WO2018130202A1 - 中央单棒的脊柱侧弯矫正系统 - Google Patents

中央单棒的脊柱侧弯矫正系统 Download PDF

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Publication number
WO2018130202A1
WO2018130202A1 PCT/CN2018/072384 CN2018072384W WO2018130202A1 WO 2018130202 A1 WO2018130202 A1 WO 2018130202A1 CN 2018072384 W CN2018072384 W CN 2018072384W WO 2018130202 A1 WO2018130202 A1 WO 2018130202A1
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Prior art keywords
rod
correction system
bridge
orthopedic
scoliosis correction
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PCT/CN2018/072384
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English (en)
French (fr)
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邹德威
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邹德威
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Publication of WO2018130202A1 publication Critical patent/WO2018130202A1/zh

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/701Longitudinal elements with a non-circular, e.g. rectangular, cross-section
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002Longitudinal elements, e.g. rods
    • A61B17/7011Longitudinal element being non-straight, e.g. curved, angled or branched
    • A61B17/7013Longitudinal element being non-straight, e.g. curved, angled or branched the shape of the element being adjustable before use
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical 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
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/70Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7032Screws or hooks with U-shaped head or back through which longitudinal rods pass

Definitions

  • the invention relates to the field of medical instruments, in particular to a surgical correction of a spinal scoliosis surgery, in particular to a central single rod scoliosis correction system.
  • Harrington Rod which is called “Harvey Rod” by later generations, is a cylindrical metal rod placed on the concave side of the scoliosis of the body, which is opened by the upper and lower points to reduce the curvature and correct the deformity. This laid the theoretical foundation for the mechanics of a variety of orthopaedic instruments that were later complicated.
  • SRS Scoliosis Research Society
  • the prior art has the following problems: the existing scoliosis medical device enables adolescents to lose growth and increase their height after scoliosis surgery.
  • the invention provides a central single rod scoliosis correction system, that is, a scoliosis correction system with a central single rod, also called a central single rod, a pedicle lateral connection, a three-dimensional rotation correction, a growable scoliosis correction System to address the problem of adolescents losing their ability to grow and increase their height after scoliosis surgery.
  • a central single rod scoliosis correction system that is, a scoliosis correction system with a central single rod, also called a central single rod, a pedicle lateral connection, a three-dimensional rotation correction, a growable scoliosis correction System to address the problem of adolescents losing their ability to grow and increase their height after scoliosis surgery.
  • the present invention provides a central single rod scoliosis correction system, the central single rod scoliosis correction system comprising:
  • n gears are sleeved on the single orthopedic rod, n is a natural number greater than 1; n gears are arranged on the single orthopedic rod at intervals along the length direction of the single orthopedic rod;
  • n arched bridges are arranged on the single orthopedic rod at intervals along the length direction of the single orthopedic rod;
  • Each of the arched bridges includes: a toroidal body having a lateral opening, and a bridge body attached to a top surface of the toroidal body and projecting to an outer side of the toroidal body, the number of the bridge bodies In two stages, the two sections of the bridge body are perpendicular to the longitudinal direction of the single orthopedic rod; the two sections of the bridge body intersect at an angle of 150°-175°;
  • the annular body has: a toothed inner wall that meshes with the gear and is unidirectionally locked, and a locking groove disposed outside the toothed inner wall and parallel to the toothed inner wall;
  • a pedicle screw is disposed at each end of the bridge body, and two pedicle screws are arranged on the two bridges, and the axes of the two pedicle screws intersect at an angle of 5°-30° .
  • the orthopedic rod has a square cross section.
  • each of the sections of the bridge has a platform for clamping the pedicle screws.
  • the gear is circular, the axis of the gear is coincident with the center line of the orthopedic rod, and the annular body and the two sections of the bridge body are symmetrical about a center line of the orthopedic rod.
  • the distance of the locking groove from both ends of the torus is greater than zero.
  • the central single-rod scoliosis correction system further includes: an internal stress-assisted growth column connected between two adjacent arched bridges, the internal stress-assisted growth column comprising: a sleeve, disposed at Two telescopic rods in the sleeve, and springs disposed in the sleeve and pressed between the two telescopic rods, the two telescopic rods respectively telescope at both ends of the sleeve.
  • each of the telescopic rods is provided with a clamp capable of engaging the bridge body.
  • clamp is U-shaped.
  • the single orthopedic rod and the arched bridge are made of medical titanium alloy.
  • the spring is a compression spring, and the spring is made of medical spring steel.
  • the inventor After long-term research, the inventor also found that although the three-dimensional rotation correction reconstructs the physiological curvature while correcting the pathological curvature, its scientificity and operability are confirmed by both theory and practice; but so far, all of them are cylindrical rods.
  • the pedicle screws at each point of the segment are longitudinally connected, and the three-dimensional rotation is performed on the side deviated from the median line.
  • the cylindrical rod rotates 90° in the axial direction, and it is almost impossible to be accurate. Visual observation and skills, experience. What's more important is that when the orthopedic rod is pre-bent and adapted to pathological bending, it is still difficult to keep it in a plane because of the cylindrical rod. Because it is cylindrical, it is easy to roll when bending, especially in the change.
  • the angle between the coronal plane and the sagittal plane is 90°, and the effect is often not perfect, and there is a big gap with the operator's eyesight, hand skills and experience, but for the patient, it is almost a lifetime. The only chance of surgery.
  • the pier thus forming a laterally stable mechanical structure; and the long axis of the pedicle and the posterior median line form a regular acute angle from top to bottom, gradually increasing from 5° to the lower lumbar spine At 30°, the screw enters the vertebral body from the posterior pedicle and is completely buried in the bone tissue (Fig. 4), so it has better physical strength than the hook and the steel wire.
