WO2019210774A1 - 基于机体成骨功能的医用防松动螺钉 - Google Patents

基于机体成骨功能的医用防松动螺钉 Download PDF

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Publication number
WO2019210774A1
WO2019210774A1 PCT/CN2019/082922 CN2019082922W WO2019210774A1 WO 2019210774 A1 WO2019210774 A1 WO 2019210774A1 CN 2019082922 W CN2019082922 W CN 2019082922W WO 2019210774 A1 WO2019210774 A1 WO 2019210774A1
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WIPO (PCT)
Prior art keywords
screw
main rod
cross
medical
thread
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PCT/CN2019/082922
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English (en)
French (fr)
Inventor
胡斯旺
肖建如
蔡小攀
丁红
陈顺贵
刘铁龙
Original Assignee
Hu Siwang
Xiao Jianru
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Application filed by Hu Siwang, Xiao Jianru filed Critical Hu Siwang
Priority to US16/645,412 priority Critical patent/US11369423B2/en
Publication of WO2019210774A1 publication Critical patent/WO2019210774A1/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
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8625—Shanks, i.e. parts contacting bone tissue
    • 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
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B17/8605—Heads, i.e. proximal ends projecting from bone
    • 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
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/86—Pins or screws or threaded wires; nuts therefor
    • A61B2017/8655—Pins or screws or threaded wires; nuts therefor with special features for locking in the bone

Definitions

  • the present application relates to the field of medical device technology, and in particular to a medical anti-loose screw based on an ossification function of a body.
  • the human bone has the function of “breaking bone-forming bone”, and the fracture has a self-healing tendency.
  • the natural healing process of the fracture is roughly through the hematoma (2 weeks), the epiphysis formation period (1-2 months), and the bone remodeling period (February-2 years).
  • the purpose of the present application is to provide a medical anti-loose screw based on the osteogenesis function of the body, which can be applied to the medical fields of orthopedics (spine, limb pelvis, joints, etc.), maxillofacial surgery, dentistry, veterinary, etc., after implantation. It can effectively prevent the screw from loosening after surgery.
  • the present application provides a medical anti-loose screw based on an ossification function of a body, comprising: a screw cap and a screw connected to the screw cap;
  • the screw includes a main rod and a thread spirally wound on the main rod; the main rod has a cross-sectional shape that is non-circular.
  • the main rod has a cross section of a fat triangle or a quadrangle or a pentagon or a hexagon or an ellipse.
  • the ratio of the long and short half axes of the ellipse is smaller than
  • the outer edge cross-sectional area of the thread is 1.49 - 3.61 times the cross-sectional area of the main rod.
  • the outer circular cross-sectional area of the thread is 1.49-3.61 times the cross-sectional area of the main rod.
  • the main rod has a regular quadrangle, and the outer circular cross-sectional area of the thread is 1.59-3.61 times the cross-sectional area of the main rod.
  • the main rod has a cross section of a regular pentagon, and the outer circular cross-sectional area of the thread is 1.44 - 3.61 times the cross-sectional area of the main rod.
  • the main rod has a regular hexagonal cross section, and the outer edge cross-sectional area of the thread is 1.49-3.61 times the cross-sectional area of the main rod.
  • the ratio of the radius of the outer circumference of the thread to the radius of the circumscribed circle of the main rod is 1.2-1.9.
  • the thread has an outer diameter to pitch ratio of 1.5 to 5.5.
  • the end of the screw facing away from the screw cap has a tapping slot.
  • a cavity structure is formed inside the main rod
  • the inside of the main rod is a solid structure.
  • the screw cap is circular, and the screw cap is formed with a hexagonal groove or a cross slot or a slot or a plum groove or a rice slot;
  • the screw cap is dovetail shaped.
  • the round screw cap has a locking thread.
  • the dovetail screw cap is a universal nail cap.
  • the present application provides a medical anti-loose screw based on an ossification function of a body, comprising: a screw cap and a screw connected to the screw cap; the screw comprises a main rod and a thread spirally wound on the main rod; the cross-sectional shape of the main rod is non- Round.
  • the medical anti-loose screw based on the osteogenesis function provided by the present application is applied to the clinic, and the bone tunnel is formed after the screw tapping, and the thread cutting enters the side wall of the bone to form a grip; and in the main diameter of the screw and the bone There is a gap between them, and the "bone residue" formed by the tapping in the gap is filled. Because the bones of the organism have osteogenesis, about 1-2 months after the operation, the "bone slag" forms the bone bones and even the normal new bone tissue after the "bone formation period".
