WO2011006413A1 - 股骨近端骨折髓内钉固定装置 - Google Patents

股骨近端骨折髓内钉固定装置 Download PDF

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Publication number
WO2011006413A1
WO2011006413A1 PCT/CN2010/074207 CN2010074207W WO2011006413A1 WO 2011006413 A1 WO2011006413 A1 WO 2011006413A1 CN 2010074207 W CN2010074207 W CN 2010074207W WO 2011006413 A1 WO2011006413 A1 WO 2011006413A1
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WO
WIPO (PCT)
Prior art keywords
hole
intramedullary nail
nail
distal end
cap
Prior art date
Application number
PCT/CN2010/074207
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English (en)
French (fr)
Inventor
杨利波
山卫东
王志敏
王彤
杨康
蒋庆辛
丁伟
王爱平
蒋凯
崔建培
彭豪
Original Assignee
常州市康辉医疗器械有限公司
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Publication date
Application filed by 常州市康辉医疗器械有限公司 filed Critical 常州市康辉医疗器械有限公司
Publication of WO2011006413A1 publication Critical patent/WO2011006413A1/zh
Priority to US13/349,542 priority Critical patent/US8409205B2/en

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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, 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
    • A61B17/74—Devices for the head or neck or trochanter of the femur
    • A61B17/742—Devices for the head or neck or trochanter of the femur having one or more longitudinal elements oriented along or parallel to the axis of the neck
    • A61B17/744—Devices for the head or neck or trochanter of the femur having one or more longitudinal elements oriented along or parallel to the axis of the neck the longitudinal elements coupled to an intramedullary nail
    • 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
    • A61B17/72—Intramedullary pins, nails or other devices
    • A61B17/7216—Intramedullary pins, nails or other devices for bone lengthening or compression
    • A61B17/7225—Intramedullary pins, nails or other devices for bone lengthening or compression for bone compression

Definitions

  • the intramedullary nail fixation device for proximal femoral fracture of the present invention relates to an intramedullary nail fixation device for treating a proximal femoral fracture.
  • the structure of the conventional intramedullary nail is fixed at the proximal end by screws and screwed into the neck of the femur.
  • the shortcoming is the use of a single large lag screw at the proximal end.
  • the screw cutting of the femoral head occurs frequently.
  • the complications of the treatment of femoral intertrochanteric fractures are higher, such as the fracture area.
  • the compression screw can cut the femoral head and osteoporosis and the fracture end may have potential rotation and shear force.
  • Another type of intramedullary nail is known from CN1378438A.
  • This intramedullary nail is fixed at the proximal end with double nails.
  • the anti-rotation screw For the lag screw, one is the anti-rotation screw. Compared with the single-nail intramedullary nail, the complications are obviously reduced, but the screw cut-out occurs, and the anti-rotation and angular stability cannot be better. Summary of the invention
  • the intramedullary nail fixation device for the proximal femoral fracture includes an intramedullary nail, a combination staple and a cortical screw; the intramedullary nail has a longitudinal axis, a proximal end and a distal end with a tip. a proximal end at an angle to the longitudinal axis and with means for coupling to the insertion device, said proximal
  • the end includes a through hole for mounting the combination lock, the through hole having a cross of 1 10 with the longitudinal axis. ⁇ 150.
  • An axis of the angle, the distal end comprising a lateral long waist through hole with an axis and a transverse circular through hole with an axis;
  • the combination lock has a head, a distal end of the staple, a sleeve, a connecting block and a cap, the cap has an internal thread matched with the externally threaded connecting block, a symmetric sliding plane, a convex block, and the distal end surface of the cap has
  • the shape of the head is a spiral blade-shaped head
  • the distal end of the locking pin is a toothed tail portion
  • the distal end of the locking nail is provided with a platform
  • the protruding block is disposed on the cap
  • the connecting block is provided with a left-handed external thread
  • one end of the connecting block is provided with a hexagonal hole
  • the other end is provided with a cylindrical step
  • the cylindrical step of the connecting block is matched with the step of the right-angled incision at the distal end of the locking nail, at the center line Both of the directions are connected by the step.
  • the cap includes a raised block that is snapped into the symmetrical sliding plane end of the bore of the sleeve and a left-handed inner thread that mates with the left-handed external thread of the connecting block.