  • the orthopaedic technique has so far connected the pedicle screws of different segments longitudinally on the side deviating from the midline, and a pair of vertebral pedicles forming an angle has become a separate point in the longitudinal correction force. Therefore, when the vertebral body is under stress overload, it often occurs loose until it is pulled out. This is a common problem that always plagues the surgeon during scoliosis surgery, which directly affects the overall quality and effect of the operation.
  • the original single rectangular orthopedic rod of the present invention penetrates into a plurality of outer circular inner unidirectional rotating gears, and is connected to each other along the center line of the long axis of the spine in the central portion of the transverse plane bridge of different planes, and is most balanced in the longitudinal direction.
  • the control force for correcting the longitudinal rotation of the scoliosis deformity is realized, and the rectangular orthopedic rod can still slide up and down freely in the square hole of the outer square inner wheel, while realizing the longitudinal three-dimensional rotation correction It completely eliminates the longitudinal extension of the contradiction that contradicts the growth of the spine, does not affect the growth of the human body, and discards the notion that two orthopedic rods must be used.
  • an orthopedic rod having a rectangular shape such as a square is characterized in that: 1) the mechanical strength is equal to the diameter of the circular orthopedic rod when the length of each side of the square is equal to the diameter of the circular rod, for example, when the side length is Equal to the diameter, when the diameter is 5mm, the diagonal is 7mm. In the case of no obvious thickening, the mechanical strength is inferior to the circular rod; 2) every square of the square is 90°, the minute and the second are not bad.
  • Figure 1 is a perspective view showing the structure of a single orthopedic rod of the present invention
  • FIG. 2 is a schematic top plan view of a single orthopedic rod of the present invention.
  • Figure 3 is a front view showing the structure of a single orthopedic rod of the present invention.
  • Figure 4 is a perspective view showing the structure of a single orthopedic rod of the present invention.
  • Figure 5 is a side elevational view showing the gear of the present invention.
  • Figure 6 is a perspective view showing the structure of the gear of the present invention.
  • Figure 7 is a front view showing the structure of the gear of the present invention.
  • Figure 8 is a front view of the arched bridge of the present invention.
  • Figure 9 is a schematic plan view showing the arched bridge of the present invention.
  • Figure 10 is a rear perspective view of the arched bridge of the present invention.
  • Figure 11 is a bottom plan view showing the arched bridge of the present invention.
  • Figure 12 is a perspective view showing the structure of the arched bridge of the present invention.
  • Figure 13 is a front view showing the structure of the pedicle screw of the present invention.
  • Figure 14 is a top plan view showing the pedicle screw of the present invention.
  • Figure 15 is a perspective exploded view of the pedicle screw and nut of the present invention.
  • Figure 16 is a perspective view showing the structure of a central single rod scoliosis correction system of the present invention.
  • Figure 17 is a schematic view showing the orthopedic process of the central single rod scoliosis correction system of the present invention, wherein the single orthopedic rod has not been installed in the arched bridge;
  • Figure 18 is a schematic view showing the orthopedic process of the central single rod scoliosis correction system of the present invention, wherein the single orthopedic rod is bent and installed in the arched bridge;
  • Figure 19 is a schematic view showing the orthopedic process of the central single rod scoliosis correction system of the present invention, wherein the single orthopedic rod is bent and installed in the arched bridge to be corrected;
  • Figure 20 is a schematic view showing the structure of the upper thoracic plane
  • Figure 21 is a schematic view showing the structure of the upper thoracic vertebra, which shows the stable mechanical structure of the arched bridge connecting the pedicle screws to form a fulcrum;
  • Figure 22 is a schematic view showing the structure of the lower thoracic plane
  • Figure 23 is a front view showing the structure of the internal stress promoting column of the present invention, wherein the telescopic rod is not extended;
  • Figure 24 is a perspective view showing the internal structure of the internal stress promoting column of the present invention, wherein the telescopic rod is extended;
  • Figure 25 is a schematic perspective view showing the internal stress promoting column of the present invention.
  • the central single rod scoliosis correction system of the present invention comprises:
  • the orthopedic rod 1 has a rectangular cross section; the end of the orthopedic rod 1 is provided with a screw hole, and a screw 6 can be installed for fastening or connecting. To the spine;
  • n gears 2 are sleeved on the single orthopedic rod 1, n is a natural number greater than 1; the length of the spine actually corrected according to the need, n is a plurality, n gear edges
  • the longitudinal direction of the single orthopedic rod is sequentially arranged on the single orthopedic rod; as shown in FIG. 5, FIG. 6 and FIG. 7, the gear 2 is a one-way gear inside the outer circle, and has a rectangular shape. a mounting hole 20 and external teeth 21 arranged along a circular circumference; the orthopedic rod 1 is bored in the rectangular mounting hole 20;
  • Gear 2 is a one-way gear inside the outer circle. It is an inner circle structure of ancient Chinese “coin” and “dry dragon”.
  • the inner side is square, the side length is slightly larger than the side length of the square rod, and the positive and negative working difference is ⁇ 0.5mm, so that it can be easily inserted into the square rod without resistance, and it is put into a string by a square rod, and the rail is free to slide.
  • the arc of the "rod” is proportional, and when it reaches a thickness sufficient to maintain stability, as long as the bar does not appear at right angles to an acute arc, it can still slide freely; when rotating from the adjacent side of the rectangle, when rotating from a to the b-plane
  • the external one-way gear must realize precise 90° rotation and is irreversible, achieving the purpose of precise orthopedics and locking at any time.
