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CN108697511A - 椎间融合器 - Google Patents

椎间融合器 Download PDF

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Publication number
CN108697511A
CN108697511A CN201780000693.6A CN201780000693A CN108697511A CN 108697511 A CN108697511 A CN 108697511A CN 201780000693 A CN201780000693 A CN 201780000693A CN 108697511 A CN108697511 A CN 108697511A
Authority
CN
China
Prior art keywords
fusion device
lumbar fusion
invasive lumbar
main body
intervertebral
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201780000693.6A
Other languages
English (en)
Inventor
金西坤
金
金�一
河明宪
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alphanox Co Ltd
Original Assignee
Solco Biomedical Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Solco Biomedical Co Ltd filed Critical Solco Biomedical Co Ltd
Publication of CN108697511A publication Critical patent/CN108697511A/zh
Pending legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • 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, e.g. stabilisers comprising fluid filler in an implant
    • A61B17/7071—Implants for expanding or repairing the vertebral arch or wedged between laminae or pedicles; Tools therefor
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/4455—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages
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    • A61F2/4465—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or kidney shaped cross-section substantially perpendicular to the axis of the spine
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    • A61F2002/30471—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
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    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30537—Special structural features of bone or joint prostheses not otherwise provided for adjustable
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Abstract

本发明涉及椎间融合器，尤其涉及一种实现关节式旋转运动，并且插入椎骨间时可稳定插入的椎间融合器。本发明的一种椎间融合器，其特征在于，包括：椎间融合器主体；及旋转部件，可旋转地连接于所述椎间融合器主体，与椎间融合器插入装置的内杆结合，其中，所述旋转部件包括：与所述椎间融合器主体连接的连接部；及螺纹部，从所述连接部的端部延伸向所述椎间融合器主体的外部突出地形成，与所述内杆螺丝结合。

Description

椎间融合器
技术领域
本发明涉及椎间融合器，尤其涉及一种实现关节式旋转运动，并且插入椎骨间时可稳定插入的椎间融合器。
背景技术
椎间盘是夹设于脊椎的椎骨之间的软骨的圆盘，在除颈椎的一部分之外的各脊椎之间，吸收身体的重量和冲击，像弹簧一样起到分散冲击的缓冲作用。此时，椎间盘起到保持脊椎不脱离，为防止脊椎神经受到压迫，分离两个脊椎以确保脊椎关节空间的范围，确保各脊椎的移动变得顺利。
上述椎间盘由纤维环和髓核构成，纤维环调节脊椎运动，而内部的髓核由70～80％的水分构成。脊椎缓冲或传递沿垂直方向施加的重量和冲击，而若患退行性椎间盘突出症，则纤维环的移动或承载髓核的能力变弱，水分含量减少。因上述综合影响，将引起椎管狭窄、形成骨赘(osteophyte)、椎间盘突出、神经根压迫等疾病。
作为一种治疗由椎间盘引起的疾病的方法，有在去除人体受损的椎间盘之后，将两个相邻的脊椎体之间的空间用人工椎间盘或种植体，即所谓的椎间融合器(cage)替代的方法。即通过移植椎间融合器恢复尽可能自然的状态，恢复作为椎间盘的原来的高度的两个相邻的脊椎体之间原来的距离，以此恢复脊椎的功能。
近来，作为将上述椎间融合器插入脊椎之间的手术方法提出TLIF(Transforaminal Lumbar Interbody Fusion)。TLIF是脊椎体融合术的一种，是从后方接近插入椎间融合器的手术方法。具体而言，是沿脊椎肌肉的两侧切开小口，为固定螺钉露出尽可能少的部分之后，在将脊椎关节部位沿神经孔出来的方向去除的同时，利用插入装置插入椎间融合器的手术，具有出血少，可缩短手术时间的优点。
在TLIF中，为最大限度地减少切口的大小和在人体内的伤害，一般来说首先使椎间融合器的前端通过人体的后面(背部一侧)插入病位于椎间之后，使椎间融合器的侧面设置于椎间的前面(人体的肚子一侧)，以此完成椎间融合器的插入。即，为使插入的椎间融合器的侧面朝向椎间的前面，需要作为辅助器具的撞击器(Impactor)，利用撞击器向椎间融合器的侧面施力，以旋转椎间融合器设置椎间融合器。但是，利用撞击器的手术存在手术变难，且手术的成功与否只能取决于手术者的能力的缺点。
作为使椎间融合器的位置调节变得容易的方法，提出注册专利公报第10-1273199号(下称“专利文献1”)及注册专利公报第10-0371308号(下称“专利文献2”)等技术。上述先行技术中的椎间融合器插入装置，实现插入椎间融合器以使椎间融合器的前端朝向椎间的额前面之后，旋转椎间融合器的关节式旋转运动，即所谓的Articulating mechanism。
在能够实现上述Articulating mechanism的椎间融合器插入装置中，最重要的是在插入椎间融合器的过程中使椎间融合器不进行旋转而保持竖立的姿态。另外，最重要的是根据要求配置最小化椎间融合器的高度(厚度)的同时，提高与插入装置之间的结合力，以可进行稳定插入，而为了解决上述技术课题研究者们开展各种研究及开发。
发明内容
技术问题
本发明的目的在于解决上述技术课题，提供一种实现关节式旋转运动，并且提高与椎间融合器插入装置之间的结合力以可进行稳定插入的椎间融合器。
本发明所要解决的技术问题不受上述技术课题的限制，而对于本领域技术人员而言，未被提及的其他技术课题可通过下面的内容将变得明了。
