|Publication number||CN104382642 A|
|Application number||CN 201410625607|
|Publication date||4 Mar 2015|
|Filing date||6 Nov 2014|
|Priority date||6 Nov 2014|
|Publication number||201410625607.9, CN 104382642 A, CN 104382642A, CN 201410625607, CN-A-104382642, CN104382642 A, CN104382642A, CN201410625607, CN201410625607.9|
|Inventors||付索超, 夏虹, 吴增晖, 马向阳, 尹庆水, 雷伟|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (5), Non-Patent Citations (1), Classifications (7), Legal Events (3)|
|External Links: SIPO, Espacenet|
技术领域 TECHNICAL FIELD
 本发明涉及医疗器械领域，特别是一种椎弓根钉道输注器及椎弓根局部强化螺钉组件。  The present invention relates to the field of medical devices, in particular a pedicle screw channel infusion device and pedicle screw assembly of local strengthening.
背景技术 Background technique
目前，经椎弓根内固定技术已经成为脊柱外科一项常规技术。  Currently, the pedicle screw fixation spine surgery has become a routine technique. 椎弓根螺钉可以通过牵引、加压、旋转等方式三维矫治脊柱畸形和进行脊柱稳定重建。 Pedicle screws through traction, pressure, rotation, etc. were three-dimensional correction of spinal deformity and spinal reconstruction. 椎弓根螺钉固定稳定性的关键取决于能否获得足够的“骨质一螺钉”界面把持力，而且，这种把持力要持续到融合节段间达到坚固的骨性融合为止。 Pedicle screw fixation stability depends critically on the availability of adequate "bone a screw" screen holding force, and that this gripping force to continue to achieve solid fusion segments between bony fusion so far. 但在临床工作中，骨质疏松常导致椎弓根螺钉固定能力下降，螺钉松动脱出，从而导致手术失败。 However, in clinical work, osteoporosis often leads to a reduced ability of pedicle screws, screw loosening emerge, leading to surgical failure. 如何解决骨质疏松条件下椎弓根螺钉固定强度下降的问题，也日益成为困扰脊柱外科医师的棘手问题。 How to solve the conditions under osteoporotic pedicle screw fixation strength of the problem of declining, it has increasingly become troubled by spine surgeons thorny issue.
 为解决上述问题，国内外学者进行了大量的相关研究，主要集中在螺钉设计的改进和钉道的强化两个方面。  In order to solve the above problems, domestic and foreign scholars have done a lot of research, focused on two aspects of strengthening screw design improvements and nail tract. 但是，增加螺钉直径有导致椎弓根崩裂引起椎弓根骨折的危险，增加螺钉长度则可能破坏椎体前柱，引起内脏及血管损伤，导致严重的手术并发症。 However, increasing the lead to pedicle screw diameter pedicle fractures dangerous crack caused by increased length of the screws may damage the anterior column, causing damage to internal organs and blood vessels, leading to severe complications. 在强化钉道方面，目前临床上主要采用向钉道内全长填充骨水泥类材料的方法，该方法存在较多问题:1.钉道全长填充式灌注骨水泥后，骨水泥类材料与螺钉全长之间紧密粘合，骨水泥固化后螺钉取出极为困难，即使勉强旋出螺钉也会导致钉道周围大量的骨质缺损，甚至伤及椎弓根根部及神经组织，产生严重的并发症；2.更为重要的是，传统的灌注式填充骨水泥会导致骨质和螺钉之间出现骨水泥夹层，形成“螺钉一骨水泥一骨质”的二次界面，界面之间难以形成良好的骨整合效果，影响术后螺钉的长期稳定，最终必然导致螺钉松动，临床应用存在极大安全隐患；3.缺少合适的骨水泥灌注装置，在灌注骨水泥时不慎，可能导致部分骨水泥流入椎管中，导致严重的神经损伤并发症；4.还有比较常见的传统的椎弓根螺钉钉道强化由椎体成形术发展而来，其所强化的骨质多是骨质疏松的椎体部分，未主张对椎弓根部位骨质进行强化。 Strengthen nails Road, the current clinical mainly to the full-length internal screw channel filled with bone cement-based material way, there are more problems to which: 1. The total length of the screw channel filled after infusion of bone cement, cement-like material with the screw the close bond between the total length of the screw is extremely difficult to remove the bone cement solidification, even if reluctantly unscrew the screw will lead to a lot of bone defects around the screw channel, and even hurt the pedicle and the nerve root tissue, resulting in serious complications ; 2. More importantly, the traditional perfusion filling bone cement can cause bone cement dissection occurs between the bone and screws, the formation of "a bone screw and a bone cement," the secondary interface, it is difficult to form a good interface between osseointegration effect, the impact of long-term stability after screws, screw loosening would lead to clinical applications there is a great security risk; 3. the lack of suitable bone cement perfusion device accidentally during infusion of bone cement, bone cement may cause some It flows into the spinal canal, resulting in severe neurological damage complications; 4. There are more common traditional pedicle screw hole strengthen bone by the vertebroplasty evolved, mostly to strengthen their osteoporosis vertebral body part, did not advocate intensive pedicle bone parts.
