WO2020191807A1 - 穿刺针组件和球囊导管套件 - Google Patents

穿刺针组件和球囊导管套件 Download PDF

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Publication number
WO2020191807A1
WO2020191807A1 PCT/CN2019/081523 CN2019081523W WO2020191807A1 WO 2020191807 A1 WO2020191807 A1 WO 2020191807A1 CN 2019081523 W CN2019081523 W CN 2019081523W WO 2020191807 A1 WO2020191807 A1 WO 2020191807A1
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WIPO (PCT)
Prior art keywords
seat
catheter
balloon
needle core
puncture needle
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PCT/CN2019/081523
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English (en)
French (fr)
Inventor
官国锋
李午阳
徐勇
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深圳市擎源医疗器械有限公司
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Publication of WO2020191807A1 publication Critical patent/WO2020191807A1/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
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • 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
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the present invention relates to the technical field of medical devices, in particular to a puncture needle assembly and a balloon catheter kit.
  • Trigeminal neuralgia is a very painful disease. Mainly manifested as short-term, recurrent lightning-like pain in the distribution area of the facial trigeminal nerve. From the etiology, it is divided into primary trigeminal neuralgia and secondary trigeminal neuralgia.
  • Percutaneous trigeminal nerve semilunar balloon compression was used in the clinical treatment of trigeminal neuralgia by Mulla and Lichtor in 1978 and was published in 1983.
  • the original purpose of this technique is to relieve trigeminal neuralgia that cannot be controlled due to the failure of other techniques.
  • it has been widely used in the treatment of various trigeminal neuralgia.
  • the puncture currently used for percutaneous trigeminal nerve semilunar balloon compression to treat various trigeminal neuralgia causes excessive damage to the human body.
  • the main technical problem solved by the present invention is how to reduce the damage to the human body caused by the puncture used for the treatment of various trigeminal neuralgia by percutaneous trigeminal nerve and meniscus balloon compression.
  • a technical solution adopted by the present invention is to provide a puncture needle assembly that can be used for percutaneous trigeminal nerve and meniscus balloon compression to treat various trigeminal neuralgias, including:
  • the puncture needle includes a needle core and a needle core seat, one end of the needle core is fixedly connected to the needle core seat;
  • the outer sheath includes a sheath body and an outer sheath, one end of the sheath body is fixedly connected to the outer sheath seat, the needle core can be inserted into the sheath body, and the needle core seat is buckled with the outer sheath seat connection.
  • the needle core seat is provided with a snap portion;
  • the outer sheath seat includes a base, a connecting portion, a holding portion, and a snapping portion, and the holding portion is connected to the base through the connecting portion.
  • one end of the sheath body is fixedly connected to the base part, the clamping part is fixedly connected to one end of the holding part, and the buckle part is connected to the clamping part.
  • the length of one end of the holding part is less than the length of the other end of the holding part.
  • the present invention also provides a balloon catheter kit that can be used for percutaneous trigeminal nerve semilunar balloon compression to treat various trigeminal neuralgias, including the puncture needle assembly and balloon catheter described above.
  • the balloon catheter includes a balloon, a catheter, and a connecting seat.
  • the balloon is arranged at one end of the catheter, the connecting seat is arranged at the other end of the catheter, and the connecting seat passes through
  • the catheter is in communication with the balloon.
  • one end of the guide member is semi-spherical or conical, and the other end is in communication with one end of the catheter;
  • the side wall of the guide member is provided with an air outlet, and the balloon is sleeved on the The outer side wall of the guide member, and communicates with the guide member through the air outlet hole.
  • the balloon catheter further includes a visualization pressure ring, and the visualization pressure ring is fixed to one end of the catheter and is close to the balloon.
  • the balloon catheter further includes a round head for guiding the catheter to be smoothly inserted into the puncture needle assembly, the round head is fixed to the end surface of one end of the catheter, and the balloon is located at the Between the round head and the developing pressing ring.
  • the maximum outer diameter of the round head is greater than the outer diameter of the developing pressure ring.
  • a scale is provided on the catheter, and the depth of the catheter into the puncture needle assembly is obtained by reading the scale.
  • the balloon catheter further includes an inner core and a cap, the cap is mounted on the connecting seat through a threaded connection, and the inner core is fixed on the connecting seat and the thread of the cap. Inside the catheter.
  • the puncture needle assembly in the embodiment of the present invention includes a puncture needle and an outer sheath
  • the puncture needle includes a needle core and a needle core seat, and one end of the needle core Fixedly connected to the needle core seat
  • the outer sheath includes a sheath body and an outer sheath, one end of the sheath body is fixedly connected to the outer sheath seat, the needle core can be inserted into the sheath body, the needle core seat It is buckled and connected with the outer sheath seat.
