WO2022057017A1 - 一种椎体撑开填充装置及推进器 - Google Patents

一种椎体撑开填充装置及推进器 Download PDF

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Publication number
WO2022057017A1
WO2022057017A1 PCT/CN2020/124581 CN2020124581W WO2022057017A1 WO 2022057017 A1 WO2022057017 A1 WO 2022057017A1 CN 2020124581 W CN2020124581 W CN 2020124581W WO 2022057017 A1 WO2022057017 A1 WO 2022057017A1
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WIPO (PCT)
Prior art keywords
sleeve
expansion
casing
mandrel
ring
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PCT/CN2020/124581
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English (en)
French (fr)
Inventor
李维铭
潘会会
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山东冠龙医疗用品有限公司
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Publication of WO2022057017A1 publication Critical patent/WO2022057017A1/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
    • A61B17/56—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
    • A61B17/885—Tools for expanding or compacting bones or discs or cavities therein
    • A61B17/8852—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc
    • A61B17/8855—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc inflatable, e.g. kyphoplasty balloons
    • 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 the field of medical instruments, in particular to a vertebral body expansion and filling device, and also to a propeller.
  • Vertebroplasty (PVP) and kyphoplasty (PKP) are currently the most effective and simple surgical methods for the treatment of vertebral compression fractures.
  • PKP uses balloons or other mechanical devices to stretch the compressed vertebral body.
  • the kyphosis is partially or completely corrected, and then the filler (bone cement) is injected to strengthen the vertebral body, so as to stabilize the fracture, restore the mechanical strength of the vertebral body and relieve pain.
  • the present invention provides a vertebral body distraction filling device, comprising an expansion sleeve, a mandrel and a limit ring.
  • the sleeve is made of non-metallic material, and the expansion sleeve is provided with a number of slots cut along the axial direction of the expansion sleeve.
  • These slots are arranged around the expansion sleeve, and the expansion sleeve is sleeved on the mandrel,
  • the front end of the mandrel is provided with a blocking structure for blocking the downward movement of the expansion sleeve
  • the limit ring is matched and connected with the mandrel
  • the limit ring is located behind the expansion sleeve
  • the mandrel is provided with a Ring positioning structure
  • the expansion sleeve is made of non-metallic material, such as peek material, which can be implanted into the human body; the expansion sleeve is provided with a slot to make it have an expansion function, and the sleeve is slotted at a certain length every time. 4-6 are equally divided, and the included angle of each slot is 60-90°.
  • the expansion part can be designed with various specifications. The doctor can choose the required specifications according to the patient's condition.
  • the mandrel is hinged by a plurality of movable joints, and the mandrel is set as a hinge structure, so that the expanded sleeve can be bent at a certain angle according to the shape of the vertebral body and the direction of instrument placement, so as to prevent forcible expansion damage
  • the upper and lower endplates; the expansion sleeve is sleeved on the mandrel, and the expansion sleeve can be expanded by pushing the limit ring. It is easy to insert in the contracted state. After insertion, it is expanded to achieve the purpose of filling the vertebral body. Cement filling can reduce the risk.
  • connection structures at two adjacent hinged positions are in a vertical relationship.
  • tie rod connection structure is a threaded hole provided on the rear end surface of the mandrel. Realize detachable connection with the pull rod of the propeller.
  • the limit ring is sleeved on the mandrel, the limit ring is provided with a snap ring, and the ring positioning structure includes an elastic hook.
  • the elastic hook When the snap ring passes over the elastic hook, the elastic hook will pop out by its own elasticity. and hook the snap ring.
  • the elastic hook By arranging the elastic hook to cooperate with the snap ring, after the snap ring passes over the elastic hook, the elastic hook will clamp it, preventing the limit ring from moving backward, so as to maintain the expanded state after the expansion sleeve is opened.
  • the limit ring is sleeved on the mandrel, the side wall of the limit ring is provided with a through expansion cut, and the ring positioning structure includes an annular groove, when the limit ring moves to the position of the annular groove.
  • the limit ring When in position, the limit ring will shrink and snap into the annular groove. Due to the existence of the expansion incision, the limit ring will shrink after entering the annular groove, so as to realize the limit of the pushed limit ring, so as to maintain the expanded state after the expansion sleeve is stretched.
  • the present invention also provides a pusher, which includes the above-mentioned vertebral body distraction and filling device, and also includes sequentially arranged from the inside to the outside.
  • the front end of the draw rod is connected with the mandrel, the front end of the inner sleeve is against the limit ring, and also includes an inner and outer threaded rod and a limit block.
  • the end is connected with the inner thread of the inner and outer threaded rods through the inner casing connection structure
  • the rear end of the outer casing is connected with the outer thread of the inner and outer threaded rods through the outer casing connection structure
  • the limit block is used for the inner casing and the outer casing. Rotation limit, the connection between the pull rod and the limit block can tighten the mandrel; before the expansion sleeve is opened, the expansion sleeve is located in the outer sleeve, and the outer sleeve can be moved backward by rotating the inner and outer threaded rods. The casing moves forward, and the inner casing pushes the limit ring to move forward to spread the expansion casing.