目前，也有学者发明并使用一种椎弓根螺钉，在螺钉内设置空腔，在螺钉拧入钉道后，骨水泥类生物材料注入空腔内并从螺钉上设置的侧孔流至骨质上，这种螺钉虽然操作简便，也具备一定的强化效果，但是具备较大的局限性，其原因在于:在椎弓根螺钉置入位置不佳行翻修术或其他因素导致需要取出椎弓根螺钉时，从孔中流出的骨水泥与钉道内的骨水泥连成一体，在旋出螺钉的过程中破坏椎体骨质的危险性大大增加，不便于骨水泥强化后螺钉的取出。  Currently, there are scholars invention is the use of a pedicle screw, disposed within a cavity in the screw after the screw into the screw channel, bone cement biomaterial injection side cavity hole and set screw from the stream to the bone, the screw, although easy to operate, but also with some strengthening effect, but with a big limitation, the reason is: poor location in pedicle screw line revision surgery or other factors lead to the need to remove When the pedicle screws, bone cement flowing from the hole fused bone cement and nail tract, unscrew the screw in the process of destruction of vertebral bone greatly increased risk, not easy after the bone cement augmentation screws removed .
发明内容 SUMMARY OF THE INVENTION
 为了克服上述技术问题，本发明的目的在于提供一种提高螺钉与钉道界面之间力学强度的椎弓根钉道输注器。  In order to overcome the above-mentioned technical problems, an object of the present invention to provide a method for improving the mechanical strength of the interface between the screw and the screw channel pedicle screw channel infusion device.
 本发明所采用的技术方案是:  The technical solution adopted by the invention are:
一种椎弓根钉道输注器，包括表面平滑的侧孔鞘，所述侧孔鞘中部沿自身轴线设有输注通道，所述侧孔鞘的远端封闭，近端设有连通输注通道的开口，所述侧孔鞘的侧壁设有若干连通输注通道的侧孔，所述各侧孔沿侧孔鞘轴线由远端至近端呈螺旋状分布。 One kind of pedicle screw channel infusion device includes a smooth surface side hole of the sheath, the sheath side hole with a central passage along its axis infusion, the distal end of the sheath side hole closed, lost communication with a proximal end opening of the injection channel, said side wall of the sheath side hole communicating with a plurality of infusion side passage hole, said side hole of each side hole along the axis of the sheath distal to proximal spiral distribution.
 作为上述技术方案的进一步改进，所述侧孔的直径由远端向近端递减。  As a further modification of the above technical solution, the diameter of the hole is decreased from the distal side to the proximal end.
 作为上述技术方案的进一步改进，所述侧孔从远端至近端的直径递减量为0.25mm,所述输注通道的直径为2mm。  As a further modification of the above aspect, the side hole from the distal end to the proximal end diameter decreasing the amount of 0.25mm, the infusion passage diameter 2mm.
 作为上述技术方案的进一步改进，沿所述侧孔鞘的周向每90°设有一个侧孔。  As a further improvement of the technical proposal, week along the side of the hole of the sheath has a 90 ° to each side of the hole.
