WO2017166425A1 - 用于锁骨骨折治疗的锁定外固定装置 - Google Patents

用于锁骨骨折治疗的锁定外固定装置 Download PDF

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Publication number
WO2017166425A1
WO2017166425A1 PCT/CN2016/084361 CN2016084361W WO2017166425A1 WO 2017166425 A1 WO2017166425 A1 WO 2017166425A1 CN 2016084361 W CN2016084361 W CN 2016084361W WO 2017166425 A1 WO2017166425 A1 WO 2017166425A1
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Prior art keywords
fracture
frame body
clavicle
screw
fixation device
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PCT/CN2016/084361
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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 WO2017166425A1 publication Critical patent/WO2017166425A1/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
    • A61B2017/564—Methods for bone or joint treatment

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  • the invention relates to a locking external fixation device for the treatment of a clavicle fracture, belonging to the technical field of medical instruments.
  • Clavicular fracture is a common fracture.
  • Surgical treatment is one of the main treatment methods.
  • the purpose of treatment is to reset and fix the fracture site.
  • the fixation method is mainly internal fixation.
  • 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 is often necessary to take out the second operation; because the shape of the clavicle is irregular and the variation is large, the shape of the steel plate is difficult during the operation. Even the anatomical plate is difficult to meet the surgical requirements, resulting in increased difficulty in operation, prolonged time, and fracture of the steel plate. The risk of surgery is significantly increased.
  • the object of the present invention is to overcome the shortcomings of the existing fixation device for the treatment of clavicle fracture, and to provide a locking external fixation device for the treatment of clavicular fracture.
  • the device has the advantages of simple structure, easy operation, good clavicle fixation effect, and can simplify the fracture of the clavicle. The treatment process and effectively reduce the complications of clavicle fracture treatment.
  • the locking external fixation device for treating a clavicle fracture is characterized in that the locking external fixation device is composed of an S-shaped cylindrical frame body or a rectangular frame body and a plurality of fracture fixing screws, and the S-shaped cylindrical body is laterally opened. There are a plurality of threaded holes, the threaded holes of the frame are matched with the threads of the screw, and the fracture fixing screw is screwed into the threaded hole and integrated with the frame body, and the head of the fracture fixing screw is fixed with the fracture clavicle.
  • the locking external fixation device of the invention is used in vitro, belonging to the external fixation category, so the traumatic small bleeding is small, the incision is doubled, only 3-4 cm, located in the fracture area, the incision complications are obviously reduced, and the scar is small and beautiful.
  • the locking external fixation device of the invention is used in vitro, belonging to the external fixation category, and the external fixation device does not need to conform to the bone surface, thereby avoiding the difficulty of shaping the intraoperative steel plate, reducing the difficulty of operation, shortening the operation time, and corresponding surgery concurrently.
  • the risk of illness (such as broken plate) is reduced, young doctors are easy to master, and the learning curve is shortened.
  • the locking external fixation device of the present invention is externally fixed, it is not necessary to perform a second hospitalization to remove the clavicle internal fixation, thereby avoiding the risk of secondary surgery and saving medical expenses for the patient.
  • the locking external fixing device of the invention can adopt light materials such as stainless steel, titanium alloy, carbon fiber or aluminum alloy, which is smaller than the traditional external fixing frame, light in weight and small in patient suffering, and is beneficial to the rehabilitation of the patient.
  • the locking external fixing device of the invention can be drilled by K-wire, and the damage is small compared with the drilling of the conventional electric drill. There are fewer complications in the nail, which improves the safety of the operation.
  • the locking external fixation device of the present invention can be fixed by multiple nails with a small nail, and the fixing method has the effects of small trauma and reliable fixation.
  • the locking external fixing device of the present invention has an angle change of the locking screws at both ends, which can produce an angle-stabilizing effect, thereby increasing the overall stability and preventing the screw from being pulled out.
  • the locking external fixing device of the invention adopts a thread locking structure to replace the connection manner of a traditional external fixing frame such as a nail clip, so that the overall structure is firmer and the volume is smaller and the failure is not easy.
  • FIG. 1 is a schematic view showing the structure of a locking external fixation device for treatment of a clavicle fracture according to the present invention.
  • FIG. 2 is a schematic view showing the structure of a screw for fixing a locking outer fixing device frame for a treatment of a clavicle fracture and a human body clavicle according to the present invention.
  • 1 is an S-shaped cylinder (or a rectangular parallelepiped)
  • 2 is a threaded hole
  • 3 is a screw tail
  • 4 is a screw middle portion
  • 5 is a screw tip.
