WO2018027676A1 - 人工椎体固定*** - Google Patents

人工椎体固定*** Download PDF

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Publication number
WO2018027676A1
WO2018027676A1 PCT/CN2016/094396 CN2016094396W WO2018027676A1 WO 2018027676 A1 WO2018027676 A1 WO 2018027676A1 CN 2016094396 W CN2016094396 W CN 2016094396W WO 2018027676 A1 WO2018027676 A1 WO 2018027676A1
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WO
WIPO (PCT)
Prior art keywords
vertebral body
artificial vertebral
connecting portion
hole
fixation system
Prior art date
Application number
PCT/CN2016/094396
Other languages
English (en)
French (fr)
Inventor
刘忠军
王彩梅
Original Assignee
北京爱康宜诚医疗器材有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 北京爱康宜诚医疗器材有限公司 filed Critical 北京爱康宜诚医疗器材有限公司
Priority to EP16912131.6A priority Critical patent/EP3498205B1/en
Priority to US16/324,381 priority patent/US10856995B2/en
Priority to PCT/CN2016/094396 priority patent/WO2018027676A1/zh
Publication of WO2018027676A1 publication Critical patent/WO2018027676A1/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
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A—HUMAN NECESSITIES
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • 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
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
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    • 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
    • A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
    • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
    • A61B17/7002—Longitudinal elements, e.g. rods
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    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8033—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers
    • A61B17/8047—Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates having indirect contact with screw heads, or having contact with screw heads maintained with the aid of additional components, e.g. nuts, wedges or head covers wherein the additional element surrounds the screw head in the plate hole
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    • A61F2/446—Joints for the spine, e.g. vertebrae, spinal discs for the fusion of spinal bodies, e.g. intervertebral fusion of adjacent spinal bodies, e.g. fusion cages having a circular or elliptical cross-section substantially parallel to the axis of the spine, e.g. cylinders or frustocones
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30433—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
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    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30576—Special structural features of bone or joint prostheses not otherwise provided for with extending fixation tabs
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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Definitions

  • the present invention relates to the field of orthopedic implants, and in particular to an artificial vertebral body fixation system.
  • vertebral body damage is often caused by spinal tumors, tuberculosis and severe fractures, which may lead to spinal nerve damage and have to undergo vertebral resection.
  • the spine after vertebral body resection needs to be reconstructed, and the appearance of artificial vertebral body replacement is an ideal method for treating such diseases. Since the first report of vertebral tumor resection and replacement with prosthesis in the late 1960s, artificial vertebral body has been widely used as a kind of effective vertebral body substitute.
  • anterior or posterior nail plate or nail rod fixation system In order to reduce the impact of the above problems, it is necessary to additionally implement a anterior or posterior nail plate or nail rod fixation system while implanting the artificial vertebral body to improve the stability of the early stage and the bone fusion period.
  • the anterior or posterior apex or staple rod fixation system is typically coupled to the artificial vertebral body by transverse screws.
  • the joint of the transverse screw and the artificial vertebral body is matched by an external thread and a threaded hole.
  • the cooperation of the external thread and the threaded hole is not stable enough, and the thread is prone to occur, which leads to displacement or even prolapse of the artificial vertebral body.
  • the present invention aims to provide an artificial vertebral body fixation system to solve the problem of poor stability of the artificial vertebral body in the prior art.
  • an artificial vertebral body fixation system comprising: an artificial vertebral body disposed between adjacent human physiological vertebral bodies; and two longitudinal connecting rods respectively disposed at The two sides of the spinous process of the human body vertebral body; the transverse connecting nail is connected between the artificial vertebral body and each longitudinal connecting rod; the connecting portion is connected to the artificial vertebral body, and the connecting portion has a self-tapping hole or a threaded hole When the connecting portion has a self-tapping hole, the horizontal connecting pin is self-tapping to form a thread structure when the self-tapping hole is screwed, and when the connecting portion has a threaded hole, the transverse connecting pin is engaged with the threaded hole.
  • the artificial vertebral body includes an earring structure, and the connecting portion is disposed in the connecting hole of the earring structure, and the connecting portion includes the connecting portion main body and the rotation preventing portion disposed on the connecting portion main body, and the rotation preventing portion and the artificial vertebral body The limit part abuts.
  • rotation stop portion is an arcuate block.
  • the connecting portion further includes a latching mechanism, and the connecting portion is limited in the connecting hole by the latching mechanism.
  • the connecting portion main body has a first end facing the longitudinal connecting rod and a second end remote from the longitudinal connecting rod, the rotation stopping portion is disposed at the first end of the connecting portion main body, and the latching mechanism is disposed at the second end of the connecting portion main body .
  • the latching mechanism includes a first block and a second block which are oppositely disposed, and the first block and the second block protrude from the connecting body in a radial direction of the connecting body, the first block and the first block There is a deformation gap between the two blocks.
  • the latching mechanism further includes a transition straight section, the first end of the transition straight section being connected to the connecting body, the first block and the second block being connected on the transition straight section and in the radial direction of the transition straight section Projecting from the transition straight section, the transition straight section has a slot that communicates with the deformation gap.
  • the circumferential outer surface of the connecting portion main body has a tapered shape, and the outer diameter of the connecting portion main body gradually decreases from the first end to the second end thereof, and the connecting hole of the earring structure is adapted to the connecting portion main body. Conical hole.
  • an engaging step is provided in the connecting hole of the earring structure, and the latching mechanism cooperates with the engaging step.
  • the artificial vertebral body is provided with a longitudinal through hole.
  • the artificial vertebral body fixation system further comprises a fixing plate disposed at the end of the artificial vertebral body, the fixing plate is used for connecting with the human physiological vertebral body, and the fixing plate is provided with a fixing hole.
