WO2014169684A1 - 一种经单侧椎弓根行椎体成型术的操作装置 - Google Patents

一种经单侧椎弓根行椎体成型术的操作装置 Download PDF

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Publication number
WO2014169684A1
WO2014169684A1 PCT/CN2013/090621 CN2013090621W WO2014169684A1 WO 2014169684 A1 WO2014169684 A1 WO 2014169684A1 CN 2013090621 W CN2013090621 W CN 2013090621W WO 2014169684 A1 WO2014169684 A1 WO 2014169684A1
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WIPO (PCT)
Prior art keywords
bone cement
vertebral body
sleeve
hose
cement injection
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PCT/CN2013/090621
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English (en)
French (fr)
Inventor
曹晓建
李海俊
陈强
余利鹏
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南京医科大学第一附属医院
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Publication of WO2014169684A1 publication Critical patent/WO2014169684A1/zh

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1757—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the spine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1662—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans for particular parts of the body for the spine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8819—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1613—Component parts
    • A61B17/1631—Special drive shafts, e.g. flexible shafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/16—Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans
    • A61B17/1613—Component parts
    • A61B17/1633—Sleeves, i.e. non-rotating parts surrounding the bit shaft, e.g. the sleeve forming a single unit with the bit shaft
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8816—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections

Definitions

  • the invention relates to an operating device for vertebral body shaping by unilateral pedicle, belonging to the field of medical instruments.
  • Galibert et al. first described percutaneous vertebroplasty (PVP) for the treatment of pain caused by vertebral hemangioma.
  • PVP percutaneous vertebroplasty
  • the operation is guided by X-ray guided bone biopsy and perforating through the pedicle through the pedicle to enter the diseased vertebral body.
  • the bone cement is injected into the vertebral body through the needle, which increases the strength of the vertebral body, stabilizes the fracture, relieves the pain. Subsequently, it is widely used in pain caused by vertebral osteolytic malignant tumors and osteoporotic fractures.
  • PVP percutaneous kyphoplasty
  • This technical design approach differs from PVP in that, before injecting bone cement, the collapsed endplate is lifted with an expanded balloon catheter to restore the height and shape of the collapsed vertebral body, reducing kyphosis and causing vertebral body A bone cavity is then injected into the cavity with low viscosity to the higher viscosity bone cement.
  • PVP and PKP technologies have been widely used in clinical practice, and are currently widely used in the treatment of vertebral metastases, myeloma and osteoporotic vertebral compression fractures. But still face some problems. The first is the need for repeated perspective, followed by bone cement leakage.
  • Intraoperative repeated fluoroscopy in addition to the patient's need for unprotected repeated radiation exposure, while the protective operator is exposed to a long-term low-dose radiation exposure.
  • the current risk of long-term low-dose radiation exposure is unknown, and the individual dose limit for radiation protection in individuals in the public should be less than 5 mS V (0.5 r e m).
  • the long-term sustainability by radiation exposure individuals in public life, whole body irradiation by year's annual dose equivalent limit shall not be higher than lmSv (0.1 re m). It is clearly stated that individual dose limits are mandatory and must be strictly observed.
  • the personal dose limit is the lower bound of the unacceptable dose range, rather than the upper dose limit that can be accepted.
  • the specified personal dose limit cannot be used as a standard or design indicator to achieve satisfactory protection and can only be used as a constraint to control exposure with optimal principles. The essence is that the less the radiation exposure, the better. It is best not to "eat" the radiation.
  • Bone cement leakage can cause serious consequences. Epidural leakage and leakage of intervertebral foramen can cause severe nerve root pain. Surgical decompression is often needed to relieve pain. Intervertebral disc leakage can lead to degeneration of intervertebral disc and increase adjacent vertebrae. The risk of a body fracture; venous plexus leakage has the risk of causing pulmonary embolism, which can cause death in severe cases.