  • the sleeve is sleeved outside the distal end of the locking pin, and the sleeve comprises a symmetric sliding fit plane in the hole, which cooperates with the symmetric sliding plane on the cap and can slide relative to each other;
  • the sleeve cannot be rotated about the centerline relative to the combination lock head after the connecting block is threaded.
  • the spiral blade-shaped head is a 2 to 6 blade, and the tail portion of the head includes a cylinder of a smaller diameter, a step of a right-angled slit, and a circumferentially distributed 60 of the end surface. tooth.
  • the proximal end of the main nail of the intramedullary nail is cylindrical, and the cylindrical bore contains two grooves coaxial with the hole in the longitudinal direction of the main nail.
  • the main nail of the intramedullary nail is close to the round hole and the long waist hole contained in the distal end portion, and can accommodate the cortical bone screw, and the axis of the round hole and the long waist hole is at an angle ⁇ of 60 with the longitudinal axis. ⁇ 100. .
  • the proximal end of the main nail of the intramedullary nail matches the shape of the combined locking sleeve, and the latter can The former slides longitudinally along the centerline but cannot rotate around the centerline in the former.
  • the combination lock is assembled by threading, and the platform on the distal end of the combination lock pin and the convex block on the cap are assembled with the symmetric sliding fit plane end on the inner hole of the sleeve, and the tooth shape and the combination lock of the end face of the cap are integrated.
  • the end face tooth shape of the distal end of the nail can be matched, and the outer shape cross section of the sleeve is matched with the cross section of the proximal end hole of the main nail of the intramedullary nail, so as to achieve the combination when the screw connection block of the combination lock pin is tightened
  • the distal end of the locking nail is non-rotatable relative to the proximal end of the main nail of the intramedullary nail, and when the connecting block of the combined locking nail is not tightened, the two are directly rotatable, and the combined locking screw threading block is tightly tightened. Refers to the rotation of the connecting block, the teeth on the cap contact the teeth of the distal end of the combination lock and fully match.
  • the invention has the advantages that: due to the use of the conventional proximal single nail type, the anti-rotation and angular stability are realized by the new combined nail internal structure, so that there is no additional disadvantage compared with the prior art, and the prior art is made up. Part of the shortcomings.
  • the stability is high in the osteoporotic bone, and the spiral blade combined with the locking nail is pressed into the surrounding bone.
  • the wide surface area and increasing core diameter ensure maximum indentation and ideal anchoring force, providing excellent resistance to cutting even in patients with osteoporosis.
  • the second is that the combination locking screw blade is designed as a spiral cross. When it is inserted, it can compress the surrounding bone to obtain the ideal anchoring force. It has angular stability and prevents hip varus. When the blade is locked, it can effectively prevent the stock.
  • the bones rotate.
  • the third is the combination of the slender rod shape of the locking head and the relatively flexible tip, which makes the insertion of the intramedullary nail more convenient and avoids stress concentration on the bone.
  • Intramedullary nail The end lock nails the static interlock selection. When the interlocking screw is screwed in vertically, it is dynamic interlocking. When the screw is screwed into the screw, it is static interlocking. At the same time, the traditional static interlocking can be selected.
  • the locking mode can be determined according to the type of fracture, and more surgical options can be provided.
  • the first hole of the proximal end of the intramedullary nail is made into a conventional cylindrical hole, and two angled openings are added in the longitudinal direction of the main nail, and the opening angle is between 100° and 130°,
  • the shape of the sleeve of the combination of the proximal end of the intramedullary nail must be in a matching embodiment.
  • the self-locking of the combination lock nail is mainly realized by the multi-component structure of the lock nail, and the function described in the invention is completed. In the self-locking form, there should be a left-handed screw assembly as power transmission.
  • a toothed structure for anti-rotation preferably having a good strength, preferably a tooth of 60°.
  • the cap of the combination lock has a convex block, and the block is used to restrict the combination lock from rotating and self-locking without dispersing.
  • the connection between the combination of the screw head and the externally threaded connecting block is formed by a concave and convex cylinder whose diameter is a suitable value between the outer diameter of the combined locking pin and the diameter of the inner hole, and the strength thereof is required to satisfy the working state of the locking nail. Limit requirements.