  • the outer one-way gear must realize precise 90° rotation and irreversible, achieve precise orthopedic and lock at any time;
  • n arched bridges 3 are arranged on the single orthopedic rods at intervals along the length direction of the single orthopedic rod;
  • each of the arched bridges 3 includes: a toroidal body 30 having a lateral opening 301, and a top surface connected to the toroidal body 30.
  • a bridge body extending upwardly and outwardly of the annular body, the number of the bridge body being two sections, respectively a bridge body 31 and a bridge body 32, and the two sections of the bridge body are perpendicular to the single orthopedic rod
  • the length direction; the bridge body 31 and the bridge body 32 intersect at an angle of 150°-175°; so that the two pedicle screws that enter the vertebral body with the pedicle anatomical long axis are at an angle to each other, forming a complete mechanical structure with physiological state Consistent and most stable mechanical structure;
  • the annular body 30 has: a toothed inner wall 303 engaged with the gear 2 and unidirectionally locked, and a locking groove 305 disposed outside the toothed inner wall and parallel to the toothed inner wall;
  • the inserting plate 5 for positioning the gear 2 is detachably engaged in the locking groove 305 as shown in FIG. 16 to position the gear 2 after the gear 2 is mounted in the arched bridge 3. tight;
  • a pedicle screw 4 is disposed at an end of each of the bridge bodies, and two pedicle screws are disposed on the bridge body, as shown in Figs. 16 and 21, two pedicle screws
  • the axes intersect at an angle of between 5 and 30 degrees.
  • the arch bridge structure connecting the vertebral arches of the same vertebral body horizontally horizontally replicates the most reasonable mechanical structure of a pair of pedicles with a stable fulcrum in the physiological state, and the correction is applied to each stress plane. When the force is balanced, the vertebral body is balanced and the looseness is effectively avoided.
  • the present invention allows the spine to be freely extended along the corrected long axis to achieve the objective of retaining the growth function under the premise of achieving accurate orthopedicity and maintaining sufficient stability.
  • the orthopedic rod 1 has a square cross section.
  • the orthopedic rod 1 is a square square orthopedic rod.
  • the cross-angle in the square must be larger than the diameter of the circular orthopedic rod, for example, when the side length is equal to When the diameter is 5mm, the diagonal is 7mm.
  • each section of the bridge body has a platform 320 for clamping the pedicle screw 4, and the end of the bridge body is, for example, a rectangular cross section, so that the pedicle screw 4 is clamped. hold.
  • the gear 2 is circular, as shown in FIG. 16, the axis of the gear coincides with the center line of the orthopedic rod, and the annular body 30 and the two sections of the bridge body are related to the center line of the orthopedic rod 1. Symmetrical to achieve uniform force on both sides.
  • the distance between the locking grooves 305 from both ends of the toroidal body 30 is greater than zero in order to fix the insertion plate 5 and prevent the insertion plate 5 from coming off.
  • the central single rod scoliosis correction system further comprises: an internal stress assisting column 7 connected between two adjacent arched bridges, as shown in FIG. 23, FIG. 24 and FIG.
  • the internal stress assisted growth column includes a sleeve 70, a telescopic rod 71 and a telescopic rod 72 disposed in the sleeve, and a spring 75 disposed in the sleeve 70 and pressed between the two telescopic rods Two telescopic rods are respectively telescoped at both ends of the sleeve. Through the elastic action of the spring, the two telescopic rods can be extended to help increase the distance between the adjacent two arched bridges, thereby making the human body grow taller.
  • each of the telescopic rods is provided with a clamp 710 capable of engaging the bridge body so as to be caught on the bridge body.
  • clamp 710 is U-shaped, and the clamping is convenient and quick.
  • the single orthopedic rod 1 and the arched bridge 3 are made of medical titanium alloy, which is light and strong, and has good mechanical properties.
  • the spring 75 is a compression spring, and the spring 75 is made of medical spring steel, which is suitable for human body use.
  • the arched bridge connects the pair of pedicles of the same vertebral body in three directions, wherein the points are facing the back of the spine.
  • the center line, the bridge deck is longitudinally slotted, allowing only the square bar to be placed longitudinally from the surface, perpendicularly intersecting the deck surface, and the side of the side is fully rounded to fit and accommodate the space of the round wheel, and the other side is larger than the square.
  • the bar is diagonal but smaller than the circular opening of the round wheel, effectively preventing the round wheel from entering the one-way tooth from one side and being engaged with each other, and then coming out from the other side.
  • the bridge connects a pair of pedicle screws laterally, providing the most stable mechanical fulcrum. Any one of the screws can hardly be pulled out alone. In the correction of the lateral bending, it must also be replaced by a square rod. Face rotation accurately restores the physiological curvature of the spine.
  • the central force axis of the single rod on the median line behind the spine is used to correct the three-dimensional rotation of the spine, and in the process of rotation, the local curvature is inevitably caused by the path curvature.
  • the vertebral body is laterally inclined in the coronal plane, and it is also necessary to return to the horizontal balance of the coronal plane as the surface changes.
  • the pedicle screw 4 as shown in Fig. 13, Fig. 14 and Fig. 15, uses a universal gimbal pedicle screw, as shown in Fig. 20, Fig. 21 and Fig. 22, for the upper thoracic vertebra 91 and the lower thoracic vertebra 92, which can be completely satisfied.
  • the angle between the pair of pedicles from top to bottom is 5°-30°, and the universal joint is locked after screwing into the top nut (nut 40), so that the pair of screws and the transverse bridge are accurate. The angle is firmly combined.