  • the buckle connection of the needle core seat and the outer sheath seat can not only prevent the needle core from retreating when the puncture needle assembly is used for puncture, but also prevent the needle core from driving the outer sheath to shift in the human tissue due to torsion when the needle core is withdrawn after puncture, thereby reducing The damage to human tissues and nerves caused by the puncture needle assembly during puncture and withdrawal of the needle core.
  • Fig. 1 is a schematic structural diagram of a balloon catheter kit in an embodiment of the present invention
  • Figure 2 is a side view of the balloon catheter in the balloon catheter kit of the embodiment of the present invention.
  • FIG. 3 is a perspective view of the puncture needle assembly in the balloon catheter kit of the embodiment of the present invention.
  • FIG. 4 is an exploded view of the puncture needle assembly in the balloon catheter kit of the embodiment of the present invention.
  • FIG. 5 is a perspective view of the needle core seat in the puncture needle assembly of the embodiment of the present invention.
  • Figure 6 is a perspective view of the outer sheath in the puncture needle assembly of the embodiment of the present invention.
  • Fig. 7 is a cross-sectional view of a puncture needle assembly according to an embodiment of the present invention.
  • the present invention provides a balloon catheter kit that can be used for percutaneous trigeminal nerve semilunar balloon compression to treat various trigeminal neuralgias.
  • the balloon catheter kit 100 provided by the embodiment of the present invention includes: a balloon The catheter 10 and the puncture needle assembly 20.
  • the balloon catheter 10 is used to compress the meniscus of the trigeminal nerve.
  • the puncture needle assembly 20 is used to puncture human tissue and guide the balloon catheter 10 to a predetermined position in the human tissue.
  • the trigeminal nerve is compressed on the half moon.
  • the doctor can use the balloon catheter 10 and the puncture needle assembly 20 in cooperation to complete the percutaneous trigeminal nerve semilunar balloon compression operation to treat various trigeminal neuralgias.
  • Fig. 2 is a side view of the balloon catheter in the balloon catheter kit of the embodiment of the present invention.
  • the balloon catheter 10 in the embodiment of the present invention includes a balloon 11, a catheter 12, a round head 13, a developing pressure ring 14, a connecting seat 15, an inner core (not shown) and a cap 17.
  • the balloon 11 is disposed at one end of the catheter 12 and communicates with the catheter 12.
  • the round head 13 is arranged on one end surface of the pipe 12.
  • the imaging pressing ring 14 is disposed at one end of the catheter 12, and the balloon 11 is located between the round head 13 and the imaging pressing ring 14.
  • the connecting seat 15 is arranged at the other end of the pipe 12 and communicates with the pipe 12.
  • the inner core is fixedly installed in the duct 12.
  • the cap 17 is installed on the connecting seat 15.
  • the balloon 11 is compliant or semi-compliant. Compliance refers to the ease with which the elastic body deforms under the action of external force.
  • the balloon 11 can be made of thermoplastic elastomer plastics such as latex, nylon, silica gel, TPU or TPE.
  • the shape of the balloon 11 after expansion may be spherical, oval, pear-shaped, capsule-shaped or peanut-shaped.
  • the catheter 12 is a solid-color tube body with a transparent color bar, which is beneficial for the doctor to observe the state of the liquid in the catheter 12 and adjust the operation method.
  • the solid color part of the catheter is added with imaging agents (for example, barium sulfate, strontium sulfate, magnesium carbonate, etc.) to realize visualization in human tissues, so that the doctor can judge the specific position of the catheter 12 in the human tissue.
  • the conduit 12 can be made of a thermoplastic resin material with toughness and strength such as PA, PVC, PE, FEP, Pebax polyether block elastomer, etc., so that it has certain toughness and rigidity, and is not easy to bend, which is beneficial to the conduit 12 Insert into the puncture needle assembly 20.
  • a scale is provided on the catheter 12, and the scale is related to the total length of the puncture needle assembly 20, and it is known that the catheter 12 enters the puncture by reading the scale. The depth within the needle assembly 20.
  • one end of the catheter 12 connected to the balloon 11 is made of elastic metal material, and the other end is made of medical polymer material, and the two ends are connected by bonding or heat sealing.
  • the round head 13 is fixed on the end surface of one end of the conduit 12, and is made of stainless steel, tantalum, platinum-iridium alloy, platinum, gold, nickel-titanium, iron or other metals or alloy materials with certain rigidity and imaging effect.
  • the round head 13 is used to guide the catheter 12 into the puncture needle assembly 20 smoothly.
  • the shape of the round head 13 can be a semi-circular head, an elliptical head, or a tapered head with a certain arc, and its maximum outer diameter is slightly larger than the outer diameter of the developing pressure ring 14 to prevent the developing pressure ring 14 from falling out.
  • the imaging pressure ring 14 is fixed at one end of the catheter 12 and is close to the balloon 11. It is made of stainless steel, tantalum, platinum-iridium alloy, platinum, gold, nickel-titanium, iron or other metals with certain rigidity and imaging effect. Made of alloy material. The doctor can locate the specific position of the visualization pressure ring 14 in the human tissue by X-rays, thereby positioning the specific position of the balloon catheter 10 in the human tissue.