  • the hard non-cylindrical bone is closely attached to the main path of the screw, which has a significant restriction on the side of the main rod of the screw.
  • the medical anti-loose screw based on the osteogenesis function of the present application can be applied to the medical fields of orthopedics (spine, limb pelvis, joints, etc.), maxillofacial surgery, dentistry, veterinary, etc., and can effectively prevent the screw after implantation. Loose after surgery.
  • FIG. 1 is a schematic structural view of a medical anti-loose screw based on an ossification function of a body according to an embodiment of the present application;
  • FIG. 2 is a schematic view showing an elliptical cross section of a main rod according to an embodiment of the present application
  • FIG. 3 is a schematic diagram of a cross section of a main pole being a fat triangle according to an embodiment of the present application:
  • FIG. 4 is a schematic view showing a cross section of a main pole in a regular square according to an embodiment of the present application
  • FIG. 5 is a schematic view showing a cross section of a main rod in a regular pentagon according to an embodiment of the present application
  • FIG. 6 is a schematic view showing a cross section of a main rod in a regular hexagon according to an embodiment of the present application
  • Icons 1-screw cap; 2-screw; 21-master; 22-thread.
  • connection In the description of the present application, it should be noted that the terms “installation”, “connected”, and “connected” are to be understood broadly, and may be fixed or detachable, for example, unless otherwise specifically defined and defined. Connected, or integrally connected; can be mechanical or electrical; can be directly connected, or indirectly connected through an intermediate medium, can be the internal communication of the two components.
  • Connected, or integrally connected can be mechanical or electrical; can be directly connected, or indirectly connected through an intermediate medium, can be the internal communication of the two components.
  • the specific meanings of the above terms in the present application can be understood in the specific circumstances for those skilled in the art.
  • FIG. 1 , FIG. 2 , FIG. 3 , FIG. 4 , FIG. 5 and FIG. 6 the medical anti-loose screw based on the osteogenesis function of the embodiment of the present application will be described in detail below with reference to the accompanying drawings.
  • the embodiment of the present application provides a medical anti-loose screw based on the body osteogenesis function, comprising: a screw cap 1 and a screw 2 connected to the screw cap 1;
  • the screw 2 includes a main rod 21 and a thread 22 spirally wound around the main rod 21; the main rod 21 has a non-circular cross-sectional shape.
  • the medical anti-loose screw based on the body osteogenesis function provided by the embodiment of the present application is applied to the clinic, and the bone tunnel is formed after the screw tapping, and the thread 22 is cut into the side wall of the bone to form a grip; and the main diameter of the screw is There is a gap between the bone and the bone, and the "bone” formed by the tapping in the gap is filled. Because the bones of the organism have osteogenesis, about 1-2 months after the operation, the "bone slag" forms the bone bones and even the normal new bone tissue after the "bone formation period".
  • the hard non-cylindrical bone is closely attached to the main diameter of the screw, and has a significant restriction on the side of the main rod 21 of the screw.
  • the medical anti-loose screw based on the body osteogenesis function provided by the embodiment of the present application can be applied to the medical fields of orthopedics (spine, limb pelvis, joints, etc.), maxillofacial surgery, dentistry, veterinary, etc., and traditional medical Compared with the anti-loose screw, it can effectively prevent the screw from loosening after the operation after implantation.
  • the main rod 21 has a cross section of a fat triangle or a quadrangle or a pentagon or a hexagon or an ellipse.
  • the main strut 21 of the medical anti-loose screw has a cross-section of a fat triangle.
  • the bone is formed after the screw tapping, and the thread 22 is cut into the side wall of the bone to form a grip; and there is a "crescent" gap between the main rod 21 and the bone, and the gap
  • the "bone residue” formed after tapping is filled. Because the bones of the organism have osteogenesis, about 1-2 months after the operation, the "bone slag" forms the bone bones and even the normal new bone tissue after the "bone formation period".
  • the hard fat triangular prismatic bone is closely attached to the screw main rod 21, and has a significant restriction on the side of the screw-triangular prism-shaped main rod 21, and generates a relatively strong lateral thrust resistance when the screw is screwed out (similar The driving force of the hexagonal screwdriver), the lateral pushing resistance is much larger than the friction between the surface of the conventional screw and the bone, and has the function of the Karton screw, so that the looseness rate and the extraction rate can be significantly reduced, and the anti-disclosure rate is obvious. Loose action. In addition, in the later stage of bone healing, if it is necessary to remove the anti-loose screws, as long as the screw is tightened, the torque can be removed smoothly. Other shapes of screws have similar mechanisms of action.