技术方案
为了实现上述课题，本发明提供一种椎间融合器，其特征在于，包括：椎间融合器主体；及旋转部件，可旋转地连接于所述椎间融合器主体，与椎间融合器插入装置的内杆结合，其中，所述旋转部件包括：与所述椎间融合器主体连接的连接部；及螺纹部，从所述连接部的端部延伸向所述椎间融合器主体的外部突出地形成，与所述内杆螺丝结合。
根据本发明的椎间融合器，所述连接部通过销部件连接于所述椎间融合器主体，所述旋转部件及销部件由强度高于所述椎间融合器主体的材质形成。例如，所述椎间融合器主体具有聚醚醚酮(PEEK)材质，所述旋转部件及销部件具有钛合金材质。
根据本发明的椎间融合器，所述螺纹部包括与形成于所述内杆的内螺纹结合的外螺纹。
根据本发明的椎间融合器，在所述椎间融合器主体上设置销状的第一和第二标记物，所述销部件被布置成与第一和第二标记物形成三角形结构，以起到标记的作用。
根据本发明的椎间融合器，在所述椎间融合器主体的后端形成提供所述旋转部件的旋转空间的槽，在所述槽内部形成被所述椎间融合器插入装置的推杆所支撑的第一支撑壁和被所述椎间融合器插入装置的支撑杆所支撑的第二支撑壁。
根据本发明的椎间融合器，所述第一和第二支撑壁以相对于所述椎间融合器插入装置的结合方向各自形成预定角度的方式形成，例如，所述第一支撑壁相对于所述椎间融合器插入装置的结合方向以45°角度倾斜地形成，第二支撑壁相对于所述椎间融合器插入装置的结合方向形成90°。
根据本发明的椎间融合器，在所述椎间融合器主体的表面反复形成凹凸图案，从沿所述椎间融合器主体的插入方向的前后方向观察时，所述凹凸图案形成为三角形形状，而从垂直于所述前后方向的侧面方向观察时，形成为梯形形状。
技术效果
根据上述结构的本发明，通过向椎间融合器外部突出形成与椎间融合器主体旋转连接的旋转部件的结构，可以最小化椎间融合器主体的高度，并且可以增加旋转部件的螺纹部的直径，因此提供与椎间融合器插入装置之间的更牢固的结合力。
另外，根据本发明，在椎间融合器主体的槽内以预定的角度形成第一和第二支撑壁，以实现椎间融合器的关节式旋转运动，同时在前期插入时可进行稳定插入。
另外，根据本发明，通过具有考虑椎间融合器的插入方向的形状的凹凸图案结构，在前期插入椎间融合器时，使插入变得容易，并且可防止椎间融合器安置之后在椎骨间的前后方向上滑脱。
附图说明
图1为本发明一实施例的椎间融合器的斜视图。
图2为图1所示的椎间融合器的分解斜视图。
图3为图1所示的椎间融合器的俯视图。
图4为图3所示的椎间融合器的截面图。
图5为本发明一实施例的椎间融合器插入装置的斜视图。
图6为依次表示图5所示的椎间融合器插入装置的运行状态的截面图。
图7为根据椎间融合器的旋转的第一支撑壁的位置变化的示意图。
图8为根据图5所示的椎间融合器插入装置的运行的椎间融合器的插入过程的示意图。
图9为表示图1所示的凹凸图案形式的椎间融合器的正视图。
图10为表示图1所示的凹凸图案形式的椎间融合器的侧视图。
具体实施方式
下面，结合附图对本发明相关联的椎间融合器进行详细说明。
图1为本发明一实施例的椎间融合器的斜视图，图2为图1所示的椎间融合器的分解斜视图。此外，图3为图1所示的椎间融合器的俯视图。
如图1至图3所示，本实施例的椎骨间插入用椎间融合器(100)包括椎间融合器主体(110)和可旋转地连接于之的旋转部件(120)。
椎间融合器主体(110)形成椎间融合器(100)的外观，具体而言，为插入椎骨之间具有一定的厚度，即近似未损坏的椎间盘的厚度。椎间融合器主体(110)在解剖学上具有弯曲形状，以适宜插入于椎骨间。也就是，被插入后相应于人体的肚子侧的侧部呈凸起形状，相应于背侧的侧部呈凹状，整体上呈弯曲的形状。
椎间融合器主体(110)的前端呈倾斜状，而前端的倾斜面(111)以上下对称的形状形成以方便插入。在椎间融合器主体(110)的上下面可反复形成在与脊椎体(10)接触时防止打滑的凹凸图案(116)，而其在防止打滑的同时，还可使与脊椎体(10)的融合变得更加牢固。凹凸图案(116)的形状将在后面详细地描述。