  • the length of the combination lock sleeve is between 40 ⁇ and 80 ⁇ ⁇ , and the diameter of the outer diameter is preferably slightly larger than the outer diameter of the spiral blade portion of the head of the lock.
  • Figure 1 is a schematic exploded view of all components of the intramedullary nail fixation device for proximal femoral fractures.
  • Figure 2 is a partial cross-sectional view of the combination lock of the intramedullary nail fixation device for the proximal femoral fracture.
  • FIG. 3 is a cross-sectional view of a combination lock sleeve of an intramedullary nail fixation device for a proximal femoral fracture.
  • Figure 4 is a longitudinal view of the proximal hole of the intramedullary nail of the proximal femoral nail fixation device.
  • Fig. 5 is a schematic view of the proximal femoral fracture intramedullary nail fixation device after the combination of the locking nails and the upper and lower teeth are engaged.
  • Figure 6 is a perspective view of the implantation and fixation of the proximal femoral nail fixation device into the femur. detailed description
  • the proximal femoral nail fixation device comprises an intramedullary nail, a combination staple 2 and a cortical screw 3, having a full thread 22;
  • the intramedullary nail 1 has a longitudinal A shaft 16, a proximal end 15 and a distal end 21 with a tip end, the proximal end 15 being angled with the longitudinal axis 16 and having means for coupling to an insertion device, the proximal end 15 including a through hole 18 for mounting a combination
  • the locking pin 2 has an axis intersecting the longitudinal axis 16 at an angle of 10 10 to 150, and the distal end 21 includes a lateral long waist through hole 20 with an axis and an axis a transverse circular through hole 19;
  • the combination locking pin 2 has a head 14, a distal end 13 of the locking bolt, a sleeve 10, a connecting block 50 and a cap 40, the cap 40 having an internal thread, symmetrical with the external thread 7 of
  • the cap 40 includes a cap that can be caught in the sleeve 10
  • the symmetrical sliding of the inner bore cooperates with the raised latch 5 at the end of the plane 9 and the left-handed internal thread that mates with the left-handed external thread 7 of the connecting block 50.
  • the sleeve 10 is sleeved on the outside of the distal end of the locking pin 13, and the sleeve 10 comprises a symmetrical sliding matching plane 9 in the hole, which cooperates with the symmetric sliding plane 4 on the cap 40 and can slide relative to each other;
  • the sleeve 10 is not rotatable relative to the combination lock head 14 about the centerline after the connecting block 50 is threaded.
  • the spiral blade-shaped head portion 14 is a 2 to 6 blade, and the tail portion of the head portion includes a cylinder of a smaller diameter, a step 12 of a right-angled slit, and a 60-degree face tooth 11 of a circumferentially distributed end surface.
  • the proximal end of the intramedullary nail main nail 1 is cylindrical, and the cylindrical hole contains two grooves coaxial with the hole in the longitudinal direction of the main nail.
  • the intramedullary nail main nail 1 is adjacent to the distal end 21 and includes a circular hole 19 and a long waist hole 20, each of which can accommodate the cortical bone screw 3, and the axes of the circular hole 19 and the long waist hole 20 are at an angle ⁇ to the longitudinal axis 16. For 60° ⁇ .
  • the through hole 18 of the proximal end of the intramedullary nail main nail 1 matches the outer shape of the sleeve 10 of the combination staple 2, and the latter can slide longitudinally along the center line 17 in the former but cannot surround the center line 17 in the former. Turn.
  • the combination lock 2 is assembled by a thread, and the platform 12 on the distal end of the combination lock, the convex block 5 on the cap 40 and the symmetric sliding fit plane 9 end of the sleeve 10 are integrally assembled, and the end face of the cap 40
  • the tooth profile 6 can cooperate with the face tooth 11 of the distal end 13 of the combination staple, the profile cross section of the sleeve 10 is matched with the contour cross section of the proximal end hole 18 of the intramedullary nail to achieve a combination lock
  • the distal end 14 of the combination staple 2 is non-rotatable relative to the proximal end of the staple of the intramedullary nail, and when the connection block 50 of the combination staple is not tightened, the two are straight Rotating, the combination of the locking bolt threading block 50 means that the teeth 6 on the cap 40 are in contact with and completely coincide with the teeth 11 of the distal end 13 of the combination locking pin by the rotation of the connecting block 50.