  • the outer edge cross-sectional area of the thread 22 is 1.49 - 3.61 times the cross-sectional area of the main rod 21, and may be, for example but not limited to, 1.49, 1.69, 1.96, 2.25, 2.56, 2.89, 3.24 or 3.61.
  • the outer circular cross-sectional area of the thread 22 is 1.49-3.61 times the cross-sectional area of the main rod 21, for example, Not limited to 1.49, 1.69, 1.96, 2.25, 2.56, 2.89, 3.24 or 3.61. As shown in Fig.
  • A, B, C are the three equal points on ⁇ 3 , mutual
  • For the radius arc BC, arc AC, arc AB, define the boundary of the main pole 21 of "fat ⁇ ABC" as “fat triangle", which is "constant height” and satisfies S ⁇ 2 S ⁇ ABC ; Point D, and make each standard auxiliary line (as shown by the dotted line), then:
  • constant height AD 2.11 of the cross section of the main rod 21
  • radius R 1 (1.22-1.9) of the outer edge of the thread 22, for example R 1 can be, but not limited to, 1.22, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8 or 1.9.
  • the outer circular cross-sectional area of the thread 22 is 1.49 - 3.61 times the cross-sectional area of the main rod 21.
  • the main rod 21 has a regular quadrangle
  • the outer circular cross-sectional area of the thread 22 is 1.59-3.61 times the cross-sectional area of the main rod 21, for example, but not only Limited to 1.59, 1.69, 1.96, 2.25, 2.56, 2.89, 3.24 or 3.61.
  • the auxiliary lines are shown in Figure 4.
  • the range of R 1 is (1.26-1.9), for example, R 1 may be, but not limited to, 1.26, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, or 1.9.
  • the outer circular cross-sectional area of the thread 22 is 1.59 - 3.61 times the cross-sectional area of the main rod 21.
  • the main rod 21 has a regular pentagon cross section
  • the outer circular cross-sectional area of the thread 22 is 1.44 - 3.61 times the cross-sectional area of the main rod 21, for example, but not limited to 1.44, 1.69, 1.96, 2.25, 2.56, 2.89, 3.24 or 3.61.
  • the outer radius R 1 of the thread 22 ranges from (1.2 to 1.9), for example R 1 may be, but not limited to, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8 or 1.9.
  • the outer circular cross-sectional area of the thread 22 is 1.44 - 3.61 times the cross-sectional area of the main rod 21.
  • the main rod 21 has a regular hexagonal cross section, and the outer edge cross-sectional area of the thread 22 is 1.49-3.61 times the cross-sectional area of the main rod 21, for example, Not limited to 1.49, 1.69, 1.96, 2.25, 2.56, 2.89, 3.24 or 3.61. As shown in Fig.
  • A, B, C, D, E, F are six on ⁇ 3
  • the outer radius R 1 of the thread 22 ranges from (1.2 - 1.9), for example R 1 can be, but is not limited to, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7 , 1.8 or 1.9.
  • the outer circular cross-sectional area of the thread 22 is 1.49 - 3.61 times the cross-sectional area of the main rod 21.
  • the cross section of the main rod 21 may be other non-circular shapes in addition to the above fat triangle, regular quadrilateral, regular pentagon, regular hexagon or elliptical shape.
  • the shape, and the ratio of the outer circle radius of the thread 22 to the circumscribed circle radius of the main rod 21 is 1.2-1.9, and may be, for example but not limited to, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8 or 1.9.
  • the thread 22 has an outer diameter to pitch ratio of 1.5-5.5, such as, but not limited to, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, or 5.5. .
  • the angle ⁇ between the thread 22 and the axis of the main rod 21 can be “tangent ⁇ 2” (ie “outer diameter to pitch ratio” or “a few turns of complete thread 22 within the distance of one outer diameter”), which can be used as a thread
  • the relative density and grip of 22 are in the range of 1.5-5.5, and the ratio of double-threaded 22 screws can be as low as 1. The larger the ratio, the larger the angle ⁇ , and the closer the thread 22 is to the axis of the main rod 21, the higher the density, and the greater the pull-out resistance.
  • the screw 2 has a tapping groove at an end facing away from the screw cap 1.
  • the screw tip can also be additionally designed as a self-tapping screw with a tapping slot.
  • a cavity structure is formed inside the main rod 21;
  • the inside of the main rod 21 has a solid structure.
  • the screw cap 1 is more circular, with or without locking threads, and the screw cap 1 is formed with a hexagonal groove or a cross slot or a slot or a plum blossom groove or a rice word. groove;
  • the screw cap 1 is a gimbal type cap that can be arbitrarily turned, and the screw cap has a dovetail shape.