  • the internal stress-assisted growth column 7 is realized by a compressed spring in the sleeve. Depending on the age and individual condition of the patient, the doctor chooses to use it between the upper and lower transverse bridges, and is located on the original pathological curved concave side of the central column. Different internal stress strengths (spring-determined) and final point lengths, a single axial center square rod, itself allows the spine to grow freely along its fixed physiologically curved longitudinal axis, but the axial lift can further stimulate growth. Therefore, it can be used at the discretion of the doctor.
  • the present invention is preferably a square orthopedic rod, but as a single rod correction of the posterior midline of the spine, the orthopedic rod of any other shape is not excluded.
  • outer circumference inner one-way gear and the corresponding arch type bridge are preferred in the present invention. However, it is not excluded that the same purpose is achieved in the art, that is, the stepping is irreversible. Any other structure that can perform both one-way circumferential rotation and axial free sliding.
  • a transverse bridge that laterally connects a pair of pedicles of the same vertebral body is used.
  • other stick-and-plate-shaped devices that laterally connect the same vertebral body to a pair of pedicles (the prior art has a lateral connecting device, but none of them directly traverse a pair of pedicles, both are connected longitudinally on both sides A rod with a single plane pedicle of different planes has been attached).
  • a number of planes are selected in the laterally curved spine, and a pair of pedicle screws are implanted in each planar vertebral body to lock the screws with the arched bridge.
  • the orthopedic rods adapted to the pre-bend and the side bends are inserted into the one-way gears of the outer circumference of the same number; the orthopedic rods adapted to the pre-bend are placed into the bridge by the top surface, and the inner side of the outer circle is unidirectional
  • the gear slides along the positioned square bar, and is pushed into the arched bridge by the side.
  • the wrench 8 is used to rotate the two ends of the handle with the orthopedic rod 90°; after the central orthopedic rod is rotated by 90°, the human body has a coronal (front) pathological curvature. It was corrected and the sagittal (lateral) physiological curvature was reconstructed. The both ends of the anti-slip screw were installed.