  • the intramedullary nail 1 for treating a femoral fracture shown in Figures 1 and 6 has a proximal end 15, a longitudinal axis 16, and a distal end 21 which are defined for insertion into the medullary canal. A distal end 21 and a longitudinal axis 16 for insertion of a cortical bone screw. Furthermore, the intramedullary nail 1 has a through hole 18 having a center line 17 which is transversely intersected by the proximal end 15 and the longitudinal axis 16, which is defined to accommodate the femoral head screw, i.e. the combination lock. The centerline 17 of the aperture 18 intersects the longitudinal axis 16 to form a 110 to 150.
  • the obtuse angle ⁇ or a 30° to 70.
  • the acute angle is 180° - ⁇ .
  • the distal end of the intramedullary nail has two transverse holes, the two transverse holes are parallel and perpendicular to the longitudinal axis of the intramedullary nail 1, wherein the first hole closer to the distal end 21 is the waist hole 20, and the second is farther
  • the hole is a round hole 19, the diameter of the two holes is the same, and the waist hole length is 2rmin to 5mm.
  • the two holes are used to accommodate the cortical bone screw.
  • the internal structure of the combination lock 2 is such that the cap 40 and the connecting block 50 are connected by a left-hand thread, and the connecting block 50 and the sleeve 10 are restricted by the convex block 5
  • the position of the connecting block 50 and the spiral blade head 13 are connected by a cylindrical step 8
  • the end faces of the cap 40 which can be in contact with the spiral blade head 13 include end face teeth 11 which can be fitted, and the sleeve 10 is placed over the head of the spiral blade
  • the tail of 13. 5rrm, the two sides of the convex block 5 have two 0. 5rrm, and the two sides of the convex block 5 are 0.