  • the connecting seat 15 is arranged at the other end of the pipe 12 and communicates with the pipe 12.
  • the connecting seat 15 is provided with a Luer taper and a standard thread, which is convenient for connecting with other medical devices.
  • the connecting seat 15 has an inner cavity, which can be single cavity, Y-type double-cavity, T-type double-cavity, three-cavity or four-cavity, and is made of medical polymer materials such as PP, PE, PC, ABC, POM, etc. .
  • the connecting seat 15 can be connected with a syringe, and the syringe can inject the developer into it, enter the catheter 12, and then flow into the balloon 11, so that the balloon 11 expands; on the contrary, when the liquid is drawn out, the balloon 11 contracts.
  • the inner core penetrates the catheter 12.
  • the cap 17 is installed on the connecting seat 15 through a threaded connection.
  • the inner core is fixed in the conduit 12 by the threads of the connecting seat 15 and the cap 17.
  • the cap 17 is provided with a Luer taper and a standard thread inside, which can be screwed tightly with the connecting seat 15 to keep the inner core from moving in the duct 12.
  • the cap 17 is provided with anti-skid patterns on the outside to prevent slippage when grasped.
  • the round head 13, the developing pressure ring 14, the inner core 16 and the cap 17 in the balloon catheter 10 can be omitted.
  • the balloon 11 is arranged at one end of the catheter 12
  • the connecting seat 15 is arranged at the other end of the catheter 12, and the connecting seat 15 communicates with the balloon 11 through the catheter 12.
  • the puncture needle assembly 20 in the embodiment of the present invention includes a puncture needle 21 and an outer sheath 22, and the puncture needle 21 can be inserted into the outer sheath 22.
  • the puncture needle 21 includes a needle core 211 and a needle core seat 212, and one end of the needle core 211 is fixedly connected to the needle core seat 212.
  • the outer sheath 22 includes a sheath body 221 and an outer sheath base 222, one end of the sheath body 221 is fixedly connected to the outer sheath base 222.
  • the needle core 211 can be inserted into the sheath body 221, and the needle core seat 212 is snap-connected to the outer sheath seat 222.
  • one end of the needle core 211 is a needle tail, which is fixedly connected to the needle core seat 212; the other end of the needle core 211 is a needle, which can be round, pointed, semi-circular, or oval. Or a cone head with a certain arc.
  • the needle core holder 212 is cylindrical, with one end closed and the other end having an opening.
  • the needle core seat 212 is provided with a fixing portion 2121 for fixed connection with the needle core 211.
  • a buckle portion 2122 is provided outside the other end of the needle core seat 212. In this embodiment, there are two buckle portions 2122, which are respectively located on two opposite sides of the needle core seat 212.
  • the sheath body 221 is made of thin and tough materials, which can be specifically made of stainless steel, alloy, or pre-processed and tearable thermoplastic elastomer plastics such as PP, PEP, or TPU/TPE.
  • the thickness of the side wall of the sheath body 221 can be as low as 0.1 mm, so that its intervention diameter is greatly reduced.
  • the fit gap between the needle core 211 and the sheath body 221 is between 0.05 mm and 0.2 mm, and the fit is excellent, which can effectively reduce the puncture resistance caused by capillary action during the puncture process and reduce bleeding.
  • the sheath base 222 includes a base 2221, a connecting portion 2223, a holding portion 2224, and a clamping portion 2225.
  • One end of the base 2221 is cylindrical, and the other end is conical.
  • a through hole 2222 is provided along its axis.
  • One end of the sheath body 221 passes through the through hole 2222 and is fixedly connected to the base 2221 through the through hole 2222.
  • the holding portion 2224 is in the shape of a long flat plate, the side surface of the holding portion 2224 is fixedly connected to the base 2221 through the connecting portion 2223, and the holding portion 2224 is arranged along the axis of the base 2221.
  • the clamping portion 2225 is fixedly connected to one end of the holding portion 2224, and the clamping portion 2225 is located on the surface of the holding portion 2224 facing the base 2221. There are two holding portions 2224 and two clamping portions 2225, and the two clamping portions 2225 are opposite to each other.
  • the buckle portion 2122 and the buckle portion 2225 cooperate with each other.
  • the specific structure of the buckle portion 2122 is a bump, and the specific structure of the buckle portion 2225 It is also a bump.
  • the specific structure of the latching portion 2122 is a groove, and the specific structure of the latching portion 2225 is a bump.
  • the specific structure of the locking portion 2122 is a bump, and the specific structure of the locking portion 2225 is a groove.