  • the mandrel is tightened by the tie rod to realize the inner casing pushes the limit ring forward along the mandrel shaft, and the expansion casing is stretched to expand it.
  • the transmission speed of the casing and the outer casing ensures that the expansion casing is spread out smoothly.
  • the front end of the outer sleeve is sleeved on the outside of the expansion sleeve, and the expansion sleeve part contained in the outer sleeve is not deformed when the expansion sleeve is constrained to be squeezed by the inner sleeve.
  • the limiting block is fixedly connected with the casing
  • the thrust bearing is installed at the rear of the casing
  • the rear part of the inner and outer threaded rod is connected to the handle after passing through the thrust bearing and the casing.
  • a thrust bearing is provided to reduce the axial resistance when the screw is rotated, and the rotation of the internal and external threaded rods can be driven by turning the handle, which is convenient for operation.
  • the inner sleeve connection structure includes an inner sleeve seat, the middle of the inner sleeve seat is provided with a long slot hole for accommodating the stop block, and the rear of the inner sleeve seat is provided with a long slot hole.
  • the outer casing is provided with a reverse external thread and the inner thread of the inner and outer threaded rods are matched to connect;
  • the outer casing connection structure includes an outer casing seat, and a long slot hole for accommodating a limit block is also arranged in the middle of the outer casing seat.
  • the rear part of the outer casing seat is provided with an inner thread and an outer thread of an inner and outer threaded rod; the limit block passes through the long slot hole, and the outer side of the limit block is connected with a shell cover, and the shell cover is installed with a shell cover.
  • a through hole is arranged in the middle of the limiting block, the pull rod passes through the through hole, and a pull rod handwheel is connected to the rear of the pull rod.
  • the inner casing connecting structure includes an inner casing seat, an inner casing connecting rod and a connecting seat, the inner casing seat is fixedly connected with the lower part of the inner casing connecting rod, and the The upper part of the inner casing connecting rod is fixedly connected with the connecting seat.
  • the connecting seat is provided with an indicator needle to be displayed from the window of the outer casing;
  • the outer casing is fixedly connected with the outer casing seat, the outer casing seat is connected with the lower part of the outer casing connecting rod, and the upper part of the outer casing connecting rod is connected with the external thread of the inner and outer threaded rod.
  • mandrel and the limit ring are made of titanium alloy.
  • the present invention has the following advantages:
  • the invention provides a vertebral body expansion and filling device.
  • the expansion and filling part is made of materials that meet the biocompatibility requirements of implanted medical devices, the expansion sleeve is made of non-metallic materials, and the mandrel and the limit ring are made of titanium alloy materials.
  • the collapsed vertebral body can be raised and the height of the vertebral body can be restored. Since no bone cement is injected, the risk of bone cement leakage is fundamentally solved.
  • the mandrel adopts two pairs of mutually perpendicular hinge structures, so that the expanded sleeve can be bent at a certain angle according to the shape of the vertebral body and the direction of instrument placement, so as to prevent the upper and lower endplates from being damaged by forced expansion.
  • the expansion part can be designed with various specifications, and the doctor can choose the required specification according to the patient's condition.
  • the present invention also provides a propeller, which has two schemes, both of which adopt the working principle of the forward and reverse internal and external thread structure. Through the design of the thread and the pitch, the rotating screw is realized, and the inner and outer casings move in two directions according to different speeds. , compact structure and easy operation.
  • FIG. 1 is a schematic structural diagram of Embodiment 1 of the present invention.
  • FIG. 2 is a schematic structural diagram of the mandrel and the limiting ring in FIG. 1 .
  • FIG. 3 is an overall schematic diagram of the outside of FIG. 1 .
  • FIG. 4 is another schematic structural diagram of Embodiment 1 of the present invention.
  • FIG. 5 is a schematic structural diagram of the mandrel and the limiting ring in FIG. 2 .
  • FIG. 6 is an overall schematic diagram of the outside of FIG. 2 .
  • FIG. 7 is a schematic structural diagram of Embodiment 2 of the present invention.
  • FIG. 8 is a side view of Embodiment 2 of the present invention.
  • FIG. 9 is a schematic structural diagram of Embodiment 3 of the present invention.
  • FIG. 10 is a schematic diagram of Embodiment 3 of the present invention after the upper half of the casing is hidden.
  • FIG. 11 is a schematic structural diagram of the expansion sleeve in Embodiments 1-4 of the present invention.
  • this specific embodiment provides a vertebral body distraction filling device, which mainly includes an expansion sleeve 1 , a mandrel 2 and a limit ring 3 , the mandrel 2 and the limit ring 3. Titanium alloy material is used.
  • the expansion sleeve 1 is made of peek non-metallic material, which can be implanted in the human body.
  • the expansion sleeve 1 is provided with several slots 101 cut along the axial direction of the expansion sleeve 1. These slots 101 is arranged around the expansion casing 1. By setting the slot 101 on the expansion casing 1, it has the expansion function.
  • the casing is slotted 101, and the circumference is equally divided into 4-6, and the included angle of each slot is 60-90°, by adjusting the initial length of the expansion sleeve 1, the length and quantity of the slot 101, the expansion part can be designed with various specifications, and the doctor can choose the required specification according to the patient's condition;
  • the expansion sleeve 1 set On the mandrel 2 the front end of the mandrel 2 is provided with a blocking structure for blocking the downward movement of the expansion sleeve 1 , the limit ring 3 is connected with the mandrel 2 , and the limit ring 3 is located behind the expansion sleeve 1 .