  • the operation of the vertebral body shaping operation through the unilateral pedicle can effectively reduce the time of radiation exposure, and at the same time, the one-side operation reduces the number of the perforating parts once, and also reduces the position of the perforating area.
  • the sputum is relatively easy to enter the anterior central part of the vertebral body, so unilateral sputum is relatively feasible; and in the lumbar vertebra, because the vertebral body is oblate, Therefore, even if the camber angle of the sputum is increased, it is difficult to enter the anterior central part of the vertebral body, and the operation is difficult.
  • the bone cement is often asymmetrically dispersed in the vertebral body.
  • the unilateral pedicle can be inserted through the normal angle of the pedicle and the balloon can be placed into the anterior middle 1/3 of the vertebral body to expand.
  • the injection site of the bone cement is closer to the center of the vertebral body than the bilateral bone cement injection, the distance from the bone cement to the edge of the vertebral body can be increased, and the leakage of the bone cement can be effectively reduced.
  • the angle can be worn and the balloon can be placed into the central portion of the anterior middle 1/3 of the vertebral body for expansion, which can effectively reduce radiation exposure and leakage of bone cement.
  • the operating device for unilateral pedicle vertebral body shaping comprises a guiding sleeve, a bone drill and a bone cement injection channel;
  • the top end of the guiding sleeve is provided with a tapered head, and the tapered head has a through hole for accommodating the guide pin in the axial direction thereof, and the bottom surface of the tapered head inside the guiding sleeve is curved a sloped hole, the side wall of the guiding sleeve is opposite to the curved slope surface;
  • the bone drill includes a push rod and a universal drill bit, and the universal drill bit is connected to the push rod through an elastic rod that can be bent in any direction, and the universal drill bit enters the guide sleeve and can be guided on the curved slope surface a predetermined position passing through the foramen ovale into the vertebral body;
  • the bone cement injection passage includes a bone cement injection sleeve and a hose connected at a tip end thereof and bendable in an arbitrary direction, the hose being built with elasticity
  • the polyethylene guide wire, the entry guide sleeve can pass through the foramen ovale into a predetermined position in the vertebral body under the guidance of the curved slope.
  • the end of the guiding sleeve is fixed with a handle
  • the handle includes a connecting end and a steering end
  • the guiding sleeve is fixedly fixed in the connecting end of the handle, and the orientation of the oval hole is consistent with the direction of the steering end .
  • the elastic rod is a coil spring.
  • the side wall of the hose has three rows of through holes along the length thereof, and the three rows of through holes are evenly distributed on the side wall of the hose in the circumferential direction near the distal end of the hose, the hose
  • the portion having the through hole contains a material that blocks radiation.
  • a push handle is fixed to an end of the bone cement injection sleeve, and the bone cement injection sleeve is fixedly fixed at a central position of the push handle, and the through hole is oriented perpendicular to a longitudinal direction of the push handle,
  • the outer wall of the end of the bone cement injection sleeve extending from the push handle portion is provided with a thread that is closely coupled to the bone cement injection device.
  • the invention has the following beneficial effects: (1) simple operation, easy grasping, and good doctor acceptance; (2) using the device, the balloon can be opened and the bone cement injection site is located in front of the vertebral body. 2/3 central part, which makes the diseased vertebrae get stronger and stable support; (3) Compared with the previous vertebral body shaping, the injection site of the bone cement is closer to the center of the vertebral body, and the edge of the vertebral body is far apart, and the cement is infiltrated. The probability of leakage is reduced.
  • the bilateral side of the surgical route is changed to one side, which can be obvious Shorten the operation time, reduce the patient's injury, and at the same time significantly reduce the radiation exposure of patients and medical staff;
  • the intra-osseous injection point of bone cement is expanded from one point to multiple points, so that the bone cement is more evenly dispersed in the bone; Widely used, and the scope of use of existing vertebral body forming technology is exactly the same.
  • Figure 1 is a schematic view showing the structure of the guide sleeve.
  • FIG. 2 is a schematic structural view of a tapered drill bit of the guide sleeve.