  • the locking external fixation device for treating a clavicle fracture is characterized in that the locking external fixation device is composed of an S-shaped cylindrical frame body or a rectangular frame body and a plurality of fracture fixing screws, and the S-shaped cylindrical body is laterally opened. There are a plurality of threaded holes, the threaded holes of the frame are matched with the threads of the screw, and the fracture fixing screw is screwed into the threaded hole and integrated with the frame body, and the head of the fracture fixing screw is fixed with the fracture clavicle.
  • the S-shaped cylindrical frame or the rectangular frame body is formed by connecting the inclined section, the straight section and the V-shaped curved section, and the shape and size of the frame are matched with the clavicle; wherein the inclined section and the V-shaped bend of the frame body A plurality of screw holes of the same aperture are laterally distributed on both sides of the segment; the straight section of the frame has a length of 65-75 mm, and the diameter of the fracture fixing screw is 3.0 mm-4.0 mm.
  • the length of the fracture fixation screw matches the thickness of the frame, the distance between the frame and the skin, and the thickness of the soft tissue outside the bone and the depth of the embedded clavicle.
  • the locking external fixation device for the treatment of clavicle fracture of the invention combines the advantages of the traditional clavicular steel plate and the external fixation frame, and the S-shaped cylindrical or rectangular frame body is designed according to the contour of the clavicle, and the fixing screw is combined with the threaded hole of the frame body.
  • the fixing screw tip 5 is screwed into the human clavicle to fix the fracture. With minimally invasive, no secondary surgery, it can effectively reduce the complications of clavicle fracture treatment.
  • the frame body may be metal such as stainless steel, aluminum alloy, titanium alloy or any material such as carbon steel or carbon fiber, if the strength of the frame is required.
  • 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 locking external fixation device of this embodiment is composed of an S-shaped cylindrical frame body or a rectangular frame body and a plurality of fracture fixing screws.
  • the frame body of the embodiment is shown in FIG. 1 , and the frame body 1 is formed by a slanted section, a straight section and a V-shaped curved section, wherein the inclined section and the straight section are at an angle of 147°, the straight section and the V-shaped curved section.
  • the connected side has an angle of 147°, and the other side of the straight section and the V-shaped curved section is at an angle of 90°; and the end of the V-shaped curved section is at the same height as the straight section; the lengths of the sections are respectively: inclined section 40 mm, straight line Section 70mm, V-shaped curved section on both sides are 30mm, 17mm.
  • the screw holes 2 for uniformly distributing the same aperture on both sides of the inclined section and the V-shaped curved section are 7, 5 and 2 respectively, and the diameter is 3.5 mm; the threaded hole of the frame matches the thread of the fracture fixing screw.
  • the number of threaded holes can also depend on the strength of the material and the flexibility of the position at which the screw is screwed into the application. 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 length of the fracture fixation screw matches the thickness of the frame, the distance between the frame and the skin, and the thickness of the soft tissue outside the bone and the depth of the embedded clavicle.
  • 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 clavicle 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 a screw hole is formed in the middle of the tip end of the tail to facilitate screwing the screw into the thread of the elongated frame body 1 with the corresponding tool Inside the hole 1, the tip end 5 of the screw is screwed into the human clavicle to fix the fracture at the corresponding position.
  • the locking operation of the locking external fixation device for the treatment of clavicle fracture of the present invention is as follows:
  • the clavicle fracture is restored by incision or closure, and the temporary fixation fracture is made by Kirschner wire, cannulated nail or headless nail.
  • the position of the locking external fixation device is confirmed under fluoroscopy, and the K-wire is drilled and then screwed in. The screw fixes the fracture.
  • the extension of the collar is used to restore the length of the clavicle, and the small fracture block is crushed to achieve a functional reset. Then the external fixation device is locked. At this time, the screws are used as much as possible to increase the fixation effect.
  • the shape of the body part of the clavicle locking external fixation device is designed according to the contour of the skin of the clavicle surface, and the shape is designed to be a large "S shape", so as to satisfy the mechanical and aesthetic requirements of the fixed clavicle to the utmost.
  • the material of the locking external fixation device for the treatment of clavicle fracture of the present invention is located outside the body without contact with the skin, and may be stainless steel, titanium alloy, carbon fiber or Lightweight materials such as aluminum alloy.
  • the threaded holes are evenly distributed on the frame body, and the density is large, so that the doctor can freely select the fixed position of the screw according to the need, and at the same time reduce the weight of the frame body.
  • a threaded hole in the frame characterized in that the threaded hole matches the thread at the end of the screw.
  • the screw is a locking screw, which is divided into a middle end and a tail end. The tip is threaded to hold the bone, the middle part is smooth to contact with the skin and the soft tissue, and the tail end is threaded and the locking outer fixing device is locked by the locking.