  • the mandrel 2 is provided with a ring positioning structure, pushing the limit ring 3 forward can squeeze the expansion sleeve 1 to make it expand, and the limit ring 3 is connected to the ring positioning structure to maintain the expansion state of the expansion sleeve 1;
  • the rear part of the shaft 2 is provided with a connection structure of the pull rod 4 for connecting with the propeller.
  • the mandrel 2 is hinged by a plurality of movable joints. In this scheme, there are four movable joints, and the connection between two adjacent hinge positions The structure is in a vertical relationship, so that it can bend at a certain angle in different directions.
  • the mandrel 2 is set as a hinge structure, so that the expanded sleeve can be bent at a certain angle according to the shape of the vertebral body and the direction in which the instrument is placed. It adapts well to the internal shape of the vertebral body and prevents the upper and lower endplates from being damaged by forced expansion.
  • connection structure of the pull rod 4 is a threaded hole 21 provided on the rear end surface of the mandrel 2 to realize detachable connection with the pull rod 4 of the propeller.
  • the limit ring 3 is sleeved on the mandrel 2, the limit ring 3 is provided with a snap ring 31, and the ring positioning structure includes the elastic hook 22.
  • the elastic hook 22 relies on It elastically pops out and hooks the snap ring 31.
  • the snap ring 31 crosses the elastic hook 22 and then the elastic hook 22 clamps it, preventing the limit ring 3 from moving backward to keep the The expanded state after the expansion sleeve 1 is stretched.
  • the limit ring 3 is sleeved on the mandrel 2 , and a through expansion cut 32 is provided on the side wall of the limit ring 3 , and the limit ring 3 is installed on the On the mandrel 2, the ring positioning structure includes an annular groove.
  • the limit ring 3 moves to the position of the annular groove, the limit ring 3 will shrink and snap into the annular groove.
  • the limit ring 3 contracts after entering the annular groove, so as to limit the pushed limit ring 3 to maintain the expanded state after the expansion sleeve 1 is stretched.
  • this specific embodiment provides a pusher, including the vertebral body distraction filling device in the specific embodiment 1, and also includes a housing 12, a handle 10, a thrust force
  • the bearing 9, and the pull rod 4 are arranged sequentially from the inside to the outside.
  • the front end of the pull rod 4 is provided with a threaded head to connect with the mandrel 2.
  • the rear end of the inner sleeve 5 is connected with the inner thread of the inner and outer threaded rod 8 through the inner sleeve 5 connection structure, and the rear end of the outer sleeve 6 is connected with the inner and outer threads through the outer sleeve 6 connection structure.
  • the external thread of the rod 8 is connected, the limit block 7 limits the rotation of the inner sleeve 5 and the outer sleeve 6, and the connection between the pull rod 4 and the limit block 7 can tighten the mandrel 2;
  • the expansion sleeve 1 is located in the outer sleeve 6.
  • the outer sleeve 6 By rotating the inner and outer threaded rods 8, the outer sleeve 6 can move backwards while the inner sleeve 5 moves forward, and the inner sleeve 5 pushes the limit ring 3 to move forward to move the expansion sleeve
  • the tube 1 is stretched open, the limit block 7 is fixedly connected with the housing 12 , the thrust bearing 9 is installed at the rear of the housing 12 , and the rear part of the inner and outer threaded rod 8 passes through the thrust bearing 9 and the housing 12 and is connected to the handle 10 .
  • the mandrel 2 is tightened by the tie rod 4 to realize that the inner sleeve 5 pushes the limit ring 3 forward along the mandrel 2, and the expansion sleeve 1 is stretched to expand it.
  • the expansion casing 1 With a certain internal and external thread pitch, coordinate the front and rear movement speeds of the inner casing 5 and the outer casing 6, the expansion casing 1 is stretched from the front to the rear, and the front end of the outer casing 6 is sleeved on the outside of the expansion casing 1, constraining the expansion casing 1 When pressed by the inner sleeve 5, the part of the expansion sleeve 1 contained in the outer sleeve 6 is not deformed.
  • connection structure of the inner sleeve 5 includes an inner sleeve seat 51, the middle of the inner sleeve seat 51 is provided with a long slot hole for accommodating the stop block 7, and the rear of the inner sleeve seat 51 is provided with a reverse
  • the external thread is connected with the internal thread of the internal and external thread rod 8
  • connection structure of the outer sleeve 6 includes an outer sleeve seat 61, and the middle of the outer sleeve seat 61 is also provided with a long slotted hole for accommodating the stop
  • the rear part is provided with an inner thread and is connected with the outer thread of the inner and outer thread rod 8; the limit block 7 passes through the long slot hole, and the outer side of the limit block 7 is connected with an outer casing 12 cover.
  • the middle of the block 7 is provided with a through hole through which the pull rod 4 passes, and a pull rod handwheel 11 is connected to the rear of the pull rod 4 .