  • the spiral blade head 13 has a step 12 at its rear end, and the lower end of the step 12 has an inner hole for accommodating the cylindrical step 8 of the connecting block 50, so that the cylindrical step 8 of the connecting block 50 can be inserted laterally through the step 12, in the longitudinal direction and the connecting block. 50 connections.
  • the intramedullary nail 1 has a proximal through hole 18 shape and a combination lock 2 sleeve. 10 cross-sectional shape is the same, the cross-sectional dimension of the sleeve 10 is slightly smaller than the size of the hole 18, so that the intramedullary nail can accommodate the combination lock, but only the proximal end hole 18 of the intramedullary nail 1 and the sleeve 10 of the combination lock 1 are only It can slide along the center line 17 and cannot rotate relative to each other.
  • Intramedullary nails are inserted into the medullary canal through corresponding tools;

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Description

股骨近端骨折髓内钉固定装置 技术领域
本发明股骨近端骨折髓内钉固定装置涉及的是一种用于处理股骨近端 骨折的髓内钉固定装置。 背景技术
传统髓内钉的结构是， 在近端采用螺丝钉固定， 以拧入方式固定于股骨 头颈内。 其缺点是在近端采用单枚粗大的拉力螺钉固定， 在一些骨质疏松 及不稳定骨折病例中， 螺钉切割股骨头时有发生， 治疗股骨粗隆间骨折时 并发症较高， 如骨折区域的塌陷、 股骨颈螺钉的切出、 钉尾附近的股骨干 骨折等。 而加压螺钉切割股骨头与骨质疏松及骨折端可能存在潜在旋转及 剪切力， 另外由 CN1378438A已知另一类型髓内钉， 这种髓内钉在近端采用 双钉固定， 1枚为拉力螺钉， 1枚为防旋螺钉， 同单钉髓内钉相比， 并发症 明显降低， 但仍有螺钉切出发生， 不能较好的做到抗旋转及成角稳定性。 发明内容
本发明的目的是， 提供一种股骨近端骨折髓内钉固定装置， 解决了上 述并发症以及螺钉切出的问题。
本发明的技术解决方案是： 股骨近端骨折髓内钉固定装置包括髓内钉 主钉、 组合锁钉和皮质骨螺钉； 髓内钉主钉具有纵轴、 近端和带有尖端的 远端， 近端与纵轴成一定角度并带有用于联接到插入装置的部件， 所述近 端包括通孔， 用于安装组合锁钉， 所述通孔具有与纵轴相交成 1 10。 〜 150。角度的轴线， 所述远端包括一个带有轴线的横向长腰通孔和一个带有 轴线的横向圆通孔；
组合锁钉具有头部、 锁钉远端、 套筒、 连接块和盖帽、 该盖帽带有与 外螺紋连接块配合的内螺紋、 对称滑动平面、 凸起卡块， 该盖帽的远端面 有齿形； 所述的头部形状为螺旋刀片形头部， 所述的锁钉远端形状为端面 齿形尾部， 锁钉远端上设有平台， 所述凸起卡块设置在盖帽上； 所述的连 接块上设有左旋的外螺紋， 连接块的一端设有六角孔， 另一端设有圆柱台 阶， 连接块的圆柱台阶与锁钉远端的直角切口的台阶相吻合， 在中心线方 向上二者通过所述台阶连接为一体。 所述的盖帽包含一个能卡在套筒内孔 的对称滑动平面末端的凸起卡块以及与连接块左旋外螺紋相配的左旋内螺 紋。 套筒套在锁钉远端外部， 所述的套筒包含一个在孔内的对称滑动配合 平面， 与盖帽上的对称滑动平面相配合， 并能相对滑动；