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Abstract

一种用于锁骨骨折治疗的锁定外固定装置，该锁定外固定装置由类S形圆柱架体或长方形架体（1）和多个骨折固定螺丝钉组成，该架体（1）由倾斜段、直线段和V形弯段连接而成；其中该架体（1）的倾斜段和V形弯段的两边横向分布有相同孔径的多个螺纹孔（2）；该架体（1）的螺纹孔（2）与螺钉的螺纹相匹配，该骨折固定螺钉拧入螺纹孔（2）内与架体（1）连接成一体，骨折固定螺丝钉头部与骨折锁骨固定。

Description

用于锁骨骨折治疗的锁定外固定装置 技术领域
本发明涉及一种用于锁骨骨折治疗的锁定外固定装置，属于医疗器械技术领域。
背景技术
锁骨骨折是常见骨折，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复位固定，固定方法主要采用内固定方式。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；由于锁骨形状不规则并且变异较大，手术过程中，钢板塑形困难，即便是解剖型钢板，也很难达到手术要求，导致手术困难增加，时间延长，钢板断裂等手术风险明显增加。
发明内容
本发明的目的是为克服已有锁骨骨折治疗的固定装置的缺点，提出一种用于锁骨骨折治疗的锁定外固定装置，本装置结构简单，操作容易，锁骨固定效果好，可简化锁骨骨折的治疗过程，并有效减少锁骨骨折治疗的并发症。
本发明提出的用于锁骨骨折治疗的锁定外固定装置，其特征在于，该锁定外固定装置由类S形圆柱架体或长方形架体和多个骨折固定螺丝钉组成，该S形圆柱体横向开有多个螺纹孔,该架体的螺纹孔与螺钉的螺纹相匹配，该骨折固定螺钉拧入螺纹孔内与架体连接成一体，骨折固定螺丝钉头部与骨折锁骨固定。
本发明提出的用于锁骨骨折治疗的锁定外固定装置，其优点是：
1、本发明的锁定外固定装置用于体外，属于外固定范畴，因此创伤小出血少，切口成倍缩小，只有3-4cm，位于骨折区域，切口并发症明显降低，并且瘢痕小、美观。
2、本发明的锁定外固定装置用于体外，属于外固定范畴，外固定装置不需要与骨面相服帖，因此避免了术中钢板塑形的困难，手术难度降低，手术时间缩短，相应手术并发症(如断板)风险降低，年轻医生容易掌握，学习曲线缩短。
3、本发明的锁定外固定装置由于是外固定，因此不需要二次住院手术取出锁骨内固定，避免了二次手术的风险，并为患者节省医疗费用。
4、本发明的锁定外固定装置可以采用不锈钢、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。
5、本发明的锁定外固定装置，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。
6、本发明的锁定外固定装置，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。
7、本发明的锁定外固定装置，两端锁定螺钉有角度变化，可以产生成角稳定的效果，即可增加整体稳定性，又可以防止螺钉拔出。
8、本发明的锁定外固定装置，采用螺纹锁定结构结合，替代了钉夹等传统外固定架的连接方式，使其整体结构更加牢固和体积更小不易失效。
附图说明
图1是本发明提出的用于锁骨骨折治疗的锁定外固定装置的结构示意图。
图2是用于使本发明的用于锁骨骨折治疗的锁定外固定装置架体与人体锁骨结合固定的螺丝钉的结构示意图。
图1和图2中，1是S形圆柱体(或长方体)，2是螺纹孔，3是螺丝钉尾部，4是螺丝钉中部，5是螺丝钉尖端。
具体实施方式