  • this specific embodiment provides a propeller that is different from the specific embodiment 2, which includes the vertebral body distraction and filling device in the specific embodiment 1, It also includes a shell, a handle 10, a thrust bearing 9, a tie rod 4, an inner sleeve 5 and an outer sleeve 6 that are sequentially arranged from the inside to the outside, and the upper and lower shells are detachably connected together.
  • the shaft 2 is connected, the front end of the inner sleeve 5 is against the limit ring 3, and also includes an inner and outer threaded rod 8 and a limit block 7, and the rear end of the inner sleeve 5 is connected to the inner part of the inner and outer threaded rod 8 through the connection structure of the inner sleeve 5.
  • the rear end of the outer sleeve 6 is connected with the external thread of the inner and outer threaded rod 8 through the connection structure of the outer sleeve 6, the limit block 7 limits the rotation of the inner sleeve 5 and the outer sleeve 6, and the pull rod 4 and the limit block 7
  • the connection can tighten the mandrel 2; before the expansion sleeve 1 is opened, the expansion sleeve 1 is located in the outer sleeve 6, and the outer sleeve 6 can be moved backward by rotating the inner and outer threaded rod 8 while the inner sleeve 5 moves forward Move, the inner sleeve 5 pushes the limit ring 3 to move forward to spread the expansion sleeve 1, the limit block 7 is fixedly connected with the outer shell 12, the thrust bearing 9 is installed at the rear of the outer shell 12, the rear of the inner and outer threaded rod 8 The part is connected with the handle 10 after passing through the thrust bearing 9 and the casing 12 .
  • the mandrel 2 is tightened by the tie rod 4 to realize that the inner sleeve 5 pushes the limit ring 3 forward along the mandrel 2, and the expansion sleeve 1 is stretched to expand it.
  • a certain internal and external thread pitch coordinate the front and rear movement speed of the inner casing 5 and the outer casing 6, spread the expansion casing 1 from front to back in turn, and the front end of the outer casing 6 is sleeved on the outside of the expansion casing 1, constraining the expansion casing 1
  • the part of the expansion sleeve 1 contained in the outer sleeve 6 is not deformed.
