WO2014012491A1 - 一种脊柱动态稳定植入单元 - Google Patents

一种脊柱动态稳定植入单元 Download PDF

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Publication number
WO2014012491A1
WO2014012491A1 PCT/CN2013/079517 CN2013079517W WO2014012491A1 WO 2014012491 A1 WO2014012491 A1 WO 2014012491A1 CN 2013079517 W CN2013079517 W CN 2013079517W WO 2014012491 A1 WO2014012491 A1 WO 2014012491A1
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Prior art keywords
silicone rubber
rubber
elastic
dynamic
implant unit
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PCT/CN2013/079517
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English (en)
French (fr)
Inventor
高耀平
田芳
林忠
Original Assignee
上海微创骨科医疗科技有限公司
苏州海欧斯医疗器械有限公司
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Publication of WO2014012491A1 publication Critical patent/WO2014012491A1/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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
    • A61B17/7026—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a part that is flexible due to its form
    • A61B17/7028—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a part that is flexible due to its form the flexible part being a coil spring
    • 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
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
    • A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
    • A61B17/7031—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other made wholly or partly of flexible material

Definitions

  • the invention relates to the field of medical devices.
  • the present invention relates to a spinal dynamic stabilization implant unit. Background technique
  • the main implementation is that after the connecting rod and the pedicle screw are fixed, the rigidity of the connecting rod is provided to provide the immediate moment of the spine. stability.
  • the elastic portion of the connecting rod can provide a certain range of motion of the spine, maintain the biomechanical environment of the normal spine, and prevent excessive load caused by the strong fixation of adjacent segments, thereby preventing the degeneration of adjacent segments.
  • the Chinese Patent Application No. 200710001142.X to the German Patent Application No. EP1810624A1 relates to an elastic connector implanted in a human or animal body, comprising: a first rod comprising two connections An elastic section between the segments, the two connecting segments being adapted to be attached to a device to be secured to a human or animal body.
  • 200510090810 relates to a bio-flexible spinal fixation device with a shape memory containing gold, the elastic connecting rod of which is wound by a nickel-titanium memory alloy material. Spring-formed.
  • the longitudinal rod has an elastic section, and the longitudinal rod is installed in the rod groove of the mounting seat; at least one transverse link has a flexible section in the straight part, and the hook part is straight Extending at both ends of the rod portion, rigidly fixing the longitudinal rod; a plurality of fixing screws rigidly inserted into the mounting seat of the screw head to prevent the longitudinal rod from moving, wherein the longitudinal rod and the transverse connecting rod adopt a shape capable of deforming at a predetermined temperature Made of memory alloy.
  • the material of the elastic member of the invention is a nickel-titanium alloy. Since the nickel-titanium alloy does not have machinability, the screws in the system can only be formed by using a titanium alloy material. When the two materials are simultaneously implanted in the human body, a pitting potential difference is generated.
  • Chinese Patent Application No. 038271 11.7 European Common Patent Application No. EP1667591A1 relates to a device (1) for elastically stabilizing a vertebral body.
  • the device (1) has: elastic means (5) having a longitudinal axis (12) and connectable to the head sections (4) of two adjacent bone anchors (2) such that The longitudinal axis (12) is transverse to the central axis (3); wherein the elastic means (5) has a progressive spring characteristic (20) under pressure loading; characterized in that: the elastic means (5) consists of a metal material; and comprising a coil (19), wherein at least two coils (19) have at least one different geometrical dimension; and the spring characteristic (20) of the elastic means (5) is in force - The deformation amount curve has a continuous progressive direction.
  • the patent has a complex elastic structure, many parts, and is difficult to implant.
  • the products already on the market include Isobar® from Scient'x-Alphatec Spine, France.
  • the Isobar® TTL implant is a dynamic connecting rod with a complete buffer in the middle of the connecting rod.
  • a laminated disc-shaped titanium alloy structure that allows linear stretching to control axial and angular motion.
  • Each coil spring is nitrogen oxidized to enhance wear resistance.
  • the cushioning characteristics of the rods allow for a maximum axial compression and tension of 0.4 mm while allowing a maximum of ⁇ 2.25° of motion (in flexion and extension).
  • the above products are not ideal in terms of therapeutic effect.
  • the main disadvantages are that the elastic zone has hysteresis, internal pressure, tension, relaxation and creep characteristics are not ideal, fatigue resistance is poor, and some implants have poor self-sealing properties. In the decompression surgery, the intervertebral disc repair environment cannot be well constructed; Surgery can not bear too much activity of adjacent segments; there are many possibilities for reoperation. Summary of the invention
  • the present invention relates to a spinal dynamic stabilization implant unit characterized by incorporating a silicone rubber material in its elastic region.
  • the elastic zone is preferably an elastic slit or an elastic groove
  • the silicone rubber is a medically inert silicone rubber.
  • Silicone rubber is a special synthetic rubber, which is a kind of linear polymer (green rubber) which is polymerized by dimethylsiloxane monomer and other silicone monomers under the action of acid or basic catalyst. Mixing, vulcanization, can be cross-linked into a rubber elastomer, the basic structural links are
  • R and R' represent a substituent and n represents a positive integer.
  • the basic structural unit of silicone rubber is composed of silicon-oxygen chain links, and the side chains are connected to various other organic groups through silicon atoms. Therefore, in the structure of the silicone rubber, it contains both an "organic group” and an “inorganic structure”. This special composition and molecular structure make it combine the properties of organic matter with the function of inorganic substances.