  • the artificial vertebral body fixation system further includes a pedicle screw, and the longitudinal connecting rod and the human physiological vertebral body are connected by a pedicle screw.
  • transverse connecting nail has the same structure as the pedicle screw.
  • the artificial vertebral body is obtained from patient CT data.
  • the artificial vertebral body fixing system comprises an artificial vertebral body, two longitudinal connecting rods, lateral connecting nails and a connecting portion.
  • the artificial vertebral body is disposed between adjacent human physiological vertebral bodies, and the two longitudinal connecting rods are respectively disposed on both sides of the spinous process of the human vertebral body.
  • the artificial vertebral body and each longitudinal connecting rod are connected by a transverse connecting nail.
  • the connecting portion is coupled to the artificial vertebral body, and the connecting portion has a self-tapping hole or a threaded hole.
  • the horizontal connecting pin is self-tapping to form a thread structure when being screwed into the self-tapping hole.
  • the transverse connecting pin engages with the threaded hole.
  • the transverse connecting nail can be closely matched with the thread structure or the threaded hole formed by the self-tapping, and the connection is stable, so that the connection between the transverse connecting nail and the connecting portion is stabilized, and the thread is not released.
  • Figure 1 shows a schematic structural view of an embodiment of an artificial vertebral body fixation system according to the present invention
  • FIG. 2 is a schematic structural view of an artificial vertebral body of the artificial vertebral body fixation system of FIG. 1;
  • Figure 3 is a cross-sectional view showing the A-A direction of the artificial vertebral body fixing system of Figure 2;
  • Figure 4 is a schematic view showing the structure of the artificial vertebral body fixing system of Figure 2;
  • Figure 5 is a schematic view showing the structure of the connecting portion of the artificial vertebral body fixing system of Figure 1;
  • Figure 6 is a schematic view showing the structure of another angle of the connecting portion of Figure 5;
  • Figure 7 is a front elevational view showing the connecting portion of Figure 5;
  • Figure 8 is a bottom plan view showing the connecting portion of Figure 5;
  • Fig. 9 is a cross-sectional view showing the connecting portion of Fig. 5.
  • the artificial vertebral body fixation system of the present embodiment includes an artificial vertebral body 10, two longitudinal connecting rods 20, lateral connecting nails 30, and a connecting portion 40.
  • the artificial vertebral body 10 is disposed between the adjacent human physiological vertebral bodies 1, and the two longitudinal connecting rods 20 are respectively disposed on both sides of the spinous processes of the human physiological vertebral body 1.
  • the artificial vertebral body 10 is used to implant a replacement of the removed or missing host vertebral body segment to restore and reconstruct the physiological height of the spine, and will form a bone fusion between the upper and lower adjacent human physiological vertebral bodies 1 in the future.
  • the artificial vertebral body 10 and the longitudinal connecting rod 20 described above are respectively disposed on both sides of the spinal cord 2.
  • the artificial vertebral body 10 and each of the longitudinal connecting rods 20 are connected by a transverse connecting nail 30.
  • the transverse connecting stud 30 is provided with a rod connecting section corresponding to the longitudinal connecting rod 20.
  • the rod connecting section includes a through hole structure that accommodates the longitudinal connecting rod 20 passing therethrough and locks the positional relationship between the through hole structure itself and the longitudinal connecting rod 20 by the locking means.
  • the through hole structure is an open groove structure.
  • the connecting portion 40 is coupled to the artificial vertebral body 10, and the connecting portion 40 has a self-tapping hole 41. When the transverse connecting pin 30 is screwed into the self-tapping hole 41, the self-tapping forms a thread structure.
  • the thread diameter of the above threaded structure is preferably from 1 to 10 mm.
  • the transverse connecting nail 30 and the threaded structure formed by the self-tapping are tightly coupled, and the connection is stable, so that the connection between the transverse connecting nail 30 and the connecting portion 40 is stabilized, and the thread is not released.
  • the connecting portion 40 is made of a plastic material such as a PE material.
  • the connecting portion has a threaded hole
  • the connecting portion is made of a metal material
  • the transverse connecting pin cooperates with the threaded hole to achieve a stable connection between the transverse connecting pin and the connecting portion.
  • the artificial vertebral body 10 is a cylindrical body, and a vertebral body fusion surface is disposed at the upper and lower ends of the artificial vertebral body 10.
  • the cylindrical body cross-sectional shape of the artificial vertebral body 10 is circular, oblong, circular, elliptical, fan-shaped, polygonal, kidney-shaped, and a graphic shape combined by the above-mentioned figures.
  • the surface of the vertebral body fusion surface has a microporous structure.
  • the above microporous structure is a multidirectional microporous structure comprising a plurality of interconnected micropores.
  • the pores of the microporous structure have a pore diameter of from 100 ⁇ m to 1800 ⁇ m.
  • the artificial vertebral body 10 is obtained according to the patient CT data, so that it can perform good structural matching with the adjacent human physiological vertebral body 1 and improve the stability of the artificial vertebral body fixation system.
  • the vertebral body fusion surface of the artificial vertebral body body 10 of the fixation system closely fits the end plate of the host health vertebral body adjacent to the upper and lower sides.
  • the microporous structure of the bone cells grow into the surface of the fusion surface of the vertebral body, so that the endplate of the vertebral body and the vertebral body fusion surface are fused, and the long-term stability of the artificial vertebral body is realized.
  • the surface morphology of the fusion surface is obtained by three-dimensional reconstruction of the patient's CT, so that it can be well matched with the adjacent human physiological vertebral body 1.
  • the vertebral body fusion surface When the artificial vertebral body 10 is implanted at a predetermined segment position, the vertebral body fusion surface will be in good conformity with the endplate bone of the upper and lower adjacent healthy vertebral segments, and the cylindrical surface is located on the healthy vertebral body surface.