  • the screw cap 1 can be designed as a circular hexagonal groove, a circular cross groove, a circular slot, a circular inner plum groove, a circular rice groove (trauma orthopedics, Joint surgery, cranio-maxillofacial surgery), or designed as a swallow-tailed universal or fixed, long swallow-tailed pull-up screw cap 1 (spine surgery);

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Abstract

本申请提供了一种基于机体成骨功能的医用防松动螺钉，涉及医疗器械的技术领域，包括螺钉帽和与螺钉帽连接的螺杆；螺杆包括主杆和螺旋缠绕在主杆上的螺纹；主杆的横截面形状为非圆形。本申请提供的基于机体成骨功能的医用防松动螺钉，可应用于骨科学(脊柱、四肢骨盆、关节等)、颌面外科学、牙科学、兽医等医学领域，植入后可有效防止螺钉在手术后出现松动。

Description

基于机体成骨功能的医用防松动螺钉
相关申请的交叉引用
本申请要求于2018年05月04日提交中国专利局的申请号为CN2018206649902、名称为“基于机体成骨功能的医用螺钉”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械技术领域，尤其是涉及一种基于机体成骨功能的医用防松动螺钉。
背景技术
自人类有史记载以来，“骨折”这个词就一直伴随着我们。而人体骨骼存在“破骨-成骨”的功能，骨折具有自愈倾向。骨折的自然愈合过程大致经血肿机化期(2周)、骨痂形成期(1-2月)、骨重塑期(2月-2年)。现今，借助内固定材料的“切开内固定手术”已广泛应用于创伤骨科(粉碎性或开放性等严重骨折)、脊柱外科(滑脱、侧弯、结核、肿瘤、严重退变性疾病等)、关节外科(关节置换等)、颅颌面外科(义齿植入等)以及兽医等领域，有效维持了骨折的稳定性，促使骨折愈合过程安全度过“骨痂形成期”进入“骨重塑期”，可显著减少骨折不愈合、义齿不稳定等并发症。另外，待骨折度过“骨痂形成期”后，内固定材料即完成了其作用，一般在后期均需拆除，以防止因其存在“应力遮挡”作用而阻碍骨折后期的进一步重塑。
随着内固定材料在医学领域的广泛应用，部分患者在内固定术后仍存在一些问题，其中最主要的就是内固定材料(螺钉)松动。
公开于该背景技术部分的信息仅仅旨在加深对本发明的总体背景技术的理解及本发明的工作机理，而不应当被视为承认或以任何形式暗示该信息构成已为本领域技术人员所公知的现有技术。
发明内容
本申请的目的在于提供一种基于机体成骨功能的医用防松动螺钉，可应用于骨科学(脊柱、四肢骨盆、关节等)、颌面外科学、牙科学、兽医等医学领域，植入后可有效防止螺钉在手术后出现松动。
为实现上述目的，本申请提供以下技术方案：
本申请提供一种基于机体成骨功能的医用防松动螺钉，包括：螺钉帽和与所述螺钉帽连接的螺杆；
所述螺杆包括主杆和螺旋缠绕在所述主杆上的螺纹；所述主杆的横截面形状为非圆形。
可选地，所述主杆的横截面为胖三角形或者四边形或者五边形或者六边形或者椭圆形。
可选地，当所述主杆的横截面为椭圆形时，所述椭圆形的长、短半轴之比小于
Figure PCTCN2019082922-appb-000001
所述螺纹的外缘横截面积是所述主杆的横截面积的1.49-3.61倍。
可选地，当所述主杆的横截面为胖三角形时，所述螺纹的外圆横截面积是所述主杆的横截面积的1.49-3.61倍。
可选地，所述主杆的横截面为正四边形，所述螺纹的外圆横截面积是所述主杆的横截面积的1.59-3.61倍。
可选地，所述主杆的横截面为正五边形，所述螺纹的外圆横截面积是所述主杆的横截面积的1.44-3.61倍。
可选地，所述主杆的横截面为正六边形，所述螺纹的外缘横截面积是所述主杆的横截面积的1.49-3.61倍。
可选地，所述螺纹外圆半径与所述主杆外接圆半径比为1.2-1.9。