所述套筒在连接块通过螺紋旋紧后不可绕中心线相对组合锁钉头部旋 转。
所述的螺旋刀片形头部为 2〜6刃， 所述头部的尾部包含一个较小直径 的圆柱， 一个直角切口的台阶以及端面圆周分布的 60。齿。
所述髓内钉主钉近端的孔是圆柱形， 且圆柱孔内包含 2个与孔同轴的 在主钉纵向上的凹槽。
所述髓内钉主钉靠近远端部位包含的圆孔和长腰孔， 均能容纳皮质骨 螺钉， 且圆孔和长腰孔的轴线与纵轴成角度 β 为 60。 〜100。 。
所述髓内钉主钉近端的孔与组合锁钉套筒的外形相匹配， 且后者能在 前者内沿中心线纵向滑动但不能在前者内绕中心线转动。
组合锁钉通过螺紋组合， 由组合锁钉远端上的平台、 盖帽上的凸起卡 块与套筒内孔上的对称滑动配合平面末端相配合组装为一体， 盖帽端面的 齿形与组合锁钉远端的端面齿形可以相配合， 所述套筒外形轮廓横截面与 髓内钉主钉近端通孔轮廓横截面相配合， 以达到当组合锁钉的螺紋连接块 旋紧后， 组合锁钉的远端相对髓内钉主钉近端的通孔不可旋转， 而当组合 锁钉的连接块未旋紧时， 两者直接可旋转， 所述的组合锁钉螺紋连接块旋 紧是指通过连接块的旋转， 盖帽上的齿与组合锁钉远端的齿接触并完全吻 合。
本发明的优点是： 由于采用传统的近端单钉型式， 借助新型的组合锁 钉内部结构来实现抗旋转及成角稳定性， 因而相比现有技术没有额外缺点， 同时弥补了现有技术的部分缺点。
通过组合锁钉的自锁及头部独特的螺旋刀片形形式， 可以达到这样的 优点， 一是在骨质疏松骨中具有高稳定性， 组合锁钉的螺旋刀片打入时嵌 压周围骨质， 宽大的表面积和逐渐增加的芯直径确保最大程度的嵌压以及 理想的锚合力， 即使在骨质疏松患者也能获得很强的抗切割能力。 二是组 合锁钉螺旋刀片为螺旋十字设计， 打入时能够嵌压周围骨质， 从而获得理 想的锚合力， 具备成角稳定性， 防止髋内翻发生， 当刀片锁定后， 能有效 防止股骨头旋转。 三是组合锁钉头部细长杆状设计及相对柔韧的尖端， 使 髓内钉插入更方便并且避免了骨局部的应力集中。
通过髓内钉纵向 5。 的夹角， 可以使髓内钉通过股骨大粗隆部位入路， 使髓内钉能够顺畅地插入股骨近端髓腔， 同时减少了手术切口。 髓内钉远 端锁钉动静态交锁选择。 当垂直拧入交锁螺钉时为动态交锁， 斜行拧入螺 钉时为静态交锁， 同时可选择传统静态交锁， 可根据骨折类型决定交锁方 式， 提供更多手术选择。
在本发明一种新型的实施形式中， 髓内钉近端第一孔做成传统的圆柱 孔， 同时在主钉纵向增加两处成角开口， 开口角度在 100° 〜130° 之间， 与髓内钉近端孔相配的组合锁钉的套筒外形必须采用相配的实施形式。 在 组合锁钉的新型实施形式中， 主要通过锁钉的多组件结构实现组合锁钉的 自锁完成发明所述的功能， 在该自锁形式中， 应有一种作为动力传递的左 旋的螺紋组件， 一种用于抗旋转的齿形结构， 齿形结构最好具有较好的强 度， 优选 60° 的齿。 组合锁钉的盖帽具备一种凸起卡块， 卡块用于限制组 合锁钉旋转自锁前后不会分散。 组合锁钉螺旋刀片头部和外螺紋连接块之 间的连接由一段凸凹的圆柱形成， 其直径在组合锁钉外径直径及内孔直径 之间的合适值， 其强度需满足锁钉工作状态的极限要求。 组合锁钉套筒的 长度最好在 40η^80ηκτ之间， 其外径的直径最好略大于锁钉头部螺旋刀片 部分的外圆直径。 附图说明
以下附图仅旨在于对本发明做示意性说明和解释， 并不限定本发明的 范围。 其中，
图 1是股骨近端骨折髓内钉固定装置所有组件分解示意图。
图 2是股骨近端骨折髓内钉固定装置的组合锁钉局部剖视图。
图 3是股骨近端骨折髓内钉固定装置的组合锁钉套筒的横截面图。 图 4是股骨近端骨折髓内钉固定装置的髓内钉近端孔的纵向视图。 图 5是股骨近端骨折髓内钉固定装置的组合锁钉锁紧后上下齿咬合后 的示意图。
图 6是股骨近端骨折髓内钉固定装置植入和固定到股骨内的透视图。 具体实施方式
为了对本发明的技术特征、 目的和效果有更加清楚的理解， 现对照附 图说明本发明的具体实施方式。
