WO2017166424A1 - 用于手足骨骨折治疗的微型锁定外固定装置 - Google Patents

用于手足骨骨折治疗的微型锁定外固定装置 Download PDF

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Publication number
WO2017166424A1
WO2017166424A1 PCT/CN2016/084360 CN2016084360W WO2017166424A1 WO 2017166424 A1 WO2017166424 A1 WO 2017166424A1 CN 2016084360 W CN2016084360 W CN 2016084360W WO 2017166424 A1 WO2017166424 A1 WO 2017166424A1
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frame body
hand
screw
foot
threaded hole
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PCT/CN2016/084360
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English (en)
French (fr)
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梁向党
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北京良之介医疗器械有限公司
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Publication of WO2017166424A1 publication Critical patent/WO2017166424A1/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
    • A61B17/60—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 for external osteosynthesis, e.g. distractors, contractors
    • 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
    • A61B17/60—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 for external osteosynthesis, e.g. distractors, contractors
    • A61B17/64—Devices extending alongside the bones to be positioned
    • A61B17/6416—Devices extending alongside the bones to be positioned with non-continuous, e.g. hinged, pin-clamp connecting element
    • 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
    • A61B17/60—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 for external osteosynthesis, e.g. distractors, contractors
    • A61B17/64—Devices extending alongside the bones to be positioned
    • A61B17/6441—Bilateral fixators, i.e. with both ends of pins or wires clamped

