WO2012075828A1 - 棘突间动态稳定植入装置 - Google Patents

棘突间动态稳定植入装置 Download PDF

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Publication number
WO2012075828A1
WO2012075828A1 PCT/CN2011/078289 CN2011078289W WO2012075828A1 WO 2012075828 A1 WO2012075828 A1 WO 2012075828A1 CN 2011078289 W CN2011078289 W CN 2011078289W WO 2012075828 A1 WO2012075828 A1 WO 2012075828A1
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Prior art keywords
fixing member
shaped structure
pair
dynamic stabilization
wing plates
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PCT/CN2011/078289
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English (en)
French (fr)
Inventor
李雷
冯勇
田芳
刘道志
Original Assignee
上海微创骨科医疗科技有限公司
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Application filed by 上海微创骨科医疗科技有限公司 filed Critical 上海微创骨科医疗科技有限公司
Priority to BR112013014327A priority Critical patent/BR112013014327A2/pt
Publication of WO2012075828A1 publication Critical patent/WO2012075828A1/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
    • A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices

Definitions

  • the invention relates to the technical field of human spinal diseases medical devices, in particular to a dynamic stabilization device for interspinous processes.
  • Intercalation fusion has been developed for decades as a typical method for treating human spinal diseases. Because it can reconstruct the physiological structure of the spine, and significantly improve the therapeutic effect of degenerative lesions and trauma of the spine, inter-fusion fusion has been widely used. It can be said that inter-fusion fusion is a milestone in the history of spinal surgery.
  • the interspinous dynamic stabilization device provides the restriction and elastic support of the flexion and extension of the spine by filling the elastic material or elastic structure between the spinous processes, but the existing interspinous dynamic stabilization device maintains the normal segmental activity of the spine.
  • the performance of the range is poor and it is not possible to maintain the neutral zone position during the ridge push motion.
  • the object of the present invention is to provide a novel geometrical form of spine process dynamic stability, optimize its elastic support performance, and maintain the position of the neutral zone during spinal motion, thereby allowing the spinal column after surgery. Has better biomechanical properties.
  • An interspinous dynamic stabilization implant device includes: a first fixing member, a second fixing member and an elastic member, wherein:
  • the first fixing member is an H-shaped structure composed of two pairs of wing plates and a middle partition plate, wherein a pair of wing plates are provided with through holes;
  • the second fixing member is a U-shaped structure, the U-shaped structure opening is provided with a through hole, and the outer wall of the U-shaped structure is provided with a sliding groove for accommodating the other pair of wing plates of the first fixing member, and
  • the sliding slot has a circular arc shape, and the second fixing member is movably connected to the first fixing member through the sliding slot, and the opening of the U-shaped structure is opposite to the first fixing member and the other pair of wing plates The opening direction is the same;
  • the elastic member is a deformable elastic structure disposed between the middle partition and the bottom of the second fixing member U-shaped structure and fixed to the middle partition or the second fixing member.
  • An interspinous dynamic stabilization implant device includes: a first fixing member, a second fixing member and an elastic member, wherein:
  • the first fixing member is an H-shaped structure composed of two pairs of wing plates and a middle partition plate, wherein a pair of wing plates are provided with through holes;
  • the second fixing member is a U-shaped structure, the U-shaped structure opening is provided with a through hole, and the outer wall of the U-shaped structure is provided with a sliding groove for accommodating the other pair of wing plates of the first fixing member, and
  • the sliding slot has a circular arc shape, and the second fixing member is movably connected to the first fixing member through the sliding slot, and the opening of the U-shaped structure is opposite to the first fixing member and the other pair of wing plates The opening direction is the same;
  • the elastic member is a curved-shaped elastic structure composed of a plurality of arcs, disposed between the middle partition and the bottom of the second fixing member U-shaped structure, and the middle partition or the second fixed The pieces are fixed. It can be seen from the above technical solution that the present invention transmits the load downward through the arc-shaped two wings by adopting the modified elastic structure, thereby increasing the stability and reliability of the elastic member,
  • the dispersion of the load, the structure can also be designed to be relatively light and flexible; also by setting the arc-shaped chute, in actual use, according to the size of the spinous process for the surgery, a device with a specific radius of curvature is selected to ensure the chute
  • the center of the space is located in the neutral zone of the spine before flexion and extension, which not only satisfies the requirements of the non-fusion surgery of the spine, but also ensures that the neutral zone and the motion center of the adjacent spine remain basically unchanged, thus optimizing The biomechanical properties of the spine.