  • silicone products are based on silicon-oxygen (Si—0) bonds, and the bond energy of C-C bonds is 82.6 kcal / gram, the bond of Si-O bond can be 121 kcal / gram in silicone, so the thermal stability of silicone product is high, the chemical bond of the molecule at high temperature (or radiation irradiation) is not broken, no break down. Silicone is not only resistant to high temperatures, but also resistant to low temperatures and can be used over a wide temperature range.
  • Silicones have better thermal stability and resistance to radiation and weathering than other polymer materials. The service life in the natural environment of silicone can reach several decades; and (3) physiological inertia: Polysiloxane compounds are one of the most inactive compounds known. They are very resistant to biological aging, have no rejection reaction with animals, and have good anticoagulant properties.
  • Silicone rubber can be divided into dimethyl silicone rubber (R, R' is methyl) according to the monomer used; methyl vinyl silicone rubber (part R, vinyl); phenyl silicone rubber (part R' It is a phenyl); a fluorosilicone rubber (partially R'fluoroindolyl), and a nitrile silicone rubber (part R' is a nitrilealkyl group).
  • Dimethyl silicone rubber (referred to as methyl silicone rubber)
  • Dimethicone rubber is a colorless, transparent elastomer that is usually vulcanized with a more reactive organic peroxide.
  • the vulcanized rubber can be used in the range of -60-+250 °C.
  • the dimethyl silicone rubber has low vulcanization activity, high temperature compression and permanent deformation, and is not suitable for thick products. It is difficult to vulcanize thick products, and the inner layer is also easy to foam. Since methyl vinyl silicone rubber containing a small amount of vinyl is superior in performance, dimethyl silicone rubber has been gradually replaced by methyl vinyl silicone rubber.
  • silicone rubbers produced and applied today which contain, in addition to the dimethyl siloxane structural unit, more or less structural units of other difunctional siloxanes, but the preparation method thereof and dimethylsilicon There is no essential difference between the preparation methods of rubber, and the preparation method generally comprises hydrolytic condensation of a desired bifunctional silicon monomer under conditions favorable for ring formation, and then adding Bajia according to the required ratio.
  • the base ring tetrasiloxane is obtained by co-reacting under the action of a catalyst.
  • Methyl vinyl silicone rubber (referred to as vinyl silicone rubber) Since this rubber contains a small amount of vinyl side chains, it is easier to vulcanize than methyl silicone rubber, so that a wider variety of peroxides can be used for vulcanization, and the amount of peroxide can be greatly reduced.
  • the use of a silicone rubber containing a small amount of vinyl compared to dimethyl silicone rubber provides a significant improvement in compression set resistance, and low compression deformation reflects its better support as a seal at high temperatures. It is one of the requirements that must be possessed by the 0-ring and the washer.
  • Methyl vinyl silicone rubber has good process performance and convenient operation. It can be made into thick products and the surface of extruded and calendered semi-finished products is smooth. It is a commonly used silicone rubber.
  • phenyl silicone rubber (3) methyl phenyl vinyl silicone rubber (referred to as phenyl silicone rubber)
  • Such a rubber is obtained by introducing a diphenyl siloxane chain or a methylphenyl siloxane chain in a molecular chain of a vinyl silicone rubber.
  • a diphenyl siloxane chain or a methylphenyl siloxane chain in a molecular chain of a vinyl silicone rubber.
  • phenyl content phenyl: silicon atom
  • it can be classified into a low phenyl group, a medium phenyl group, and a high phenyl silicone rubber.
  • the rubber crystallizes or approaches the glass transition point or the two cases overlap, the rubber will be stiff.
  • the introduction of an appropriate amount of large-volume groups to destroy the regularity of the polymer chain can lower the crystallization temperature of the polymer, and the glass can be changed by the introduction of a large volume group to change the force between the polymer molecules. Temperature.
  • the vulcanizate has a brittleness temperature of -120 ° C and is the best low temperature rubber available today.
  • Low phenyl silicone rubber has the advantages of vinyl silicone rubber and is not costly, so there is a tendency to replace vinyl silicone rubber.
  • Fluorosilicone rubber is a type of silicone rubber in which a side chain introduces a fluoroindenyl group.
  • a commonly used fluorosilicone rubber is a fluorosilicone rubber containing a methyl group, a trifluoropropyl group, and a vinyl group.
  • Fluorosilicone has good heat resistance and excellent oil and solvent resistance, such as aliphatic hydrocarbons, aromatic hydrocarbons, chlorinated hydrocarbons, petroleum-based fuel oils, lubricating oils, hydraulic oils and certain synthetic oils at room temperature. The stability at high temperatures is good, these are beyond the reach of pure silicone rubber.
  • Fluorosilicone rubber has good low temperature properties and is a great improvement for pure fluororubber.
  • the temperature range in which the fluorosilicone rubber containing trifluoropropyl groups maintains elasticity is generally
  • the nitrile silicone rubber is a type of silicone rubber in which a side chain is introduced with a nitrile group (generally ⁇ -nitrile ethyl or ⁇ -nitril).
  • a nitrile group generally ⁇ -nitrile ethyl or ⁇ -nitril.
  • the introduction of a polar nitrile group improves the oil resistance and durability of the silicone rubber, but its heat resistance, electrical insulation and processability are reduced.
  • the type and content of nitrile alkyl have a great influence on the properties of nitrile silicone rubber.
  • silicone rubber containing 7.5% gram of ⁇ -nitrile propyl has similar cold resistance to low phenyl silicone rubber and lower oil resistance.
  • the base silicone rubber is good.