参照附图 1〜图 6所示，股骨近端骨折髓内钉固定装置包括髓内钉主钉 1、组合锁钉 2和皮质骨螺钉 3，具有全螺紋 22;髓内钉主钉 1具有纵轴 16、 近端 15和带有尖端的远端 21，近端 15与纵轴 16成一定角度并带有用于联 接到插入装置的部件， 所述近端 15包括通孔 18， 用于安装组合锁钉 2， 所 述的通孔 18具有与纵轴 16相交成 1 10°〜150 角度的轴线， 所述的远端 21包括一个带有轴线的横向长腰通孔 20和一个带有轴线的横向圆通孔 19; 组合锁钉 2具有头部 14、锁钉远端 13、套筒 10、连接块 50和盖帽 40， 该盖帽 40带有与连接块 50的外螺紋 7配合的内螺紋、对称滑动平面 4、 凸 起卡块 5， 该盖帽 40的远端面有齿形 6; 所述的头部 14形状为螺旋刀片形 头部， 所述的锁钉远端 13形状为端面齿形尾部， 锁钉远端 13上设有平台 12， 所述凸起卡块 5设置在盖帽 40上； 所述的连接块 50上设有左旋的外 螺紋 7， 连接块 50的一端设有六角孔 41， 另一端设有圆柱台阶 8， 连接块 的圆柱台阶 8与锁钉远端 13的直角切口的台阶相吻合， 在中心线 17方向 上二者通过所述台阶连接为一体。 所述的盖帽 40包含一个能卡在套筒 10 内孔的对称滑动配合平面 9末端的凸起卡块 5以及与连接块 50左旋外螺紋 7相配的左旋内螺紋。 套筒 10套在锁钉远端 13外部， 所述的套筒 10包含 一个在孔内的对称滑动配合平面 9，与盖帽 40上的对称滑动平面 4相配合， 并能相对滑动；
所述的套筒 10在连接块 50通过螺纹旋紧后不可绕中心线相对组合锁 钉头部 14旋转。
所述的螺旋刀片形头部 14为 2〜6刃， 所述头部的尾部包含一个较小 直径的圆柱， 一个直角切口的台阶 12以及端面圆周分布的 60°端面齿 1 1。
所述髓内钉主钉 1近端的孔是圆柱形， 且圆柱孔内包含 2个与孔同轴 的在主钉纵向上的凹槽。
所述髓内钉主钉 1靠近远端 21部位包含的圆孔 19和长腰孔 20， 均能 容纳皮质骨螺钉 3， 且圆孔 19和长腰孔 20的轴线与纵轴 16成角度 β 为 60° 〜 。
所述髓内钉主钉 1近端的通孔 18与组合锁钉 2的套筒 10的外形相匹 配， 且后者能在前者内沿中心线 17纵向滑动但不能在前者内绕中心线 17 转动。
组合锁钉 2通过螺纹组合， 由组合锁钉远端上的平台 12、盖帽 40上的 凸起卡块 5与套筒 10内孔的对称滑动配合平面 9末端相配合组装为一体， 盖帽 40端面的齿形 6与组合锁钉远端 13的端面齿 11可以相配合， 所述套 筒 10外形轮廓横截面与髓内钉主钉近端通孔 18轮廓横截面相配合， 以达 到当组合锁钉螺紋连接块 50旋紧后， 组合锁钉 2的远端 14相对髓内钉主 钉近端的通孔 18不可旋转， 而当组合锁钉的连接块 50未旋紧时， 两者直 接可旋转， 所述的组合锁钉螺紋连接块 50旋紧是指通过连接块 50的旋转， 盖帽 40上的齿 6与组合锁钉远端 13的齿 11接触并完全吻合。
在附图 1和附图 6中所示的用来处理股骨骨折的髓内钉 1具有一个确 定用来插入到骨髓腔管中的近端 15、 一个纵轴 16和一个远端 21。 一个用 来插入皮质骨螺钉的远端 21和一个纵轴 16。此外所述髓内钉 1还具有一个 靠近近端 15与纵轴 16横向相交的具有中心线 17的通孔 18，它确定用来容 纳股骨头螺钉即所述组合锁钉。 该孔 18的中心线 17与纵轴 16相交成一个 110°到 150。 的钝角 α , 或者一个 30°至 70。 的锐角 180° - α。 所述髓内 钉远端具有两个横向孔， 两横向孔平行， 且与髓内钉 1 的纵轴垂直， 其中 离远端 21较近的第一孔为腰孔 20， 较远的第二孔为圆孔 19， 两孔直径一 样， 腰孔腰长 2rmin至 5mm 两孔用与容纳皮质骨螺钉。
如附图 1、 附图 2和附图 5所示， 组合锁钉 2内部结构为， 盖帽 40与 连接块 50通过左旋螺紋连接， 连接块 50与套筒 10通过凸起卡块 5限制二 者的位置， 连接块 50与螺旋刀片头部 13通过圆柱台阶 8连接， 盖帽 40与 螺旋刀片头部 13可以相接触的两端面包含可以吻合的端面齿 11， 而套筒 10套于 螺旋刀片头部 13的尾部。其中盖帽 40—端有六角孔 41或四角孔， 其对称滑动平面的其中一面上包含的凸起卡块 5高出平面 0. 5nrm左右， 而 凸起卡块 5两侧有两道 0. 5rrm左右宽 6nim左右长的纵向槽。 螺旋刀片头部 13尾部有一个台阶 12， 台阶 12的低端有一个能容纳连接块 50圆柱台阶 8 的内孔， 以便连接块 50的圆柱台阶 8可以通过台阶 12横向插入， 在纵向 与连接块 50连接。