  • a connecting portion 40 is provided at a portion between the two vertebral body fusion faces.
  • One or more connecting portions 40 may be provided on the artificial vertebral body 10 depending on the length of the vertebral body.
  • the connecting portion 40 can form a strong and tight mechanical connection with the transverse connecting stud 30.
  • the height of the artificial vertebral body 10 will be designed to increase by a gradient of 0.5 mm to 15 mm to accommodate different patient personality needs.
  • the surface and/or interior of the artificial vertebral body 10 is provided with a reinforcing structure.
  • the artificial vertebral body 10 is provided with a plurality of fixing screw holes which are inclined and extend upward or downward through the vertebral body fusion.
  • the vertebral body fixing screws pass through the fixing holes to connect the artificial vertebral body 10 with the upper and lower adjacent host vertebral body segments.
  • the segments are connected in a fixed manner.
  • the fixing hole has a pore diameter of 2 to 10 mm.
  • the inner hole wall of the fixing hole is provided with a thread having a pitch of 0.25 to 5 mm.
  • the artificial vertebral body 10 is provided with a bone graft hole.
  • the number of bone graft holes is one or more, and the pore diameter is 2 mm to 30 mm.
  • a plurality of bone graft holes are connected to each other or through a microporous structure.
  • the microporous structure is a multi-directional microporous structure comprising a plurality of interconnected micropores.
  • the pores of the microporous structure have a pore diameter of from 100 ⁇ m to 1800 ⁇ m.
  • the artificial vertebral body 10 includes a microporous structure, which can make the overall structure lightweight. In order to ensure strength, a solid structure is provided in the middle of the microporous structure.
  • the artificial vertebral body 10 can be secured using only vertebral fixation screws when the symptoms permit, without the use of lateral attachment pins 30, pedicle screws 60 and longitudinal attachment bars 20.
  • the artificial vertebral body 10, the transverse connecting nail 30, the pedicle screw 60, the longitudinal connecting rod 20 and the like in the artificial vertebral body fixing system of the present embodiment are made of medical metal and medical polymer materials. Most of these medical materials have proven their good biological properties after years of clinical experience.
  • the attachment portion 40 is attached to the artificial vertebral body 10 in a variety of manners, such as by fastener attachment or bonding.
  • the connecting portion 40 is coupled to the artificial vertebral body 10 through a connecting hole.
  • FIG. 2 is a schematic structural view of the artificial vertebral body of the artificial vertebral body of FIG. 1
  • FIG. 4 is a structural schematic view of the artificial vertebral body of the artificial vertebral body of FIG.
  • the artificial vertebral body 10 includes an earring structure 11, and the connecting portion 40 on the artificial vertebral body is disposed in the connecting hole 111 of the earring structure 11.
  • the connecting portion 40 includes the connecting portion main body 42 and is disposed at the connection.
  • the rotation preventing portion 43 of the portion main body 42 and the rotation preventing portion 43 abut against the stopper portion 12 of the artificial vertebral body 10 .
  • the earring structure 11 has a diameter of 5 to 20 mm and is made of plastic.
  • FIG. 5 is a schematic view showing the structure of the connecting portion and the latching mechanism of the artificial vertebral body fixing system of FIG. 1.
  • FIG. 9 is a cross-sectional view showing the connecting portion and the latching mechanism of FIG.
  • the rotation stop portion 43 is an arcuate block.
  • the curved block is easy to machine and has a good anti-rotation effect.
  • the limiting portion 12 disposed on the connecting portion main body 42 is preferably a semi-circular structure, and the curved block and the limiting portion 12 can be closely fitted together, thereby improving the stability of the artificial vertebral body fixing system.
  • the connecting portion 40 further includes a latching mechanism 50, and the connecting portion 40 is restrained in the connecting hole 111 by the latching mechanism 50.
  • the latch mechanism 50 can achieve locking of the connecting portion 40 and the earring structure 11, preventing the exit of the connecting portion 40 from the connecting hole 111.
  • the latching mechanism 50 can be implemented in various manners.
  • the latching mechanism 50 includes a first latching block 51 and a second latching block 52.
  • the first latching block 51 and the second latching block 52 are in the The connecting portion main body 42 protrudes from the connecting portion main body 42 in the radial direction, and the first block 51 and the second block 52 have a deformation gap therebetween. Due to the deformation gap, the first block 51 and the second block 52 are deformed during the passage of the connecting hole 111, facilitating the latching mechanism 50 to pass through the connecting hole 111.
  • the deformation gap is a flat opening.
  • the deformation gap is not limited to the above structure as long as it can be ensured that the deformation space is provided when the first block 51 and the second block 52 pass through the connection hole 111.
  • the latch mechanism 50 further includes a transition straight barrel section 53 having a first end connected to the joint body 42 and a first block 51 and a second block 52 connected to the transition straight section 53 and in the transition straight section 53
  • the radial direction protrudes from the transition straight section 53, and the transition straight section 53 has a slit communicating with the deformation gap.
  • the transition straight section 53 has two functions. On the one hand, the strength of the connecting portion 40 can be ensured, and the joint between the connecting portion main body 42 and the latching mechanism 50 is prevented from being weak. On the other hand, it is convenient to retract when machining. As shown in FIGS.
  • the connecting portion main body 42 has a first end facing the longitudinal connecting rod 20 and a second end remote from the longitudinal connecting rod 20, and the rotation preventing portion 43 is provided at the connecting portion main body 42.
  • the latch mechanism 50 is disposed at the second end of the connector body 42.
  • the circumferential outer surface of the connecting portion main body 42 has a tapered shape, and the outer diameter of the connecting portion main body 42 gradually decreases from the first end to the second end thereof.