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Abstract

提供了一种中央单棒的脊柱侧弯矫正系统。该矫正系统包括:单根矫形棒(1);n个齿轮(2),套设在单根矫形棒(1)上;n个拱形廊桥(3)。每个拱形廊桥(3)包括:具有侧向开口(301)的圆环体(30),以及连接在圆环体(30)的顶面上并向圆环体(30)的外侧伸出的桥体(31,32)。圆环体(30)具有:与齿轮(2)相啮合并单向锁紧的齿状内壁(303),以及设置在齿状内壁(303)之外并平行齿状内壁(303)的锁紧槽(305)。对齿轮(2)定位的插板(5)能拆卸的卡接在锁紧槽(305)中。椎弓根螺钉(4)设置在每段桥体(31;32)的端部。两段桥体(31,32)上设有两根椎弓根螺钉(4),两根椎弓根螺钉(4)的轴线相交成5°-30°夹角。该矫正系统使得上下椎体间仍可自由延长生长,完全保留了脊柱生长的生理功能。

Description

中央单棒的脊柱侧弯矫正系统 技术领域
本发明涉及医疗器械领域,具体涉及脊柱侧弯畸形手术矫正内置器械,尤其是一种中央单棒的脊柱侧弯矫正系统。
背景技术
脊柱侧弯(scoliosis)全球发病率约为1%左右,按人口基数统计,潜在患者以数千万计。出生后在生长发育中才逐渐表现出来,其危害是明显直观的躯干畸形,由此给患儿及家庭带来极大的自卑及心理伤害。如不加控制,相当一部分病例可持续发展,当超过90°时,可造成胸腹腔容积明显减少,心、肺、消化道功能受损、障碍,严重者可危及生命,导致患儿过早夭折。
对其致病原因,人类至今尚不明了,因此无法针对病因进行根治及预防。唯一有效的治疗方法,就是一旦发现,保守无效,在其发展到重度之前进行手术,用器械矫正畸形。
自上世纪六十年代,由美国学者Paul Harrington结束了之前人类对此疾病束手无策的局面,首先开创了用器械进行手术矫正的先河。被后人称为“哈氏棒”的矫形棒(Harrington Rod),为一圆柱状金属棒,置于体内脊柱侧弯的凹侧,由上下两点将其撑开,减少弯曲度,矫正畸形,由此奠定了后来多种甚至结构复杂的矫形器械的力学理论基础。国际脊柱侧弯研究会SRS(Scoliosis Research Society)成立近四十年来,集中了世界各国在一线手术矫正治疗实践中所有名家,每年一次年会,就手术技术和不断发展的手术器械进行充分的交流,不断地突破一个又一个手术禁区,发展到了全脊柱无障碍手术,器械也随之不断进步,从单侧的哈氏棒,发展到多样化的双侧双棒;与脊柱的结合,从上下两点的金属钩,发展到多节段多平面的全脊柱椎弓根螺钉;矫正力学理论,从单一平面的支撑矫正,到三维旋转矫正,在矫正病理弯曲的同时重建生理弯曲。SRS由此成为了全球化的脊柱侧弯手术治疗和技术发展的最活跃的交流平台和最权威的学术组织。然而,在征服疾病的道路上,没有最好,只有更好,自哈氏棒及哈氏手术开创脊柱侧弯手术至今,半个多世纪过去了,虽然手术技术及器械有了很大进步,但仍然存在诸多问题。
最为纠结的突出问题是:迄今为止,从简到繁的矫正技术及器械,总是在脊柱后方 一侧若干节段之间通过椎弓根螺钉为支点,纵向连接,再施加轴向撑开,横向对抗,三维旋转等矫正力后,均必须在纵向将矫形棒与螺钉锁固,并在另一侧再用矫形棒轴向固定锁固。因此,虽然获得脊柱侧弯矫正,但被矫正的脊柱由双棒牢牢固定并融合,从而彻底丧失生长、增加身高的能力,而接受手术者90%以上均为生长发育期的青少年,因此,青少年在脊柱侧弯手术后丧失生长、增加身高的能力。
综上所述,现有技术中存在以下问题:现有的脊柱侧弯医疗器械使青少年在脊柱侧弯手术后丧失生长、增加身高的能力。
发明内容
本发明提供一种中央单棒的脊柱侧弯矫正系统,即具有中央单棒的脊柱侧弯矫正系统,也称为中央单棒、椎弓根横向连接、三维旋转矫正、可生长脊柱侧弯矫正系统,以解决青少年在脊柱侧弯手术后丧失生长、增加身高的能力的问题。
为此,本发明提出一种中央单棒的脊柱侧弯矫正系统,所述中央单棒的脊柱侧弯矫正系统包括:
单根矫形棒,所述矫形棒的断面为矩形;
n个齿轮,套设在所述单根矫形棒上,n为大于1的自然数;n个齿轮沿所述单根矫形棒的长度方向依次间隔的排布在所述单根矫形棒上;
n个拱形廊桥,沿所述单根矫形棒的长度方向依次间隔的排布在所述单根矫形棒上;
每个拱形廊桥包括:具有侧向开口的圆环体、以及连接在所述圆环体的顶面上并向所述圆环体的外侧伸出的桥体,所述桥体的数目为两段,两段所述桥体垂直所述单根矫形棒的长度方向;两段所述桥体相交成150°-175°夹角;
所述圆环体具有:与所述齿轮相啮合并单向锁紧的齿状内壁、以及设置在所述齿状内壁之外并平行所述齿状内壁的锁紧槽;
对所述齿轮定位的插板,能拆卸的卡接在所述锁紧槽中;
椎弓根螺钉,设置在每段所述桥体的端部,两段所述桥体上设有两根椎弓根螺钉,两根椎弓根螺钉的轴线相交成5°-30°夹角。
进一步地,所述矫形棒的断面为正方形。
进一步地,每段所述桥体的端部具有供所述椎弓根螺钉夹持的平台。
进一步地,所述齿轮为圆形,所述齿轮的轴线与所述矫形棒的中线一致,所述圆环体和两段所述桥体关于所述矫形棒的中线对称。