  • the needle of the needle core 211 is aligned with the sheath body 221, and the needle core 211 is gradually inserted into the sheath body 221. While the needle core 211 is aligned with the sheath body 221, the two locking portions 2122 on the needle core seat 212 are respectively connected to the two locking parts on the outer sheath seat 222 Section 2225 is aligned.
  • the clamping portion 2225 and the buckling portion 2122 cooperate with each other, so that the needle core seat 212 and the outer sheath seat 222 complete the buckling connection.
  • both the needle core 211 and the sheath body 221 are inserted into the body tissue of the patient.
  • the needle core seat 212 and the outer sheath seat 222 adopt the above-mentioned buckle connection method.
  • connection method of the snap connection can make the needle core seat 212 and the outer sheath seat 222 separate more quickly, and the snap connection method described above
  • the needle core holder 212 and the outer sheath holder 222 are prevented from rotating mutually during the separation process, thereby preventing the needle core 211 from rotating relative to the sheath body 221. If the needle core 211 and the sheath body 221 rotate with each other, the needle core 211 will rotate in the human tissue, which will increase the damage to the human tissue.
  • the needle core seat 212 is provided with a first guide part
  • the outer sheath seat 222 is provided with a second guide part
  • the first guide part and the second guide part cooperate with each other to guide the needle core seat 212
  • the two locking parts 2122 are respectively aligned with the two locking parts 2225 on the outer sheath base 222.
  • the specific structure of the first guiding part may be a guiding groove, and the guiding groove may be opened on the inner side wall of the needle core seat 212.
  • the specific structure of the second guide portion may be a guide block, and the guide block is disposed on the outer surface of the base 2221.
  • the guide groove has an opening toward one end of the needle head of the needle core 211, and the opening is horn-shaped or V-shaped.