  • connection structure of the inner sleeve 5 includes an inner sleeve seat 51, an inner sleeve connecting rod 53 and a connecting seat 54, the inner sleeve seat 51 is fixedly connected with the lower part of the inner sleeve connecting rod 53, and the inner sleeve
  • the upper part of the connecting rod 53 is fixedly connected with the connecting seat 54
  • the connecting seat 54 is connected with the inner thread of the inner and outer threaded rod 8 through the screw 55
  • the limit block 7 is located in the inner cavity of the inner sleeve connecting rod 53, and the rear end of the pulling rod 4 After passing through the limit block 7, it is fastened by a nut, and the connecting seat 54 is provided with an indicator pin 56 for display from the window of the housing 12
  • the connection structure of the outer sleeve 6 includes an outer sleeve seat 61 and an outer sleeve connecting rod 63, The rear part is fixedly connected with the outer sleeve seat 61 , the outer s

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Abstract

一种椎体撑开填充装置，包括膨胀套管（1）、芯轴（2）和限位环（3），膨胀套管（1）为非金属材质，膨胀套管（1）上设置有若干个开槽（101），膨胀套管（1）套装在芯轴（2）上，芯轴（2）的前端部设置有阻挡结构，尾部设置有环定位结构以及与拉杆（4）配合的连接结构，限位环（3）位于膨胀套管（1）的后方，向前推动限位环（3）能够挤压膨胀套管（1）使其膨胀，限位环（3）连接到环定位结构上保持膨胀套管（1）的膨胀状态，实现撑开和填充椎体的目的，因不再注射骨水泥，从而解决了椎体填充骨水泥出现渗漏的风险问题。以及一种推进器，采用正反向内外螺纹结构的工作原理，通过螺纹和螺距的设计，实现转动内外螺纹杆（8），内、外套管（5，6）按照不同的速度向两个方向移动，操作简便。

Description

一种椎体撑开填充装置及推进器 技术领域
本发明涉及医疗器械领域，尤其涉及一种椎体撑开填充装置，另外，还涉及一种推进器。
背景技术
椎体成形术(PVP)和椎体后凸成形术(PKP)是目前治疗椎体压缩性骨折的最有效最简便的手术方式，其中PKP采用球囊或其他机械装置撑开压缩的椎体，使后凸畸形得到部分或完全纠正，再注入填充剂(骨水泥)进行椎体强化，达到稳定骨折，恢复椎体力学强度和缓解疼痛的目的。
然而，该手术的最大的风险在于注射骨水泥时出现泄露，因此，该手术特别强调的是骨水泥注射时的状态，骨水泥太稀泄漏的风险高，骨水泥太稠则注射困难，填充不饱满。
因此，针对上述现有技术中往椎体中注射骨水泥风险高的现状，研发一种椎体撑开装置以及将该椎体撑开装置置入到椎体中的推进器是急需解决的问题。
发明内容
一方面，针对上述现有技术中存在往椎体中注射骨水泥风险高的问题，本发明提供了一种椎体撑开填充装置，包括膨胀套管、芯轴和限位环，所述膨胀套管为非金属材质，所述膨胀套管上设置有若干个沿膨胀套管的轴向切割开的开槽，这些开槽环绕膨胀套管布置，所述膨胀套管套装在芯轴上，所述芯轴的前端部设置有用于阻挡膨胀套管向下移动的阻挡结构，所述限位环与芯轴配合连接，并且限位环位于膨胀套管的后方，所述芯轴上设置有环定位结构，向前推动限位环能够挤压膨胀套管使其膨胀，并且限位环连接到环定位结构上保持膨胀套管的膨胀状态；所述芯轴的后部设置有用于和推进器连接的拉杆连接结构，所述芯轴通过多根活动关节铰接而成。将膨胀套管设置为非金属材质，如peek材质的，可向人体中植入；通过在膨胀套管上设置开槽，使其具备膨胀功能，每间隔一定长度在套管上开槽，圆周4-6均分，每段槽夹角60-90°，通过调整膨胀套管的初始长度和开槽的长度，可以将膨 胀部分可以设计多种规格，医生可以根据患者情况，选择需要的规格使用；芯轴通过多根活动关节铰接而成，将芯轴设置为铰链结构，可以使膨胀后的套管根据椎体内的形状与器械置入的方向有一定角度的弯曲，防止强行膨胀损伤上下终板；通过膨胀套管套在芯轴上，推动限位环可使膨胀套管进行膨胀，在收缩状态下容易置入，置入后使其膨胀到达填充椎体的目的，相对于骨水泥的填充能够降低风险。
