从而能够适当降低上述超声诱导定位型穿刺组件的生产成本。
实施例二
本实施例提供了一种套管式小针刀，参见图4至图6，包括切割组件以及实施例一提供的穿刺组件，切割组件用于切割病变组织，切割组件包括切割针刀4以及套设于切割针刀4外侧的切割套管5。
进行小针刀治疗时，首先，采用穿刺组件从患者的体表进行穿刺，并使得穿刺套管2的穿刺端接近病变组织位置，将穿刺套管2从患者体内拔出，此时，穿刺针芯1仍然处于患者体内；然后，将穿刺针芯1处于患者体外的一端穿入切割套管5中，切割套管5在穿刺针芯1的引导下接近病变组织；接着，将穿刺针芯1从切割套管5中取出，将切割针刀4穿入切割套管5中，此时，切割针刀4切割端的切割刃未处于切割缝6中；再然后，将切割套管5和切割针刀4沿着患者组织间缝隙行进 至病变组织，利用切割针刀4切断病变组织；最后，将拉出切割套管5和切割针刀4，从而完成小针刀的治疗。
与现有技术相比，本实施例提供的套管式小针刀包括两个组件，即穿刺组件和切割组件，穿刺组件主要用于穿刺和引导，切割组件主要用于切割病变组织，其有益效果与实施例一提供的超声诱导定位型穿刺组件的有益效果基本相同，在此不一一赘述。
对于切割组件中切割针刀4和切割套管5的结构，具体来说，切割针刀4切割端的侧面形成有切割刃，切割套管5切割端的形状为弧形，其侧面部分或全部开设切割缝6。在利用切割组件切割病变组织时，首先，将切割针刀4穿入切割套管5中，此时，切割针刀4切割端的切割刃未处于切割缝6中；然后，将切割套管5和切割针刀4沿着患者组织间缝隙行进至病变组织，转动切割针刀4，使得切割端插入切割缝6中，将切割刃与病变组织接触，向外拉动切割套管5和切割针刀4，就能够使得病变组织被切断；最后，转动切割针刀4，使得切割刃脱离切割缝6，拉出切割套管5和切割针刀4，从而完成小针刀的治疗。这样，切割组件的切割套管5切割端的形状为弧形，通常钝性分离组织或神经，仅会在组织间行进；并且，在到达病变组织之前，切割针刀4的切割端一直处于切割套管5中，不会与组织相接触，从而能够减少切割刃伤害到周围的神经或血管，对患者提供有效的保证。此外，由于切割针刀4切割端的侧面形成切割刃，采用侧向切割的方式，相比于向前垂直切割的方式，更容易完成对病变组织的切割，降低了小针刀治疗的难度。
对于切割针刀4的切割端的结构，具体来说，可以在切割端的侧面形成回钩7或者侧向刃8，作为切割刃。其中，采用回钩7结构，在进行病变组织切割时，向外拉动切割套管5和切割针刀4，回钩7可以拉断病变组织，相比于侧向刃8，更加容易操作，从而进一步降低了小针刀治疗 的难度。
考虑到切割套管5仅其中一个侧面形成有切割缝6，为了使操作者能够实时获知切割缝6的朝向，切割套管5的操作端可以设置用于指示切割缝6朝向的指向标识9(例如，不同颜色的直线或者凸起等)，可以理解的是，该指向标识9可以设于切割缝6的同一侧面，且与切割缝6位于同一直线上。在切割过程中，操作者可以通过指向标识9了解切割缝6的朝向，从而切割缝6能够对准病变组织，进行准确切割。
值得注意的是，在切割套管5和切割针刀4的行进过程中，需要始终保持切割针刀4切割端的切割刃未处于切割缝6中，为了避免切割针刀4转动暴露切割刃，切割针刀4的切割端和切割套管5的切割端之间可以设置行进限位组件，用于在切割针刀4和切割套管5行进过程中限定两者之间相对转动。在行进限位组件的限位下，可以避免切割针刀4与切割套管5之间的相对转动，从而能够始终保证切割针刀4切割端的切割刃未处于切割缝6中。
示例性地，行进限位组件包括行进凹槽以及插入行进凹槽内的行进凸起。
同样值得注意的是，在切割病变组织的过程中，切割针刀4与切割套管5之间的转动，也会对小针刀治疗造成不利影响，因此，切割针刀4的切割端和切割套管5的切割端之间可以设置切割限位组件，用于在切割针刀4切割过程中限定两者之间相对转动。
示例性地，切割限位组件包括切割凹槽以及插入切割凹槽内的切割凸起。
需要说明的是，当切割针刀4的切割端和切割套管5的切割端之间需要同时进行行进限位和切割限位时，两者之间可以设置一个综合限位凸起以及两个综合限位凹槽，两个综合限位凹槽其中一个用于行进限位， 另一个用于切割限位，通过涂覆不同颜色进行区分，例如，红色和蓝色。
以上所述，仅为本申请较佳的具体实施方式，但本申请的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本申请揭露的技术范围内，可轻易想到的变化或替换，都应涵盖在本申请的保护范围之内。