  • the elastic member is set to have a curved shape composed of a plurality of arcs, the thickness of each arc can be changed, so that the response of the overall elastic structure is nonlinear, and the adjustment is more flexible.
  • FIG. 1 is a front view of the interspinous process dynamic stabilization implant device according to an embodiment of the present invention
  • FIG. 2 is a left side view of the interspinous process dynamic stabilization implant device according to an embodiment of the present invention
  • FIG. 4 is a perspective view of the interspinous process dynamic stabilization implant device after assembly according to an embodiment of the present invention
  • FIG. 4 is a perspective view of the spine interstitial dynamic stabilization implant device according to an embodiment of the present invention
  • Schematic diagram of an elastic structure of a sudden dynamic stabilization implant device
  • FIG. 6 is a schematic diagram of an elastic structure of an interspinous process dynamic stabilization implant device according to an embodiment of the present invention.
  • FIG. 7 is a schematic diagram of an elastic structure of an interspinous process dynamic stabilization implant device according to an embodiment of the present invention.
  • FIG. 8 is a schematic diagram of an elastic structure of an interspinous process dynamic stabilization implant device according to an embodiment of the present invention.
  • FIG. 9 is a schematic view showing the position of the interspinous process dynamic stabilization implant device on the spine according to an embodiment of the present invention.
  • 10 is a disassembled device for dynamically stabilizing an interspinous process with a limiting mechanism according to an embodiment of the present invention; Divided into schematic diagram 1;
  • FIG. 11 is a schematic diagram of the splitting of the interspinous process dynamic stabilization implant device with a limiting mechanism according to an embodiment of the present invention.
  • the interspinous process dynamic stabilization implant device provided by the embodiment of the present invention includes:
  • the first fixing member 1 is an H-shaped structure composed of two pairs of wing plates 4 and 5, and a middle partition plate 6, wherein a pair of wings The plate 4 is provided with a through hole 7;
  • the second fixing member 2 is a U-shaped structure, the U-shaped structure opening is provided with a through hole 8 , and the U-shaped structure outer wall is provided with a first fixing a sliding groove 9 of the other pair of wing plates 5, wherein the sliding groove 9 has a circular arc shape, and the second fixing member 2 is movably connected to the first fixing member 1 through the sliding groove 9, and
  • the opening of the U-shaped structure is the same as the opening direction of the other pair of wing plates 5 of the first fixing member 1;
  • the elastic member 3 is a changeable elastic structure, and is disposed at the middle partition plate 6 and the second fixing member Between the bottoms of the U-shaped structures of 2, and fixed to the middle partition 6 or the second fixing member 2.
  • the interspinous process dynamic stabilization implant device is configured to change the elastic member 3 into a shape, and the load is transmitted downward through the arc-shaped two wings, thereby increasing the stability and reliability of the elastic member 3;
  • the dispersion, its structure can also be designed to be relatively light.
  • the shape changing elastic structure may be disposed along the sagittal plane or along the coronal plane, and the effect can be achieved by the same.
  • Fig. 5 and Fig. 6 respectively, the structural schematic diagrams of the deformable elastic structure disposed along the sagittal plane and the coronal plane are shown.
  • the elastic member 3 is a curved-shaped elastic structure composed of a plurality of arcs. As shown in FIG. 7 and FIG. 8, respectively, a schematic structural view of the meandering elastic structure disposed along the sagittal plane and the coronal plane is shown.