Definitions

  • the invention relates to a miniature locking external fixation device for the treatment of hand and foot bone fractures, and belongs to the technical field of medical instruments.
  • Hand and foot fractures are common fractures.
  • Surgical treatment is one of the main treatments.
  • the purpose of treatment is to fix the fracture site.
  • the use of steel plate screws as the material for internal fixation is currently the main clinical treatment.
  • the disadvantage of traditional internal fixation is that the surgical trauma is large, the incision is long, and the scar is obvious. After the fracture is healed, the internal fixation plate is located under the skin, which is very obvious, due to aesthetics and other reasons.
  • It mainly includes an elongated frame body 11, a plurality of clamping screws 12, an adjusting screw 14, and a fracture fixing screw 13; the structure is adapted to the bone size of different people, and the frame body The length can be adjusted by the adjusting screw, and the fracture fixing screw 13 is fixed by the clamping screw 12 and adjusted in length; the outer fixing frame of the structure is generally long in size and the structure of the frame is complicated and heavy, the operation is complicated, the fixing effect is poor, and the looseness is easy.
  • the use of traditional external fixators in the treatment of hand and foot fractures is often limited because of the frequent scratching of adjacent fingers.
  • the object of the present invention is to provide a locking external fixation device for the treatment of hand and foot bone fractures, and to change the structure of the external fixation frame which has been used for the treatment of hand and foot bone fractures, to overcome the structural defects of the existing external fixation frame and to simplify the fracture of the hand and foot bone.
  • the invention relates to a miniature locking external fixation device for treating the treatment of hand and foot bone fracture, which is characterized in that the device comprises a fixed length elongated frame body and a plurality of fracture fixing screws matched with the elongated frame body;
  • the length of the elongate frame is 30-60 mm, and the frame body has a plurality of threaded holes laterally.
  • the diameter of the fracture fixing screw is 2.5 mm-3.5 mm, and the screw is 4-6 pieces; the threaded hole and the screw of the frame body The thread is matched, and the fracture fixing screw is screwed into the threaded hole and integrated with the frame rest.
  • the head of the fracture fixing screw is fixed with the hand and the foot bone of the fracture part.
  • the micro-locking external fixation device proposed by the invention has the following advantages: 1.
  • the external fixation device of the invention is used in vitro, belongs to the category of external fixation, and has a simple structure, so that less traumatic small bleeding, the incision is doubled, only 2-3 cm In the fracture area, the incision complications are significantly reduced, and the scar is small and beautiful; since the second surgery is not required to remove the internal fixation of the foot and foot, the risk of secondary surgery is avoided, and the medical cost is saved for the patient.
  • the external fixation device of the present invention does not need to be implanted in the body, thereby avoiding the intraoperative soft tissue peeling and the interference loss of the tendon. Injury, the difficulty of surgery is reduced, the operation time is shortened, and the risk of complications is reduced. Young doctors are easy to master and the learning curve is shortened.
  • the external fixing device of the present invention can be made of a light-weight material such as stainless steel, titanium alloy, carbon fiber or aluminum alloy, which is smaller in size, lighter in weight and less painful to the patient than the conventional external fixing device, and is beneficial to the patient's recovery.
  • the external fixation device of the present invention can be drilled by K-wire, and the damage is small compared with the conventional electric drill, and the complications of the nail are less, which improves the safety of the operation.
  • the fracture fixation screw of the external fixation device of the present invention can be fixed by multiple nails, and the fixation method has the advantages of small trauma and reliable fixation.
  • the external fixing device of the invention replaces the connection manner of the traditional external fixing device such as the adjustable frame body and the nail clip, and the frame body is combined with the direct screw locking structure of the fracture fixing screw, the length of the frame body is greatly shortened, and the whole body is made The structure is firmer, smaller, and less prone to failure.
  • Figure 1 is a schematic view showing the structure of a conventional external fixation device for a hand and foot bone fracture.
  • FIG. 1(a) is a schematic view of the overall structure, and FIG. 1(b) is a transverse cross-sectional view.
  • FIG. 2 is a schematic view showing the structure of an embodiment of the micro-locking external fixation device for the treatment of hand and foot fractures of the present invention.
  • Fig. 3 is a schematic view showing the structure of a fracture fixing screw of the embodiment.
  • 1 is a long frame body
  • 2 is a threaded hole
  • 3 is a fracture fixing screw tail
  • 4 is a middle part of a fracture fixing screw
  • 5 is a fracture fixing screw tip.
  • the invention relates to a miniature locking external fixation device for treating the treatment of hand and foot bone fracture, which is characterized in that the device comprises a fixed length elongated frame body and a plurality of fracture fixing screws matched with the elongated frame body;