  • Silicone rubber can be divided into three categories according to the vulcanization mechanism: free radical cross-linking type, polycondensation type, and addition reaction type initiated by organic peroxide. Silicone rubber can be classified into room temperature vulcanized silicone rubber (RTV) and high temperature/heat vulcanized silicone rubber (HTV) according to its vulcanization characteristics.
  • RTV room temperature vulcanized silicone rubber
  • HTV high temperature/heat vulcanized silicone rubber
  • Room temperature vulcanized silicone rubber can be divided into three types according to composition, vulcanization mechanism and use process, namely single-component room temperature vulcanized silicone rubber, two-component condensation type room temperature vulcanized silicone rubber and two-component addition type room temperature vulcanized silicone rubber. These three series of room temperature vulcanized silicone rubber Each of the glues has its own characteristics: The advantages of the one-component room temperature vulcanized silicone rubber are that it is easy to use, but the deep curing speed is difficult; the advantage of the two-component room temperature vulcanized silicone rubber is that it does not exotherm during curing, and the shrinkage rate is small and does not swell.
  • the vulcanization time of the formed room temperature vulcanized silicone rubber is mainly determined by the temperature.
  • Room temperature vulcanized silicone rubber (RTV for short) refers to a class of silicone rubber that can be vulcanized at room temperature without heating.
  • the room temperature vulcanized silicone rubber is a silicone rubber having a hydroxyl group (or acetoxy group) having a low molecular weight, for example, 30,000 to 60,000, which is usually a viscous fluid.
  • This type of rubber can be vulcanized at room temperature to form an elastomer by adding an appropriate amount of reinforcing filler, vulcanizing agent and catalyst (or by the action of moisture in the air). After the vulcanization is completed, it is excellent in heat resistance, cold resistance, dielectric properties, etc., but its mechanical strength is lower, and it can be used for casting and coating.
  • Room temperature vulcanized silicone rubber can be divided into two types: one-component type and two-component type.
  • the two-component type room temperature vulcanized silicone rubber is prepared by blending a terminal hydroxyl group-containing silicone rubber with a reinforcing filler, a vulcanizing agent, etc., and adding a catalyst when used.
  • vulcanizing agents are organotin salts, such as dibutyltin dilaurate, generally in an amount of 0.5-5 parts or stannous octoate, which is more catalytic than dibutyltin dilaurate.
  • organotin salts such as dibutyltin dilaurate
  • stannous octoate which is more catalytic than dibutyltin dilaurate.
  • the one-component type room temperature vulcanized silicone rubber is made of a silicone rubber containing an acetoxy group at the end group and a reinforcing filler and other auxiliary agents. It is used without removing the catalyst, and is taken out from the sealed package and then in the air. The action of moisture can be vulcanized into an elastomer.
  • the silicone rubber has good adhesion to metals, glass and plastics.
  • the disadvantage is that acetic acid is formed during the vulcanization process. Although it can diffuse out of the vulcanizate, it is in contact with objects, especially metals. Corrosive.
  • the one-component type is convenient, and is especially suitable for sealing, caulking and the like.
  • vulcanization is generally divided into two stages, the first stage is the mixing of silicone raw rubber, reinforcing agent, additives, vulcanizing agent and structure control agent, and then the mixing material in the metal mold Pressurized heating and vulcanization, the pressure is about 50 kg / cm 2 , the temperature is 120-130 ° C, the time is 10-30 minutes, the second stage is to remove the silicone rubber from the mold, put it in the oven, After baking at 200-250 ° C for several hours to 24 hours, the rubber is further vulcanized while the organic peroxide is decomposed and volatilized.
  • Silicone rubber reinforcing fillers are various types of silica such as: fumed silica, precipitated silica, and treated silica, which can increase the strength of the vulcanizate by a factor of ten.
  • the addition of various additives mainly reduces the cost of the glue, improves the properties of the rubber compound, and imparts various special properties such as flame retardancy and electrical conductivity to the vulcanizate.
  • the vulcanizing agent is various organic peroxides such as benzoyl peroxide, 2,4-dichlorobenzoyl peroxide, dicumyl peroxide, 2,5-dimethyl-2,5-di Butyl peroxy hexane and the like.
  • the structure control agent is added to prevent the compounding material from being placed for too long, resulting in "structuring” to make the rubber hard, and difficult to process and mature.
  • Methylhydroxy silicone oil or diphenyldihydroxysilane can be used as the structure controlling agent.
  • silicone rubber As a medical material, silicone rubber has been recognized by the medical community for decades. Its products involve various medical departments, there are hundreds of varieties, and it was used as an implant material in 1954. The first breast prosthesis in 1962. Implanted successfully. Silicone rubber has excellent biological properties: non-toxic, physiologically inert, resistant to biological aging, minimal reaction to human tissues, does not cause foreign body reaction after implantation into human tissues, and does not cause inflammation to surrounding tissues.
  • the medical silicone rubber selected in the present invention is combined with a metal material implantable in the human body, but does not react with the metal.
  • One embodiment of the present invention is based on the original dynamic rod in the structural and performance design (for example, see Figures 1 and 2, "A Spinal Dynamic Connecting Rod" from Chinese Patent Application No. 201 110041369.3; An inert silicone rubber material is added to the elastic region. The combination of inert silicone rubber material and elastic rod can produce hysteresis, internal pressure, tension, relaxation and creep in the elastic region.
  • the characteristics are basically consistent with the biomechanical properties of the intervertebral disc, so there is an alternative effect on the intervertebral disc.
  • the combination of the inert silicone rubber material and the elastic rod also greatly increases the fatigue strength of the elastic region.