 作为上述技术方案的进一步改进，所述侧孔鞘近端接有注入段，所述注入段设有连接开口的注入孔，所述注入孔的直径大于输注通道的内径。  As a further modification of the above aspect, the inner diameter of the sheath side hole near the termination section includes an injection, the injection section is provided with connection openings of the injection hole, the injection hole is larger than the diameter of the infusion channel.
 作为上述技术方案的进一步改进，所述注入段包括垂直于侧孔鞘轴线的侧翼，所述侧翼的外周形成握持部，所述侧翼朝向侧孔鞘的端面形成定位部。  As a further modification of the above aspect, the injection section comprises lateral flanks perpendicular to the axis of the bore of the sheath, the outer periphery of the grip portion of the side flaps are formed, the flank face side toward the positioning hole of the sheath portion is formed.
 本发明还提供一种有效提高临床疗效的椎弓根钉道局部强化组件，其采用的技术方案是:  The present invention also provides a method to effectively improve the clinical efficacy of topical strengthening pedicle screw path components, technical solution which is used:
一种椎弓根钉道局部强化组件，用于对椎弓根钉道局部强化，包括: One kind of pedicle screw path strengthening local assembly for local strengthening of pedicle screw path, comprising:
输注器，对所述椎弓根钉道注入骨水泥类生物材料以进行局部强化； Infusion device of the pedicle screw path injection of bone cement biomaterials for localized enhancement;
注射装置，将骨水泥类生物材料注射入输注器并通过输注器到达椎弓根钉道； Injection device, the bone cement is injected into the infusion device biomaterials and reach pedicle screw path through the infusion device;
作为上述技术方案的进一步改进，所述注射装置包括: As a further modification of the above aspect, the injection device comprising:
针筒式注射器，从开口处对输注通道注入骨水泥类生物材料； Syringes syringes, infusion from the opening passage of bone cement injected biomaterials;
推杆，所述推杆与输注通道匹配，用于推出输注通道内残留的骨水泥类生物材料。 Putter, the putter with an infusion channel matching for launch within the infusion passage residual bone cement biomaterial.
 本发明的有益效果是:本发明的侧孔鞘设置了螺旋状分布的侧孔，在侧孔鞘置入钉道后，骨水泥类生物材料可以由输注通道和侧孔流入使对应于侧孔位置的钉道周壁进行局部强化，而侧孔鞘的表面平滑，局部强化钉道周围骨质后易于从钉道内取出，取出后拧入普通的椎弓根螺钉，保证螺钉与局部强化的骨水泥类物质接触的同时仍有部分同周围骨质充分接触，植入螺钉后即刻提高螺钉与钉道界面之间的力学强度，远期可为进一步的钉-骨界面的骨整合提供机会从而达到远期强化椎弓根螺钉固定的目的；同时注射骨水泥强化后，相比于目前存在的空心侧孔螺钉，椎弓根螺钉与骨水泥之间形成的界面存在于螺钉表面，而不存在连通螺钉内外的骨水泥结构，故当旋出螺钉时对椎体骨质的破坏没有太大的影响。  The beneficial effects of the present invention are: the side hole of the sheath of the present invention is provided with a side hole spiral distribution sheath into the hole in the side of the pin tract, bone cement type of biological material can flow into the channel and infusion side holes make corresponding to the side of the hole locations screw channel peripheral wall locally reinforced, while smoothing the surface side of the hole of the sheath, after partial strengthen bone around the screw channel easier to remove from the screw channel, remove screwed into ordinary screw, screw with partial guarantee while strengthening bone cement material in contact with the surrounding bone are still some full contact immediately improve the mechanical strength of the interface between the screw and the screw channel after implantation of screws, forward for further nail - bone interface osseointegration offer opportunity to achieve long-term strengthening of pedicle screw fixation purposes; after simultaneous injection of bone cement augmentation, compared to between existing screw holes hollow side, pedicle screws and bone cement interface exists in the form of a screw surface, and there is no communication with screw inside and outside the cement structure, unscrew the screws so when there is not much effect on the destruction of the vertebral bone.
附图说明 Brief Description
 下面结合附图和实施方式对本发明进一步说明。  below in conjunction with the accompanying drawings and embodiments of the present invention is further described below.