  • 3 is a schematic structural view of the bone drill.
  • Fig. 5 is a structural schematic view of the bone cement injection passage.
  • an operation device for unilateral pedicle vertebral body formation includes a guiding sleeve 1, a bone drill 2, a balloon expander, and a bone cement injection channel 3 ;
  • the top end of the guiding sleeve 1 is provided with a conical head 4, and the conical head 4 has a through hole 5 for accommodating a guide pin in the axial direction thereof, and a tapered head inside the guiding sleeve
  • the bottom surface is an arc-shaped slope surface 6 , and a side wall of the guide sleeve 1 opposite to the curved slope surface 6 is provided with an oval hole 7; the end of the guiding sleeve 1 is fixed with a handle 8
  • the handle comprises a connecting end 9 and a turning end 10, the guiding sleeve being fixedly connected in the connecting end 9 of the handle, the orientation of the oval hole 7 being aligned with the direction of the connecting end 9 to the turning end 10.
  • the bone drill 2 includes a push rod 11 and a gimbal drill bit 12, and the gimbal drill bit 12 is connected to the push rod 11 by a coil spring 13 that can be bent in any direction, and the gimbal drill bit 12 enters the guide sleeve 1 Guided by the curved slope 6 through the foramen ovale 7 into a predetermined position within the vertebral body.
  • the guide wire inside the balloon expander and the bone cement injection passage 3 is a polyethylene guide wire.
  • the bone cement injection passage 3 includes a bone cement injection sleeve 14 and a hose 15 connected at its top end which is bendable in any direction, and the hose 15 is embedded with an elastic polyethylene guide wire, the hose 15
  • the guiding sleeve 1 can enter the predetermined position of the vertebral body through the foramen ovale 7 under the guidance of the curved slope surface 6.
  • the side wall of the hose 15 has three rows of through holes along its length, three rows. The through hole is evenly distributed on the side wall of the hose in the circumferential direction, and is located near the distal end of the hose, and the portion of the hose having the through hole contains a material for blocking radiation, which facilitates the position of the through hole in the intraoperative perspective.
  • the distal end of the hose is a closed end, and the end of the bone cement injection sleeve 3 is fixed with a push handle 16 , and the bone cement injection sleeve 3 is fixedly fixed at a central position of the push handle 16 , the orientation of the through hole
  • the outer wall of the bone cement injection sleeve extending from the push handle portion is provided with a thread closely connected to the bone cement injection device, perpendicular to the longitudinal direction of the push handle.
  • the patient's position is the same as that of general vertebroplasty. Take the prone position, routine disinfection and drape, C-arm X-ray machine to locate the diseased vertebrae, and determine the head tilt and tail tilt angle of the piercing.
  • the guide sleeve will be rotated 90 degrees by the handle so that the steering end of the sleeve points inward and perpendicular to the torso.
  • the bone drill is placed along the guide sleeve, and the electric drill is turned in because the bevel design in the guide sleeve is 10,000.
  • the drill bit reaches the slope, the direction changes with the slope, and enters the vertebral body at a 145 ° angle with the guide sleeve along the foramen ovale.
  • the C-arm X-ray machine monitors the position of the universal drill bit in the front and side fluoroscopy, confirming that the electric drill does not penetrate the edge of the vertebral body and is located at the center of the front 1/3 of the vertebral body.
  • the polyethylene guide wire is pulled out from the balloon and placed into the steerable bone cement injection channel.
  • the guide sleeve is placed into the channel, and the perspective end shows that the distal end of the hose is placed in the correct position and then pulled out.
  • the bone cement was injected after the guide wire was taken out.