  • the present invention can fill the elastic groove 2 in the dynamic rod 1 with an inert silicone rubber material.
  • the elastic groove 2 of the dynamic rod elastic region is filled with an inert silicone rubber material, so that the elastic region structure is a fusion of the rigid material and the flexible material, thereby solving the problem that the elastic region is deformed per unit time and increasing the fatigue strength of the elastic region.
  • the unit product of the invention after the unit product of the invention is implanted into the human body, it does not change with the body position, and the bone or blood clot around the spine is embedded in the elastic groove, which affects the dynamic effect.
  • the combination of rigid and flexible materials allows the patient to achieve stability after surgery while also accelerating the repair of the disc and the repair of the intervertebral foramen.
  • Imported high temperature vulcanized silicone rubber such as: high temperature vulcanized silicone rubber (green rubber) produced by Dow Corning, processed by ordinary silicone The process changes from a highly viscous plastic state to an elastic state, and the raw rubber is blended with a reinforcing filler, a crosslinking agent and other auxiliaries, and is kneaded into a uniform rubber compound on the rubber mixing machine, and then selected for injection or extrusion.
  • the invention has the following advantages: (1) The elastic zone enhances the damping effect, has the effect of replacing the intervertebral disc, accelerates the repair of the intervertebral disc and the repair of the intervertebral foramen; (2) solves the possibility of deformation failure of the elastic zone per unit time; (3) solves the problem of weight loss The possibility of large inoperability; and (4) the fatigue strength of the elastic zone is significantly increased.
  • Figure 1 shows a spinal dynamic stabilization implant unit, where 1 is a pedicle screw, 2 is a dynamic rod, and 3 is a compression nut.
  • Figure 2 shows a dynamic rod, where 1 is a dynamic rod and 2 is an elastic groove.
  • Figure 3 shows a prior art bioflex spinal fixation device with a shape memory alloy.
  • Figure 4 shows a prior art device for resiliently stabilizing vertebral bodies.
  • the elastic gap (154) in the bio-flexible spinal fixation device with shape memory gold-containing in the patent application No. 200510090810 is filled with an inert silicone rubber phenyl silicone rubber, and the silicone rubber also wraps the outer layer of the entire elastic region (150). In a closed form, see Figure 3.