  • the puncture needle 21 needs to be withdrawn from the outer sheath 22. Since the structure of the holding portion 2224 and the clamping portion 2225 is similar to a seesaw, when the other end of the holding portion 2224 is pressed down, one end of the holding portion 224 is tilted, resulting in the clamping portion 2225 Staggered from the buckle portion 2122, the needle core seat 212 and the outer sheath seat 222 are separated from each other, and the puncture needle 21 is drawn out from the outer sheath 22. In order for the user to easily press down the other end of the holding portion 2224, the length of one end of the holding portion 2224 is smaller than the length of the other end of the holding portion 2224.
  • the specific use method of the balloon catheter kit 100 in the embodiment of the present invention the patient is placed in a supine position after general anesthesia, and the shoulder pad is covered with cloth at an appropriate height to ensure mild neck extension.
  • the puncture needle assembly 20 is used to puncture from the side of the patient, and the puncture point is selected about 2.5 cm from the side of the patient's mouth.
  • the balloon catheter 10 is inserted along the outer sheath 22, and its insertion depth is determined by the X-image positioning and the scale line on the catheter 12.
  • the diluted imaging agent is injected through the connecting seat 15 to make the balloon 11 inflated, and the filling condition of the balloon 11 is monitored by X-image.
  • the balloon 11 inflated and compress the trigeminal nerve for 1 minute, then withdraw the imaging agent, withdraw the balloon catheter 10 and the outer sheath 22, and compress the puncture point for several minutes to stop bleeding, and the operation is completed.

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Abstract

一种穿刺针组件(20)和球囊导管套件(100)，其中，穿刺针组件(20)包括穿刺针(21)和外鞘(22)，穿刺针(21)包括针芯(211)和针芯座(212)，针芯(211)的一端固定连接于针芯座(212)；外鞘(22)包括鞘体(221)和外鞘座(222)，鞘体(221)的一端固定连接于外鞘座(222)，针芯(211)可插入鞘体(221)内，针芯座(212)与外鞘座(222)卡扣连接。针芯座(212)与外鞘座(222)卡扣连接不但可防止使用穿刺针组件(20)穿刺时针芯(211)后退；而且在穿刺完成退出针芯(211)时，可防止针芯(211)带动外鞘(22)在人体组织内因扭转发生位移，从而减少了穿刺以及退出针芯(211)时穿刺针组件(20)对人体组织和神经的伤害。

Description

穿刺针组件和球囊导管套件 技术领域
本发明涉及医疗器械技术领域，特别是涉及一种穿刺针组件和球囊导管套件。
背景技术
三叉神经痛是一种令人十分痛苦的疾病。主要表现为在面部三叉神经分布区域短暂的、反复发作的闪电样剧痛。从病因学上分为原发性三叉神经痛和继发性三叉神经痛。
经皮三叉神经半月节球囊压迫术由Mulla和Lichtor于1978年开始用于于临床治疗三叉神经痛，并于1983年发表。这项技术最初的目的是为了缓解由于其它技术失败而不能控制的三叉神经痛。近年来，由于这项技术的易操作性及其安全性，已经被广泛应用于各种三叉神经痛的治疗。
目前用于经皮三叉神经半月节球囊压迫术治疗各种三叉神经痛的穿刺针对人体造成的损伤过大。
发明内容
本发明主要解决的技术问题是如何减小用于经皮三叉神经半月节球囊压迫术治疗各种三叉神经痛的穿刺针对人体造成的损伤。
本发明采用的一个技术方案是：提供一种能够用于经皮三叉神经半月节球囊压迫术治疗各种三叉神经痛的穿刺针组件，包括：
穿刺针，包括针芯和针芯座，所述针芯的一端固定连接于所述针芯座；
外鞘，包括鞘体和外鞘做，所述鞘体的一端固定连接于所述外鞘座，所述针芯可插入所述鞘体内，所述针芯座与所述外鞘座卡扣连接。