Abstract

一种经单侧椎弓根行椎体成型术的操作装置，包括导向套筒（1）、骨钻（2）和骨水泥注入通道（3）。导向套筒（1）的顶端设置有锥形头部（4），锥形头部（4）沿其轴线方向开有容纳导针穿过的贯通孔（5）。导向套筒（1）内侧的锥形头部底面为弧形坡面（6）。导向套筒（1）的侧壁上与弧形坡面（6）相对的位置处开有卵圆孔（7）。骨钻（2）包括推杆（11）和万向钻头（12），万向钻头（12）通过可向任意方向弯转的弹性杆件（13）与推杆（11）连接。万向钻头（12）进入导向套筒（1）可在弧形坡面（6）的引导下穿过卵圆孔（7）进入椎体内的预定位置。骨水泥注入通道（3）包括骨水泥注入套管（14）和连接在其顶端的可向任意方向弯转的软管（15），软管（15）内置入有弹性聚乙烯导丝，进入导向套筒（1）可在弧形坡面（6）的引导下穿过卵圆孔（7）进入椎体内的预定位置。该操作装置操作简单，容易掌握，医生接受度好。

Description

说 明 书 一种经单侧椎弓根行椎体成型术的操作装置 技术领域
本发明涉及一种经单侧椎弓根行椎体成型术的操作装置， 属于医疗器械领域。
背景技术
1987 年 Galibert 等首次描述了经皮椎体成形术 （percutaneous vertebroplasty, PVP) 用 于治疗椎体血管瘤所致的疼痛。 该术式在 X线引导下用骨活检穿剌针经皮经椎弓根穿剌进 入病变椎体内， 通过穿剌针向椎体内注射骨水泥， 增加椎体强度、 稳定骨折、 缓解疼痛， 随 后又广泛应用于椎体溶骨性恶性肿瘤和骨质疏松性骨折等所致的疼痛。 1998 年 Wong 等首 次实施经皮椎体后凸成形术 （percutaneous kyphoplasty, PKP), 构思上起源于 PVP。 这种 技术设计思路与 PVP 不同的是在注射骨水泥之前， 先用扩张球囊导管抬起塌陷的终板， 恢 复塌陷椎体的高度和形态， 减少脊柱后凸畸形， 同时在椎体内造成一个骨性空腔， 然后向空 腔内低压力注射较高黏滞性的骨水泥。
经过这些年的发展， 目前 PVP 和 PKP 技术在临床上获得广泛的应用， 目前广泛应用于 治疗椎体转移瘤、 骨髓瘤以及骨质疏松性椎体压缩骨折等疾病的治疗。 但仍然面临一些问题。 首先是需要反复透视的问题， 其次是骨水泥渗漏。
术中反复透视除了病人需要无防护的反复放射暴露以外， 同时有防护的操作医生处于一 种长期低剂量射线暴露下。 目前长期低剂量射线暴露的风险是未知的， 而放射防护中关于个 人剂量限制规定公众中个人受照射的年剂量当量应低于 5mSV(0.5rem)。 当长期持续受放射性 照射时， 公众中个人在一生中每年全身受照射的年剂量当量限值不应高于 lmSv(0.1rem)。 其中明确规定个人剂量限制是强制性的， 必须严格遵守。 个人剂量限值是不可接受的剂量范 围的下界， 而不是可以允许接受的剂量上限。 即使个人所受剂量没有超过规定的相应的剂量 当量限值， 仍然必须按照最优化原则考虑是否要进一步降低剂量。 所规定的个人剂量限值不 能作为达到满意防护的标准或设计指标， 只能作为以最优化原则控制照射的一种约束条件而 已。 其实质就是指射线暴露越少越好， 不 "吃"射线最好。
骨水泥渗漏会造成严重的后果， 硬膜外渗漏、 椎间孔渗漏可引起严重的神经根疼， 常需 要手术减压以缓解疼痛； 椎间盘渗漏会导致椎间盘退变， 增加邻近椎体骨折的风险； 静脉丛 渗漏有导致肺栓塞的风险， 严重时可以造成病人的死亡。