可选地，所述螺纹的外径与螺距比为1.5-5.5。
可选地，所述螺杆背离所述螺钉帽的一端带攻丝槽。
可选地，所述主杆内部形成有空腔结构；
或者，所述主杆内部为实心结构。
可选地，所述螺钉帽为圆形，且所述螺钉帽上形成有六角槽或者十字槽或者一字槽或者梅花槽或者米字槽；
或者，所述螺钉帽为燕尾形。
可选地，所述圆形螺钉帽带锁定螺纹。
可选地，所述燕尾形螺钉帽为万向型钉帽。
本申请提供的基于机体成骨功能的医用防松动螺钉具有以下有益效果：
本申请提供一种基于机体成骨功能的医用防松动螺钉，包括：螺钉帽和与螺钉帽连接的螺杆；螺杆包括主杆和螺旋缠绕在主杆上的螺纹；主杆的横截面形状为非圆形。
采用本申请提供的基于机体成骨功能的医用防松动螺钉应用于临床后，螺钉攻丝植入后形成骨道，螺纹切割进入骨道侧壁形成抓持；而在螺钉主径和骨道之间存在间隙，且间隙内被攻丝后形成的“骨渣”充填。因生物体骨骼具有成骨功能，在术后1-2月左右，“骨渣”在“骨痂形成期”以后即似“混凝土硬化”般形成骨性骨痂乃至正常的新生骨组织，构筑成坚硬的非圆柱形骨道并紧贴在螺钉主径周围，对螺钉主杆的侧面存在明显的限制作用，在螺钉拧出时产生较为强大的侧推阻力，该侧推阻力远远大于在传统螺钉表面与骨道之间的摩擦力，具有卡顿螺钉的作用，故而能明显降低松动率、拔出率，具有明显的防松动作用。另外，骨愈合后期，若需要拆除防松动螺钉，只要加大螺钉拧出力矩即可顺利拆除。
本申请提供的基于机体成骨功能的医用防松动螺钉，可应用于骨科学(脊柱、四肢骨盆、关节等)、颌面外科学、牙科学、兽医等医学领域，植入后可有效防止螺钉在手术后出现松动。
附图说明
为了更清楚地说明本申请具体实施方式或现有技术中的技术方案，下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本申请的一些实施方式，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为本申请实施例提供的基于机体成骨功能的医用防松动螺钉的结构示意图；
图2为本申请实施例提供的主杆的横截面为椭圆形的示意图；
图3为本申请实施例提供的主杆的横截面为胖三角形的示意图：
图4为本申请实施例提供的主杆的横截面为正四边形的示意图；
图5为本申请实施例提供的主杆的横截面为正五边形的示意图；
图6为本申请实施例提供的主杆的横截面为正六边形的示意图；
图标：1-螺钉帽；2-螺杆；21-主杆；22-螺纹。
具体实施方式
下面将结合附图对本申请的技术方案进行清楚、完整地描述，显然，所描述的实施例是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，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，都属于本申请保护的范围。
在本申请的描述中，需要说明的是，术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。此外，术语“第一”、“第二”、“第三”仅用于描述目的，而不能理解为指示或暗示相对重要性。
在本申请的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本申请中的具体含义。
以下结合附图对本申请的具体实施方式进行详细说明。应当理解的是，此处所描述的具体实施方式仅用于说明和解释本申请，并不用于限制本申请。
请参照图1、图2、图3、图4、图5和图6，下面将结合附图对本申请实施例提供的基 于机体成骨功能的医用防松动螺钉作详细说明。
本申请的实施例提供了一种基于机体成骨功能的医用防松动螺钉，包括：螺钉帽1和与螺钉帽1连接的螺杆2；
螺杆2包括主杆21和螺旋缠绕在主杆21上的螺纹22；主杆21的横截面形状为非圆形。
采用本申请的实施例提供的基于机体成骨功能的医用防松动螺钉应用于临床后，螺钉攻丝植入后形成骨道，螺纹22切割进入骨道侧壁形成抓持；而在螺钉主径和骨道之间存在间隙，且间隙内被攻丝后形成的“骨渣”充填。因生物体骨骼具有成骨功能，在术后1-2月左右，“骨渣”在“骨痂形成期”以后即似“混凝土硬化”般形成骨性骨痂乃至正常的新生骨组织，构筑成坚硬的非圆柱形骨道并紧贴在螺钉主径周围，对螺钉主杆21的侧面存在明显的限制作用，在螺钉拧出时产生较为强大的侧推阻力，该侧推阻力远远大于在传统螺钉表面与骨道之间的摩擦力，具有卡顿螺钉的作用，故而能明显降低松动率、拔出率，具有明显的防松动作用。另外，骨愈合后期，若需要拆除防松动螺钉，只要加大螺钉拧出力矩即可顺利拆除。