本发明提出的用于锁骨骨折治疗的锁定外固定装置，其特征在于，该锁定外固定装置由类S形圆柱架体或长方形架体和多个骨折固定螺丝钉组成，该S形圆柱体横向开有多个螺纹孔,该架体的螺纹孔与螺钉的螺纹相匹配，该骨折固定螺钉拧入螺纹孔内与架体连接成一体，骨折固定螺丝钉头部与骨折锁骨固定。
所述S形圆柱架体或长方架体由倾斜段、直线段和V形弯段连接而成，该架体的外形及尺寸与锁骨相匹配；其中该架体的倾斜段和V形弯段的两边横向分布有相同孔径的多个螺丝孔；该架体的直线段长度为65-75mm，该骨折固定螺钉直径为3.0mm-4.0mm。
所述骨折固定螺丝钉长度与架体的厚度、架体与皮肤之间的距离及骨外的软组织厚度及嵌入锁骨的深度之和相匹配。
本发明的用于锁骨骨折治疗的锁定外固定装置，将传统的锁骨钢板和外固定架的优点结合，S形圆柱形或长方形架体按照锁骨的外形轮廓设计，固定螺丝钉与架体螺纹孔结合成一体，固定螺丝钉尖端5拧入人体锁骨，以固定骨折。具有微创、不用二次手术取出等特点，能够有效减少锁骨骨折治疗的多种并发症。
本装置由于架体位于体外，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锁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：
本实施例的锁定外固定装置由类S形圆柱架体或长方形架体和多个骨折固定螺丝钉组成。
本实施例的架体如图1所示，该架体1由倾斜段、直线段和V形弯段连接而成，其中倾斜段与直线段呈147°夹角，直线段和V形弯段相连的一边呈147°夹角，直线段和V形弯段的另一边呈90°夹角；且V形弯段的末端与直线段同高；各段的长度分别为：倾斜段40mm、直线段70mm，V形弯段两边分别为30mm、17mm。其中倾斜段和V形弯段的两边均匀分布相同孔径的螺丝孔2分别为7个、5个和2个，直径为3.5mm；该架体的螺纹孔与骨折固定螺丝钉的螺纹相匹配。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。骨折固定螺丝钉长度与架体的厚度、架体与皮肤之间的距离及骨外的软组织厚度及嵌入锁骨的深度之和相匹配。
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锁骨以固定骨折；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拧入人体锁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。本实施例的螺丝钉采用医用不锈钢或钛合金材料制成。
本发明的用于锁骨骨折治疗的锁定外固定装置，其手术操作过程如下：
首先通过切开或闭合撬拔方式复位锁骨骨折，以克氏针、空心钉或无头钉等临时固定骨折，透视下确认锁定外固定装置的位置正确，以克氏针钻孔，再拧入螺丝钉固定骨折。
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，采取后伸牵引恢复锁骨长度，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。
锁骨锁定外固定装置架体部分的外形按照锁骨表面皮肤的外形轮廓进行设计，外形设计成大“S形”，以便最大限度满足固定锁骨的力学及美观需要。本发明的用于锁骨骨折治疗的锁定外固定装置的材质由于不接触皮肤位于体外，可以是不锈钢、钛合金、碳纤维或 铝合金等轻型材料。架体上均匀分布有螺纹孔，密度较大，便于医生根据需要自由选择螺丝钉的固定位置，同时减轻架体重量。架体上的螺纹钉孔，其特征是螺纹孔与螺丝钉尾端螺纹相匹配。螺丝钉为锁定螺丝钉，分为尖端中段和尾端，尖端带螺纹把持骨骼，中段光滑与皮肤及软组织接触，尾端有螺纹与锁定外固定装置通过锁定结合。