进一步地,所述锁紧槽距离圆环体的两端的距离均大于零。
进一步地,所述中央单棒的脊柱侧弯矫正系统还包括:连接在相邻两个拱形廊桥之间的内应力助生长柱,所述内应力助生长柱包括:套管、设置在所述套管中的两个伸缩杆、以及设置在所述套管中并抵压在两个伸缩杆之间的弹簧,两个伸缩杆分别在所述套管的两端伸缩。
进一步地,每个所述伸缩杆上设有能够卡接所述桥体的夹钳。
进一步地,所述夹钳为U型。
进一步地,所述单根矫形棒和拱形廊桥的材质为医用钛合金。
进一步地,所述弹簧为压缩弹簧,所述弹簧的材质为医用弹簧钢。
发明人经过长期研究还发现:虽然三维旋转矫正在纠正病理弯曲的同时重建生理弯曲,其科学性和可操作性,从理论和实践均得到证实;但迄今为止,均由圆柱状的棒将多节段各点的椎弓根螺钉纵向连接起来,在偏离后正中线的一侧实施三维旋转,圆柱状的棒沿轴向作90°的旋转,几乎不可能做到准确,只能凭借术者的肉眼观察和技巧、经验。更重要的是在将矫形棒预弯并适配病理弯曲时,还是因为圆柱状的棒,很难做到保持在一个平面,因为是圆柱状,很容易在折弯时发生滚动,尤其在改变弯曲方向时,故常常出现“麻花”状而不尽人意。但遗憾的是迄今为止,全球各国多种矫形棒均为清一色的圆柱状,其结果是虽然成功的证实了预弯的矫形棒沿长轴旋转90°后,可将其连接的脊柱冠状面的病理弯曲消除而转变为矢状面的生理弯曲,即人体侧面的自然曲线,但常常因为难以准确在同一平面预弯完全适配病理弯曲的圆柱状矫形棒,旋转时,也常常难以准确掌握由冠状面到矢状面夹角90°的转换,而效果常常达不到完美,并随操作者的眼力、手技和经验的差异而出现较大的差距,但对患者而言,却几乎是一生中唯一的一次手术机会。
自上世纪末、世纪之交,椎弓根螺钉技术被广泛接受并在全球普遍开展以来,在脊柱侧弯手术中,完全取代了挂钩及钢丝捆绑,而成了各种圆柱状矫形棒的基本力学支点。虽然在人类每一椎节的椎弓根均为水平面左右各一的一对,并由椎板、横向连接形成中空的骨性椎管,椎板就好似一座拱桥,而椎弓根就是两端的桥墩,由此形成了一个横向稳定的力学构造;并且椎弓根的长轴与后正中线自上而下形成有规律的锐角夹角,逐渐加大,自上胸椎的5°,至下腰椎的30°,螺钉自后方经椎弓根进入椎体,完全埋于骨组织(图4),因此较挂钩和钢丝捆绑有了更理想的物理强度。但迄今为止的矫形技术均是在偏离中线的一侧将不同节段的椎弓根螺钉纵向连接起来,一对互成夹角的椎弓根在纵向矫正力过程中却成了一个单独的点,故当此椎体局部应力过载时,常常发生松动、直至被拔出,这是脊柱侧弯矫形手术中始终困扰着术者的常见问题,从而直接影响 手术的整体质量和效果。
本发明创新性的横向连接同一椎体的一对椎弓根,沿椎弓根解剖长轴进入椎体的两枚椎弓根螺钉互为夹角,形成与生理状态力学构造完全一致的最稳定的力学结构。当对其中一枚施加拔出力时,立即沿横向的廊桥传递到另一枚螺钉并转变为推进力,故几乎完全避免了被松动拔出的可能。以此独创方式,取代现行的通过纵向单侧椎弓根连接上下椎体并锁固,使脊柱丧失生长增高能力的模式。即使将每一节均横向连接后,上下椎体间仍可自由延长生长,完全保留了脊柱生长的生理功能。
另外,本发明独创性的单根矩形矫形棒,穿进多枚外圆内方的单向转动齿轮,在不同平面横向廊桥的中央部位,沿脊柱长轴中心线相互连接,在纵向最平衡的力线轴上,即实现了矫正脊柱侧弯畸形所必需的纵向旋转对抗的控制力,同时矩形矫形棒仍可在外圆内方轮的方孔中自由上下滑动,在实现纵向三维旋转矫正的同时,又完全消除了与脊柱生长相矛盾的纵向延长的限制力,不会影响人体生长,同时扬弃了必须使用两根矫形棒的观念。
进而,采用矩形例如为正方形的矫形棒特点:1)力学强度在正方形的每一边长等于圆形棒的直径时,其正方形内交叉对角线必然大于圆形矫形棒的直径,例如当边长等于直径,均为5mm时,对角线则为7mm,在没有明显增粗的情况下,力学强度必然优于圆形棒;2)正方形每旋转一个面,就是90°,分秒不差,需要预弯适配脊柱病理弯曲时,沿一个面用通用手术器械“三点折弯器”预弯时,因平面不会滑动,同样分秒不差,不会发生角度偏转,从而彻底消除手术中的“麻花”现象。
附图说明
图1为本发明的单根矫形棒的立体结构示意图;
图2为本发明的单根矫形棒的俯视结构示意图;
图3为本发明的单根矫形棒的主视结构示意图;
图4为本发明的单根矫形棒安装上齿轮的立体结构示意图;
图5为本发明的齿轮的侧视结构示意图;
图6为本发明的齿轮的立体结构示意图;
图7为本发明的齿轮的主视结构示意图;
图8为本发明的拱形廊桥的主视结构示意图;
图9为本发明的拱形廊桥的俯视结构示意图;
图10为本发明的拱形廊桥的后视结构示意图;
图11为本发明的拱形廊桥的仰视结构示意图;
图12为本发明的拱形廊桥的立体结构示意图;
图13为本发明的椎弓根螺钉的主视结构示意图;
图14为本发明的椎弓根螺钉的俯视结构示意图;
图15为本发明的椎弓根螺钉与螺母的立体分解结构示意图;
图16为本发明的中央单棒的脊柱侧弯矫正系统的立体结构示意图;
图17为本发明的中央单棒的脊柱侧弯矫正系统的矫形过程示意图,其中,单根矫形棒尚未安装到拱形廊桥中;
图18为本发明的中央单棒的脊柱侧弯矫正系统的矫形过程示意图,其中,单根矫形棒弯曲后安装到拱形廊桥中;
图19为本发明的中央单棒的脊柱侧弯矫正系统的矫形过程示意图,其中,单根矫形棒弯曲安装到拱形廊桥中后被矫正;
图20为上胸椎平面的结构示意图;
图21为上胸椎平面的结构示意图,其中示出了拱形廊桥横向连接椎弓根螺钉形成互为支点的稳定力学结构;
图22为下胸椎平面的结构示意图;
图23为本发明的内应力助生长柱的主视结构示意图,其中,伸缩杆未伸出;