本申请的实施例提供的基于机体成骨功能的医用防松动螺钉，可应用于骨科学(脊柱、四肢骨盆、关节等)、颌面外科学、牙科学、兽医等医学领域，与传统的医用防松动螺钉相比，植入后可有效防止螺钉在手术后出现松动。
本实施例可选的方案中，更加可选地，主杆21的横截面为胖三角形或者四边形或者五边形或者六边形或者椭圆形。
在至少一个实施例中，如图1和图3所示，该医用防松动螺钉的主杆21的横截面为胖三角形。该螺钉应用于临床后，螺钉攻丝植入后形成骨道，螺纹22切割进入骨道侧壁形成抓持；而在螺钉主杆21和骨道之间存在“新月形”间隙，且间隙内被攻丝后形成的“骨渣”充填。因生物体骨骼具有成骨功能，在术后1-2月左右，“骨渣”在“骨痂形成期”以后即似“混凝土硬化”般形成骨性骨痂乃至正常的新生骨组织，构筑成坚硬的胖三棱柱形骨道并紧贴在螺钉主杆21周围，对螺钉胖三棱柱形主杆21的侧面存在明显的限制作用，在螺钉拧出时产生较为强大的侧推阻力(类似内六角螺丝刀的驱动力)，该侧推阻力远远大于在传统螺钉表面与骨道之间的摩擦力，具有卡顿螺钉的作用，故而能明显降低松动率、拔出率，具有明显的防松动作用。另外，骨愈合后期，若需要拆除防松动螺钉，只要加大螺钉拧出力矩即可顺利拆除。其他形状的螺钉其作用机理类似。
需要说明的是，设传统螺钉主杆21半径R 2＝1(螺纹22半径R 1＝1.5)，以下分别就不同的主杆21横截面形状作详细说明：
当主杆21的横截面为椭圆形时，椭圆形的长、短半轴之比小于
Figure PCTCN2019082922-appb-000002
螺纹22的外缘横截面积是主杆21的横截面积的1.49-3.61倍，例如可以但不仅限于为1.49、1.69、1.96、2.25、 2.56、2.89、3.24或3.61。如图2所示，横截面上作假想同心椭圆⊙ 3，定义椭圆长、短半轴长分别为a、b，半径为R 3，R 1＞a＞R 2＝1＞b，且满足S ⊙2＝S ⊙3，作各辅助线如图2；由S ⊙2＝π×R 2×R 2＝S ⊙3＝π×a×b，得：a×b＝1；建议：
Figure PCTCN2019082922-appb-000003
计算得：椭圆长半轴a＝1.19，短半轴b＝0.84；螺纹22外圆半径R 1的范围为(1.2-1.9)，例如R 1可以但不仅限于为1.2、1.3、1.4、1.5、1.6、1.7、1.8或1.9。螺纹22的外圆横截面积是主杆21的横截面积的1.49-3.61倍。
本实施例可选的方案中，更加可选地，当主杆21的横截面为胖三角形时，螺纹22的外圆横截面积是主杆21的横截面积的1.49-3.61倍，例如可以但不仅限于为1.49、1.69、1.96、2.25、2.56、2.89、3.24或3.61。如图3所示，横截面上作假想同心圆⊙ 3，半径为R 3，R 1≥R 3＝a＞R 2＝1；A、B、C为⊙ 3上的三等分点，互为半径作弧BC、弧AC、弧AB，定义“胖△ABC”为“胖三角形”的主杆21边界，呈“恒高”，且满足S ⊙2＝S △ABC；取弧BC的中点D，并作各标准辅助线(如图虚线)，则：
Figure PCTCN2019082922-appb-000004
计算得：R 3＝a＝1.22；主杆21横截面的恒高AD＝2.11；螺纹22外缘半径R 1＝(1.22-1.9)，例如R 1可以但不仅限于为1.22、1.3、1.4、1.5、1.6、1.7、1.8或1.9。螺纹22的外圆横截面积是主杆21的横截面积的1.49-3.61倍。
本实施例可选的方案中，更加可选地，主杆21的横截面为正四边形，螺纹22的外圆横截面积是主杆21的横截面积的1.59-3.61倍，例如可以但不仅限于为1.59、1.69、1.96、2.25、2.56、2.89、3.24或3.61。如图4所示，横截面上作假想同心圆⊙ 3，半径为R 3，R 1＞R 3＞R 2＝1；A、B、C、D为⊙ 3上的四等分点，则□ABCD呈正方形，并定义为四边形螺钉的主杆21边界，作各辅助线如图4，边长为a，对角线为b，则
Figure PCTCN2019082922-appb-000005