在一些实施例中，所述针芯座设置有卡扣部；所述外鞘座包括基部、连接部、握持部和卡接部,所述握持部通过所述连接部与所述基部固定 连接，所述鞘体的一端固定连接于所述基部，所述卡接部固定连接于所述握持部的一端，所述卡扣部与所述卡接部。
在一些实施例中，所述卡扣部共有两个，两个所述卡扣部分别位于所述针芯座的两侧；所述握持部和所述卡接部均有两个，并且两个所述卡接部彼此相对。
在一些实施例中，所述握持部一端的长度小于所述握持部另一端的长度。
本发明还提供一种能够用于经皮三叉神经半月节球囊压迫术治疗各种三叉神经痛的球囊导管套件，包括：以上所述的穿刺针组件和球囊导管。
在一些实施例中，所述球囊导管包括球囊、导管和连接座,所述球囊设置于所述导管的一端，所述连接座设置于所述导管的另一端，所述连接座通过所述导管与所述球囊连通。
在一些实施例中，所述引导件的一端呈半圆球状或者圆锥状，另一端与所述导管的一端连通；所述引导件的侧壁开设有出气孔，所述球囊套设于所述引导件的外侧壁，并且通过所述出气孔与所述引导件连通。
在一些实施例中，所述球囊导管还包括显影压环，所述显影压环固定于所述导管的一端，并靠近所述球囊。
在一些实施例中，所述球囊导管还包括用于引导导管顺畅地插入所述穿刺针组件内的圆头，所述圆头固定于所述导管一端的端面，所述球囊位于所述圆头和所述显影压环之间。
在一些实施例中，所述圆头的最大外径大于所述显影压环的外径。
在一些实施例中，所述导管上设置有刻度，通过读取所述刻度获知所述导管进入到所述穿刺针组件内的深度。
在一些实施例中，所述球囊导管还包括内芯和盖帽，所述盖帽通过螺纹连接安装于所述连接座，所述内芯通过所述连接座和所述盖帽的螺纹固定在所述导管内。
本发明实施例的有益效果是：区别于现有技术的情况，本发明实施 例中穿刺针组件包括穿刺针和外鞘，所述穿刺针包括针芯和针芯座，所述针芯的一端固定连接于所述针芯座；外鞘包括鞘体和外鞘做，所述鞘体的一端固定连接于所述外鞘座，所述针芯可插入所述鞘体内，所述针芯座与所述外鞘座卡扣连接。针芯座与所述外鞘座卡扣连接不但可防止使用穿刺针组件穿刺时针芯后退；而且在穿刺完成退出针芯时，可防止针芯带动外鞘在人体组织内因扭转发生位移，从而减少了穿刺以及退出针芯时穿刺针组件对人体组织和神经的伤害。
附图说明
图1是本发明实施例中球囊导管套件的结构示意图；
图2是本发明实施例的球囊导管套件中球囊导管的侧视图；
图3是本发明实施例的球囊导管套件中穿刺针组件的立体图；
图4是本发明实施例的球囊导管套件中穿刺针组件的分解图；
图5是本发明实施例的穿刺针组件中针芯座的立体图；
图6是本发明实施例的穿刺针组件中外鞘座的立体图；
图7是本发明实施例的穿刺针组件的剖视图。
具体实施方式
为了便于理解本发明，下面结合附图和具体实施例，对本发明进行更详细的说明。需要说明的是，当元件被表述“固定于”另一个元件，它可以直接在另一个元件上、或者其间可以存在一个或多个居中的元件。当一个元件被表述“连接”另一个元件，它可以是直接连接到另一个元件、或者其间可以存在一个或多个居中的元件。本说明书所使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的。
除非另有定义，本说明书所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本说明书中在本发明的说明书中所使用的术语只是为了描述具体的实施例的目的，不是用于限制本发明。本说明书所使用的术语“和/或”包括一个或多个相关的 所列项目的任意的和所有的组合。
本发明提供一种能够用于经皮三叉神经半月节球囊压迫术治疗各种三叉神经痛的球囊导管套件，请参阅图1，本发明实施例提供的球囊导管套件100包括：球囊导管10和穿刺针组件20，球囊导管10用于进行三叉神经半月节压迫，穿刺针组件20用于对人体组织进行穿刺，并引导球囊导管10进入到人体组织内的预定位置，并对三叉神经半月节压迫。医生可将球囊导管10和穿刺针组件20相互配合使用，完成经皮三叉神经半月节球囊压迫术治疗各种三叉神经痛。
图2为本发明实施例的球囊导管套件中球囊导管的侧视图。如图2所示，本发明实施例中球囊导管10包括球囊11、导管12、圆头13、显影压环14、连接座15、内芯(图未示)和盖帽17。所述球囊11设置于所述导管12的一端，并与所述导管12连通。所述圆头13设置于所述导管12的一端端面。所述显影压环14设置于所述导管12的一端，并且所述球囊11位于所述圆头13和所述显影压环14之间。所述连接座15设置于所述导管12的另一端，并且与所述导管12连通。所述内芯固定安装于所述导管12内。所述盖帽17安装于所述连接座15。
具体的，所述球囊11具有顺应性或半顺应性。顺应性是指弹性体在外力作用下发生形变的难易程度。所述球囊11可由乳胶、尼龙、硅胶、TPU或TPE等热塑性弹性体塑料制成。扩张后的球囊11形状可以为球形、椭圆形、梨型、胶囊形或花生型。
所述导管12为带有透明色条的实色管体，有利于医生观察导管12内液体的状态，调整手术方式。导管的实色部分添加有显影剂(例如，硫酸钡、硫酸锶、碳酸镁等)，可实现在人体组织内显影，便于医生判断导管12在人体组织内的具体位置。所述导管12可由PA、PVC、PE、FEP、Pebax聚醚嵌段弹性体等具有韧性和强度的热塑性树脂材料制成，使其具有一定韧性和刚性，不易弯折，有利于所述导管12插入所述穿刺针组件20内。为了便于医生获知导管12进入到穿刺针组件20内的深度，所述导管12上设置有刻度，该刻度与穿刺针组件20的总长相关，通过读取所述刻度获知所述导管12进入到穿刺针组件20内的深度。
在其中一种具体实施方式中，所述导管12与球囊11连接的一端由弹性金属材料制成，另一端由医用高分子材料制成，并且两端之间使用粘接或热合工艺连接。