图24为本发明的内应力助生长柱的立体结构示意图,其中,伸缩杆伸出;
图25为本发明的内应力助生长柱的立体结构示意图。
附图标号说明:
1矫形棒 2齿轮 3拱形廊桥 4椎弓根螺钉 5插板 6螺钉 7内应力助生长柱 8扳手 9脊椎
20安装孔 21外齿
30圆环体 31桥体 32桥体 301开口 303齿状内壁 305锁紧槽 320平台
40螺母
70套管 71伸缩杆 72伸缩杆 75弹簧 710夹钳
91上胸椎 92下胸椎
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。
如图16、图17、图18、图19所示,本发明的中央单棒的脊柱侧弯矫正系统包括:
单根矫形棒1,如图1、图2、图3所示,所述矫形棒1的断面为矩形;矫形棒1的端部设有螺孔,可以安装螺钉6,用于紧固或连接到脊椎部位;
n个齿轮2,如图3和图4所示,套设在所述单根矫形棒1上,n为大于1的自然数;根据需要实际矫正的脊椎长度,n为多个,n个齿轮沿所述单根矫形棒的长度方向依次间隔的排布在所述单根矫形棒上;如图5、图6和图7所示,齿轮2为外圆内方的单向齿轮,具有矩形的安装孔20以及沿圆形的圆周排布的外齿21;矫形棒1穿设在矩形的安装孔20中;
齿轮2为外圆内方单向齿轮,为中国古代“钱币”“乾龙通宝”等外圆内方构造,其内方为正方形,边长略大于方棒的边长,正负工差≤0.5mm,如此,可方便无阻力的套入方棒,并由方棒将其穿成串,并以此为轨自由滑动,当方棒呈一面弯曲时,其滑动性与“币”的厚度与“棒”的弧度呈比例关系,在达到足够维持稳定的厚度时,只要棒不出现直角至锐角的弧,仍可自由滑行;当从矩形的相邻侧面转动当从a面向b面转动方棒,外圆单向齿轮必然实现精确90°旋转并且不可逆,达到精准矫形并随时锁定的目的棒,外圆单向齿轮必然实现精确90°旋转并且不可逆,达到精准矫形并随时锁定的目的;
n个拱形廊桥3,沿所述单根矫形棒的长度方向依次间隔的排布在所述单根矫形棒上;
如图8、图9、图10、图11、图12所示,每个拱形廊桥3包括:具有侧向开口301的圆环体30、以及连接在所述圆环体30的顶面上并向所述圆环体的外侧伸出的桥体,所述桥体的数目为两段,分别为桥体31和桥体32,两段所述桥体垂直所述单根矫形棒的长度方向;桥体31和桥体32相交成150°-175°夹角;以使椎弓根解剖长轴进入椎体的两枚椎弓根螺钉互为夹角,形成与生理状态力学构造完全一致的最稳定的力学结构;
所述圆环体30具有:与所述齿轮2相啮合并单向锁紧的齿状内壁303、以及设置在所述齿状内壁之外并平行所述齿状内壁的锁紧槽305;
对所述齿轮2定位的插板5,如图16所示,能拆卸的卡接在所述锁紧槽305中,以在齿轮2安装到拱形廊桥3中后,对齿轮2定位锁紧;
椎弓根螺钉4,设置在每段所述桥体的端部,两段所述桥体上设有两根椎弓根螺钉,如图16和图21所示,两根椎弓根螺钉的轴线相交成5°-30°夹角。采用横向水平连接同一椎体一对椎弓根的拱型桥梁结构,复制了生理状态下单一椎体一对椎弓根互为稳定支点的最合理力学构造,实现了在每一应力平面施加矫正力时,既平衡了椎体,又有效避免了松脱
本发明在实现精准矫形并维持足够稳定的前题下,仍允许脊柱自由的沿矫正后的长 轴伸展延长,实现保留生长功能的重要目的。
进一步地,所述矫形棒1的断面为正方形。矫形棒1为正方形的方矫形棒特点:1)力学强度在正方形的每一边长等于圆形棒的直径时,其正方形内交叉对角线必然大于圆形矫形棒的直径,例如当边长等于直径,均为5mm时,对角线则为7mm,在没有明显增粗的情况下,力学强度必然优于圆形棒;2)正方形每旋转一个面,就是90°,分秒不差,需要预弯适配脊柱病理弯曲时,沿一个面用通用手术器械“三点折弯器”预弯时,因平面不会滑动,同样分秒不差,不会发生角度偏转,从而彻底消除手术中的“麻花”现象。
进一步地,如图12所示,每段所述桥体的端部具有供所述椎弓根螺钉4夹持的平台320,桥体的端部例如为矩形截面,以便椎弓根螺钉4夹持。
进一步地,所述齿轮2为圆形,如图16,所述齿轮的轴线与所述矫形棒的中线一致,所述圆环体30和两段所述桥体关于所述矫形棒1的中线对称,以实现两侧受力均匀。
进一步地,如图12所示,所述锁紧槽305距离圆环体30的两端的距离均大于零,以便固定插板5,防止插板5脱离。
进一步地,所述中央单棒的脊柱侧弯矫正系统还包括:连接在相邻两个拱形廊桥之间的内应力助生长柱7,如图23、图24和图25所示,所述内应力助生长柱包括:套管70、设置在所述套管中的伸缩杆71和伸缩杆72、以及设置在所述套管70中并抵压在两个伸缩杆之间的弹簧75,两个伸缩杆分别在所述套管的两端伸缩。通过弹簧的弹性作用,能够使两个伸缩杆伸出,辅助增加相邻两个拱形廊桥之间的距离,从而使人体长高。
进一步地,每个所述伸缩杆上设有能够卡接所述桥体的夹钳710,以便卡在桥体上。
进一步地,所述夹钳710为U型,卡接方便快捷。
进一步地,所述单根矫形棒1和拱形廊桥3的材质为医用钛合金,轻便、结实,力学性能好。
进一步地,所述弹簧75为压缩弹簧,所述弹簧75的材质为医用弹簧钢,适合人体使用。