目前一般认为经过单侧椎弓根进行椎体成型手术的操作， 可以有效的降低射线暴露的时 间， 同时， 经过单侧操作因为减少了穿剌部位为一次， 同时也减少了经穿剌部位的硬膜外渗 说 明 书
漏、 椎间孔渗漏。 但单侧椎弓根穿剌进行椎体成型操作也面临很多的问题， 如为了使穿剌针 头尽量进入椎体的前中央部位， 一般需要增加穿剌的外倾角度， 这同时也增加了穿剌针进入 椎管和损伤神经根的风险和增了骨水泥硬膜外渗出及骨水泥热灼伤神经根的风险。 在胸椎， 因为椎体形态接近正圆， 只要进针点略偏外， 穿剌相对容易进入椎体的前中央部位， 所以单 侧穿剌相对可行； 而在腰椎因为椎体呈扁椭圆形， 所以即使增大穿剌的外倾角度， 进入椎体 前中央部位比较困难， 操作难度较大， 注射骨水泥后常导致骨水泥在椎体内不对称弥散。
理论上来讲， 如果设计可以在椎体内拐弯的操作通道， 经过单侧椎弓根正常角度进行穿 剌而又可以将球囊置入到椎体的前中 1/3 交界中央部位进行扩张， 可以有效的解决以上问题。 另外因为骨水泥的注射部位较双侧骨水泥注射更接近椎体的中央， 可以增加骨水泥渗出到椎 体边缘的距离， 有效的减少骨水泥的渗漏。
发明内容
发明目的： 本发明的目的在于提供一种经单侧椎弓根行椎体成型术的操作装置， 其设计 有可以引导软管在椎体内拐弯的操作套筒， 经过单侧椎弓根正常角度进行穿剌而又可以将球 囊置入到椎体的前中 1/3 交界中央部位进行扩张， 可以有效的减少射线的暴露和骨水泥的渗 漏。
技术方案： 本发明所述的一种经单侧椎弓根行椎体成型术的操作装置， 包括导向套筒、 骨钻和骨水泥注入通道；
所述导向套筒的顶端设置有锥形头部， 所述锥形头部沿其轴线方向开有容纳导针穿过的贯通 孔， 所述导向套筒内侧的锥形头部底面为弧形坡面， 所述导向套筒的侧壁上与弧形坡面相对 的位置处开有卵圆孔；
所述骨钻包括推杆和万向钻头， 所述万向钻头通过可向任意方向弯转的弹性杆件与推杆连接， 所述万向钻头进入导向套筒可在弧形坡面的引导下穿过卵圆孔进入椎体内的预定位置； 所述骨水泥注入通道包括骨水泥注入套管和连接在其顶端的可向任意方向弯转的软管， 所述 软管内置入有弹性聚乙烯导丝， 进入导向套筒可在弧形坡面的引导下穿过卵圆孔进入椎体内 的预定位置。
进一步地， 所述导向套筒的末端固定有手柄， 所述手柄包括连接端和转向端， 所述导向 套筒贯穿固定在手柄的连接端内， 所述卵圆孔的朝向与转向端方向一致。
进一步地， 所述弹性杆件为螺旋弹簧。
进一步地， 所述软管的侧壁上沿其长度方向开有三排通孔， 三排通孔位于靠近软管远端 位置处沿圆周方向均匀分布在软管的侧壁上， 所述软管开有通孔的部分含有阻挡射线的材料， 说 明 书
便于术中透视定位通孔位置， 软管的远端为封闭端。
进一步地， 所述骨水泥注入套管的末端固定有推柄， 所述骨水泥注入套管贯穿固定在推 柄的中央位置处， 所述通孔的朝向与推柄的长度方向垂直， 所述骨水泥注入套管末端伸出推 柄部分的外壁设有和骨水泥注射装置紧密相连的螺纹。