进一步的，所述活动关节设置有四个，在相邻两个铰接位置的连接结构呈垂直关系。通过将四个活动关节设置为两组相互垂直的结构，实现一定程度的弯曲以更好的适应椎体内部形状。
进一步的，所述拉杆连接结构为设置于芯轴后端面上的螺纹孔。实现与推进器的拉杆进行可拆卸连接。
进一步的，所述限位环套装在芯轴上，所述限位环上设置有卡环，所述环定位结构包括弹性钩，当卡环越过弹性钩后，弹性钩依靠自身弹性向外弹出并将卡环钩住。通过设置弹性钩和卡环配合，卡环越过弹性钩后弹性钩将其卡住，防止限位环后移，以保持膨胀套管撑开后的膨胀状态。
进一步的，所述限位环套装在芯轴上，所述限位环的侧壁上设置有贯通的扩张切口，所述环定位结构包括环形凹槽，当限位环移动到环形凹槽的位置时，所述限位环会收缩卡入到环形凹槽中。由于扩张切口的存在，会使限位环在进入环形凹槽后收缩，实现对推进后的限位环进行限位，以保持膨胀套管撑开后的膨胀状态。
另一方面，为了实现上述椎体撑开填充装置更好的植入到椎体中，本发明还提供了一种推进器，包括上述的椎体撑开填充装置，还包括由内向外依次设置的拉杆、内套管和外套管，所述拉杆的前端与芯轴连接，所述内套管的前端抵住限位环，还包括内外螺纹杆以及限位块，所述内套管的后端通过内套管连接结构与内外螺纹杆的内螺纹连接，所述外套管的后端通过外套管连接结构与内外螺纹杆的外螺纹连接，所述限位块对内套管和外套管进行转动限位，所述拉杆与限位块连接能够对芯轴拉紧；在膨胀套管撑开前，膨胀套管位于外套管中，通过转动内外螺纹杆能够使外套管向后移动的同时内套管向前移动，内套管推动限位环向前移动进而将膨胀套管撑开。通过拉杆将 芯轴拉紧以实现内套管向前推动限位环沿芯轴向前移动，将膨胀套管撑开使其膨胀，并且通过在内外螺纹杆上设置一定的内外螺距，协调内套管和外套管的传动速度保证顺利将膨胀套管撑开。外套管前端套装在膨胀套管的外面，约束撑开套管在受到内套管挤压时，外套管所包含的膨胀套管部分不变形。
进一步的，还包括外壳、手柄以及推力轴承，所述限位块与外壳固连，推力轴承安装在外壳的后部，所述内外螺纹杆的后部穿过推力轴承与外壳后与手柄连接。通过设置推力轴承来减小螺杆转动时的轴向阻力，通过转动手柄即可带动内外螺纹杆的转动，便于操作。
进一步的，第一种方案为：所述内套管连接结构包括内套管座，所述内套管座的中间设置有用于容纳限位块的长槽孔，所述内套管座的后部设置有反向外螺纹与内外螺纹杆的内螺纹配合连接；所述外套管连接结构包括外套管座，所述外套管座的中间也设置有用于容纳限位块的长槽孔，所述外套管座的后部设置有内螺纹与内外螺纹杆的外螺纹配合连接；所述限位块穿过长槽孔，所述限位块的外侧连接有外壳盖，所述外壳盖上安装有手柄，所述限位块的中间设置有通孔，所述拉杆从该通孔穿过，所述拉杆的后部连接有拉杆手轮。
进一步的，第二种方案为：所述内套管连接结构包括内套管座、内套管连杆以及连接座，所述内套管座与内套管连杆的下部固连，所述内套管连杆的上部与连接座固连，所述连接座通过螺杆与内外螺纹杆的内螺纹配合连接，所述限位块位于内套管连杆的内腔中，所述拉杆的后端穿过限位块后通过螺母紧固，所述连接座上设置有指示针从外壳的开窗显示；所述外套管连接结构包括外套管座和外套管连杆，所述外套管的后部与外套管座固连，所述外套管座与外套管连杆的下部连接，所述外套管连杆的上部与内外螺纹杆的外螺纹配合连接。
进一步的，所述芯轴和限位环采用钛合金材质。
从以上技术方案可以看出，本发明具有以下优点：
本发明提供了一种椎体撑开填充装置，膨胀填充部分是采用符合植入医疗器械的生物相容性要求的材料，膨胀套管采用非金属材质，芯轴、限位环采用钛合金材质，膨胀时可以抬高塌陷的椎体，恢复椎体高度，由于不用注 射骨水泥，从根本上解决了骨水泥渗漏的风险。芯轴采用两对相互垂直的铰链结构，可以使膨胀后的套管根据椎体内的形状与器械置入的方向有一定角度的弯曲，防止强行膨胀损伤上下终板。过调整膨胀套管的初始长度和开槽的长度，可以将膨胀部分可以设计多种规格，医生可以根据患者情况，选择需要的规格使用。
本发明还提供了一种推进器，具有两种方案，均采用正反向内外螺纹结构的工作原理，通过螺纹和螺距的设计，实现转动螺杆，内外套管按照不同的速度向两个方向移动，结构紧凑，操作简便。
附图说明
为了更清楚地说明本发明的技术方案，下面将对描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本发明具体实施方式1的一种结构示意图。
图2为图1中芯轴与限位环的结构示意图。
图3为图1的外侧整体示意图。
图4为本发明具体实施方式1的另一种结构示意图。
图5为图2中芯轴与限位环的结构示意图。
图6为图2的外侧整体示意图。
图7为本发明具体实施方式2的结构示意图。
图8为本发明具体实施方式2的侧试图。
图9为本发明具体实施方式3的结构示意图。
图10为本发明具体实施方式3隐藏外壳上半部分后的示意图。
图11为本发明具体实施方式1-4中膨胀套管的结构示意图。
图中，1、膨胀套管，2、芯轴，3、限位环，4、拉杆，5、内套管，6、外套管，7、限位块，8、内外螺纹杆，9、推力轴承，10、手柄，11、拉杆手轮，12、外壳，21、螺纹孔，22、弹性钩，31、卡环，32、扩张切口，51、内套管座，53、内套管连杆，54、连接座，55、螺杆，56、指示针，61、外套管座，63、外套管连杆，101、开槽。
具体实施方式