Claims (8)

  1. 一种用于锁骨骨折治疗的锁定外固定装置，其特征在于，该锁定外固定装置由类S形圆柱架体或长方形架体和多个骨折固定螺丝钉组成，该S形圆柱体横向开有多个螺纹孔,该架体的螺纹孔与螺钉的螺纹相匹配，该骨折固定螺钉拧入螺纹孔内与架体连接成一体，骨折固定螺丝钉头部与骨折锁骨固定。
  2. 如权利要求1所述用于锁骨骨折治疗的锁定外固定装置，其特征在于，所述S形圆柱架体或长方架体由倾斜段、直线段和V形弯段连接而成，该架体的外形及尺寸与锁骨相匹配；其中该架体的倾斜段和V形弯段的两边横向分布有相同孔径的多个螺丝孔；该架体的直线段长度为65-75mm，该骨折固定螺钉直径为3.0mm-4.0mm。
  3. 如权利要求2所述用于锁骨骨折治疗的锁定外固定装置，其特征在于，所述架体倾斜段与直线段呈147°夹角，直线段和V形弯段相连的一边呈147°夹角，直线段和V形弯段的另一边呈90°夹角；且V形弯段的末端与直线段同高；各段的长度分别为：倾斜段40mm、直线段70mm，V形弯段两边分别为30mm、17mm。其中倾斜段和V形弯段的两边均匀分布相同孔径的螺丝孔2分别为7个、5个和2个，直径为3.5mm；该架体的螺纹孔与骨折固定螺丝钉的螺纹相匹配。
  4. 如权利要求1-3中任一项所述用于锁骨骨折治疗的锁定外固定装置，其特征在于，所述骨折固定螺丝钉长度与架体的厚度、架体与皮肤之间的距离及骨外的软组织厚度及嵌入锁骨的深度之和相匹配。
  5. 如权利要求1-4中任一项所述用于锁骨骨折治疗的锁定外固定装置，其特征在于，所述架体上的螺纹孔为上大下小的阶梯状，与长形架体成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中任一项所述用于锁骨骨折治疗的锁定外固定装置，其特征在于，所述骨折固定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孔径相匹配，尖端接触并穿过光滑皮肤及软组织进入人体锁骨以固定骨折；尾部设置有外螺纹，尾部顶端中部开有螺孔，使螺丝钉的尖端拧入人体锁骨以固定相应位置的骨折，尾部与螺纹孔的上端螺纹固定。
  7. 如权利要求1-6所述任一项用于锁骨骨折治疗的锁定外固定装置，其特征在于，所述螺丝钉采用医用不锈钢或钛合金材料制成。
  8. 如权利要求1-7所述任一项所述用于锁骨骨折治疗的锁定外固定装置，其特征在于，所述架体是不锈钢、铝合金、钛合金或者是碳素钢、碳纤维中任何一种材料。
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