在椎间融合器主体(110)的上下面沿上下方向贯通形成用于容置骨粉的骨粉容置孔(112)，而在椎间融合器主体(110)的侧面可形成使骨粉的容置变得更加顺利的多个侧面贯通孔(113、114)。通过这种侧面贯通孔(113、114)顺利进行骨粉的容置，并增加被容置骨粉的密度，以可有效地防止空隙(空的空间)的产生。
旋转部件(120)可旋转地连接于椎间融合器主体(11)的后端。在椎间融合器主体(110)的后端具备形成旋转部件(20)的旋转空间的槽(115)，而旋转体(20)在槽(15)内可旋转地与椎间融合器主体(11)连接。
旋转部件(120)包括与椎间融合器主体(110)连接的连接部(121)和从连接部(121)的端部延伸形成的螺纹部(122)。
连接部(121)的端部可被形成为圆形以适合于旋转运动，它可通过销部件(123)连接于椎间融合器主体(110)。在连接部(121)上贯通形成插入销部件(123)的插入孔(124)，销部件(123)穿过形成于椎间融合器主体(110)的结合孔(119)被贯通插入于连接部(121)的插入孔(124)中，以形成连接部(121)的连接结构。
螺纹部(122)从连接部(121)的端部延伸向椎间融合器主体(110)的外部突出形成，且具有可结合于后述的椎间融合器插入装置(200，参照图5)的内杆(250)的结构。
螺纹部(122)具有在从连接部(121)延伸的圆柱形部件形成螺纹的形状。根据本实施例，螺纹部(122)包括与形成于内杆(250)的内螺纹结合的外螺纹。然而，本发明并不限于此，也可在螺纹部(122)上形成内螺纹，在内杆(250)上形成外螺纹。
如上述，通过将旋转部件(120)的螺纹部(122)向椎间融合器主体(110)的外部突出形成的结构，椎间融合器主体(110)的高度可最小化，并且螺纹部(122)不受椎间融合器主体(110)的厚度的限制而其直径可增加(例如，可用M3.0以上的螺纹)，因此，可更提高与椎间融合器插入装置(200)的、特别是与内杆(250)之间的结合力，这使得在前期插入椎间融合器(100)时，可以进行稳定的插入。手术结束后，旋转部件(120)仍以插入状态遗留在椎骨之间，因此考虑减少直径的方面，在螺纹部(122)上采用外螺纹比较合适。
在另一方面，根据本实施例，旋转部件(120)和销部件(123)可由强度高于椎间融合器主体(110)的材质形成。例如，椎间融合器主体(110)可由具有对于人体的生体适合性和接近骨的物理性质的树脂材质形成，例如聚醚醚酮(PEEK：Polyetheretherketone)等，旋转部件(120)和销部件(123)可具有钛合金(例如，Ti6Al4V ELI)材质。通过上述结构，旋转部件(120)和销部件(123)可执行支持强度高于聚醚醚酮材料的垂直载荷的功能。此外，通过使用钛合金材质，可以提供骨融合物质和附加融合效果。
在另一方面，在椎间融合器主体(110)上设置销状的第一标记(131)和第二标记(132)，使它们通过辐射线可以很容易地掌握做手术时椎间融合器(100)的位置和姿态。第一和第二标记(131、132)可具有放射线不透射性材质，例如钽(Tantalum)材质。
根据本实施例，用于连接旋转部件(120)的销部件(123)也由放射线不透射性材质(例如，钛合金)形成，以便起到标记的作用。销部件(123)被布置为与第一和第二标记物(131、132)形成一个三角形结构。本实施例中，第一标记(131)位于椎间融合器主体(110)的前端侧，第二标记(132)位于椎间融合器主体(110)的中央侧部，销部件(123)位于椎间融合器主体(110)的后端部，以形成连接它们的三角形结构。
在上述结构中，可根据辐射线检测出的三角形形态掌握椎间融合器主体(10)的位置和姿态。本实施例中，好处在于，使销部件(123)兼备用作连接部件和标记的功能，从而可减少制作椎间融合器主体时所需的标记的数目。
图4为图3示出的椎间融合器的截面图。
如图4所示，在形成于椎间融合器主体(110)的后端的槽(115)内可形成第一支撑壁(117)和第二支撑壁(118)。第一支撑壁(117)被后述椎间融合器插入装置(200)的推杆(220)所支撑，第二支撑壁(118)被椎间融合器插入装置(200)的支撑杆(200)所支撑。