  • the connecting hole 111 of the earring structure 11 is a tapered hole that is fitted to the connecting portion main body 42.
  • the connecting portion main body 42 has a tapered shape, and a tapered hole adapted thereto is required to be connected.
  • the engaging hole 111 is disposed in the connecting hole 111 of the earring structure 11, and the latching mechanism 50 is engaged with the engaging step 112.
  • the latch mechanism 50 is caught on the engaging step 112 via the connecting hole 111.
  • the latching mechanism 50 only partially protrudes from the connecting hole 111, and the wall of the connecting hole 111 can play a certain protective effect on the latching mechanism 50.
  • the latch mechanism 50 is prevented from being withdrawn from the connecting hole 111 due to deformation.
  • the artificial vertebral body 10 is provided with a longitudinal through hole 13.
  • the longitudinal through hole 13 described above can be bone grafted and is easy to be osseointegrated.
  • the artificial vertebral body fixing system further includes a fixing plate 14 disposed at an end of the artificial vertebral body 10 , and the fixing plate 14 is used for connecting with the human physiological vertebral body 1 , and the fixing plate 14 is disposed on the fixing plate 14 .
  • the fixing hole is preferably a screw hole.
  • the doctor screws the vertebral body fixation screw into the end plate of the upper and lower adjacent human healthy human vertebral bodies 1 through the above-mentioned fixed holes, and the human vertebral body endplates of the two adjacent hosts will pass through.
  • the vertebral body fixation screw closely fits the vertebral body fusion surface on the artificial vertebral body 10.
  • the artificial vertebral body fixation system further includes a pedicle screw 60, and the longitudinal connecting rod 20 and the human physiological vertebral body 1 are connected by a pedicle screw 60.
  • the above structure enables the longitudinal connecting rod 20 to be coupled with the adjacent healthy human physiological vertebral body 1, which effectively improves the stability of the artificial vertebral body fixation system.
  • the pedicle screw 60 and the longitudinal connecting rod 20 will form a fixation and support function of the posterior spinal rod system on the posterior side of the spine by surgery.
  • the transverse connecting stud 30 is used to interconnect the artificial vertebral body 10 and the longitudinal connecting rod 20.
  • the artificial vertebral body 10 is tightly fixed with the upper and lower adjacent vertebral bodies by the vertebral body fixing screws.
  • the artificial vertebral body 10 is further tightly connected to the posterior spinal rod system formed by the pedicle screw 60 and the longitudinal connecting rod 20 by the transverse connecting nail 30, thereby finally forming an artificial vertebral body fixing system.