  • the spring gap (1 1) in the device for elastically stabilizing the vertebral body is filled with an inert silicone rubber fluorosilicone rubber in the patent application No. 0382711 1.7, see Fig. 4.
  • the elastic zone structure of the invention is an organic combination of a rigid material and a flexible material, which solves the problem of failure of the elastic zone per unit time deformation and increases the fatigue strength of the elastic zone. The patient can be stabilized after the operation and can accelerate the repair of the intervertebral disc and the repair of the intervertebral foramen.
  • the elastic region of the present invention is an enclosed body, after being implanted into a human body, It does not cause the bones or blood clots around the spine to be embedded in the pores as the position changes, affecting the dynamic effect.
  • the above description of the embodiments is merely for helping to understand the core idea of the present invention. It should be noted that those skilled in the art can make several improvements and modifications to the method of the present invention without departing from the principles of the present invention, but such modifications and modifications are also within the scope of the claims of the present invention. Inside.

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Abstract

一种脊柱动态稳定植入单元，在其弹性区内加入惰性硅橡胶材料，弹性区结构是刚性材料和柔性材料有机结合，解决了弹性区单位时间变形失效的问题，增加了弹性区疲劳强度。

Description

一种脊柱动态稳定植入单元 技术领域
本发明涉及医疗器械领域。 具体而言， 本发明涉及一种脊柱动态 稳定植入单元。 背景技术
脊柱外科医生和研究者研究发现， 在治疗椎间盘突出和椎间孔狭 窄症时， 现有的椎弓根钉棒系统在植入后限制固定区节段活动， 虽然 增加了固定区节段的稳定性， 但是改变了相邻节段的生物力学环境， 从而导致邻近节段退变的速度。 鉴于此， 临床上已发明了十几种动态 稳定连接棒来改变此前刚性连接棒。 这些动态稳定连接棒的主要功能 是： 在保证脊柱稳定的基础上， 提供额外的动态运动效果， 防止邻近 节段退变加速。 本申请人的中国专利申请 No.2011 10041369.3 涉及一种脊柱动态 连接棒 (参见图 1和 2)， 主要实现方式是：连接棒和椎弓根螺钉固定后， 依靠连接棒的刚度提供脊柱的即刻稳定性。 同时， 连接棒的弹性部分 又可以提供脊柱一定范围的活动度， 保持正常脊柱的生物力学环境， 防止邻近节段因坚强固定而导致的过度载荷， 从而防止了邻近节段的 退变。 比德曼莫泰赫有限公司的中国专利申请 No.200710001142.X(欧洲 同族专利申请 NO.EP1810624A1)涉及一种植入人体或动物体的弹性连 接件， 包括： 第一杆， 其包括位于两个连接段之间的弹性段， 所述两 个连接段适于连接到将要固定于人体或动物体的装置上。 中国专利申请公开 No.200510090810涉及带形状记忆含金的生物 柔性脊柱固定装置， 该产品的弹性连接杆是由镍钛记忆合金材料绕成 弹簧状形成的。参见图 3，该脊柱固定装置中，纵向杆上有一个弹性段， 纵向杆安装在安装座的杆槽中； 至少一根横向连杆， 其直杆部分有一 个弹性段， 钩形部分从直杆部分的两端延伸， 刚性地固定纵向杆； 若 干刚性地插在螺钉头的安装座内以防止纵向杆移动的固定螺钉， 其中 纵向杆和横向连杆采用在预定温度下能产生变形的形状记忆合金制 成。 该发明的弹性部件的材料为镍钛合金， 因镍钛合金不具备切削性， 系统中的螺钉只能用钛合金材料加工形成， 这两种材料同时植入人体， 会产生点蚀电位差。 中国专利申请 No.038271 11.7(欧洲同族专利申请 NO.EP1667591A1) 涉及一种用于弹性的稳定椎骨体的装置 (1)。 参见图 4， 该装置 (1)具有： 弹性装置 (5)，这些弹性装置具有一个纵轴线 (12)并且可以与两个相邻骨 锚定件 (2)的头段 (4)连接， 使得纵轴线 (12)横向于中心轴线 (3); 其中所 述弹性装置 (5)在受压力载荷时具有一种渐进的弹簧特性曲线 (20);其特 征在于： 所述弹性装置 (5)由一种金属材料制成； 并且包括弹簧圈（19)， 其中至少两个弹簧圈 (19)具有至少一个相互不同的几何尺寸； 以及所述 弹性装置 (5)的弹簧特性曲线 (20)在力 -变形量曲线图中具有连续渐进的 走向。 该专利弹性结构复杂， 零件多， 植入难度大。 已上市产品还包括法国 Scient'x-Alphatec Spine 公司的 Isobar®