 图1是侧孔鞘的结构示意图；  FIG. 1 is a schematic structural view of a sheath side hole;
图2是侧孔鞘与钉道连接状态示意图； Figure 2 is a side hole of the sheath and screw channel connection status schematic;
图3是骨水泥类生物材料输注状态示意图； Figure 3 is a type of biological material with bone cement infusion state schematic;
图4是骨水泥类生物材料注入钉道示意图； Figure 4 is a type of biological material is injected bone cement screw channel schematic;
图5是推杆推出残留骨水泥类生物材料状态示意图； Figure 5 is a putter Release residual bone cement biomaterial state schematic;
图6是椎弓根螺钉与钉道连接状态示意图。 Figure 6 is a pedicle screw and screw channel connected state. Fig.
具体实施方式 DETAILED DESCRIPTION
 如图1所示的椎弓根钉道输注器，包括表面平滑的侧孔鞘1，侧孔鞘I为中空的圆柱状结构，其中空部分为沿自身轴线的输注通道2。  FIG pedicle screw path infusion device shown, the surface smoothness of the side hole includes a sheath, the sheath side hole I is a hollow cylindrical structure, wherein the hollow portion of the infusion channel along its axis 2 . 侧孔鞘I的远端为钝圆形尖部并封闭，近端设有连通输注通道2的开口。 I distal side hole of the sheath is blunt rounded tip and closed infusion passage communicating with a proximal opening 2. 侧孔鞘I的侧壁设有若干连通输注通道2的侧孔3，各侧孔3沿侧孔鞘I轴线由远端至近端呈螺旋状分布。 I sidewall of the sheath side hole communicating with a plurality of infusion side holes 2 of the passage 3, each side of the hole 3 along the axis of the side hole I sheath distal to proximal spiral distribution.
 优选的，侧孔3的直径由远端向近端递减，在注射压力减少的前提下相对较远的侧孔3同样仍能流出较多的骨水泥，保证骨水泥由不同远近的侧孔3流出相对均匀的量。  Preferably, the diameter side hole 3 decreased from distal to proximal, under the premise of the injection pressure is reduced relatively far side of the hole 3 is also still out of more bone cement, bone cement guaranteed by the different distances side hole 3 flowing relatively uniform amount.
 优选的，沿侧孔鞘I的周向每90°设有一个侧孔3，即由远至近每旋转90°即有一个侧孔3，总共有4个这样的侧孔3，其数量适中，符合钉道内局部强化的要求。  Preferably, the sheath side hole along the peripheral I has a 90 ° to each side of the hole 3, i.e. from far to near 90 ° for each rotation i.e., a side hole 3, a total of four such side hole 3, which moderate amount, in line with local strengthening of internal screw channel requirements. 侧孔3从远端至近端的直径递减量为0.25mm，最远端的为第一侧孔，第一侧孔直径为2.25mm，之后依次为2mm、1.75mm、1.5mm,而输注通道2的直径为2mm。 3 from the distal side to the proximal hole diameter decreasing amount of 0.25mm, the most distal hole of the first side, the first side holes having a diameter of 2.25mm, followed, after 2mm, 1.75mm, 1.5mm, and the infusion channel 2 The diameter of 2mm.
 优选的，侧孔鞘I近端接有注入段，注入段中部设有连接开口的注入孔4，该注入孔4为通孔，其直径大于输注通道2的内径，保证骨水泥注入时有输注通道2内有足够的压力，同时满足注入孔4能够与针筒式注射器7头部形成良好的连接。  Preferably, the sheath side hole injection section I had nearly terminated, the middle section is provided with injection openings 4 connected to the injection hole, the injection hole 4 is a through hole having a diameter larger than the inner diameter of the infusion channel 2, to ensure that the bone cement infusion channel when there is sufficient pressure in the injection 2, the injection hole 4 can satisfy the syringe barrel 7 of the head to form a good connection.
 优选的，注入段包括垂直于侧孔鞘I轴线的侧翼5，侧翼5的外径大于侧孔鞘I的外径，使得侧翼5的外周形成握持部，便于注射时的把持，侧翼5朝向侧孔鞘I的端面形成定位部，便于侧孔鞘I置入角度的定位和置入深度的掌握。  Preferably, the injection section including flank perpendicular to the axis of the side hole of the sheath I 5, flank 5 is larger than the outer diameter of the sheath I outer diameter side of the hole, so that the outer peripheral flank 5 forms the grip portion to facilitate gripping when injected, flank 5 toward the side of the hole I end surface of the sheath is formed positioning unit, to facilitate positioning the side hole of the sheath into perspective and I grasp the depth of insertion.