本发明与现有技术相比， 其有益效果是： （1 ) 操作简单， 容易掌握， 医生接受度好； （2) 使用该装置可以使球囊撑开及骨水泥注入的部位位于椎体前 2/3 中央部位， 使得病椎得到更 牢固稳定的支撑； （3 ) 和之前椎体成型术相比， 骨水泥的注入部位更接近椎体中央， 和椎体 边缘相距较远， 骨水泥渗漏的概率降低， 同时， 因为是单侧穿剌， 也减少穿剌通道进入椎管 的风险而降低骨水泥椎管渗漏的风险； （4) 手术入路由双侧改为单侧， 可以明显缩短手术时 间， 降低病人的损伤， 同时可以明显降低患者和医护人员的射线暴露； （5 ) 骨水泥骨内注射 点由一点扩大为多点， 使得骨水泥在骨质内弥散更加均匀； （6 ) 使用范围广泛， 和现有的椎 体成型技术的使用范围完全相同。
附图说明
图 1为所述导向套筒的结构示意图。
图 2为所述导向套筒的锥形钻头的结构示意图。
图 3为所述骨钻的结构示意图。
图 4为所述万向钻头的结构示意图。
图 5为所述骨水泥注入通道的结构示意图。
具体实施方式
下面对本发明技术方案进行详细说明， 但是本发明的保护范围不局限于所述实施例。
实施例 1: 如图 1 至 5所示， 一种经单侧椎弓根行椎体成型术的操作装置， 包括导向套 筒 1、 骨钻 2、 球囊撑开器和骨水泥注入通道 3 ;
所述导向套筒 1 的顶端设置有锥形头部 4， 所述锥形头部 4沿其轴线方向开有容纳导针穿过 的贯通孔 5， 所述导向套筒内侧的锥形头部底面为弧形坡面 6， 所述导向套筒 1 的侧壁上与 弧形坡面 6相对的位置处开有卵圆孔 7; 所述导向套筒 1 的末端固定有手柄 8， 所述手柄包 括连接端 9和转向端 10， 所述导向套筒贯 1穿固定在手柄的连接端 9内， 所述卵圆孔 7的 朝向与连接端 9往转向端 10的方向一致。
所述骨钻 2包括推杆 11和万向钻头 12， 所述万向钻头 12通过可向任意方向弯转的螺旋 弹簧 13与推杆 11连接， 所述万向钻头 12进入导向套筒 1可在弧形坡面 6的引导下穿过卵 圆孔 7进入椎体内的预定位置。 说 明 书
所述球囊撑开器及骨水泥注入通道 3内部的导丝为聚乙烯导丝。
所述骨水泥注入通道 3包括骨水泥注入套管 14和连接在其顶端的可向任意方向弯转的软 管 15， 所述软管 15内置入有弹性聚乙烯导丝， 所述软管 15进入导向套筒 1可在弧形坡面 6 的引导下穿过卵圆孔 7进入椎体内的预定位置， 所述软管 15 的侧壁上沿其长度方向开有三 排通孔， 三排通孔沿圆周方向均匀分布在软管的侧壁上， 且位于靠近软管远端位置处， 所述 软管开有通孔的部分含有阻挡射线的材料， 便于术中透视定位通孔位置， 软管的远端为封闭 端， 所述骨水泥注入套管 3 的末端固定有推柄 16， 所述骨水泥注入套管 3 贯穿固定在推柄 16 的中央位置处， 所述通孔的朝向与推柄的长度方向垂直， 所述骨水泥注入套管末端伸出 推柄部分的外壁设有和骨水泥注射装置紧密相连的螺纹。
具体的手术步骤如下：
1、 患者体位和一般椎体成型术操作一样， 取俯卧位， 常规消毒铺巾， C臂 X光机定位病椎， 同时确定穿剌的头倾和尾倾角度。
2、 C臂 X光机引导下和目前椎体成型术一样 （使用目前的穿剌器械） 进行病椎单侧椎弓根 的穿剌， 确认穿剌针进入椎弓根且位置正确后置入导针。
3、 顺着导针置入可转向的所述导向套筒， 保持导向套筒的手柄和躯干平行， 此时侧位透视 可以观察到套筒上卵圆孔的位置， C臂 X光机透视确认导向套筒的深度以及卵圆孔是否已经 超过椎体的后缘； 一般以卵圆孔完全超过椎体的后缘且中心位于椎体侧位投影中后 1/3 处为 最佳位置， 然后拔出导针。