TTL 和韩国 BioSpine Co., Ltd 的脊柱弹性内固定系统 (Bioflex Spine Rod System) 其中 Isobar® TTL的植入物为一种动态连接棒， 连接棒 中间有一个完整的缓冲装置组成， 该缓冲装置包含层叠的盘状钛合金 结构， 允许线性伸缩控制轴向和成角运动。 每个盘簧都经过氮氧化处 理， 增强了抗磨损能力。 棒的缓冲特性在设计上允许 0.4mm最大轴向 压缩和拉伸， 同时允许最大成 ±2.25°的运动 (在屈伸和侧屈）。 上述产品在治疗效果上不太理想， 主要不足之处是弹性区滞后、 内压、 张力、 松弛和蠕变特性不理想、 耐疲劳性能较差， 有的植入物 自封闭性差。 在减压手术上不能很好地营造椎间盘修复环境； 在融合 手术上不能过多承担相邻节段活动度； 导致再次手术的可能性多。 发明内容
为克服现有技术及产品的缺陷， 并在脊柱减压手术上营造一个比 较好的椎间盘、 椎间孔修复环境， 以及在脊柱融合手术上更多地承担 相邻节段活动度， 本发明提供一种解决方案。 本发明涉及一种脊柱动态稳定植入单元， 其特征在于， 在其弹性 区内加入硅橡胶材料。 根据本发明， 所述弹性区优选为弹性缝隙或弹 性槽， 而所述硅橡胶为医用惰性硅橡胶。 硅橡胶为一特种合成橡胶， 它是由二甲基硅氧烷单体及其它有机 硅单体， 在酸或碱性催化剂作用下聚合成的一类线型高聚物 (生胶)， 经 过混炼、 硫化， 可以相互交联成为橡胶弹性体， 其基本结构链节为
- Si— 0— Si^, 表示通式：
R
i— 0
R' 其中， R和 R'表示取代基， n表示正整数。 硅橡胶的基本结构单元是由硅一氧链节构成的， 侧链则通过硅原 子与其他各种有机基团相连。 因此， 在硅橡胶的结构中既含有"有机基 团"， 又含有"无机结构"， 这种特殊的组成和分子结构使它集有机物的 特性与无机物的功能于一身。 与其他高分子材料相比， 硅橡胶的最突 出性能是 (1)耐温特性：有机硅产品是以硅一氧 (Si— 0)键为主链结构的， C一 C键的键能为 82.6千卡 /克分子， Si— O键的键能在有机硅中为 121 千卡 /克分子， 所以有机硅产品的热稳定性高， 高温下 (或辐射照射)分 子的化学键不断裂、 不分解。 有机硅不但可耐高温， 而且也耐低温， 可在一个很宽的温度范围内使用。 无论是化学性能还是物理机械性能， 随温度的变化都很小； （2)耐候性： 有机硅产品的主链为一Si— 0—， 无 双键存在， 因此不易被紫外光和臭氧所分解。 有机硅具有比其他高分 子材料更好的热稳定性以及耐辐照和耐候能力。 有机硅中自然环境下 的使用寿命可达几十年； 以及 (3)生理惰性： 聚硅氧烷类化合物是己知 的最无活性的化合物中的一种。 它们十分耐生物老化， 与动物体无排 异反应， 并具有较好的抗凝血性能。 硅橡胶按所用单体的不同， 可分为二甲基硅橡胶 (R、 R'为甲基)； 甲基乙烯基硅橡胶 (部分 R，为乙烯基)； 苯基硅橡胶 (部分 R'为苯基)； 氟 硅橡胶 (部分 R'氟垸基)， 以及腈硅橡胶 (部分 R'为腈烷基)等。
(1)二甲基硅橡胶 (简称甲基硅橡胶）
制备高分子量的线型二甲基聚硅氧垸橡胶， 必须要有高纯度的原 料，为保证原料的纯度，工业上通常是先将经过精镏提纯，含量为 99.5% 以上的二甲基二氯硅垸在乙醇一水介质中， 在酸催化下进行水解缩合， 并分离出双官能度的硅氧垸四聚体即八甲基环四硅氧烷， 然后再使四 环体在催化剂作用下， 形成高分子线型二甲基聚硅氧垸。 二甲基硅橡胶生胶为无色透明的弹性体， 通常用活性较高的有机 过氧化物进行硫化。硫化胶可在 -60-+250°C范围内使用， 二甲基硅橡胶 的硫化活性低， 高温压缩永久变形大， 不宜于制厚制品， 厚制品硫化 比较困难， 内层亦易起泡。 由于含少量乙烯基的甲基乙烯基硅橡胶性 能较之为优， 故二甲基硅橡胶己逐渐被甲基乙烯基硅橡胶所取代。 现 今生产和应用的其它类型的硅橡胶， 它们除含有二甲基硅氧垸结构单 元外， 还含有或多或少的其它双官能硅氧烷的结构单元， 但其制备方 法与二甲基硅橡胶的制法没有本质的区别， 其制备方法一般为在有利 于环体形成的条件下， 使所需的某种双官能度的硅单体进行水解缩合， 然后按其所需比例加入八甲基环四硅氧烷， 再在催化剂作用下共同反 应而制得。
(2)甲基乙烯基硅橡胶 (简称乙烯基硅橡胶） 此种橡胶由于含有少量的乙烯基侧链，故比甲基硅橡胶容易硫化， 使之有更多种类的过氧化物可供硫化使用， 并可大大减少过氧化物的 用量。 采用含少量乙烯基的硅橡胶与二甲基硅橡胶相较， 可使抗压缩 永久变形性能获得显著的改进， 低的压缩变形反映了它作为密封件在 高温下具有较佳的支撑性， 这乃是 0型圈和垫圈等所必须具备的要求 之一。 甲基乙烯基硅橡胶工艺性能较好， 操作方便， 可制成厚制品且 压出、 压延半成品表面光滑， 是目前较常用的一种硅橡胶。
(3)甲基苯基乙烯基硅橡胶 (简称苯基硅橡胶）