第一和第二支撑壁(117、118)以相对于椎间融合器插入装置(200)F的结合方向(A)，即沿椎间融合器的前期插入方向的轴方向各自形成预定角度的方式形成。例如，第一支撑壁(117)相对于椎间融合器插入装置(200)的结合方向(A)以45°角度倾斜形成，第二支撑壁(118)相对于椎间融合器插入装置(200)的结合方向可形成90°角度。这样的第一和第二支撑壁(117、118)可实现椎间融合器(100)的关节式旋转运动，且起到在前期插入椎间融合器(100)时可进行稳定插入的作用。对此将在后面详细描述。
图5为本发明一实施例的椎间融合器插入装置的斜视图，图6为依次表示图5所示的椎间融合器插入装置的运行状态的截面图。此外，图7为表示根据椎间融合器旋转的第一支撑壁的位置变化的示意图，图8为表示根据图5的椎间融合器插入装置的运行的椎间融合器的插入过程的示意图。
如图5和图6所示，本实施例的椎间融合器插入装置包括主体(210)、推杆(220)、支撑杆(130)和调节部(140)。
主体(210)容置与椎间融合器(100)结合的内杆(250)。在内杆(250)的前端形成与椎间融合器(100)的旋转部件(120)结合的内螺纹部，在后端具备用于旋转操作的旋钮(252)。
推杆(220)可滑动地设置于主体(210)内。推杆(220)沿来自主体(210)的前进移动，即朝向椎间融合器(100)方向的移动，推动椎间融合器(100)的第一支撑壁(117)。
支撑杆(230)与推杆(220)并排可滑动地设置于主体(210)，在推杆(220)前进移动时向与其相反的方向后退移动，以实现椎间融合器(100)的关节式旋转运动，即所谓的Articulating mechanism。
调节部(240)可被使用者操作地设置于主体，根据使用者的操作调节推杆(220)及支撑杆(230)的移动。在本实施例中，示例性地说明调节部(240)具备可旋转地设置于主体(210)的后端部的旋转把手的形式。因此，当向一个方向旋转调节部(240)，则支撑杆(230)后退移动，推杆(120)前进移动，而当向相反方向旋转调节部(240)，则支撑杆(230)前进移动，推杆(120)后退移动。这种原理可通过基于内置于主体(210)的动力传递单元的动力传递而实现。
在主体(210)上设置用于锁定/解锁支撑杆(230)的位置的锁定单元(260)，及供使用者拿起做手术的把手(270)等。
关于椎间融合器插入装置(200)的运行过程进行说明，首先，使用者通过旋转内杆(250)的旋钮(252)结合内杆(250)和椎间融合器(100)的旋转部件(120)，并运行锁定单元(160)以固定支撑杆(230)的位置。另外，将椎间融合器插入装置(200)推入脊椎体(10)的插入位置插入椎间融合器(100)。
在前期插入椎间融合器(100)的过程中，推杆(220)支撑形成于椎间融合器(100)的槽(115)内的第一支撑壁(117)，而支撑杆(230)支撑第二支撑壁(118)。因支撑杆(230)的位置被锁定单元(260)固定，在前期插入椎间融合器(100)时，通过牢固的支撑力防止椎间融合器(101)随意旋转而稳定插入。
在前期插入椎间融合器主体(100)之后解锁锁定单元(260)，则支撑杆(230)恢复可自由移动的状态。在此状态下，若旋转调节部(240)，则推杆(220)前进移动推动椎间融合器(110)的第一支撑壁(117)，而支撑杆(230)后退移动提供椎间融合器主体(111)的旋转空间，从而实现椎间融合器(100)的关节式旋转运动。
若继续旋转调节部(140)，则椎间融合器(10)可旋转至约90°，椎间融合器(100)的第二支撑壁(118)与旋转部件(120)的侧表面接触，从而限制其旋转，可以上述状态将椎间融合器(100)插入椎间。
结束椎间融合器(100)的插入之后，使用者向与结合时相反的方向旋转旋钮(152)，以将内杆(250)从椎间融合器(100)的旋转部件(120)分离，并从手术位置拉出椎间融合器插入装置(200)。