 本实施例还提供一种椎弓根钉道局部强化组件，用于对椎弓根钉道局部强化，除了上述的输注器外，还包括注射装置和椎弓根螺钉6。  The present embodiment also provides a partial strengthening pedicle screw path components for local strengthening pedicle screw path, in addition to the infusion device, also comprising an injection device and pedicle screws 6.
 注射装置用于将骨水泥类生物材料注射入输注器并通过输注器到达椎弓根钉道，其包括针筒式注射器7和推杆8。  means for injecting bone cement is injected into the infusion device biomaterials and reach pedicle screw path through the infusion device, which includes a syringe-type injector 7 and putt 8.
 针筒注射器从开口处对输注通道2注入骨水泥类生物材料；推杆8直径2_，与输注通道2匹配，用于推出输注通道2内残留的骨水泥类生物材料。  The syringe barrel from the opening of the Channel 2 infusion injection of bone cement biomaterial; the diameter of the plunger 8 2_, and infusion channel 2 match for the introduction of an infusion channel 2 within the residual bone cement biomaterial.
 椎弓根螺钉6为手术中常用的螺钉，用于在输注器取出后拧入钉道。  The pedicle screw 6 is commonly used in surgical screws for infusion is removed after screwing the screw channel.
 本实施例中的椎弓根钉道局部强化组件使用方法如下:  partial strengthening component uses the method of this embodiment of the pedicle screw path as follows:
O预先使用手钻在椎体内常规制备钉道； O previously within the vertebral body using a hand drill in conventional manufacturing screw channel;
2)当确认钉道位置良好后，调制可强化钉道周壁的骨水泥类生物材料，并将其抽入针筒式注射器7内； 2) When the confirmation in good position after the screw channel modulation may strengthen the screw channel of the peripheral wall of cement type of biological material, which was drawn into the syringe barrel 7;
3)如图2所示，向钉道内插入侧孔鞘I ; 3) As shown in Figure 2, is inserted into the screw channel sheath side hole I;
4)如图3和图4所示，在注入孔4中连接针筒式注射器7，逐渐将一定体积的骨水泥类生物材料推入侧孔鞘I内，使其沿侧孔鞘I的侧孔3流出至钉道内，在一定压力下，流出的骨水泥材料沿椎弓根钉道在侧孔3周围的骨质内呈螺旋形分布，分布范围在椎体中部及椎弓根腹侧部； 4) as shown in FIG. 3 and FIG. 4, is connected to the injection hole 4 syringe barrel 7, and gradually a volume of bone cement type of biological material pushed into the sheath side hole I, I make the sheath along the lateral side of the hole 3 out of the hole into the screw channel, under pressure, out of the bone cement material pedicle screw path along a spiral-shaped distribution in the bone around the side of the hole 3, the distribution range in the middle of the vertebral body and pedicle ventral portion ;
5)如图5所示，解除针筒式注射器7连接，向侧孔鞘I内插入推杆8，将残存于鞘内的骨水泥完全推注至鞘外周围骨质，对螺钉钉道形成规律性强化； 5) shown in Figure 5, the lifting of a syringe injector 7 is connected, the lateral bore sheath I insert putter 8, will remain in the intrathecal injection of bone cement to complete the outer sheath surrounding bone, for screw hole formed strengthening regularity;
6)在骨水泥未凝固前，拔出侧孔鞘I及推杆8 ； 6) Before uncured bone cement, I pull out the side of the hole and push rod sheath 8;
7)如图6所示，骨水泥硬化前，将相应直径的普通椎弓根螺钉6沿此经局部强化处理的钉道拧入，确定椎弓根螺钉6位置良好后，安装内固定装置，即可完成。 7) shown in Figure 6, before the bone cement hardening, the common pedicle screw diameter of 6 along the corresponding partial strengthening treatment by screwing the screw channel, in good position to determine the pedicle screw 6, install fixtures, to complete.