且满足：S ⊙2＝S □ABCD；计算得：主杆21边长为
Figure PCTCN2019082922-appb-000006
对角线为
Figure PCTCN2019082922-appb-000007
螺纹22外缘半径
Figure PCTCN2019082922-appb-000008
R 1的范围为(1.26-1.9)，例如R 1可以但不仅限于为1.26、1.3、1.4、1.5、1.6、1.7、1.8或1.9。螺纹22的外圆横截面积是主杆21的横截面积的1.59-3.61倍。
本实施例可选的方案中，更加可选地，主杆21的横截面为正五边形，螺纹22的外圆横截面积是主杆21的横截面积的1.44-3.61倍，例如可以但不仅限于为1.44、1.69、1.96、2.25、2.56、2.89、3.24或3.61。如图5所示，横截面上作假想同心圆⊙ 3，半径为R 3，R 1＞R 3＞R 2＝1；A、B、C、D、E为⊙3上的五等分点，则五边形ABCDE呈正五边形，并定义为五边形螺钉的主杆21边界；且满足S ⊙2＝S 五边形ABCDE；作各辅助线如图5，边长AE＝c；最小径为“高”：AG＝a+b，最大径“对角线”AD；各边长AB＝BC＝CD＝DE＝AE＝c，五边 形相关计算方法：
面积S 五边形ABCDE＝1.720×c×c；
外切圆半径R 3＝a＝0.851×c；
内切圆半径b＝0.688×c；
高AG＝1.539×c；
对角线AD＝1.618×c＝1.902×a
且R 1＞R 3＞R 2＝1；满足S ⊙2＝S 五边形ABCDE，S ⊙2＝π×R 2×R 2＝S 五边形ABCDE＝1.720×c×c；
计算得：外切圆半径a＝0.851×c＝1.15；边长c＝1.35；
最小径即“高”AG＝1.539×c＝2.08；
最大径即“对角线”AD＝1.618×c＝2.19；
螺纹22外圆半径R 1的范围为(1.2-1.9)，例如R 1可以但不仅限于为1.2、1.3、1.4、1.5、1.6、1.7、1.8或1.9。螺纹22的外圆横截面积是主杆21的横截面积的1.44-3.61倍。
本实施例可选的方案中，更加可选地，主杆21的横截面为正六边形，螺纹22的外缘横截面积是主杆21的横截面积的1.49-3.61倍，例如可以但不仅限于为1.49、1.69、1.96、2.25、2.56、2.89、3.24或3.61。如图6所示，横截面上作假想同心圆⊙ 3，半径为R 3，且R 1＞R 3＞R 2＝1；A、B、C、D、E、F为⊙ 3上的六等分点，则六边形ABCDEF呈正六边形，并定义为六边形螺钉的主杆21边界；且满足S ⊙2＝S 六边形ABCDEF，作各辅助线如图6；各边长及外接圆半径为：AB＝BC＝CD＝DE＝EF＝OF＝a＝R 3；对角线AD＝2a，高
Figure PCTCN2019082922-appb-000009
计算得：边长及外切圆半径AB＝a＝R 3＝1.10，最小径即“高”：
Figure PCTCN2019082922-appb-000010
最大径即“对角线”：AD＝2a＝2.20；螺纹22外圆半径R 1的范围为(1.2-1.9)，例如R 1可以但不仅限于为1.2、1.3、1.4、1.5、1.6、1.7、1.8或1.9。螺纹22的外圆横截面积是主杆21的横截面积的1.49-3.61倍。
本实施例可选的方案中，更加可选地，主杆21横截面除了为以上的胖三角形、正四边形、正五边形、正六边形或椭圆形之外，还可以为其他非圆形形状，且螺纹22外圆半径与主杆21外接圆半径比为1.2-1.9，例如可以但不仅限于为1.2、1.3、1.4、1.5、1.6、1.7、1.8或1.9。
本实施例可选的方案中，更加可选地，螺纹22的外径与螺距比为1.5-5.5，例如可以但不仅限于为1.5、2、2.5、3、3.5、4、4.5、5或5.5。螺纹22与主杆21轴线的夹角α，可将其“正切×2”(即“外径与螺距比”或“一个外径的距离内有几圈完整的螺纹22”)，可作为螺纹22的相对密度和抓持力的指标，比值范围为1.5-5.5，双螺纹22螺钉该比值可低至1。该比值越大提示α角度越大，螺纹22越接近垂直于主杆21轴线、密度越高，抗拔出力越大。
本实施例可选的方案中，更加可选地，螺杆2背离螺钉帽1的一端带攻丝槽。在至少一个实施例中，螺钉尖端还可附加设计为带攻丝槽的自攻螺钉。