如附图 3和附图 4所示， 髓内钉 1近端通孔 18形状与组合锁钉 2套筒 10截面外形一致， 套筒 10截面外形尺寸稍小于孔 18的尺寸， 以便髓内钉 能容纳组合锁钉， 但髓内钉 1近端通孔 18与组合锁钉 1的套筒 10之间只 可沿中心线 17滑动， 不可绕相对转动。
下面简要说明按本实用新型的髓内钉进行手术的操作歩骤：
1、 对需手术的股骨部位进行骨髓腔管的相关准备工作；
2、 通过相应工具将髓内钉打入骨髓腔管内；
3、 将导针插入到髓内钉 1近端孔 18中；
4、 在骨头内钻出用于组合锁钉 2的孔；
5、 将未自锁的组合锁钉 2通过已钻好的孔插入股骨头内， 在组合锁钉 2的螺紋完全锁紧后， 股骨头相对髓内钉便不可转动。
6、 钻出用于远端固定髓内钉 1的孔， 将相应的皮质骨螺钉 3插入髓内 钉 1的远端孔 19或 20中。

Claims

权 利 要 求 书
1、 一种股骨近端骨折髓内钉固定装置， 其特征在于包括髓内钉主钉、 组合锁钉和皮质骨螺钉； 髓内钉主钉具有纵轴、 近端和带有尖端的远端， 近端与纵轴成一定角度并带有用于联接到插入装置的部件， 所述近端包括 通孔， 用于安装组合锁钉， 所述的通孔具有与纵轴相交成 1 10° 〜150° 角 度的轴线； 所述的远端包括一个带有轴线的横向长腰通孔和一个带有轴线 的横向圆通孔， 均能容纳皮质骨螺钉；
组合锁钉具有头部、 锁钉远端、 套筒、 连接块和盖帽， 该盖帽带有与 外螺紋连接块配合的内螺纹、 对称滑动平面、 凸起卡块， 该盖帽的远端面 有齿形； 所述的头部形状为螺旋刀片形头部， 所述的锁钉远端形状为端面 齿形尾部， 锁钉远端上设有平台， 所述凸起卡块设置在盖帽上； 所述的连 接块上设有左旋的外螺紋， 连接块的一端设有六角孔， 另一端设有圆柱台 阶， 连接块的圆柱台阶与锁钉远端的直角切口的台阶相吻合， 在中心线方 向上二者通过所述台阶连接为一体； 所述的盖帽包含一个能卡在套筒内孔 的对称滑动平面末端的凸起卡块以及与连接块左旋外螺纹相配的左旋内螺 紋， 套筒套在锁钉远端外部， 所述的套筒包含一个在孔内的对称滑动配合 平面， 与盖帽上的对称滑动平面相配合， 并能相对滑动；
组合锁钉通过螺紋组合， 由组合锁钉远端上的平台、 盖帽上的凸起卡 块与套筒孔内的对称滑动配合平面末端相配合组装为一体， 盖帽端面的齿 形与组合锁钉远端的端面齿形相配合， 所述套筒外形轮廓横截面与髓内钉 主钉近端通孔轮廓横截面相配合， 以达到当组合锁钉螺紋连接块旋紧后， 组合锁钉的远端相对髓内钉主钉近端的通孔不可旋转， 而当组合锁钉的连 接块未旋紧时， 两者直接旋转。
2、 根据权利要求 1所述的股骨近端骨折髓内钉固定装置， 其特征在于 所述的螺旋刀片形头部为 2〜6刃，所述头部的尾部包含一个小直径的圆柱、 一个直角切口的台阶以及端面圆周分布的 60° 齿。
3、 根据权利要求 1所述的股骨近端骨折髓内钉固定装置， 其特征在于 所述髓内钉主钉近端的孔是圆柱形， 且圆柱孔内包含 2个与孔同轴的在主 钉纵向上的凹槽。
4、 根据权利要求 1所述的股骨近端骨折髓内钉固定装置， 其特征在于 所述髓内钉主钉靠近远端部位包含的圆孔和长腰孔， 圆孔和长腰孔的轴线 与纵轴成角度 β为 60° 〜100° 。
5、 根据权利要求 1所述的股骨近端骨折髓内钉固定装置， 其特征在于 所述髓内钉主钉近端的孔与组合锁钉套筒的外形相匹配， 且后者能在前者 内沿中心线纵向滑动但不能在前者内绕中心线转动。
6、 根据权利要求 1所述的股骨近端骨折髓内钉固定装置， 其特征在于 所述组合锁钉的盖帽一端有六角孔或四角孔， 其对称滑动平面的其中一面 上包含的凸起卡块高出平面 0. 5mm 而凸起卡块两侧有两道 0. 5nrm宽、 6mm 长的纵向槽。
7、 根据权利要求 1 所述的股骨近端骨折髓内钉固定装置， 其特征在 于所述的套筒在连接块通过螺紋旋紧后不可绕中心线相对组合锁钉头部旋 转。
8、 根据权利要求 1所述的股骨近端骨折髓内钉固定装置， 其特征在于 所述的组合锁钉螺紋连接块旋紧是指通过连接块的旋转， 盖帽上的齿与组 合锁钉远端的齿接触并完全吻合。
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