  • the vertebral body fixation system has extremely high anti-rotation and anti-dislocation ability, and the spinal column can be reliably and instantly stabilized to facilitate the bone fusion between the artificial vertebral body and the upper and lower adjacent vertebral bodies as early as possible.
  • the lateral connecting nail 30 and the pedicle screw 60 have the same structure in order to facilitate the operation of the doctor's operation and reduce the types of products and surgical tools.
  • One surgical procedure of the artificial vertebral body fixation system of the present invention is:
  • the transverse connecting nail 30 is mounted such that the artificial vertebral body 10 is connected to the longitudinal connecting rod 20 on the posterior side of the spine.
  • contoured bow design according to the characteristics of normal people, customize the physiological curvature of the spine
  • the artificial vertebral body and the posterior nail rod system are firmly connected by pedicle screws to form an overall truss structure
  • the posterior nail rod system adapts to the pedicle screw of any manufacturer and is flexible to use;
  • the bionic morphology of the contact surface of the upper and lower vertebral bodies is reserved for effective support
  • the upper and lower ends of the custom artificial vertebral body have a fixing plate and the remaining upper and lower vertebral bodies are connected by a plurality of screws to assist the fixation;
  • the main body of the artificial vertebral body needs to have sufficient strength, and the inside has a rib structure
  • the upper and lower ends of the custom artificial vertebral body should provide a porous structure with bone ingrowth
  • connection part is flexible, the installation effect is good, and the connection is stable.

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Abstract

一种人工椎体固定***，包括：人工椎体主体(10)，设置在相邻的人体生理椎体(1)之间；两个纵向连接棒(20)，分别设置在人体生理椎体(1)的棘突的两侧；横向连接钉(30)，连接在人工椎体主体(10)和各纵向连接棒(20)之间；连接部(40)，连接在人工椎体主体(10)上，连接部(40)具有自攻通孔(41)或者螺纹孔，连接部(40)具有自攻通孔(41)时，横向连接钉(30)旋入自攻通孔(41)时自攻形成螺纹结构，连接部(40)具有螺纹孔时，横向连接钉(30)与螺纹孔配合。该人工椎体固定***有效地解决了现有技术中人工椎体稳定性差的问题。

Description

人工椎体固定*** 技术领域
本发明涉及骨科植入领域，具体而言，涉及一种人工椎体固定***。
背景技术
在人类脊柱疾病的治疗中，由于脊柱肿瘤、结核和严重的骨折常引起椎体破坏，可能导致脊髓神经损害而不得不施行椎体切除术。椎体切除后的脊柱需重建其稳定性，人工椎体置换术的出现为治疗此类疾病提供了一种较为理想的方法。自上个世纪60年代末首次报道椎体肿瘤切除并以假体替代以来,人工椎体作为一类有效的椎体替代物在临床上得到了广泛应用。
但在临床应用以及一系列的生物力学测试中显示出传统的人工椎体在某些方面存在一些待解决的问题，特别是：术后轴向旋转方面的稳定性不够，与上下椎体早期结合强度低易导致植入物移位甚至脱出。为保证中心植骨孔的骨量致使人工椎体上下终板的设计面积缩小，支撑力度不足从而使得人工椎体陷入上下椎体的终板内而最终丧失了理想高度。
为了减少上述问题的影响，人们不得不在植入人工椎体主体的同时附加实施前路或后路的钉板或钉棒固定***以期提高早期及骨融合期的稳定性。在现有技术中，前路或者后路的顶板或钉棒固定***通常通过横向螺钉与人工椎体主体连接。横向螺钉与人工椎体主体连接处通过外螺纹和螺纹孔配合。在临床中及生物力学测试中发现，经过一段时间的使用后，上述外螺纹与螺纹孔的配合不够稳定，容易出现螺纹脱出的情况，进而导致人工椎体主体的移位甚至脱出。
发明内容
本发明旨在提供一种人工椎体固定***，以解决现有技术中人工椎体稳定性差的问题。