  • the length of the elongate frame is 30-60 mm, and the frame body has a plurality of threaded holes laterally.
  • the diameter of the fracture fixing screw is 2.5 mm-3.5 mm, and the screw is 4-6 pieces; the threaded hole and the screw of the frame body The thread is matched, and the fracture fixing screw is screwed into the threaded hole and integrated with the frame rest.
  • the head of the fracture fixing screw is fixed with the hand and the foot bone of the fracture part.
  • the micro-locking external fixation device for the treatment of hand and foot fractures combines the advantages of the traditional hand-foot bone plate and the external fixation frame, and designs a strip-shaped locking external fixation device according to the contour of the hand-foot bone, wherein the frame body
  • the length is matched with the length of the hand and foot bones.
  • the shape of the frame body may be a long strip shape of a rectangular parallelepiped or a semi-column.
  • the upper half of the semi-column is a flat surface, the lower surface is a flat surface or a concave cylindrical surface, and the two sides are convex cylindrical surfaces.
  • the frame body may be stainless steel, aluminum alloy, or the like in order to meet the strength requirement of the length.
  • a metal such as a titanium alloy or any material such as carbon steel or carbon fiber.
  • the width and thickness of the frame are both to meet the size of the threaded hole, depending on the strength of the material selected.
  • the micro-locking external fixation device for treating the hand-foot bone fracture of the present embodiment is composed of the elongated frame body 1 and a plurality of fracture fixing screws as shown in Figs. 1 and 2; wherein the length of the elongated frame body 1 is fixed according to the need
  • the embodiment can be made into a frame body of several lengths in the range of 30-60 mm; the width and thickness of the elongated frame body are determined according to the strength of the material used, and the frame body is satisfied. The strength at the time of application in turn reduces the overall weight.
  • different lengths of the frame body have 4-6 unequal threaded holes 2 in the transverse direction, and the diameter of the threaded holes is matched with the screws.
  • the number of the threaded holes can also be screwed into the position of the screw according to the strength of the material and the application. Depending on the flexibility. It is convenient for the doctor to freely select the fixed position of the screw as needed, and at the same time to reduce the weight of the elongated frame.
  • the threaded hole 2 in the frame body of the embodiment has a stepped shape which is large and small, and is perpendicular to the elongated frame body 1 at 90 degrees.
  • the upper end is a threaded hole matching the thread of the screw, and the lower end is slightly smaller than the upper end thread. Through hole of the hole.
  • the structure of the fracture fixation screw of the present embodiment is as shown in FIG. 2, and is composed of an integrally formed tip 5, a cylindrical middle section 4 and a tail portion 3, wherein the tip end 5 is a conical shape with an external thread for holding the bone;
  • the outer diameter of 4 matches the lower end aperture of the threaded hole 2 of the elongated frame body, the outer diameter of the middle section 4 is slightly smaller than the lower end aperture of the threaded hole 2, the section passes through the lower end of the threaded hole 2, and the tip passes through the smooth and skin and soft tissue Contact and enter the human hand and foot bone to fix the fracture;
  • the tail 3 is provided with an external thread, the diameter matches the inner diameter of the upper end of the threaded hole 2, and the screw has a screw hole at the middle of the tip end, which facilitates screwing the screw into the elongated frame body with the corresponding tool
  • the threaded hole 1 of 1 is screwed into the human hand and the foot bone to fix the fracture at the corresponding position.
  • the tail portion 3 is screwed to the upper end of the threaded hole 2.
  • the screws are made of fine nails.
  • the diameter is selected from 2.5mm to 3.5mm according to the width of the frame.
  • the thickness and the depth of the embedded hand and foot bone are matched.
  • the screw of this embodiment is made of medical stainless steel or titanium alloy material.
  • This embodiment has the characteristics of minimally invasive, no secondary surgical removal, and can effectively reduce various complications of treatment of hand and foot bone fractures.
  • the invention discloses a miniature locking external fixation device for the treatment of hand and foot bone fractures, and the operation procedure thereof is as follows:
  • the hand and foot bone of the fracture are restored by incision or closure, and the long-shaped frame body is fixed by Kirschner wire, hollow nail or headless nail.
  • the position of the frame body is confirmed under fluoroscopy, and the needle is drilled with K-wire.
  • the hole passes through the threaded hole of the appropriate position of the frame body, the opponent's foot and the foot bone, and finally the screw hole of the drilled tibia is screwed into the screw to fix the broken hand and the foot bone.
  • traction is used to restore the length of the hand and foot bones, and the small fracture blocks are crushed to achieve functional reset. Then, the external fixation device is locked, and the screws are used as much as possible to increase the fixation effect.