图7依次表示椎间融合器(100)的旋转过程，图8表示与此对应的椎间融合器(100)的位置及旋转的状态。图7中，P点表示沿推杆(220)的移动的推杆(220)和第一支撑壁(117)之间的接触点。如上，推杆(220)沿倾斜状的第一支撑壁(117)移动，同时传递力，以使椎间融合器主体(110)绕着销部件(123)旋转。换言之，呈倾斜状的第一支撑壁(117)起到将推杆(220)的前进运动转换为椎间融合器主体(110)的旋转运动的作用。
在前期插入椎间融合器(100)时，第二支撑壁(118)不仅通过支撑杆(130)支撑防止椎间融合器主体(110)随意旋转而稳定插入，并且在椎间融合器主体(210)旋转至约90°时，起到限制椎间融合器主体(210)旋转的作用。
图9为表示图1所示的凹凸图案形式的椎间融合器的正视图。图10为表示图1所示的凹凸图案形式的椎间融合器的侧视图。
如图9和图10所示，在椎间融合器主体(110)的上下面可反复形成凹凸图案(116)，这些附图放大示出这种凹凸图案(116)的结构。
根据本实施例，如图9所示，凹凸图案(116)从沿所述椎间融合器主体(110)的插入方向的前后方向观察时，形成为三角形形状，而如图10所示，从垂直于前后方向的侧面方向观察时，形成为梯形形状。
根据上述结构，在前期插入椎间融合器(100)时，构成为凹凸图案(116)沿插入方向长条形成的结构，实际上凸状图案(116)沿插入方向先接触，从而凹凸图案(116)起到轨道的作用，因此可容易进行椎间融合器(100)的插入。
此外，椎间融合器(100)约旋转90°于椎间安装完毕时，凹凸图案(116)在椎骨之间的左右方向上延伸形成，因此可相对于在椎间的前后方向，即朝向人的背和腹部的方向上的流动增加摩擦力。因此，可以将安装椎间融合器(100)后结束骨整合之前因腰椎弯曲延伸运动(Lumbar Flextion-Extension)等可引起的椎间融合器(100)的打滑最小化，以防止椎间融合器(100)脱离。
上述说明的椎间融合器并不限定于上面说明的实施例的结构和方法，可选择性地组合各实施例的全部或一部分，来对所述实施例进行各种变形。

Claims (10)

1.一种椎间融合器，其特征在于，包括：
椎间融合器主体；及
旋转部件，可旋转地连接于所述椎间融合器主体，与椎间融合器插入装置的内杆结合，其中，
所述旋转部件包括：
与所述椎间融合器主体连接的连接部；及
螺纹部，从所述连接部的端部延伸向所述椎间融合器主体的外部突出地形成，与所述内杆螺丝结合。
2.根据权利要求1所述的椎间融合器，其特征在于，
所述连接部通过销部件连接于所述椎间融合器主体，所述旋转部件及所述销部件由强度高于所述椎间融合器主体的材质形成。
3.根据权利要求2所述的椎间融合器，其特征在于，
所述椎间融合器部件具有聚醚醚酮(PEEK)材质，所述旋转部件及所述销部件由钛合金材质形成。
4.根据权利要求1所述的椎间融合器，其特征在于，
所述螺纹部包括与形成于所述内杆的内螺纹结合的外螺纹。
5.根据权利要求1所述的椎间融合器，其特征在于，
在所述椎间融合器主体上设置销状的第一和第二标记物，所述销部件被布置成与所述第一和第二标记物形成三角形结构，以起到标记的作用。
6.根据权利要求1所述的椎间融合器，其特征在于，
在所述椎间融合器主体的后端形成提供所述旋转部件的旋转空间的槽，在所述槽内部形成被所述椎间融合器插入装置的推杆所支撑的第一支撑壁和被所述椎间融合器插入装置的支撑杆所支撑的第二支撑壁。
7.根据权利要求6所述的椎间融合器，其特征在于，
所述第一支撑壁和所述第二支撑壁以相对于所述椎间融合器插入装置的结合方向各自形成预定角度的方式形成。
8.根据权利要求7所述的椎间融合器，其特征在于，
所述第一支撑壁相对于所述椎间融合器插入装置的结合方向以45°角度倾斜地形成，所述第二支撑壁相对于所述椎间融合器插入装置的结合方向形成90°。
9.根据权利要求1所述的椎间融合器，其特征在于，
在所述椎间融合器主体的表面反复形成凹凸图案。
10.根据权利要求9所述的椎间融合器，其特征在于，
从沿所述椎间融合器主体的插入方向的前后方向观察时，所述凹凸图案形成为三角形形状，而从垂直于所述前后方向的侧面方向观察时，形成为梯形形状。
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