为了实现上述目的，根据本发明的一个方面，提供了一种人工椎体固定***，包括：人工椎体主体，设置在相邻的人体生理椎体之间；两个纵向连接棒，分别设置在人体生理椎体的棘突的两侧；横向连接钉，连接在人工椎体主体和各纵向连接棒之间；连接部，连接在人工椎体主体上，连接部具有自攻通孔或者螺纹孔，连接部具有自攻通孔时，横向连接钉旋入自攻通孔时自攻形成螺纹结构，连接部具有螺纹孔时，横向连接钉与螺纹孔配合。
进一步地，人工椎体主体包括耳环结构，连接部穿设在耳环结构的连接孔内，连接部包括连接部主体及设置在连接部主体上的止转部，止转部与人工椎体主体的限位部抵接配合。
进一步地，止转部为弧形块。
进一步地，连接部还包括卡锁机构，连接部通过卡锁机构限位在连接孔内。
进一步地，连接部主体具有朝向纵向连接棒的第一端以及远离纵向连接棒的第二端，止转部设置在连接部主体的第一端，卡锁机构设置在连接部主体的第二端。
进一步地，卡锁机构包括相对设置的第一卡块和第二卡块，第一卡块和第二卡块在连接部主体的径向方向上突出于连接部主体，第一卡块和第二卡块之间具有变形间隙。
进一步地，卡锁机构还包括过渡直筒段，过渡直筒段的第一端与连接部主体连接，第一卡块和第二卡块连接在过渡直筒段上并在过渡直筒段的径向方向上突出于过渡直筒段，过渡直筒段具有与变形间隙连通的切槽。
进一步地，连接部主体的周向外表面呈锥面状，连接部主体的外径由其第一端至第二端的方向上逐渐减小，耳环结构的连接孔为与连接部主体适配的锥形孔。
进一步地，耳环结构的连接孔内设置有卡合台阶，卡锁机构与卡合台阶配合。
进一步地，人工椎体主体上设置有纵向通孔。
进一步地，人工椎体固定***还包括设置在人工椎体主体端部的固定板，固定板用于与人体生理椎体连接，固定板上设置有固定孔。
进一步地，人工椎体固定***还包括椎弓根螺钉，纵向连接棒与人体生理椎体之间通过椎弓根螺钉连接。
进一步地，横向连接钉与椎弓根螺钉结构相同。
进一步地，人工椎体主体根据患者CT数据得到。
应用本发明的技术方案，人工椎体固定***包括人工椎体主体、两个纵向连接棒、横向连接钉以及连接部。其中，人工椎体主体设置在相邻的人体生理椎体之间，两个纵向连接棒分别设置在人体椎体的棘突的两侧。人工椎体主体和各纵向连接棒之间通过横向连接钉连接。在本发明中，连接部连接在人工椎体主体上，连接部具有自攻通孔或者螺纹孔。连接部具有自攻通孔时，横向连接钉旋入自攻通孔时自攻形成螺纹结构。连接部具有螺纹孔时，横向连接钉与螺纹孔配合。这样，横向连接钉与自攻形成的螺纹结构或者螺纹孔之间能够配合紧密，连接稳定，进而使得横向连接钉与连接部之间连接稳定，不会出现螺纹脱出的情况。这样使得本发明的人工椎体固定***稳定性好，不会出现现有技术中的移位现象。
附图说明
构成本申请的一部分的说明书附图用来提供对本发明的进一步理解，本发明的示意性实施例及其说明用于解释本发明，并不构成对本发明的不当限定。在附图中：
图1示出了根据本发明的人工椎体固定***的实施例的结构示意图；
图2示出了图1的人工椎体固定***的人工椎体主体的结构示意图；
图3示出了图2的人工椎体主体固定***的A-A向的剖视示意图；
图4示出了图2的人工椎体主体固定***的结构示意图；
图5示出了图1的人工椎体固定***的连接部的结构示意图；
图6示出了图5的连接部的另一角度的结构示意图；
图7示出了图5的连接部的主视示意图；
图8示出了图5的连接部的仰视示意图；以及
图9示出了图5的连接部的剖视示意图。
其中，上述附图包括以下附图标记：
1、人体生理椎体；2、脊髓；10、人工椎体主体；11、耳环结构；111、连接孔；112、卡合台阶；12、限位部；13、纵向通孔；14、固定板；20、纵向连接棒；30、横向连接钉；40、连接部；41、自攻通孔；42、连接部主体；43、止转部；50、卡锁机构；51、第一卡块；52、第二卡块；53、过渡直筒段；60、椎弓根螺钉。
具体实施方式
需要说明的是，在不冲突的情况下，本申请中的实施例及实施例中的特征可以相互组合。下面将参考附图并结合实施例来详细说明本发明。
图1示出了根据本发明的人工椎体固定***的实施例的结构示意图。如图1所示，本实施例的人工椎体固定***包括：人工椎体主体10、两个纵向连接棒20、横向连接钉30以及连接部40。其中，人工椎体主体10设置在相邻的人体生理椎体1之间，两个纵向连接棒20分别设置在人体生理椎体1的棘突的两侧。人工椎体主体10用于植入替代被切除或缺失的宿主椎体节段以恢复及重建脊柱生理高度，并将在未来形成与上下相邻人体生理椎体1之间的骨性融合。从图1中可以看出，上述的人工椎体主体10和纵向连接棒20分别设置在脊髓2的两侧。人工椎体主体10和各纵向连接棒20之间通过横向连接钉30连接。横向连接钉30设有与纵向连接棒20相对应的棒连接段。棒连接段包括通孔结构，该通孔结构可容纳纵向连接棒20从其中穿过，且通过锁定装置对通孔结构自身与纵向连接棒20之间的位置关系进行锁定。优选地，该通孔结构为开口槽结构。在本实施例中，连接部40连接在人工椎体主体10上，连接部40具有自攻通孔41。横向连接钉30旋入自攻通孔41时自攻形成螺纹结构。上述螺纹结构的螺纹直径优选为1至10mm。
应用本实施例的技术方案，横向连接钉30与自攻形成的螺纹结构之间配合紧密，连接稳定，进而使得横向连接钉30与连接部40之间连接稳定，不会出现螺纹脱出的情况。这样使得本实施例的人工椎体固定***稳定性好，不会出现现有技术中的移位现象。在本实施例中，连接部40的材质为塑料，比如PE材料。
在图中未示出的其他实施方式中，连接部具有螺纹孔，连接部由金属材质制成，横向连接钉与螺纹孔配合实现横向连接钉与连接部之间的稳定连接。
人工椎体主体10为一个柱形体，在人工椎体主体10的上下两端设置有椎体融合面。优 选地，人工椎体主体10的柱形体横截面形状为圆形、长圆形、环形、椭圆形、扇形、多边形、肾形以及由上述图形组合而成的图形形状。优选地，椎体融合面的表面具有微孔结构。上述微孔结构为包括多个相互连通的微孔隙的多向微孔隙结构。优选地，微孔结构的孔隙的孔径为100μm至1800μm。
在本实施例的技术方案中，人工椎体主体10根据患者CT数据得到，因此能与相邻的人体生理椎体1进行很好的结构匹配，提高人工椎体固定***的稳定性。
人工椎体固定***被植入人体后，该固定***的人工椎体主体10椎体融合面与上下两相邻的宿主健康椎体的终板紧密贴合。未来骨细胞长入椎体融合面表面的微孔结构，使得椎体的终板与椎体融合面的骨性融合，实现人工椎体主体的远期稳定。融合面的表面形态结构通过患者CT三维重建获得，因此能与相邻的人体生理椎体1进行很好的结构匹配。当人工椎体主体10被植入预定节段位置后，椎体融合面将与上下相邻的健康椎体节段的终板骨质实现良好贴合，其柱形表面位于健康椎体生理表面以内。在两个椎体融合面之间的部位设有连接部40。人工椎体主体10上根据椎体长度可以设置有一个或多个连接部40。连接部40可与横向连接钉30形成牢固紧密的机械连接。人工椎体主体10的高度将被设计成以每0.5mm～15mm为一个级差梯度进行增加以适应不同患者个性需要。优选地，人工椎体主体10的表面和/或内部设置有加强结构。