Claims (15)

  1. 一种超声诱导定位型穿刺组件，其特征在于，包括穿刺针芯以及套设于穿刺针芯外侧的穿刺套管，所述穿刺套管的外壁沿穿刺套管周向开设有朝向超声仪探头的环形凹槽，所述环形凹槽沿穿刺套管径向的截面形状为耳状。
  2. 根据权利要求1所述的超声诱导定位型穿刺组件，其特征在于，所述环形凹槽沿穿刺套管径向的截面包括圆弧边以及与圆弧边连接的直边，所述直边靠近超声显影设备，所述圆弧边靠近穿刺组件的穿刺端。
  3. 根据权利要求2所述的超声诱导定位型穿刺组件，其特征在于，所述直边与穿刺套管轴线的夹角为45～60°。
  4. 根据权利要求1至3任一项所述的超声诱导定位型穿刺组件，其特征在于，所述穿刺针芯的穿刺端形成有切割刃。
  5. 根据权利要求4所述的超声诱导定位型穿刺组件，其特征在于，所述切割刃为单斜面或双斜面。
  6. 根据权利要求1至3、5任一项所述的超声诱导定位型穿刺组件，其特征在于，所述穿刺套管的穿刺端形成有单斜面或双斜面。
  7. 一种套管式小针刀，其特征在于，包括切割组件以及权利要求1至6任一项所述的穿刺组件，所述切割组件包括切割针刀以及套设于切割针刀外侧的切割套管。
  8. 根据权利要求7所述的套管式小针刀，其特征在于，所述切割针刀切割端的侧面形成有切割刃，所述切割套管切割端的形状为弧形，所述切割套管的侧面部分或全部开设切割缝。
  9. 根据权利要求8所述的套管式小针刀，其特征在于，所述切割刃为回钩或者侧向刃。
  10. 根据权利要求8所述的套管式小针刀，其特征在于，所述切割套 管的操作端设有用于指示切割缝朝向的指向标识。
  11. 根据权利要求10所述的套管式小针刀，其特征在于，所述指向标识设于切割缝的同一侧面，且与切割缝位于同一直线上。
  12. 根据权利要求7至11任一项所述的套管式小针刀，其特征在于，所述切割针刀的切割端和切割套管的切割端之间设有行进限位组件，用于在切割针刀和切割套管行进过程中限定切割针刀和切割套管之间相对转动。
  13. 根据权利要求12所述的套管式小针刀，其特征在于，所述行进限位组件包括行进凹槽以及插入行进凹槽内的行进凸起。
  14. 根据权利要求7至11、13任一项所述的套管式小针刀，其特征在于，所述切割针刀的切割端和切割套管的切割端之间设有切割限位组件，用于在切割针刀切割过程中限定切割针刀和切割套管之间相对转动。
  15. 根据权利要求14所述的套管式小针刀，其特征在于，所述切割限位组件包括切割凹槽以及插入切割凹槽内的切割凸起。
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CN109259834A (zh) * 2018-09-21 2019-01-25 上海康德莱企业发展集团股份有限公司 一种一次性使用卵母细胞采集器
CN210472185U (zh) * 2019-06-14 2020-05-08 北京市隆福医院 一种防护型定向切割小针刀组套

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