圆头13固定于所述导管12一端的端面，其由具有一定刚性和显影作用的不锈钢、钽、铂铱合金、铂金、金、镍钛、铁或其他金属、合金材料制成。该圆头13用于引导导管12顺畅地插入穿刺针组件20内。圆头13的形状可是半圆头、椭圆头或带有一定弧度的锥头，其最大外径略大于显影压环14的外径，以防止显影压环14脱出。
显影压环14固定于所述导管12的一端，并靠近所述球囊11，其由具有一定刚性和显影作用的不锈钢、钽、铂铱合金、铂金、金、镍钛、铁或其他金属、合金材料制成。医生可以通过X射线定位显影压环14在人体组织内的具体位置，从而定位球囊导管10的在人体组织内的具体位置。
所述连接座15设置于所述导管12的另一端，并且与所述导管12连通。所述连接座15设置有鲁尔锥度和标准螺纹，便于与其它医疗器械连接。
所述连接座15具有内腔，其内腔可为单腔、Y型双腔、T型双腔、三腔或者四腔，采用PP、PE、PC、ABC、POM等医用高分子材料制成。连接座15可与注射器连接，并由注射器向其注入显影液，进入导管12，进而流入球囊11，使得球囊11膨胀；相反地，抽出液体时，球囊11收缩。
所述内芯贯穿于所述导管12内。所述盖帽17通过螺纹连接安装于所述连接座15。所述内芯通过所述连接座15和盖帽17的螺纹固定在所述导管12内。盖帽17内部设置有鲁尔锥度和标准螺纹，可与连接座15旋接紧密，保持内芯在导管12内不发生移动。盖帽17外部设置有防滑纹，抓握时防止滑脱。
可以理解的是，在其它一些实施例中，为了简化所述球囊导管10的结构，上述球囊导管10中的圆头13、显影压环14、内芯16和盖帽17均可省略，所述球囊11设置于所述导管12的一端，所述连接座15 设置于所述导管12的另一端，所述连接座15通过所述导管12与所述球囊11连通。
如图3和图4所示，本发明实施例中穿刺针组件20包括穿刺针21和外鞘22，所述穿刺针21可插入所述外鞘22内。所述穿刺针21包括针芯211和针芯座212，所述针芯211的一端固定连接于所述针芯座212。所述外鞘22包括鞘体221和外鞘座222，所述鞘体221的一端固定连接于所述外鞘座222。所述针芯211可插入所述鞘体221内，所述针芯座212与所述外鞘座222卡扣连接。
具体的，所述针芯211的一端为针尾，其固定连接于所述针芯座212；所述针芯211的另一端为针头，其可为圆头、尖头、半圆头、椭圆头或带有一定弧度的圆锥头等。
如图5所示，所述针芯座212呈筒状，其一端封闭，另一端具有开口。所述针芯座212内设置有用于与所述针芯211固定连接的固定部2121。所述针芯座212的另一端外侧设置有卡扣部2122。在本实施例中，卡扣部2122共有两个，分别位于所述针芯座212的两相对侧。
所述鞘体221采用的材料薄且坚韧，其具体可由不锈钢、合金或经过预先加工过可撕裂的PP、PEP或TPU/TPE等热塑性弹性体塑料制成。所述鞘体221的侧壁厚度可低至0.1毫米，使得其介入直径大幅减少。所述针芯211与鞘体221之间的配合间隙在0.05毫米至0.2毫米之间，其配合度优良，可有效降低穿刺过程中毛细作用带来的穿刺阻力并减少出血。
如图6所示，所述外鞘座222包括基部2221、连接部2223、握持部2224和卡接部2225，所述基部2221的一端呈圆柱状，另一端呈圆锥状，所述基部2221沿其轴线设置有贯孔2222，所述鞘体221的一端穿过所述贯孔2222，并通过所述贯孔2222与所述基部2221固定连接。所述握持部2224呈长平板状，所述握持部2224的侧面通过所述连接部2223与所述基部2221固定连接，并且所述握持部2224沿所述基部2221的轴线设置。所述卡接部2225固定连接于所述握持部2224的一端，并且所述卡接部2225位于所述握持部2224朝向所述基部2221的表面。 所述握持部2224和卡接部2225均有两个，并且两个所述卡接部2225彼此相对。
如图7所示，所述卡扣部2122和所述卡接部2225相互配合，在本实施例中，所述卡扣部2122的具体结构为凸块，所述卡接部2225的具体结构也为凸块。在另一实施例中，所述卡扣部2122的具体结构为凹槽，所述卡接部2225的具体结构为凸块。在又一实施例中，所述卡扣部2122的具体结构为凸块，所述卡接部2225的具体结构为凹槽。
在使用该穿刺针组件20时，用针芯211的针头对准鞘体221，并逐渐将针芯211插入鞘体221中。在所述针芯211与所述鞘体221对准的同时，使得所述针芯座212上的两个所述卡扣部2122分别与所述外鞘座222上的两个所述卡接部2225对齐。在所述针芯211插入所述鞘体221的过程中，所述卡接部2225与所述卡扣部2122相互配合，从而使得所述针芯座212和所述外鞘座222完成卡扣连接。
在使用该穿刺针组件20的过程中，所述针芯211和鞘体221均插入患者的人体组织中。所述针芯座212和所述外鞘座222采用上述卡扣连接的方式，在将所述针芯211由患者的人体组织内抽离时，需要先将所述针芯座212和所述外鞘座222的连接断开，再握住所述针芯座212抽离。显然，卡扣连接的连接方式相比于其它的连接方式(例如，螺纹连接)，可以使所述针芯座212和所述外鞘座222更加快速地分离，并且，上述卡扣连接的方式避免了所述针芯座212和所述外鞘座222在分离过程中相互旋转，从而避免了所述针芯211相对于鞘体221相互转动。若所述针芯211和鞘体221相互转动，则会导致针芯211在人体组织内旋转，增大对人体组织的损伤。
可以理解的是，在其它一些实施例中，为了便于所述针芯座212上的两个所述卡扣部2122分别与所述外鞘座222上的两个所述卡接部2225对齐，所述针芯座212设置有第一引导部，所述外鞘座222设置有第二引导部，所述第一引导部与所述第二引导部相互配合引导所述针芯座212上的两个所述卡扣部2122分别与所述外鞘座222上的两个所述卡接部2225对齐。所述第一引导部的具体结构可以为引导槽，该引导 槽可开设于所述针芯座212的内侧壁。所述第二引导部的具体结构可以为引导块，所述引导块设置于所述基部2221的外侧面。所述引导槽朝向所述针芯211的针头的一端开设有开口，所述开口呈喇叭状或者呈V型。