为使得本发明的目的、特征、优点能够更加的明显和易懂，下面将结合本具体实施例中的附图，对本发明中的技术方案进行清楚、完整地描述，显然，下面所描述的实施例仅仅是本发明一部分实施例，而非全部的实施例。基于本专利中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其它实施例，都属于本专利保护的范围。
具体实施方式1
如图1至图6以及图11所示，本具体实施方式提供了一种椎体撑开填充装置，主要包括膨胀套管1、芯轴2和限位环3，芯轴2和限位环3采用钛合金材质，膨胀套管1为peek非金属材质，能够在人体中植入，膨胀套管1上设置有若干个沿膨胀套管1的轴向切割开的开槽101，这些开槽101环绕膨胀套管1布置，通过在膨胀套管1上设置开槽101，使其具备膨胀功能，每间隔一定长度在套管上开槽101，圆周4-6均分，每段槽夹角60-90°，通过调整膨胀套管1的初始长度、开槽101的长度以及数量，可以将膨胀部分可以设计多种规格，医生可以根据患者情况，选择需要的规格使用；膨胀套管1套装在芯轴2上，芯轴2的前端部设置有用于阻挡膨胀套管1向下移动的阻挡结构，限位环3与芯轴2配合连接，并且限位环3位于膨胀套管1的后方，芯轴2上设置有环定位结构，向前推动限位环3能够挤压膨胀套管1使其膨胀，并且限位环3连接到环定位结构上保持膨胀套管1的膨胀状态；芯轴2的后部设置有用于和推进器连接的拉杆4连接结构，芯轴2通过多根活动关节铰接而成，本方案中，活动关节设置有四个，在相邻两个铰接位置的连接结构呈垂直关系，实现朝不同方向呈一定角度的弯曲，将芯轴2设置为铰链结构，可以使膨胀后的套管根据椎体内的形状与器械置入的方向有一定角度的弯曲，更好的适应椎体内部形状，防止强行膨胀损伤上下终板。
其中，拉杆4连接结构为设置于芯轴2后端面上的螺纹孔21，实现与推进器的拉杆4进行可拆卸连接。
在一些实施方式中，限位环3套装在芯轴2上，限位环3上设置有卡环31，环定位结构包括弹性钩22，当卡环31越过弹性钩22后，弹性钩22依靠自身弹性向外弹出并将卡环31钩住，通过设置弹性钩22和卡环31配合，卡 环31越过弹性钩22后弹性钩22将其卡住，防止限位环3后移，以保持膨胀套管1撑开后的膨胀状态。
在另一些实施方式中，限位环3套装在芯轴2上，限位环3的侧壁上设置有贯通的扩张切口32，限位环3通过扩张切口32的扩张加大直径后安装在芯轴2上，环定位结构包括环形凹槽，当限位环3移动到环形凹槽的位置时，限位环3会收缩卡入到环形凹槽中，由于扩张切口32的存在，会使限位环3在进入环形凹槽后收缩，实现对推进后的限位环3进行限位，以保持膨胀套管1撑开后的膨胀状态。
具体实施方式2
如图7和图8所示(这是其中一种方案)，本具体实施方式提供了一种推进器，包括具体实施方式1中椎体撑开填充装置，还包括外壳12、手柄10、推力轴承9、以及由内向外依次设置的拉杆4、内套管5和外套管6，拉杆4的前端设置有螺纹头与芯轴2连接，内套管5的前端抵住限位环3，还包括内外螺纹杆8以及限位块7，内套管5的后端通过内套管5连接结构与内外螺纹杆8的内螺纹连接，外套管6的后端通过外套管6连接结构与内外螺纹杆8的外螺纹连接，限位块7对内套管5和外套管6进行转动限位，拉杆4与限位块7连接能够对芯轴2拉紧；在膨胀套管1撑开前，膨胀套管1位于外套管6中，通过转动内外螺纹杆8能够使外套管6向后移动的同时内套管5向前移动，内套管5推动限位环3向前移动进而将膨胀套管1撑开，限位块7与外壳12固连，推力轴承9安装在外壳12的后部，内外螺纹杆8的后部穿过推力轴承9与外壳12后与手柄10连接。通过拉杆4将芯轴2拉紧以实现内套管5向前推动限位环3沿芯轴2向前移动，将膨胀套管1撑开使其膨胀，并且通过在内外螺纹杆8上设置一定的内外螺距，协调内套管5和外套管6的前后移动速度，由前置后依次将膨胀套管1撑开，外套管6前端套装在膨胀套管1的外面，约束膨胀套管1在受到内套管5挤压时，外套管6所包含的膨胀套管1部分不变形。
进一步的改进还有：内套管5连接结构包括内套管座51，内套管座51的中间设置有用于容纳限位块7的长槽孔，内套管座51的后部设置有反向外螺纹与内外螺纹杆8的内螺纹配合连接；外套管6连接结构包括外套管座61， 外套管座61的中间也设置有用于容纳限位块7的长槽孔，外套管座61的后部设置有内螺纹与内外螺纹杆8的外螺纹配合连接；限位块7穿过长槽孔，限位块7的外侧连接有外壳12盖，外壳12盖上安装有手柄10，限位块7的中间设置有通孔，拉杆4从该通孔穿过，拉杆4的后部连接有拉杆手轮11。
具体实施方式3
如图9和图10所示(这是另外一种方案)，本具体实施方式提供了一种不同于具体实施方式2中的推进器，它包括具体实施方式1中椎体撑开填充装置，还包括上下壳体可拆卸式连在一块的外壳、手柄10、推力轴承9、以及由内向外依次设置的拉杆4、内套管5和外套管6，拉杆4的前端设置有螺纹头与芯轴2连接，内套管5的前端抵住限位环3，还包括内外螺纹杆8以及限位块7，内套管5的后端通过内套管5连接结构与内外螺纹杆8的内螺纹连接，外套管6的后端通过外套管6连接结构与内外螺纹杆8的外螺纹连接，限位块7对内套管5和外套管6进行转动限位，拉杆4与限位块7连接能够对芯轴2拉紧；在膨胀套管1撑开前，膨胀套管1位于外套管6中，通过转动内外螺纹杆8能够使外套管6向后移动的同时内套管5向前移动，内套管5推动限位环3向前移动进而将膨胀套管1撑开，限位块7与外壳12固连，推力轴承9安装在外壳12的后部，内外螺纹杆8的后部穿过推力轴承9与外壳12后与手柄10连接。通过拉杆4将芯轴2拉紧以实现内套管5向前推动限位环3沿芯轴2向前移动，将膨胀套管1撑开使其膨胀，并且通过在内外螺纹杆8上设置一定的内外螺距，协调内套管5和外套管6的前后移动速度，由前至后依次将膨胀套管1撑开，外套管6前端套装在膨胀套管1的外面，约束膨胀套管1在受到内套管5挤压时，外套管6所包含的膨胀套管1部分不变形。