4、 将通过手柄将导向套筒旋转 90度， 使得套筒的转向端指向内侧且和躯干垂直， 沿着导向 套筒置入骨钻， 电钻转入， 因为导向套筒内的斜面设计， 万向钻头在到达斜面时方向随着斜 面而变换， 顺着卵圆孔与导向套筒呈 145 ° 角进入椎体。 同时 C臂 X光机正位和侧位透视监 测万向钻头位置， 确认电钻不穿透椎体边缘且位置位于椎体的前中 1/3交界的中央部位。
5、 拔出万向钻头后， 置入球囊撑开器 （球囊撑开器内部的金属导丝更换为聚乙烯导丝） 至 合适位置后， 行撑开复位。
6、 撑开复位满意后将聚乙烯导丝由球囊拔出后置入可转向的所述骨水泥注入通道， 经导向 套筒置入通道， 透视提示远端软管置入正确位置后拔出导丝后开始注射骨水泥。
7、 骨水泥注射结束在骨水泥凝固前拔出软管， 使软管退入导向套筒， 但不完全拔出， 同时 旋转导向套筒 90° 。 于骨水泥凝固后拔出导向套筒， 手术结束。
如上所述， 尽管参照特定的优选实施例已经表示和表述了本发明， 但其不得解释为对本发 明自身的限制。 在不脱离所附权利要求定义的本发明的精神和范围前提下， 可对其在形式上 说 明 书 和细节上作出各种变化。

Claims

权 利 要 求 书
1. 一种经单侧椎弓根行椎体成型术的操作装置， 包括导向套筒、 骨钻和骨水泥注入通道， 其特征在于：
所述导向套筒的顶端设置有锥形头部， 所述锥形头部沿其轴线方向开有容纳导针穿过的贯通 孔， 所述导向套筒内侧的锥形头部底面为弧形坡面， 所述导向套筒的侧壁上与弧形坡面相对 的位置处开有卵圆孔；
所述骨钻包括推杆和万向钻头， 所述万向钻头通过可向任意方向弯转的弹性杆件与推杆连接， 所述万向钻头进入导向套筒可在弧形坡面的引导下穿过卵圆孔进入椎体内的预定位置； 所述骨水泥注入通道包括骨水泥注入套管和连接在其顶端的可向任意方向弯转的软管， 所述 软管内置入有弹性聚乙烯导丝， 进入导向套筒可在弧形坡面的引导下穿过卵圆孔进入椎体内 的预定位置。
2. 根据权利要求 1 所述的经单侧椎弓根行椎体成型术的操作装置， 其特征在于， 所述导向 套筒的末端固定有手柄， 所述手柄包括连接端和转向端， 所述导向套筒贯穿固定在手柄的连 接端内， 所述卵圆孔的朝向与转向端的方向一致。
3. 根据权利要求 1 所述的经单侧椎弓根行椎体成型术的操作装置， 其特征在于， 所述弹性 杆件为螺旋弹簧。
4. 根据权利要求 1 所述的经单侧椎弓根行椎体成型术的操作装置， 其特征在于， 所述软管 的侧壁上沿其长度方向开有三排通孔， 三排通孔位于靠近软管远端位置处沿圆周方向均匀分 布在软管的侧壁上， 所述软管开有通孔的部分设有阻挡射线的材料， 便于术中透视定位通孔 位置， 所述软管的远端为封闭端。
5. 根据权利要求 4 所述的经单侧椎弓根行椎体成型术的操作装置， 其特征在于， 所述骨水 泥注入套管的末端固定有推柄， 所述骨水泥注入套管贯穿固定在推柄的中央位置处， 所述通 孔的朝向与推柄的长度方向垂直， 所述骨水泥注入套管末端伸出推柄部分的外壁设有和骨水 泥注射装置紧密相连的螺纹。
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