当使用刺穿组件20完成穿刺工作后，需要将穿刺针21从外鞘22中抽离出来。由于所述握持部2224和卡接部2225的结构类似于跷跷板，因此当所述握持部2224另一端被压下时，所述握持部224一端翘起，导致所述卡接部2225与所述卡扣部2122相互错开，所述针芯座212与所述外鞘座222相互分离，进而将穿刺针21从外鞘22中抽离出来。为了便于使用者能够比较容易的将所述握持部2224的另一端压下，所述握持部2224一端的长度小于所述握持部2224另一端的长度。
本发明实施例中球囊导管套件100的具体使用方法：患者经全身麻醉后取仰卧位，肩下垫适当高度包布卷以保证颈部轻度伸展。在X射线环境下，用穿刺针组件20从患者侧面部穿刺，穿刺点选在患者侧口角旁约2.5厘米处。通过X影像定位和鞘体221上的刻度引导穿刺针组件20进入卵圆孔，但不要刺穿卵圆孔上缘。解锁针芯座212和外鞘做222，拔出穿刺针21，将外鞘22留置在人体组织内。将球囊导管10沿外鞘22的插入，其插入深度通过X影像定位和导管12上的刻度线判定。当球囊11进入Meckle's腔的三叉神经的半月节定位完成后，将稀释显影剂通过所述连接座15注入，使得球囊11充盈膨胀，并通过X影像监测球囊11的充盈状况。持续注入稀释显影剂至球囊11刚好填满Meckle's腔，并通过X影像监测球囊11的充盈形状为理想梨形外观。保持球囊11膨胀压迫三叉神经半月节1分钟，然后抽出显影剂，退出球囊导管10和外鞘22，穿刺点压迫数分钟止血，手术完成。
需要说明的是，本发明的说明书及其附图中给出了本发明的较佳的实施例，但是，本发明可以通过许多不同的形式来实现，并不限于本说明书所描述的实施例，这些实施例不作为对本发明内容的额外限制，提供这些实施例的目的是使对本发明的公开内容的理解更加透彻全面。并且，上述各技术特征继续相互组合，形成未在上面列举的各种实施例， 均视为本发明说明书记载的范围；进一步地，对本领域普通技术人员来说，可以根据上述说明加以改进或变换，而所有这些改进和变换都应属于本发明所附权利要求的保护范围。

Claims (11)

  1. 一种穿刺针组件(20)，其特征在于，包括:
    穿刺针(21)，包括针芯(211)和针芯座(212)，所述针芯(211)的一端固定连接于所述针芯座(212)；
    外鞘(22)，包括鞘体(221)和外鞘做(222)，所述鞘体(221)的一端固定连接于所述外鞘座(222)，所述针芯(211)可插入所述鞘体(221)内，所述针芯座(212)与所述外鞘座(222)卡扣连接。
  2. 根据权利要求1所述的穿刺针组件(20)，其特征在于，
    所述针芯座(212)设置有卡扣部(2122)；
    所述外鞘座(222)包括基部(2221)、连接部(2223)、握持部(2224)和卡接部(2225),所述握持部(2224)通过所述连接部(2223)与所述基部(2221)固定连接，所述鞘体(221)的一端固定连接于所述基部(2221)，所述卡接部(2225)固定连接于所述握持部(2224)的一端，所述卡扣部(2122)与所述卡接部(2225)。
  3. 根据权利要求2所述的穿刺针组件(20)，其特征在于，
    所述卡扣部(2122)共有两个，两个所述卡扣部(2122)分别位于所述针芯座(212)的两侧；
    所述握持部(2224)和所述卡接部(2225)均有两个，并且两个所述卡接部(2225)彼此相对。
  4. 根据权利要求3所述的穿刺针组件(20)，其特征在于，
    所述握持部(2224)一端的长度小于所述握持部(2224)另一端的长度。
  5. 一种球囊导管套件(100)，其特征在于，包括如权利要求1-4中任一项所述穿刺针组件(20)和球囊导管(10)。
  6. 根据权利要求5所述的球囊导管套件(100)，其特征在于，
    所述球囊导管(10)包括球囊(11)、导管(12)和连接座(15),所述球囊(11)设置于所述导管(12)的一端，所述连接座(15)设置于所述导管(12)的另一端，所述连接座(15)通过所述导管(12)与所述球囊(11)连通。
  7. 根据权利要求6所述的球囊导管套件(100)，其特征在于，
    所述球囊导管(10)还包括显影压环(14)，所述显影压环(14)固定于所述导管(12)的一端，并靠近所述球囊(11)。
  8. 根据权利要求7所述的球囊导管套件(100)，其特征在于，
    所述球囊导管(10)还包括用于引导导管(12)顺畅地插入所述穿刺针组件(20)内的圆头(13)，所述圆头(13)固定于所述导管(12)一端的端面，所述球囊(11)位于所述圆头(13)和所述显影压环(14)之间。
  9. 根据权利要求8所述的球囊导管套件(100)，其特征在于，
    所述圆头(13)的最大外径大于所述显影压环(14)的外径。
  10. 根据权利要求6所述的球囊导管套件(100)，其特征在于，
    所述导管(12)上设置有刻度，通过读取所述刻度获知所述导管(12)进入到所述穿刺针组件(20)内的深度。
  11. 根据权利要求6所述的球囊导管套件(100)，其特征在于，
    所述球囊导管(10)还包括内芯(16)和盖帽(17)，所述盖帽(17)通过螺纹连接安装于所述连接座(15)，所述内芯(16)通过所述连接座(15)和所述盖帽(17)的螺纹固定在所述导管(12)内。
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