  • the elastic member 3 is arranged in a curved shape composed of a plurality of arcs, and the thickness of each arc can be changed, so that the response of the overall elastic structure is nonlinear, and the adjustment is more flexible.
  • the second fixing member 2 is movably connected to the first fixing member 1 through the sliding slot 9, and the sliding slot 9 has a circular arc shape.
  • the chute 9 has a circular arc shape.
  • a device having a specific radius of curvature can be selected according to the size of the spinous process for the operation, thereby ensuring that the spatial center of the chute 9 is located in the neutral region of the spine before flexion and extension.
  • Fig. 9 The situation of the dynamic stabilization implant device between the spinous processes and the spinous process is shown in Fig. 9.
  • This structural design not only satisfies the requirements of the non-fusion surgery of the spine, but also ensures that the neutral zone and the motion center of the adjacent spine remain basically unchanged, and the biomechanical properties of the spine are optimized.
  • a fixed position mechanism is disposed on the other pair of wing plates 5 and the chute 9 of the first fixing member 1.
  • the limiting mechanism includes: a sloped cylindrical protrusion 10 disposed on the inner side of the other pair of wing plates 5 of the first fixing member 1, and disposed on the sliding slot 9 and matched with the protrusion 10 Groove 11.
  • the limiting mechanism provided by the embodiment of the invention can prevent the assembly from coming off when the waist is pushed forward, and at the same time can prevent the spine from excessive flexion.
  • the through hole 7 disposed on the pair of wings 4 of the first fixing member 1 is disposed, and/or disposed in the There are a plurality of through holes 8 at the opening of the U-shaped structure. This structural design makes the assembly more stable.