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Abstract

一种用于手足骨骨折治疗的微型锁定外固定装置，该装置由固定长度的长形架体（1）和多个与该长形架体（1）匹配的骨折固定螺丝钉组成；该长形架体（1）长度为30-60mm，该架体（1）上横向开有多个螺纹孔（2），该骨折固定螺丝钉直径为2.5mm-3.5mm，该架体（1）的螺纹孔（2）与螺丝钉的螺纹相匹配，该骨折固定螺丝钉拧入螺纹孔（2）内与架体（1）连接成一体，骨折固定螺丝钉头部与骨折部分的手、足骨固定。

Description

用于手足骨骨折治疗的微型锁定外固定装置 技术领域
本发明涉及一种用于手足骨骨折治疗的微型锁定外固定装置，属于医疗器械技术领域。
背景技术
手、足骨骨折是常见骨折，手术治疗是主要的治疗手段之一，治疗目的是对骨折部位进行固定，固定方法有内固定和外固定两种。用钢板螺丝钉作为材料的内固定是目前临床上主要的治疗手段，传统内固定的缺点是手术创伤大，切口长，瘢痕明显，骨折愈合后，内固定钢板位于皮下，非常明显，由于美观等原因，常常需要二次手术取出；由于手、足骨骨骼小，皮肤及软组织菲薄，手术过程中，放置钢板困难，钢板外露，感染等并发症较多；另外由于肌腱多、需要经常滑动，后期功能影响较大。传统的外固定架的结构如图1所示，主要包括一长形架体11、多个夹持螺钉12、调节螺钉14，及骨折固定螺钉13；这样结构为适应不同人群骨骼尺寸，架体长度可由调节螺钉调节长度，骨折固定螺钉13由夹持螺钉12固定并调节长度；由于这种结构的外固定架的尺寸一般长且架体结构复杂笨重、操作复杂、固定效果差、容易松动，常常划伤邻近手指等原因，传统外固定架在手足骨骨折治疗过程中应用受到了限制。
发明内容
本发明的目的是提出一种用于手足骨骨折治疗的锁定外固定装置，改变已有用于手足骨骨折治疗的外固定架的结构，以克服已有外固定架的结构缺点，简化手足骨骨折的治疗过程，并有效减少手足骨骨折治疗的并发症。
本发明提出的一种用于手足骨骨折治疗的微型锁定外固定装置，其特征在于，该装置由固定长度的长形架体和多个与该长形架体匹配的骨折固定螺丝钉组成；该长形架体长度为30—60mm，该架体上横向开有多个螺纹孔，该骨折固定螺丝钉直径为2.5mm-3.5mm，该螺丝钉为4-6枚；该架体的螺纹孔与螺丝钉的螺纹相匹配，该骨折固定螺丝钉拧入螺纹孔内与架休连接成一体，骨折固定螺丝钉头部与骨折部分的手、足骨固定。本发明提出的微型锁定外固定装置，其优点是：1、本发明的外固定装置用于体外，属于外固定范畴，且结构简单，因此创伤小出血少，切口成倍缩小，只有2-3cm，位于骨折区域，切口并发症明显降低，并且瘢痕小、美观；由于不需要二次手术取出手足骨内固定，避免了二次手术的风险，并为患者节省医疗费用。
2、本发明的外固定装置不需要植入体内因此避免了术中软组织剥离和肌腱的干扰损 伤，手术难度降低，手术时间缩短，相应手术并发症风险降低，年轻医生容易掌握，学习曲线缩短。
3、本发明的外固定装置由于是外固定，可以采用不锈钢、钛合金、碳纤维或铝合金等轻型材料，比传统外固定架体积小，重量轻，病人痛苦小，有利于患者康复。
4、本发明的外固定装置，可以采用克氏针钻孔，与传统电钻打孔相比较，损伤小，钉道并发症较少，提高了手术的安全性。
5、本发明外固定装置的骨折固定螺钉，可以采用细钉进行多钉固定，这样的固定方法具有创伤小，固定可靠的效果。
6、本发明的外固定装置，替代了可调架体及钉夹等传统外固定装置的连接方式，采用架体与骨折固定螺丝钉直接螺纹锁定结构结合，架体长度大大缩短，且使其整体结构更加牢固、体积更小、不易松动失效。
附图说明
图1为传统的手足骨骨折外固装置结构示意图，
其中，图1(a)为整体结构示意图，图1(b)为横向剖示图。
图2是本发明的用于手足骨骨折治疗的微型锁定外固定装置的实施例结构示意图。
图3是本实施例的骨折固定螺丝钉的结构示意图。
其中，1是长形架体，2是螺纹孔，3是骨折固定螺丝钉尾部，4是骨折固定螺丝钉中部，5是骨折固定螺丝钉尖端。
具体实施方式
下面结合附图和实施例，对本发明的具体实施方式作进一步详细描述。
本发明提出的一种用于手足骨骨折治疗的微型锁定外固定装置，其特征在于，该装置由固定长度的长形架体和多个与该长形架体匹配的骨折固定螺丝钉组成；该长形架体长度为30—60mm，该架体上横向开有多个螺纹孔，该骨折固定螺丝钉直径为2.5mm-3.5mm，该螺丝钉为4-6枚；该架体的螺纹孔与螺丝钉的螺纹相匹配，该骨折固定螺丝钉拧入螺纹孔内与架休连接成一体，骨折固定螺丝钉头部与骨折部分的手、足骨固定。本发明的用于手足骨骨折治疗的微型锁定外固定装置，将传统的手足骨钢板和外固定架的优点结合，按照手足骨的外形轮廓，设计成长条形锁定外固定装置，其中，架体长度与手足骨长度相匹配，架体外形可以是长方体或半柱体的长条形状，半柱体为上表面为平面，下表面为平面或凹柱面，两侧面为凸柱面，使用效果更佳；
由于架体位于体外，架体在满足长度的强度需要的情况下，可以是不锈钢、铝合金、 钛合金等金属或者是碳素钢、碳纤维等任何材料。
架体的宽度及厚度均以满足螺纹孔的尺寸的情况下根据选用的材料强度而定。
本发明提出的一种用于手足骨骨折治疗的微型锁定外固定装置结合实施例及附图进一步说明如下：
本实施例的手足骨骨折治疗的微型锁定外固定装置，如图1、2所示，由长形架体1和多个骨折固定螺丝钉组成；其中长形架体1的长度根据需要固定的手、足骨的长度而定，本实施例可制作成长度在30—60mm范围内的几种长度的架体；长形架体的宽度、厚度根据采用的材料强度而定，达到即满足架体在应用时的强度又能使整体重量减轻。本实施例的不同长度的架体上横向有4-6个不等的螺纹孔2，螺纹孔的直径与螺丝钉相匹配，螺纹孔的数量还可根据材料的强度及应用时拧入螺丝钉的位置的灵活性而定。便于医生根据需要自由选择螺丝钉的固定位置，同时用以减轻长形架体重量。
本实施例的架体上的螺纹孔2为上大下小的阶梯状，与长形架体1成90度垂直，上端为与螺丝钉的螺纹相匹配的螺纹孔，下端为直径略小于上端螺纹孔的通孔。
本实施例的骨折固定螺丝钉的结构如图2所示，由一体形成的尖端5、圆柱形中段4和尾部3构成，其中，尖端5为带有外螺纹的圆锥形，用以固持骨骼；中段4的外径与长形架体的螺纹孔2的下端孔径相匹配，中段4的外径略小于螺纹孔2下端孔径，其中段穿过螺纹孔2的下端，尖端穿过光滑与皮肤及软组织接触并进入人体手、足骨以固定骨折；尾部3设置有外螺纹，直径与螺纹孔2上端的内径相匹配，尾部顶端中部开有螺孔，便于用相应工具将螺丝钉拧入长形架体1的螺纹孔1内，并使螺丝钉的尖端5拧入人体手、足骨以固定相应位置的骨折。尾部3与螺纹孔2的上端螺纹固定。螺丝钉是采用细钉，根据架体的宽度选用范围在2.5mm-3.5mm内的直径，螺丝钉的长度与长形架体的厚度、架体与皮肤之间的距离及手、足骨外的软组织厚度及嵌入手、足骨骨的深度之和相匹配。本实施例的螺丝钉采用医用不锈钢或钛合金材料制成。
本实施例具有用具有微创、不用二次手术取出等特点，能够有效减少手足骨骨折治疗的多种并发症。
本发明提出的一种用于手足骨骨折治疗的微型锁定外固定装置，其手术操作过程如下：
首先通过切开或闭合撬拔方式复位骨折的手、足骨，以克氏针、空心钉或无头钉等临时固定长形架体，透视下确认架体的位置正确，以克氏针钻孔穿过架体合适位置的螺纹孔对手、足骨，最后对钻孔的胫骨处的螺纹孔拧入螺丝钉固定骨折的手、足骨。
为了固定的强度的可靠，建议螺丝钉均匀分布，间隔螺纹孔拧入螺丝钉，效果更好。
对于粉碎性骨折，采取牵引恢复手足骨长度，粉碎小骨折块，达到功能复位即可，再放置锁定外固定装置，此时螺丝钉尽量多打，以便增加固定效果。