人工椎体主体10上设置有多个倾斜并穿过椎体融合面向上或向下延伸的固定螺钉孔，椎体固定螺钉穿过固定孔将人工椎体主体10与上下相邻宿主椎体节段相连接固定。优选地，固定孔的孔径为2～10mm。优选地，固定孔的内孔壁上设置有螺纹，该螺纹的螺距为0.25～5mm。
优选地，人工椎体主体10上设置有植骨孔。植骨孔数量为一个或多个，孔径为2mm至30mm。多个植骨孔之间相互贯通或者通过微孔结构相连通。微孔结构为包括多个相互连通的微孔隙的多向微孔隙结构。优选地，微孔结构的孔隙的孔径为100μm至1800μm。人工椎体主体10包括微孔结构，这样可以使得整体结构轻量化。为了保证强度，在微孔结构的中部设置有实体结构。
优选地，当症状许可时，人工椎体主体10可以仅使用椎体固定螺钉进行固定，无须使用横向连接钉30、椎弓根螺钉60及纵向连接棒20。
优选地，本实施例人工椎体固定***中人工椎体主体10、横向连接钉30、椎弓根螺钉60、纵向连接棒20等部件采用医用金属及医用高分子材料制作。此类医用材料大都经过多年临床经验，证实了其良好的生物学性能。
连接部40连接在人工椎体主体10上的方式有多种，比如通过紧固件连接或者粘接。在本实施例中，连接部40与人工椎体主体10通过连接孔连接在一起。具体地，图2示出了图1的人工椎体的人工椎体主体的结构示意图，图4示出了图1的人工椎体的人工椎体主体的结构示意图。如图2和图4所示，在本实施例中，人工椎体主体10包括耳环结构11，人工椎体上的连接部40穿设在耳环结构11的连接孔111内。采用连接孔的方式配合使得连接部40与人工椎体主体10之间能够实现快速连接。此外，连接部40穿设在耳环结构11的连接孔111中，横向连接钉30在旋入过程中，会使得连接部40与耳环结构11之间的连接更加紧密。同 时，为了可以防止横向连接钉30在旋入自攻通孔41的过程中连接部40发生转动，如图5所示，在本实施例中，连接部40包括连接部主体42及设置在连接部主体42上的止转部43，止转部43与人工椎体主体10的限位部12抵接配合。优选地，耳环结构11的孔径为5至20mm，其材料选用塑料。图5示出了图1的人工椎体固定***的连接部及卡锁机构的结构示意图，图9示出了图5的连接部及卡锁机构的剖视示意图。如图5至图9所示，本实施例中，止转部43为弧形块。弧形块容易加工，并且抗旋效果好。设置在连接部主体42上的限位部12优选为半圆结构，弧形块和限位部12之间可以紧密贴合，继而提高人工椎体固定***的稳定性。
如图5所示，本实施例中，连接部40还包括卡锁机构50，连接部40通过卡锁机构50限位在连接孔111内。卡锁机构50可以实现对连接部40和耳环结构11的锁定，防止连接部40从连接孔111的退出。
卡锁机构50的实现方式可有多种，在本实施例中，卡锁机构50包括相对设置的第一卡块51和第二卡块52，第一卡块51和第二卡块52在连接部主体42的径向方向上突出于连接部主体42，第一卡块51和第二卡块52之间具有变形间隙。由于存在变形间隙，第一卡块51和第二卡块52在通过连接孔111的过程中会产生变形，便于卡锁机构50通过连接孔111。当卡锁机构50通过连接孔111后，第一卡块51和第二卡块52复位至突出于连接部主体42的位置，这样使得卡锁机构50能够卡设在连接孔111的一端，不会从连接孔111中退出。如图6和图8所示，在本实施例中，变形间隙为一字形开口。当然，作为本领域技术人员知道，变形间隙并不限于上述结构，只要能够保证在第一卡块51和第二卡块52通过连接孔111时提供变形空间即可。
卡锁机构50还包括过渡直筒段53，过渡直筒段53的第一端与连接部主体42连接，第一卡块51和第二卡块52连接在过渡直筒段53上并在过渡直筒段53的径向方向上突出于过渡直筒段53，过渡直筒段53具有与变形间隙连通的切槽。上述过渡直筒段53的作用有两个，一方面能够保证连接部40的强度，防止连接部主体42与卡锁机构50连接处薄弱。另一方面是方便机加工时方便退刀。如图5至图7所示，在本实施例中，连接部主体42具有朝向纵向连接棒20的第一端以及远离纵向连接棒20的第二端，止转部43设置在连接部主体42的第一端，卡锁机构50设置在连接部主体42的第二端。横向连接钉30将人工椎体主体10和纵向连接棒20连接配合时，由于上述结构，横向连接钉30从连接部主体42的止转部43旋入至卡锁机构50内，旋转过程中使得连接部主体42与人工椎体主体10之间的配合更加紧密，不容易脱离。
如图5至图7所示，本实施例中，连接部主体42的周向外表面呈锥面状，连接部主体42的外径由其第一端至第二端的方向上逐渐减小，耳环结构11的连接孔111为与连接部主体42适配的锥形孔。连接部主体42呈锥形状，需要与之适配的锥形孔进行连接。上述结构使得横向连接钉30从连接部主体42的第一端旋入至第二端的过程中，连接部主体42与耳环结构11之间越压越紧，结合越来越紧密。
如图2和图3所示，本实施例中，耳环结构11的连接孔111内设置有卡合台阶112，卡锁机构50与卡合台阶112配合。卡锁机构50经过连接孔111卡在卡合台阶112上。卡锁机构50仅部分突出于连接孔111，在连接孔111的孔壁会对卡锁机构50起到一定的保护作用，进 而防止卡锁机构50因变形导致从连接孔111中退出。
如图3所示，在本实施例的技术方案中，人工椎体主体10上设置有纵向通孔13。上述纵向通孔13可以植骨，易于骨结合。
如图1所示，本实施例中，人工椎体固定***还包括设置在人工椎体主体10端部的固定板14，固定板14用于与人体生理椎体1连接，固定板14上设置有固定孔。该固定孔优选为螺钉孔。手术过程中，医生将椎体固定螺钉通过上述固定孔旋入上下两个相邻宿主健康的人体生理椎体1的终板内，此时两相邻宿主健康的人体生理椎体终板将通过椎体固定螺钉与人工椎体主体10上的椎体融合面紧密贴合。
如图1所示，在本实施例中，人工椎体固定***还包括椎弓根螺钉60，纵向连接棒20与人体生理椎体1之间通过椎弓根螺钉60连接。上述结构使得纵向连接棒20能够与相邻的健康的人体生理椎体1之间连接在一起，这样有效地提高人工椎体固定***的稳定性。