  • the interspinous process dynamic stabilization implant device provided by the embodiment of the present invention adopts a composite material (such as carbon fiber) or an alloy material (such as titanium alloy, stainless steel, etc.) as a whole, so that the device as a whole has Good mechanical strength and chemical resistance, suitable for implantation in human spinous processes.
  • a composite material such as carbon fiber
  • an alloy material such as titanium alloy, stainless steel, etc.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
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Description

说 明 书
棘突间动态稳定 ^U 装置
技术领域
本发明涉及人体脊柱疾病医疗器械技术领域， 特别是涉及一种棘突间动 态稳定植入装置。
背景技术
推间融合术作为一种治疗人体脊柱疾病的典型方法， 已经发展了数十年。 由于其能够重建脊推的生理结构形态， 显著提高脊柱退行性病变和创伤的治 疗效果， 因此推间融合术得到了广泛的运用， 可以说， 推间融合是脊柱外科 史上的一个里程碑。
但是， 随着对大量脊柱融合病例的长期随访， 人们发现脊柱融合术后， 节段的相对固定会导致应力向邻近推体集中， 尤其加重了相邻推体的负载。 同时， 融合节段的活动度丧失导致相邻节段的活动范围增大， 以补偿融合节 段的活动能力， 从而引起邻近节段的生物力学环境异常， 生物力学环境的改 变最终导致了邻近节段退变。 其中最常见的是融合区临近节段推间盘的退行 性改变， 另外， 推体滑脱、 骨赘形成和髓核突出等也屡有文献报道， 长期治 疗效果难以令人满意。
为了提高治疗效果， 阻止产生疼痛的运动方向和运动平面的脊柱异常活 动的同时， 保留其他正常的腰推活动度， 市场上出现了一些对病变脊柱节段 不进行融合的棘突间动态稳定装置。
棘突间动态稳定装置， 是通过在棘突间填塞弹性物质或弹性结构提供对 脊柱前屈后伸的限制和弹性支撑的， 但是现有棘突间动态稳定装置， 维持脊 柱正常的节段活动范围的性能较差， 且保持无法保持脊推运动过程中的中性 区位置。 发明内容
有鉴于此， 本发明的目的， 在于提供一种新型几何形态的棘突间动态稳 同时， 优化其弹性支撑性能， 并且能维持脊柱运动过程中的中性区位置， 从 而使经过手术后的脊柱具有更优秀的生物力学性能。
为实现上述目的， 本发明的技术方案如下：
一种棘突间动态稳定植入装置， 包括： 第一固定件、 第二固定件和弹性 件， 其中：
所述第一固定件为由两对翼状板和中隔板组成的 H型结构， 其中一对翼 状板上设置有贯穿孔；
所述第二固定件为 U型结构， 所述 U型结构开口处设置有贯穿孔， 所述 U型结构外壁上设置有可容纳所述第一固定件另一对翼状板的滑槽， 且所述 滑槽呈圓弧形， 所述第二固定件通过所述滑槽与所述第一固定件活动连接， 且其 U型结构的开口与所述第一固定件另一对翼状板的开口方向相同；
所述弹性件为换形弹性结构， 设置在所述中隔板与所述第二固定件 U型 结构底部之间， 且与所述中隔板或所述第二固定件相固定。
一种棘突间动态稳定植入装置， 包括： 第一固定件、 第二固定件和弹性 件， 其中：
所述第一固定件为由两对翼状板和中隔板组成的 H型结构， 其中一对翼 状板上设置有贯穿孔；
所述第二固定件为 U型结构， 所述 U型结构开口处设置有贯穿孔， 所述 U型结构外壁上设置有可容纳所述第一固定件另一对翼状板的滑槽， 且所述 滑槽呈圓弧形， 所述第二固定件通过所述滑槽与所述第一固定件活动连接， 且其 U型结构的开口与所述第一固定件另一对翼状板的开口方向相同；