进一步的改进还有：内套管5连接结构包括内套管座51、内套管连杆53以及连接座54，内套管座51与内套管连杆53的下部固连，内套管连杆53的上部与连接座54固连，连接座54通过螺杆55与内外螺纹杆8的内螺纹配合连接，限位块7位于内套管连杆53的内腔中，拉杆4的后端穿过限位块7后通过螺母紧固，连接座54上设置有指示针56从外壳12的开窗显示；外套管6连接结构包括外套管座61和外套管连杆63，外套管6的后部与外套管座61 固连，外套管座61与外套管连杆63的下部连接，外套管连杆63的上部与内外螺纹杆8的外螺纹配合连接。
本发明的说明书和权利要求书及上述附图中的术语“上”、“下”、“外侧”、“内侧”等(如果存在)是用于区别位置上的相对关系，而不必给予定性。应该理解这样使用的数据在适当情况下可以互换，以便这里描述的本发明的实施例能够以除了在这里图示或描述的那些以外的顺序实施。此外，术语“包括”和“具有”以及他们的任何变形，意图在于覆盖不排他的包含。
对所公开的实施例的上述说明，使本领域专业技术人员能够实现或使用本发明。对这些实施例的多种修改对本领域的专业技术人员来说将是显而易见的，本文中所定义的一般原理可以在不脱离本发明的精神或范围的情况下，在其它实施例中实现。因此，本发明将不会被限制于本文所示的这些实施例，而是要符合与本文所公开的原理和新颖特点相一致的最宽的范围。

Claims (10)

  1. 一种椎体撑开填充装置，其特征在于，包括膨胀套管、芯轴和限位环，所述膨胀套管为非金属材质，所述膨胀套管上设置有若干个沿膨胀套管的轴向切割开的开槽，这些开槽环绕膨胀套管布置，所述膨胀套管套装在芯轴上，所述芯轴的前端部设置有用于阻挡膨胀套管向下移动的阻挡结构，所述限位环与芯轴配合连接，并且限位环位于膨胀套管的后方，所述芯轴上设置有环定位结构，向前推动限位环能够挤压膨胀套管使其膨胀，并且限位环连接到环定位结构上保持膨胀套管的膨胀状态；所述芯轴的后部设置有用于和推进器连接的拉杆连接结构，所述芯轴通过多根活动关节铰接而成。
  2. 如权利要求1所述的椎体撑开填充装置，其特征在于，所述活动关节设置有四个，在相邻两个铰接位置的连接结构呈垂直关系。
  3. 如权利要求1所述的椎体撑开填充装置，其特征在于，所述拉杆连接结构为设置于芯轴后端面上的螺纹孔。
  4. 如权利要求1-3任一所述的椎体撑开填充装置，其特征在于，所述限位环套装在芯轴上，所述限位环上设置有卡环，所述环定位结构包括弹性钩，当限位环越过弹性钩后，弹性钩依靠自身弹性向外弹出并将卡环钩住并阻挡膨胀套管向后脱出。
  5. 如权利要求1-3任一所述的椎体撑开填充装置，其特征在于，所述限位环套装在芯轴上，所述限位环的侧壁上设置有贯通的扩张切口，所述环定位结构包括环形凹槽，利用扩张切口的扩张加大直径后安装在芯轴的尾部，当限位环移动到环形凹槽的位置时，所述限位环会收缩卡入到环形凹槽中并阻挡膨胀套管向后脱出。
  6. 一种推进器，其特征在于，包括权利要求1-5任一所述的椎体撑开填充装置，还包括由内向外依次设置的拉杆、内套管和外套管，所述拉杆的前端与芯轴连接，所述内套管的前端抵住限位环，还包括内外螺纹杆以及限位块，所述内套管的后端通过内套管连接结构与内外螺纹杆的内螺纹连接，所述外套管的后端通过外套管连接结构与内外螺纹杆的外螺纹连接，所述限位块对内套管和外套管进行转动限位，所述拉杆与限位块连接能够对芯轴拉紧；在膨胀套管撑开前，膨胀套管位于外套管中，通过转动内外螺纹杆能够使外套管向后移动的同时内套管向前移动，内套管推动限位环向前移动进而将膨 胀套管撑开。
  7. 如权利要求6所述的推进器，其特征在于，还包括外壳、手柄以及推力轴承，所述限位块与外壳固连，推力轴承安装在外壳的后部，所述内外螺纹杆的后部穿过推力轴承与外壳后与手柄连接。
  8. 如权利要求7所述的推进器，其特征在于，所述内套管连接结构包括内套管座，所述内套管座的中间设置有用于容纳限位块的长槽孔，所述内套管座的后部设置有反向外螺纹与内外螺纹杆的内螺纹配合连接；所述外套管连接结构包括外套管座，所述外套管座的中间也设置有用于容纳限位块的长槽孔，所述外套管座的后部设置有内螺纹与内外螺纹杆的外螺纹配合连接；所述限位块穿过长槽孔，所述限位块的外侧连接有外壳盖，所述外壳盖上安装有手柄，所述限位块的中间设置有通孔，所述拉杆从该通孔穿过，所述拉杆的后部连接有拉杆手轮。
  9. 如权利要求7所述的推进器，其特征在于，所述内套管连接结构包括内套管座、内套管连杆以及连接座，所述内套管座与内套管连杆的下部固连，所述内套管连杆的上部与连接座固连，所述连接座通过螺杆与内外螺纹杆的内螺纹配合连接，所述限位块位于内套管连杆的内腔中，所述拉杆的后端穿过限位块后通过螺母紧固，所述连接座上设置有指示针从外壳的开窗显示；所述外套管连接结构包括外套管座和外套管连杆，所述外套管的后部与外套管座固连，所述外套管座与外套管连杆的下部连接，所述外套管连杆的上部与内外螺纹杆的外螺纹配合连接。
  10. 如权利要求6所述的推进器，其特征在于，所述芯轴和限位环均采用钛合金材质。
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