在本实施例中，椎弓根螺钉60与纵向连接棒20将通过手术在脊柱后侧形成脊柱后路钉棒***的固定与支撑作用。横向连接钉30用于将人工椎体主体10与纵向连接棒20相互连接。人工椎体主体10通过椎体固定螺钉与上下相邻椎体形成紧密固定。同时，人工椎体主体10又通过横向连接钉30与由椎弓根螺钉60和纵向连接棒20所形成的脊柱后路钉棒***紧密连接固定，从而最终构成人工椎体固定***。该椎体固定***具有极高的抗旋转和防脱位能力，术后可使脊柱获得可靠的即刻稳定以利于尽早实现人工椎体主体与上下相邻椎体之间的骨性融合。
在本实施例的技术方案中，为了方便医生手术的操作，减少产品及手术工具的种类，横向连接钉30与椎弓根螺钉60结构相同。
本发明人工椎体固定***的一种手术过程为：
1)取出需被替代的受损宿主椎体节段；
2)选用适当高度的人工椎体主体10装入已被取出的受损宿主椎体节段部位，必要时在人工椎体主体10的植骨孔内植入自体骨或异体骨的骨块及碎骨颗粒，用来诱导未来骨细胞的爬行长入；
3)选用适当直径及长度的椎体固定螺钉，将椎体固定螺钉通过人工椎体主体上的固定孔旋入上下两相邻宿主健康椎体的终板内，此时两相邻宿主健康椎体终板将通过椎体固定螺钉与人工椎体主体10上的椎体融合面紧密贴合；
4)在脊柱后路安放椎弓根螺钉60和纵向连接棒20，以便对相邻的健康椎体进行定位；
5)安装横向连接钉30，使得人工椎体主体10与脊柱后侧的纵向连接棒20进行连接定位。
从以上的描述中，可以看出，本发明上述的实施例实现了如下技术效果：
1.可实现跨节段椎体定制，固定稳固；
2.仿形弓形设计，依照正常人特征，定制出脊柱的生理曲度；
3.人工椎体主体与后路钉棒***通过椎弓根螺钉坚固连接，形成整体的桁架结构；
4.后路钉棒***适应与任何厂家的椎弓根螺钉，使用灵活；
5.与保留的上下椎体接触面仿生形态，利于有效支撑；
6.定制人工椎体主体上下端有固定板与保留的上下椎体通过多个螺钉连接，辅助固定；
7.人工椎体主体需保证有足够的强度，内部有加强筋结构；
8.定制人工椎体主体上下端应提供骨长入的多孔结构；
9.连接部锁定灵活、安装效果好、固定稳固。
以上所述仅为本发明的优选实施例而已，并不用于限制本发明，对于本领域的技术人员来说，本发明可以有各种更改和变化。凡在本发明的精神和原则之内，所作的任何修改、等同替换、改进等，均应包含在本发明的保护范围之内。

Claims (14)

  1. 一种人工椎体固定***，其特征在于，包括：
    人工椎体主体(10)，设置在相邻的人体生理椎体(1)之间；
    两个纵向连接棒(20)，分别设置在所述人体生理椎体(1)的棘突的两侧；
    横向连接钉(30)，连接在所述人工椎体主体(10)和各所述纵向连接棒(20)之间；
    连接部(40)，连接在所述人工椎体主体(10)上，所述连接部(40)具有自攻通孔(41)或者螺纹孔，所述连接部(40)具有所述自攻通孔(41)时，所述横向连接钉(30)旋入所述自攻通孔(41)时自攻形成螺纹结构，所述连接部(40)具有所述螺纹孔时，所述横向连接钉(30)与所述螺纹孔配合。
  2. 根据权利要求1所述的人工椎体固定***，其特征在于，所述人工椎体主体(10)包括耳环结构(11)，所述连接部(40)穿设在所述耳环结构(11)的连接孔(111)内，所述连接部(40)包括连接部主体(42)及设置在所述连接部主体(42)上的止转部(43)，所述止转部(43)与所述人工椎体主体(10)的限位部(12)抵接配合。
  3. 根据权利要求2所述的人工椎体固定***，其特征在于，所述止转部(43)为弧形块。
  4. 根据权利要求2所述的人工椎体固定***，其特征在于，所述连接部(40)还包括卡锁机构(50)，所述连接部(40)通过所述卡锁机构(50)限位在所述连接孔(111)内。
  5. 根据权利要求4所述的人工椎体固定***，其特征在于，所述连接部主体(42)具有朝向所述纵向连接棒(20)的第一端以及远离所述纵向连接棒(20)的第二端，所述止转部(43)设置在所述连接部主体(42)的第一端，所述卡锁机构(50)设置在所述连接部主体(42)的第二端。
  6. 根据权利要求4所述的人工椎体固定***，其特征在于，所述卡锁机构(50)包括相对设置的第一卡块(51)和第二卡块(52)，所述第一卡块(51)和所述第二卡块(52)在所述连接部主体(42)的径向方向上突出于所述连接部主体(42)，所述第一卡块(51)和所述第二卡块(52)之间具有变形间隙。
  7. 根据权利要求6所述的人工椎体固定***，其特征在于，所述卡锁机构(50)还包括过渡直筒段(53)，所述过渡直筒段(53)的第一端与所述连接部主体(42)连接，所述第一卡块(51)和所述第二卡块(52)连接在所述过渡直筒段(53)上并在所述过渡直筒段(53)的径向方向上突出于所述过渡直筒段(53)，所述过渡直筒段(53)具有与所述变形间隙连通的切槽。
  8. 根据权利要求2所述的人工椎体固定***，其特征在于，所述连接部主体(42)的周向外表面呈锥面状，所述连接部主体(42)的外径由其第一端至第二端的方向上逐渐减小，所述耳环结构(11)的连接孔(111)为与所述连接部主体(42)适配的锥形孔。
  9. 根据权利要求4所述的人工椎体固定***，其特征在于，所述耳环结构(11)的连接孔(111) 内设置有卡合台阶(112)，所述卡锁机构(50)与所述卡合台阶(112)配合。
  10. 根据权利要求1所述的人工椎体固定***，其特征在于，所述人工椎体主体(10)上设置有纵向通孔(13)。
  11. 根据权利要求1所述的人工椎体固定***，其特征在于，所述人工椎体固定***还包括设置在所述人工椎体主体(10)端部的固定板(14)，所述固定板(14)用于与所述人体生理椎体(1)连接，所述固定板(14)上设置有固定孔。
  12. 根据权利要求1所述的人工椎体固定***，其特征在于，所述人工椎体固定***还包括椎弓根螺钉(60)，所述纵向连接棒(20)与所述人体生理椎体(1)之间通过所述椎弓根螺钉(60)连接。
  13. 根据权利要求12所述的人工椎体固定***，其特征在于，所述横向连接钉(30)与所述椎弓根螺钉(60)结构相同。
  14. 根据权利要求1所述的人工椎体固定***，其特征在于，所述人工椎体主体(10)根据患者CT数据得到。
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US20190192306A1 (en) 2019-06-27
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US10856995B2 (en) 2020-12-08
EP3498205B1 (en) 2022-04-27

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