本实施例可选的方案中，更加可选地，主杆21内部形成有空腔结构；
或者，主杆21内部为实心结构。
本实施例可选的方案中，更加可选地，螺钉帽1为圆形，带或不带锁定螺纹，且螺钉帽1上形成有六角槽或者十字槽或者一字槽或者梅花槽或者米字槽；
或者，螺钉帽1为可以随意转向的万向型钉帽，且所述螺钉帽呈燕尾形。
需要说明的是，依照应用领域的专业差异，螺钉帽1可设计成圆形内六角槽、圆形十字槽、圆形一字槽、圆形内梅花槽、圆形米字槽(创伤骨科、关节外科、颅颌面外科)，或设计成燕尾万向或固定、长燕尾提拉螺钉帽1(脊柱外科)等；
以上对本申请的基于机体成骨功能的医用防松动螺钉进行了说明，但是，本申请不限定于上述具体的实施方式，只要不脱离权利要求的范围，可以进行各种各样的变形或变更。本申请包括在权利要求的范围内的各种变形和变更。
最后应说明的是：以上各实施例仅用以说明本申请的技术方案，而非对其限制；尽管参照前述各实施例对本申请进行了详细的说明，本领域的普通技术人员应当理解：其依然可以对前述各实施例所记载的技术方案进行修改，或者对其中部分或者全部技术特征进行等同替换；而这些修改或者替换，并不使相应技术方案的本质脱离本申请各实施例技术方案的范围。

Claims (14)

  1. 一种基于机体成骨功能的医用防松动螺钉，其特征在于，包括：螺钉帽和与所述螺钉帽连接的螺杆；
    所述螺杆包括主杆和螺旋缠绕在所述主杆上的螺纹；所述主杆的横截面形状为非圆形。
  2. 根据权利要求1所述的基于机体成骨功能的医用防松动螺钉，其特征在于，所述主杆的横截面为椭圆形或胖三角形或者四边形或者五边形或者六边形。
  3. 根据权利要求2所述的基于机体成骨功能的医用防松动螺钉，其特征在于，当所述主杆的横截面为椭圆形时，所述椭圆形的长、短半轴之比小于
    Figure PCTCN2019082922-appb-100001
    所述螺纹的外缘横截面积是所述主杆的横截面积的1.49-3.61倍。
  4. 根据权利要求2所述的基于机体成骨功能的医用防松动螺钉，其特征在于，当所述主杆的横截面为胖三角形时，所述螺纹的外圆横截面积是所述主杆的横截面积的1.49-3.61倍。
  5. 根据权利要求2所述的基于机体成骨功能的医用防松动螺钉，其特征在于，所述主杆的横截面为正四边形，所述螺纹的外圆横截面积是所述主杆的横截面积的1.59-3.61倍。
  6. 根据权利要求2所述的基于机体成骨功能的医用防松动螺钉，其特征在于，所述主杆的横截面为正五边形，所述螺纹的外圆横截面积是所述主杆的横截面积的1.44-3.61倍。
  7. 根据权利要求2所述的基于机体成骨功能的医用防松动螺钉，其特征在于，所述主杆的横截面为正六边形，所述螺纹的外缘横截面积是所述主杆的横截面积的1.49-3.61倍。
  8. 根据权利要求1所述的基于机体成骨功能的医用防松动螺钉，其特征在于，所述螺纹外圆半径与所述主杆外接圆半径比为1.2-1.9。
  9. 根据权利要求1所述的基于机体成骨功能的医用防松动螺钉，其特征在于，所述螺纹的外径与螺距比为1.5-5.5。
  10. 根据权利要求1所述的基于机体成骨功能的医用防松动螺钉，其特征在于，所述螺杆背离所述螺钉帽的一端带攻丝槽。
  11. 根据权利要求1所述的基于机体成骨功能的医用防松动螺钉，其特征在于，所述主杆内部形成有空腔结构；
    或者，所述主杆内部为实心结构。
  12. 根据权利要求1所述的基于机体成骨功能的医用防松动螺钉，其特征在于，所述螺钉帽为圆形螺钉帽，且所述螺钉帽上形成有六角槽或者十字槽或者一字槽或者梅花槽或者米字槽；
    或者，所述螺钉帽为燕尾形螺钉帽。
  13. 根据权利要求12所述的基于机体成骨功能的医用防松动螺钉，其特征在于，所述圆形螺钉帽带锁定螺纹。
  14. 根据权利要求12所述的基于机体成骨功能的医用防松动螺钉，其特征在于，所述燕尾形螺钉帽为万向型钉帽。
PCT/CN2019/082922 2018-05-04 2019-04-16 基于机体成骨功能的医用防松动螺钉 WO2019210774A1 (zh)

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