此种橡胶是在乙烯基硅橡胶的分子链中， 引入二苯基硅氧链节或 甲基苯基硅氧链节而得。 根据硅橡胶中苯基含量 (苯基：硅原子)的不同，可将其分为低苯基、 中苯基及高苯基硅橡胶。 当橡胶发生结晶或接近于玻璃化转变点或者 这两种情况重叠， 均会导致橡胶呈现僵硬状态。 引入适量的大体积的 基团使聚合物链的规整性受到破坏， 则可降低聚合物的结晶温度， 同 时由于大体积基团的引入改变了聚合物分子间的作用力， 故也可以改 变玻璃化温度。 低苯基硅橡胶 (C6H5/Si=6-l l%)即由于上述原因具有优 良的耐低温性能， 且与所用苯基单体类型无关。 硫化胶的脆性温度为 -120°C， 是现今低温性能最好的橡胶。低苯基硅橡胶兼有乙烯基硅橡胶 的优点， 而且成本也不很高， 因此有取代乙烯基硅橡胶的趋势。 在大 大提高苯基含量时则会使分子链的刚性增大， 从而导致耐寒性和弹性 的降低， 但耐烧蚀和耐辐射性能将有所提高， 苯基含量达 C6H5/Si=20-34%为中苯基硅橡胶具有耐烧蚀的特点， 高苯基硅橡胶 (C6H5/Si=35-50%)则具有优异的耐辐射性能。
(4)氟硅、 腈硅橡胶
氟硅橡胶是侧链引入氟代垸基的一类硅橡胶。 常用的氟硅橡胶为 含有甲基、 三氟丙基和乙烯基的氟硅橡胶。 氟硅胶具有良好的耐热性及优良的耐油、 耐溶剂性能， 如对脂肪 烃、 芳香烃、 氯代烃、 石油基的各种燃料油、 润滑油、 液压油以及某 些合成油在常温和高温下的稳定性均较好， 这些是单纯的硅橡胶所不 及的。 氟硅橡胶具有较好的低温性能， 对于单纯的氟橡胶而言， 是一 种很大的改进。 含三氟丙基的氟硅橡胶保持弹性的温度范围一般为
-50oC -+200°C , 耐高低温性能较乙烯基硅橡胶差， 且在加热到 300°C 以上时将会产生有毒气体。 在电绝缘性能方面较乙烯基硅橡胶差得多。 在氟硅橡胶的胶料中加入适量的低粘度羟基氟硅油， 胶料热处理， 再 加入少量乙烯基硅橡胶， 可使工艺性能显著改善， 有利于解决胶料粘 辊和存放结构化严重等问题， 能延长胶料的有效使用期。 在上述氟硅 橡胶中引入甲基苯基硅氧链节时， 会有助于耐低温性能的改善， 且加 工性能良好。 腈硅橡胶是侧链引入腈垸基 (一般为 β-腈乙基或 γ-腈丙基)的一类 硅橡胶。 极性腈基的引入改善了硅橡胶的耐油、 耐用溶剂性能， 但其 耐热性、 电绝缘性及加工性则有所降低。 腈烷基的类型和含量对腈硅橡胶的性能有较大的影响， 如含 7.5% 克分子 γ-腈丙基的硅橡胶， 其耐寒性能与低苯基硅橡胶相似， 耐油性 能 较低苯基硅橡胶为好， 当 γ-腈丙基含量增至 33-50%克分子时， 则 耐寒性显著降低， 耐油性能提高， 耐热为 200°C。 如用 β-腈乙基代替 γ- 腈丙基时则能使腈硅橡胶的耐热性进一步提高。 硅橡胶按硫化机理可分为三大类： 有机过氧化物引发的自由基交 联型、 缩聚反应型、 加成反应型。 硅橡胶按其硫化特性可分为室温硫化硅橡胶 (RTV)和高温 /热硫化 硅橡胶 (HTV)两类。 室温硫化硅橡胶按成分、 硫化机理和使用工艺不同 可分为三大类型， 即单组分室温硫化硅橡胶、 双组分縮合型室温硫化 硅橡胶和双组分加成型室温硫化硅橡胶。 这三种系列的室温硫化硅橡 胶各有其特点： 单组分室温硫化硅橡胶的优点是使用方便， 但深部固 化速度较困难； 双组分室温硫化硅橡胶的优点是固化时不放热， 收缩 率很小， 不膨胀， 无内应力， 固化可在内部和表面同时进行， 可以深 部硫化； 加成型室温硫化硅橡胶的硫化时间主要决定于温度。 室温硫化型硅橡胶 (简称 RTV)是指不需加热在室温下即可硫化的 一类硅橡胶。室温硫化硅橡胶是一种端基含有羟基 (或乙酰氧基)的硅橡 胶， 分子量较低， 例如 3-6万， 通常为粘稠状的流体。 这类橡胶中加入 适量补强填充剂、硫化剂和催化剂 (或受空气中的水分作用)后即可在室 温下硫化而成弹性体。 硫化完全之后在耐热性、 耐寒性、 介电性能等 方面都很好， 唯其机械强度较低些， 可用于浇铸和涂敷胶料。 室温硫 化硅橡胶可分为单组份型和双组份型两种。 双组份型室温硫化硅橡胶是由含端羟基的硅橡胶和补强填充剂、 硫化剂等配合而成， 使用时再添加催化剂。 常用的硫化剂为有机锡盐， 如二月桂酸二丁基锡， 用量一般为 0.5-5份或采用辛酸亚锡， 它比二月 桂酸二丁基锡的催化能力强。 硫化时即在催化剂的作用下， 使含端羟 基的硅橡胶与硫化剂之间发生脱醇缩合反应而形成交联结构。 改变硫 化剂和催化剂的用量， 即可调节硫化速度， 一般用量大时， 硫化速度 快， 反之则慢。 在硫化过程中， 生成的醇类物质逐渐从硫化胶中扩散 逸出。 单组份型室温硫化硅橡胶， 是由端基含有乙酰氧基的硅橡胶与补 强填充剂以及其它助剂配合而成， 使用时不需添加催化剂， 从密封包 装中取出后与空气中的水分作用即可硫化成为弹性体。 此种硅橡胶对 金属、 玻璃和塑料等都有很好的粘合力， 其缺点是硫化过程中伴有醋 酸生成， 虽能从硫化胶中扩散逸出， 但对接触物体， 特别是对金属有 腐蚀作用。 单组份型作用方便， 特别适用于密封、 嵌缝等用途。 或者 40-80万， 其硫化一般分为两个阶段进行， 第一阶段是将硅生胶、 补强剂、 添加剂、 硫化剂和结构控制剂进行混炼， 然后将混炼料在金 属模具中加压加热成型和硫化， 其压力为 50 kg/cm2左右， 温度为 120-130°C， 时间为 10-30分钟， 第二阶段是将硅橡皮从模具中取出后， 放人烘箱内， 于 200-250°C下烘数小时至 24小时， 使橡皮进一步硫化， 同时使有机过氧化物分解挥发。 硅橡胶的补强填料是各种类型的白炭黑如： 气相白炭黑、 沉淀白 炭黑、 处理白炭黑， 它可使硫化胶的强度增加十倍。 加入各种添加剂 主要是降低胶的成本、 改善胶料性能以及赋予硫化胶各种特殊性能如 阻燃、 导电等。 硫化剂是各种有机过氧化物， 如过氧化苯甲酰， 2，4-二 氯过氧化苯甲酰， 二枯基过氧化物， 2,5-二甲基 -2,5-二特丁基过氧已烷 等。结构控制剂是为了避免混炼胶料放置时间过长、产生"结构化 "使胶 料变硬， 难以加工熟化而加入的， 可采用甲基羟基硅油或二苯基二羟 基硅烷作为结构控制剂。 硅橡胶作为医用材料经过几十年的临床应用， 已得到医学界的认 同， 其制品涉及医学各部门， 有上百个品种， 1954 年开始用作植入材 料， 1962年第 1例乳房假体植入成功。 