本发明中,如图16、图17、图18、图19、图20、图21和图22,拱形廊桥横3向连接同一椎体的一对椎弓根,其中点正对脊柱后正中线,桥面纵向开槽,仅允许方棒从表面纵向放入,与桥面垂直交叉,其侧面一侧为全圆形开设适配并容纳圆轮的空间,另一侧为直径大于正方形棒对角线但小于圆轮的圆形开放,有效阻止圆轮从一侧进入单向齿互相咬合被容纳后,又从另一侧脱出。将外圆内方单向齿轮沿已从表面开槽放入的方棒为轴心推入定位后,仅允许齿轮单向旋转,实现在三维旋转矫正时,有效随时对抗病理畸形的阻力,将人体冠状面的病理弯曲的脊柱向矢状面90°旋转的过程中,每一步进 即刻锁定不可逆,由此实现从容、精细的步进,直至完成90°精细换面旋转,此时停止即固定不可逆,无需再做任何附加的锁定,彻底消除了圆棒对抗病理畸形阻力单向旋转时,加力的同时,必须努力维持原点,稍一松手,则逆向退回,如此反反复复,常常不是过头,就是不够,而当锁定时,动作稍不及时即发生逆转退回,度数丢失的尴尬局面。同时,廊桥横向连接一对椎弓根螺钉,提供了最稳定的力学支点,其中任何一颗螺钉,都几乎不可能被单独拔出,在矫正侧弯的同时,也必然通过方棒的换面旋转准确恢复脊柱生理弯曲。
如图20、图21和图22所示,实现了单棒于脊柱后正中线的中心力轴对脊柱进行三维旋转矫正,并且在旋转过程中,由病理弯曲不同曲度部位所必然导致的局部椎体在冠状面发生横向倾斜,也必然随着面的转换而回复到冠状面水平平衡。
椎弓根螺钉4,如图13、图14和图15所示,采用万向云台椎弓根螺钉,如图20、图21和图22,对于上胸椎91和下胸椎92,可完全满足每一节段一对椎弓根自上而下5°-30°的夹角变化,旋入顶端螺帽(螺母40)后即锁定万向关节,使一对螺钉与横向廊桥以精准的夹角牢固结合。
内应力助生长柱7,由套筒内被压缩的弹簧实现,视患者年龄及个体情况,由医生选择使用,架于每一段上下横桥之间,位于中心柱原病理弯曲凹侧,可设不同的内应力强度(弹簧决定)和最终点长度,单根轴向中心方棒,本身已允许脊柱沿其固定的生理弯曲纵轴自由生长,但因轴向的升举力可进一步刺激生长,故可由医生酌情选择使用。
本发明优选正方形的矫形棒,但作为脊柱后正中线单棒矫正时,不排除端为其它任何形状的矫形棒。
本发明优选外圆内方单向齿轮及对应拱型廊桥。但不排除用于本领域实现同样目的的,即步进不可逆。既可完成单向圆周旋转,又可允许轴向自由滑动的其它任何结构。
本发明中,采用横向连接同一椎体一对椎弓根的横向廊桥。除此外,其它棍、板形状的横向连接同一椎体一对椎弓根的装置(现有技术中已有横向连接装置,但均无直接横连一对椎弓根,都是连接两侧纵向已连接不同平面单一椎弓根的棒)。
如图17至19所示,在侧弯的脊柱选择若干平面,在每一平面椎体植入一对椎弓根螺钉,将螺钉与拱形廊桥锁定。预弯与侧弯适配的矫形棒,穿入数量相等外圆内方的单向齿轮;将预弯适配好的矫形棒由顶面放入每一廊桥,将外圆内方单向齿轮沿已定位方棒滑动,由侧面推入拱形廊桥,采用扳手8使两端手柄持矫形棒90°旋转;完成中央矫形棒90°换面旋转后,人体冠状面(正面)病理弯曲得以矫正,同时重建了矢状面(侧面)生理弯曲,安装两端止滑螺钉,术毕。
以上所述仅为本发明示意性的具体实施方式,并非用以限定本发明的范围。为本发明的各组成部分在不冲突的条件下可以相互组合,任何本领域的技术人员,在不脱离本发明的构思和原则的前提下所作出的等同变化与修改,均应属于本发明保护的范围。

Claims (10)

  1. 一种中央单棒的脊柱侧弯矫正系统,其特征在于,所述中央单棒的脊柱侧弯矫正系统包括:
    单根矫形棒,所述矫形棒的断面为矩形;
    n个齿轮,套设在所述单根矫形棒上,n为大于1的自然数;n个齿轮沿所述单根矫形棒的长度方向依次间隔的排布在所述单根矫形棒上;
    n个拱形廊桥,沿所述单根矫形棒的长度方向依次间隔的排布在所述单根矫形棒上;
    每个拱形廊桥包括:具有侧向开口的圆环体、以及连接在所述圆环体的顶面上并向所述圆环体的外侧伸出的桥体,所述桥体的数目为两段,两段所述桥体垂直所述单根矫形棒的长度方向;两段所述桥体相交成150°-175°夹角;
    所述圆环体具有:与所述齿轮相啮合并单向锁紧的齿状内壁、以及设置在所述齿状内壁之外并平行所述齿状内壁的锁紧槽;
    对所述齿轮定位的插板,能拆卸的卡接在所述锁紧槽中;
    椎弓根螺钉,设置在每段所述桥体的端部,两段所述桥体上设有两根椎弓根螺钉,两根椎弓根螺钉的轴线相交成5°-30°夹角。
  2. 如权利要求1所述的中央单棒的脊柱侧弯矫正系统,其特征在于,所述矫形棒的断面为正方形。
  3. 如权利要求1所述的中央单棒的脊柱侧弯矫正系统,其特征在于,每段所述桥体的端部具有供所述椎弓根螺钉夹持的平台。
  4. 如权利要求1所述的中央单棒的脊柱侧弯矫正系统,其特征在于,所述齿轮为圆形,所述齿轮的轴线与所述矫形棒的中线一致,所述圆环体和两段所述桥体关于所述矫形棒的中线对称。
  5. 如权利要求1所述的中央单棒的脊柱侧弯矫正系统,其特征在于,所述锁紧槽距离圆环体的两端的距离均大于零。
  6. 如权利要求1所述的中央单棒的脊柱侧弯矫正系统,其特征在于,所述中央单棒的脊柱侧弯矫正系统还包括:连接在相邻两个拱形廊桥之间的内应力助生长柱,所述内应力助生长柱包括:套管、设置在所述套管中的两个伸缩杆、以及设置在所述套管中并抵压在两个伸缩杆之间的弹簧,两个伸缩杆分别在所述套管的两端伸缩。
  7. 如权利要求6所述的中央单棒的脊柱侧弯矫正系统,其特征在于,每个所述伸缩杆上设有能够卡接所述桥体的夹钳。
  8. 如权利要求7所述的中央单棒的脊柱侧弯矫正系统,其特征在于,所述夹钳为U型。
  9. 如权利要求1所述的中央单棒的脊柱侧弯矫正系统,其特征在于,所述单根矫形棒和拱形廊桥的材质为医用钛合金。
  10. 如权利要求6所述的中央单棒的脊柱侧弯矫正系统,其特征在于,所述弹簧为压缩弹簧,所述弹簧的材质为医用弹簧钢。
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