Claims (6)

  1. 一种用于手足骨骨折治疗的微型锁定外固定装置，其特征在于，该装置由固定长度的长形架体和多个与该长形架体匹配的骨折固定螺丝钉组成；该长形架体长度为30—60mm，该架体上横向开有多个螺纹孔，该骨折固定螺丝钉直径为2.5mm-3.5mm，该螺丝钉为4-6枚；该架体的螺纹孔与螺丝钉的螺纹相匹配，该骨折固定螺丝钉拧入螺纹孔内与架休连接成一体，骨折固定螺丝钉头部与骨折部分的手、足骨固定。
  2. 如权利要求1所述的用于手足骨骨折治疗的微型锁定外固定装置，其特征在于，所述架体外形是长方体。
  3. 如权利要求1或2所述的用于手足骨骨折治疗的微型锁定外固定装置，其特征在于，所述架体外形为长条形状的半柱体，半柱体为上表面为平面，下表面为平面或凹柱面，两侧面为凸柱面。
  4. 如权利要求1-3中任一项所述的用于手足骨骨折治疗的微型锁定外固定装置，其特征在于，所述架体为不锈钢、铝合金、钛合金等金属或者是碳素钢、碳纤维任一种材料，所述骨折固定螺丝钉采用医用不锈钢或钛合金材料。
  5. 如权利要求1‐4中任一项所述的用于手足骨骨折治疗的微型锁定外固定装置，其特征在于，所述螺纹孔为上大下小的阶梯状，与长形架体1成90度垂直，上端为与螺丝钉的螺纹相匹配的螺纹孔，下端为直径略小于上端螺纹孔的通孔。
  6. 如权利要求1-5中任一项所述的用于手足骨骨折治疗的微型锁定外固定装置，其特征在于，所述螺丝钉由一体形成的尖端、圆柱形中段和尾部构成，其中，尖端为带有外螺纹的圆锥形，用以固持骨骼；中段的外径与长形架体的螺纹孔的下端通孔孔径相匹配，尾部设置有外螺纹，直径与螺纹孔上端的螺纹孔的内径相匹配，尾部顶端中部开有螺孔，便于用相应工具将螺丝钉拧入长形架体的螺纹孔内。
PCT/CN2016/084360 2016-04-01 2016-06-01 用于手足骨骨折治疗的微型锁定外固定装置 WO2017166424A1 (zh)

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