所述弹性件为多段圓弧组成的曲回形弹性结构， 设置在所述中隔板与所 述第二固定件 U型结构底部之间，且与所述中隔板或所述第二固定件相固定。 从以上技术方案可以看出， 本发明通过采用换形的弹性结构， 使载荷通 过圓弧状的两翼向下传递， 增加了弹性件的稳定性和可靠性， 由于具有对载 荷的分散作用， 其结构也可以设计加工的较为轻巧； 还通过设置圓弧形的滑 槽， 实际使用时， 可根据手术针对的棘突的大小， 选用具有特定曲率半径的 装置， 保证滑槽的空间圓心位于脊柱前屈后伸时的中性区内， 既满足了脊柱 非融合手术对活动范围的要求， 又保证了相邻脊柱的中性区和运动中心基本 保持不变， 从而优化了脊柱的生物力学性能。
此外， 如果将弹性件设置成具有多段圓弧组成的曲回形， 还可通过改变 每段圓弧的厚度， 使得整体弹性结构的响应为非线性， 调节更为灵活。
附图说明 施例或现有技术描述中所需要使用的附图作筒单地介绍， 显而易见地， 下面 描述中的附图仅仅是本发明中记载的一些实施例， 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为本发明实施例提供的棘突间动态稳定植入装置组装后的主视图； 图 2为本发明实施例提供的棘突间动态稳定植入装置组装后的左视图； 图 3为本发明实施例提供的棘突间动态稳定植入装置组装后的俯视图； 图 4为本发明实施例提供的棘突间动态稳定植入装置组装后的立体图； 图 5 为本发明实施例提供的棘突间动态稳定植入装置一种弹性结构的示 意图 1；
图 6 为本发明实施例提供的棘突间动态稳定植入装置一种弹性结构的示 意图 2;
图 7 为本发明实施例提供的棘突间动态稳定植入装置一种弹性结构的示 意图 3;
图 8 为本发明实施例提供的棘突间动态稳定植入装置一种弹性结构的示 意图 4;
图 9 为本发明实施例提供的棘突间动态稳定植入装置在脊柱上的位置示 意图；
图 10为本发明实施例提供的带限位机构的棘突间动态稳定植入装置的拆 分示意图 1;
图 11为本发明实施例提供的带限位机构的棘突间动态稳定植入装置的拆 分示意图 2。
具体实施方式
为了使本技术领域的人员更好地理解本发明中的技术方案， 下面将结合 本发明实施例中的附图， 对本发明实施例中的技术方案进行清楚、 完整地描 述， 显然， 所描述的实施例仅仅是本发明一部分实施例， 而不是全部的实施 例。 基于本发明中的实施例， 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他实施例， 都应当属于本发明保护的范围。
参见图 1、 图 2、 图 3和图 4所示， 本发明实施例提供的棘突间动态稳定 植入装置包括：
第一固定件 1、 第二固定件 2和弹性件 3, 其中： 所述第一固定件 1为由 两对翼状板 4和 5, 以及中隔板 6组成的 H型结构， 其中一对翼状板 4上设 置有贯穿孔 7; 所述第二固定件 2为 U型结构， 所述 U型结构开口处设置有 贯穿孔 8, 所述 U型结构外壁上设置有可容纳所述第一固定件 1另一对翼状 板 5的滑槽 9, 且所述滑槽 9呈圓弧形， 所述第二固定件 2通过所述滑槽 9与 所述第一固定件 1活动连接， 且其 U型结构的开口与所述第一固定件 1另一 对翼状板 5的开口方向相同； 所述弹性件 3为换形弹性结构， 设置在所述中 隔板 6与所述第二固定件 2的 U型结构底部之间， 且与所述中隔板 6或所述 第二固定件 2相固定。
本发明实施例提供的棘突间动态稳定植入装置， 将弹性件 3设置成换形， 载荷通过圓弧状的两翼向下传递， 增加了弹性件 3 的稳定性和可靠性； 由于 对载荷的分散作用， 其结构也可以设计加工的较为轻巧。
此外， 需要说明的是， 所述换形弹性结构可以沿矢状面设置， 也可以沿 冠状面设置， 所能达到的效果相同。 如图 5和图 6所示， 分别为换形弹性结 构沿矢状面和冠状面设置的结构示意图。
在本发明的一个实施例中， 弹性件 3为多段圓弧组成的曲回形弹性结构， 如图 7和图 8所示， 分别为曲回形弹性结构沿矢状面和冠状面设置的结构示 意图。
将弹性件 3设置成具有多段圓弧组成的曲回形， 还可通过改变每段圓弧 的厚度， 使得整体弹性结构的响应为非线性， 调节更为灵活。
本发明实施例提供的棘突间动态稳定植入装置中， 第二固定件 2通过滑 槽 9与第一固定件 1活动连接， 且滑槽 9呈圓弧形。 这样的结构设计， 实现 了第一固定件 1和第二固定件 2的低摩擦配合， 且使棘突间动态稳定植入装 置整体活动在一个特定的轨迹上。 滑槽 9呈圓弧形， 实际使用时， 可根据手 术针对的棘突的大小， 选用具有特定曲率半径的装置， 从而保证滑槽 9 的空 间圓心位于脊柱前屈后伸时的中性区内， 棘突间动态稳定植入装置与棘突配 合的情况如图 9所示。 这样的结构设计， 既满足了脊柱非融合手术对活动范 围的要求， 又保证了相邻脊柱的中性区和运动中心基本保持不变， 优化了脊 柱的生物力学性能。