硅橡胶具有优良的生物性能： 无毒、 生理惰性、 耐生物老化， 对人体组织反应极小， 植入人体组织 后不会引起异物反应， 对周围组织不发生炎症。 具有优良的生物可接 受性， 不致癌， 使用温度范围宽， 可高温灭菌。 本发明选用的医用硅橡胶与可植入人体的金属材料相结合， 但与 金属之间不发生任何反应。 本发明的一个实施方式是在结构和性能设计上以原有动态棒为主 体 (例如， 参见图 1和 2， 来自中国专利申请 No.201 110041369.3的"一 种脊柱动态连接棒"；)， 在原弹性区加入惰性硅橡胶材料。惰性硅橡胶材 料和弹性棒结合后可以在弹性区产生滞后、 内压、 张力、 松弛和蠕变 特性， 与椎间盘生物力学特性基本一致， 因此有替代椎间盘功能效果。 惰性硅橡胶材料和弹性棒结合也大大增加了弹性区疲劳强度。 此外， 如果不涉及到椎间盘生物化学、 成分结构的改变， 则会产生自我修复 功能。 具体而言， 本发明可以在动态棒 1 中的弹性槽 2内填充惰性硅橡 胶材料。 动态棒弹性区的弹性槽 2 内充满惰性硅橡胶材料， 使弹性区 结构为刚性材料和柔性材料融合为一体， 从而解决了弹性区单位时间 变形失效的问题， 并增加了弹性区疲劳强度。 另外， 本发明单元产品 植入人体后， 不会随着体位的变动， 脊柱周围碎骨或血块等嵌入弹性 槽中， 影响动态效果。 刚性和柔性材料有机结合， 使病人在手术后即 可获得稳定的同时还加速椎间盘修复功能和椎间孔增大修复。 将硅橡胶填充至金属动态棒弹性缝隙的方法有二： （1)选用进口的 高温硫化硅橡胶 (HTV)， 如： 道康宁公司生产的高温硫化硅橡胶 (生胶)， 采用普通有机硅的加工工艺， 使其从高粘滞塑性态转变成弹性态， 再 将生胶配以补强填料、 交联剂和其他助剂， 在炼胶机上混炼成均匀胶 料， 然后选用注射或挤出或浸渍等方法将硅橡胶填充到动态棒弹性区 的缝隙中去， 通过高温固化使硅橡胶定型； （2)加入成型室温硫化硅橡 胶 (RTV), 其工艺是将多个动态棒排列在一个密封模型里， 通过设备加 温及抽真空注入硅橡胶， 固化后取出， 清理外层即可。 本发明优点： （1)弹性区增强阻尼效应， 有替代椎间盘效果， 加速 椎间盘修复功能和椎间孔增大修复； （2)解决弹性区单位时间变形失效 的可能； （3)解决因体重过大不能手术的可能； 以及 (4)弹性区疲劳强度 明显增加。 附图说明
为了更清楚地描述本发明的技术方案， 下面将结合附图作简要介 绍。 显而易见， 这些附图仅是本申请记载的一些具体实施方式。 本发 明的技术方案包括但不限于这些附图。 图 1示出脊柱动态稳定植入单元，其中 1为椎弓根螺钉， 2为动态 棒， 3为压紧螺母。
图 2示出动态棒， 其中 1为动态棒， 2为弹性槽。
图 3示出现有的带形状记忆合金的生物柔性脊柱固定装置。
图 4示出现有的用于弹性的稳定椎骨体的装置。 具体实施方式
为了进一步理解本发明， 下面将结合实施例对本发明的优选方案 进行描述。 这些描述只是举例说明本发明脊柱动态稳定植入单元的特 征和优点， 而非限制本发明的保护范围。 实施例一
发明专利申请 No.2011 10041369.3 的脊柱动态连接棒内涉及到 10 种动态棒形式， 图 2是其中之一。 在所有动态棒的弹性槽 2 内填充硅 橡胶材料甲基硅橡胶。 实施例二
在发明专利申请 No.200510090810带形状记忆含金的生物柔性脊 柱固定装置中的弹性缝隙 (154)内填充惰性硅橡胶苯基硅橡胶， 并且硅 橡胶还将整个弹性区 (150)的外表层包裹成封闭式的， 参见图 3。 实施例三
在发明专利申请 No.0382711 1.7 用于弹性的稳定椎骨体的装置中 的弹簧缝隙 (1 1)内填充惰性硅橡胶氟硅橡胶， 参见图 4。 相对于现有技术， 本发明的弹性区结构为刚性材料和柔性材料有 机结合， 解决了弹性区单位时间变形失效的问题， 增加了弹性区疲劳 强度。 使病人在手术后获得即可稳定的同时可以加速椎间盘修复功能 和椎间孔增大修复。 此外， 本发明的弹性区是封闭体， 植入人体后， 不会随着体位的变动， 使脊柱周围碎骨或血块等嵌入孔隙中， 影响动 态效果。 以上实施例的说明只是用于帮助理解本发明的核心思想。 应当指 出， 对于本领域的普通技术人员而言， 在不脱离本发明原理的前提下， 还可以对本发明方法进行若干改进和修饰， 但这些改进和修饰也落入 本发明权利要求请求保护的范围内。

Claims

权 利 要 求 书
1.一种脊柱动态稳定植入单元， 其特征在于， 在其弹性区内加入 硅橡胶材料。
2. 权利要求 1的脊柱动态稳定植入单元， 其特征在于， 所述硅橡 胶的基本结构链节为
Figure imgf000014_0001
其中 R和 R'表示取代基， n表示正整数。
3. 权利要求 1或 2的脊柱动态稳定植入单元， 其特征在于， 所述 硅橡胶选自二甲基硅橡胶 (R、 R，为甲基)， 甲基乙烯基硅橡胶 (部分 R， 为乙烯基)， 苯基硅橡胶 (部分 R'为苯基)， 氟硅橡胶 (部分 R'氟垸基)， 以及腈硅橡胶 (部分 R'为腈垸基)。
4. 权利要求 1-3任一项的脊柱动态稳定植入单元， 其特征在于， 所述弹性区为弹性缝隙或弹性槽。
5. —种将硅橡胶填充至金属动态棒弹性区的方法， 其特征在于， (1)包括选用高温硫化硅橡胶， 采用普通有机硅的加工工艺， 使其从高 粘滞塑性转变成弹性态； 将生胶配以补强填料、 交联剂和其他助剂， 在炼胶机上混炼成均勾胶料； 然后选用注射或挤出或浸渍方法将硅橡 胶填充到动态棒弹性区的缝隙中去， 通过高温固化使硅橡胶定型， 或 者 (2)包括加入成型室温硫化硅橡胶， 其工艺是将多个动态棒排列在一 个密封模型里， 通过设备加温及抽真空注入硅橡胶， 固化后取出， 清 理外层。
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