 由于螺钉的把持力取决于螺钉螺纹与螺纹周围骨质的界面强度，因此，当强化材料经侧孔对钉道周壁进行强化后，可在一定程度上提高界面力学强度，进而增加螺钉把持力，达到强化螺钉固定的目的。  Since the gripping force depends on the interfacial strength screw thread screw thread surrounding bone and, therefore, when the reinforcing material through the side wall of the hole on the nail Daozhou be strengthened to improve the mechanical strength of the interface to some extent, thus increasing the screw holding force, to strengthen the screws purposes. 传统技术中骨水泥强化主要集中在螺钉的前端或是钉道全长，前者没有对椎弓根部位的骨质进行强化，而后者则因钉道全长灌注骨水泥，增加了其渗漏至椎管导致严重手术并发症的风险。 Traditional art bone cement augmentation are mainly concentrated in the front end of the screw or nail road full-length, the former site of no pedicle bone to strengthen, while the latter is due to the full-length screw channel infusion of bone cement, increased its leakage to spinal surgery risk of serious complications. 通过侧孔鞘，实现了对骨质疏松椎体的部分椎体和部分椎弓根的局部强化，同时又保留了钉-骨接触的界面，通过界面结构的稳定，实现了即刻的螺钉稳定性及远期通过骨整合获得的牢固的螺钉稳定性，提高置入椎弓根螺钉的近、远期把持力。 Hole through the side sheath, achieve a partial strengthening of osteoporotic vertebral pedicle portion and part of the vertebral body, while retaining the nail - bone contact interface, through a stable interface structure to achieve immediate stability screw and secure long-term stability of the screw obtained through osseointegration, improve pedicle screw close, long-term holding power.
 本实施例一是通过椎弓根局部强化螺钉组件对钉道周壁进行局部强化，在保证螺钉与骨质充分接触的同时，提高螺钉与钉道界面之间的力学强度，达到强化椎弓根螺钉固定的目的；二是骨水泥在钉道周壁骨质中的局部分布、强化，避免了因骨水泥完全包裹螺钉所带来的二次界面存留影响长期稳定性、以及骨水泥因灌注不当可能泄露到椎管内热损伤神经等问题，有效的提高临床疗效，减少手术失败发生率。  This Example One is to strengthen the local pedicle screw assembly of the screw channel peripheral wall locally reinforced to ensure full contact with the bone screw, while improving the mechanical strength of the interface between the screw and the screw channel, to strengthen the vertebral pedicle screw fixation purposes; the second is the local distribution of bone cement in the screw channel in the peripheral wall of the bone, strengthen, avoiding the bone cement screw completely wrapped brought affect long-term stability remain a secondary interface, as well as bone cement due to injury Improper disclosure of heat damage to the spinal nerves and other issues, effectively improve the clinical efficacy and reduce the incidence of surgical failure. 相较之以往的钉道全长强化或椎体部分强化，本发明装置既强化了椎体部位，又强化了椎体的椎弓根部位，同时，在提高椎弓根螺钉固定强度的同时，减少术后椎弓根螺钉取出对椎体和椎弓根骨质的破坏，降低螺钉取出对脊柱稳定性的影响。 Compared to the conventional full-length screw channel enhancement or vertebral body part enhancement device of the invention not only strengthen the vertebral body parts, and strengthen the vertebral pedicle site, while improving the strength of pedicle screw fixation, while reduce postoperative damage to the vertebral pedicle screw removed and pedicle bone and reduce the impact on the screws removed spinal stability.
 另外，针对需要在术后将椎弓根螺钉取出的情况，本实施例注射骨水泥强化后螺钉与骨水泥之间形成的界面存在于螺钉表面，当旋出螺钉时对椎体骨质的破坏没有太大的影响。 After the  In addition, the need for the case to pedicle screws removed in surgery, in this case the injection of bone cement to strengthen the implementation of the formed between the screw and the bone cement interface exists in the screw surface of the vertebral bone screws when the spin out not much impact mass destruction.
 以上所述只是本发明优选的实施方式，其并不构成对本发明保护范围的限制。  The above is only a preferred embodiment of the invention, it does not constitute a restriction on the scope of the present invention.
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