参见图 10和图 11所示， 在本发明的一个实施例中， 所述第一固定件 1 另一对翼状板 5上和滑槽 9上设置有限位机构。 所述限位机构包括： 设置在 所述第一固定件 1另一对翼状板 5内侧的带斜坡的圓柱形突起 10, 和设置在 所述滑槽 9上， 且与所述突起 10相配合的凹槽 11。
本发明实施例提供的限位机构， 可以防止装配体在腰推前屈时脱出， 同 时也能阻止脊柱过度前屈。
可以理解的是， 优选的， 本发明实施例提供的棘突间动态稳定植入装置 中， 设置在所述第一固定件 1一对翼板 4上的贯穿孔 7, 和 /或设置在所述 U 型结构开口处的贯穿孔 8 为多个。 这样的结构设计， 可以使得装配体更加稳 定。
此外， 需要说明的是， 优选的， 本发明实施例提供的棘突间动态稳定植 入装置整体采用复合材料（例如碳素纤维）或合金材料（例如钛合金、 不锈 钢等）， 使得装置整体具有良好的机械强度和抗化学性， 适合植入人体棘突间 使用。
以上所述仅是本发明的优选实施方式， 使本领域技术人员能够理解或实 现本发明。 对这些实施例的多种修改对本领域的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

权 利 要 求 书
1、 一种棘突间动态稳定植入装置， 其特征在于， 包括： 第一固定件、 第 二固定件和弹性件， 其中：
所述第一固定件为由两对翼状板和中隔板组成的 H型结构， 其中一对翼 状板上设置有贯穿孔；
所述第二固定件为 U型结构， 所述 U型结构开口处设置有贯穿孔， 所述 U型结构外壁上设置有可容纳所述第一固定件另一对翼状板的滑槽， 且所述 滑槽呈圓弧形， 所述第二固定件通过所述滑槽与所述第一固定件活动连接， 且其 U型结构的开口与所述第一固定件另一对翼状板的开口方向相同；
所述弹性件为换形弹性结构， 设置在所述中隔板与所述第二固定件 U型 结构底部之间， 且与所述中隔板或所述第二固定件相固定。
2、 根据权利要求 1所述的棘突间动态稳定植入装置， 其特征在于， 所述 第一固定件另一对翼状板和滑槽上设置有限位机构。
3、 根据权利要求 2所述的棘突间动态稳定植入装置， 其特征在于， 所述 限位机构包括：
设置在所述第一固定件另一对翼状板内侧的带斜坡的圓柱形突起， 和设 置在所述滑槽上， 且与所述突起相配合的凹槽。
4、 根据权利要求 1所述的棘突间动态稳定植入装置， 其特征在于， 设置 在所述第一固定件一对翼板上的贯穿孔， 和 /或设置在所述 U型结构开口处的 贯穿孔为多个。
5、 根据权利要求 1-4任意一项所述的棘突间动态稳定植入装置， 其特征 在于， 所述棘突间动态稳定植入装置整体采用复合材料或合金材料。
6、 一种棘突间动态稳定植入装置， 其特征在于， 包括： 第一固定件、 第 二固定件和弹性件， 其中：
所述第一固定件为由两对翼状板和中隔板组成的 H型结构， 其中一对翼 状板上设置有贯穿孔；
所述第二固定件为 U型结构， 所述 U型结构开口处设置有贯穿孔， 所述 U型结构外壁上设置有可容纳所述第一固定件另一对翼状板的滑槽， 且所述 滑槽呈圓弧形， 所述第二固定件通过所述滑槽与所述第一固定件活动连接， 且其 U型结构的开口与所述第一固定件另一对翼状板的开口方向相同； 所述弹性件为多段圓弧组成的曲回形弹性结构， 设置在所述中隔板与所 述第二固定件 U型结构底部之间，且与所述中隔板或所述第二固定件相固定。
7、 根据权利要求 6所述的棘突间动态稳定植入装置， 其特征在于， 所述 第一固定件另一对翼状板和滑槽上设置有限位机构。
8、 根据权利要求 7所述的棘突间动态稳定植入装置， 其特征在于， 所述 限位机构包括：
设置在所述第一固定件另一对翼状板内侧的带斜坡的圓柱形突起， 和设 置在所述滑槽上， 且与所述突起相配合的凹槽。
9、 根据权利要求 6所述的棘突间动态稳定植入装置， 其特征在于， 设置 在所述第一固定件一对翼板上的贯穿孔， 和 /或设置在所述 U型结构开口处的 贯穿孔为多个。
10、根据权利要求 6-9任意一项所述的棘突间动态稳定植入装置，其特征 在于， 所述棘突间动态稳定植入装置整体采用复合材料或合金材料。
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